Category Archives: Georgia Stem Cells

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--EdiGene, Inc., a global biotechnology company focused on translating gene-editing technologies into transformative therapies for patients with serious genetic diseases and cancer, will present its latest research on a novel surface marker of human hematopoietic stem cells (HSCs) which could support long-term HSCs repopulation, and on microtubule polymerization inhibition that could enhance HSC homing and engraftment at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta on December 11-14, 2021.

The research to be presented during the ASH meeting shows that CD66e is a robust functional HSC bio-marker that can support efficient long-term HSCs identification and repopulation. In a separate presentation, the company demonstrates that short-term microtubule polymerization inhibition could enhance human HSC homing and engraftment. These findings could potentially be used to further optimize HSC gene therapy development and clinical HSC transplantation.

EdiGenes ET-01, an investigational gene-editing HSC therapy for patients with transfusion-dependent -thalassemia, is in Phase I clinical study in China. ET-01 is an autologous CD34+ hematopoietic stem/progenitor cells with the erythroid-specific enhancer of the BCL11A gene-modified by CRISPR. HSCs are first removed from a patient and gene-modified, afterward, these cells are reinfused into the patient to treat the disease.

The current research strengthens our efforts to unlock the potential of gene-editing HSC Transplantation, said Dong Wei, Ph.D., CEO of EdiGene. By combining our in-depth studies of hematopoietic stem cells and knowledge of gene-editing technologies translation, we hope to engineer novel enhancement to this transformative platform, and help more patients with serious medical conditions.

As a platform technology, gene-editing can be organically integrated with life-saving technologies such as HSC Transplantation to develop novel therapies, said Wensheng Wei, Ph.D., Scientific Founder of EdiGene. Being able to specifically modify a gene in cell therapies has the potential to free patients from chronic therapies and potentially curing them of their serious diseases.

Details of the presentations:

Title: CD66e Enrichment Enhances Repopulation of Human Long-Term Hematopoietic Stem CellsPublication number: 2156Session Name: 501. Hematopoietic Stem and Progenitor Cells and Hematopoiesis: Basic and Translation: Poster IIDate/Time: Sunday, December 12, 2021 6:00PM 8:00 PM (ET)Location: Georgia World Congress Center, Hall B5Abstract: https://ash.confex.com/ash/2021/webprogram/Paper148235.html

Title: Microtubule Polymerization Inhibition Enhances Human Hematopoietic Stem Cell Homing and EngraftmentPublication Number: 3820Session Name: 701. Experimental Transplantation Basic and Translational: Poster IIIDate/Time: Monday, December 13, 2021 6:00PM 8:00PM (ET)Location: Georgia World Congress Center, Hall B5Abstract: https://ash.confex.com/ash/2021/webprogram/Paper149294.html

About EdiGene, Inc

EdiGene is a global, clinical-stage biotechnology company focused on translating gene editing technologies into transformative therapies for patients with serious genetic diseases and cancer. The company has established its proprietary ex vivo genome-editing platforms for hematopoietic stem cells and T cells, in vivo therapeutic platform based on RNA base editing, and high-throughput genome-editing screening to discover novel targeted therapies. Founded in 2015, EdiGene is headquartered in Beijing, with offices in Guangzhou and Shanghai, China and Cambridge, Massachusetts, USA. More information can be found at http://www.EdiGene.com.

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EdiGene to Present Latest Research on A Novel Surface Marker and Migration of Hematopoietic Stem Cell (HSC) That Could Enhance HSC Gene Therapy and...

TEL AVIV, Israel, Nov. 4, 2021 /PRNewswire/ --BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, today announced an oral presentation and three poster presentations at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, which is being held December 11-14, 2021 in Atlanta, GA, and virtually.

The oral presentation will elaborate on the successful results of the Company's GENESIS Phase 3 pivotal trial. The study showed highly significant and clinically meaningful results supporting the use of Motixafortide on top of G-CSF for mobilization of stem cells for subsequent collection and transplantation in patients with multiple myeloma. In addition, the poster presentations will show that extended inhibition of the CXCR4 receptor by Motixafortide results in the mobilization of high numbers of stem cells, including specific sub-populations, which were correlated with reduced time to engraftment when infused in high numbers.

The Company is also presenting findings from in-vivo and in-vitro pre-clinical studies demonstrating that Motixafortide acts as an immunomodulator by affecting the biology of regulatory T cells (Tregs), supporting biomarker findings from the Company's COMBAT Phase 2 study in pancreatic cancer patients.

"We are very pleased with the breadth of our oral and poster presentations at this year's ASH meeting, which reflect the versatility of Motixafortide as the potential backbone of promising new treatments for both hematological and solid tumor cancers," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Of particular note is the oral presentation on the outstanding results from our GENESIS Phase 3 pivotal study in stem cell mobilization demonstrating that Motixafortide effectively mobilizes a high number of cells enabling ~90% of patients to undergo transplantation following a single administration of Motixafortide and a single apheresis session. In addition, the high number of cells mobilized by Motixafortide enables infusion of an optimal number of cells, which could result in faster time to engraftment, and also allows for cryopreservation for future transplantation(s). These results, together with our recently completed successful pharmacoeconomic study, strongly support our view that Motixafortide on top of G-CSF can become the new standard of care in SCM, if approved, to the benefit of patients and payers alike. We look forward to submitting an NDA in the first half of next year, as previously communicated."

Further details of the presentations are provided below.

Oral Presentation

Title: Motixafortide (BL-8040) and G-CSF Versus Placebo and G-CSF to Mobilize Hematopoietic Stem Cells for Autologous Stem Cell Transplantation in Patients with Multiple Myeloma: The GENESIS Trial

Date: Sunday, December 12, 2021

Time: 12:00 PM

Location: Georgia World Congress Center, Hall A1

This oral presentation describes the GENESIS Phase 3 pivotal trial design, endpoints and results. The GENESIS study was a double blind, placebo controlled, multicenter trial, in which 122 patients were randomized (2:1) to receive either Motixafortide + G-CSF or placebo + G-CSF for stem cell mobilization prior to stem cell transplant in multiple myeloma patients. Total CD34+ cells/kg were analyzed on site to determine if patients mobilized to the goal and all samples were subsequently sent for assessment by a central laboratory. The number of CD34+ cells infused was determined independently by each investigator according to local practice.

The study concluded that a single administration of Motixafortide on top of G-CSF significantly increased the proportion of patients mobilizing 6x106 CD34+ cells/kg for stem cell transplantation (92.5%) vs G-CSF alone (26.2%) in up to two apheresis days (p<0.0001), while enabling 88.8% to collect 6x106 CD34+ cells/kg in just one apheresis day (vs 9.5% with G-CSF alone; p<0.0001). In addition, the median number of hematopoietic stem cells mobilized in one apheresis day with Motixafortide + G-CSF was 10.8x106 CD34+cells/kg vs 2.1x106 CD34+ cells/kg with G-CSF alone.

Poster Presentations

Title:Autologous Hematopoietic Cell Transplantation with Higher Doses of CD34+ Cells and Specific CD34+ Subsets Mobilized with Motixafortide and/or G-CSF is Associated with Rapid Engraftment A Post-hoc Analysis of the GENESIS Trial

Date: Sunday, December 12, 2021

Time: 6:00 PM - 8:00 PM

The CD34+ hematopoietic stem and progenitor cell (HSPC) dose infused during stem cell transplantation remains one of the most reliable clinical parameters to predict quality of engraftment. A minimum stem cell dose of 2-2.5x106 CD34+ cells/kg is considered necessary for reliable engraftment, while optimal doses of 5-6x106 CD34+ cells/kg are associated with faster engraftment, as well as fewer transfusions, infections, and antibiotic days.

An analysis was performed using pooled data from all patients in the GENESIS trial to evaluate time to engraftment based on the total number of CD34+ cells/kg infused, as well as specific numbers of CD34+ cell sub-populations infused.

The addition of Motixafortide to G-CSF enabled significantly more CD34+ cells to be collected in one apheresis (median 10.8x106 CD34+ cells/kg) compared to G-CSF alone (2.1x106 CD34+ cells/kg), as well as 3.5-5.6 fold higher numbers of hematopoietic stem cells (HSCs), multipotent progenitors (MPPs), common myeloid progenitors (CMPs) and granulocyte and macrophage progenitors (GMPs) (all p-values <0.0004). A dose response was observed with a significant correlation between faster time to engraftment and infusion of higher number of total CD34+ HSPC doses (6x106 CD34+ cells/kg) and combined HSC, MPP, CMP and GMP subsets. The high number of CD34+ cells/kg mobilized with Motixafortide on top of G-CSF enables the potential infusion of 6x106 CD34+ cells/kg, as well as cryopreservation of cells for later use.

Title: Immunophenotypic and Single-Cell Transcriptional Profiling of CD34+ Hematopoietic Stem and Progenitor Cells Mobilized with Motixafortide (BL-8040) and G-CSF Versus Plerixafor and GCSF Versus Placebo and G-CSF: A Correlative Study of the GENESIS Trial

Date: Monday, December 13, 2021

Time: 6:00 PM - 8:00 PM

CD34 expression remains the most common immunophenotypic cell surface marker defining human hematopoietic stem and progenitor cells (HSPCs). The addition of CXCR4 inhibitors to G-CSF has increased mobilization of CD34+ HSPCs for stem cell transplantation; yet the effect of CXCR4 inhibition, with or without G-CSF, on mobilization of specific immunophenotypic and transcriptional CD34+ HSPC subsets is not well-characterized.

Motixafortide is a novel cyclic peptide CXCR4 inhibitor with a low receptor-off rate and extended in vivo action when compared to plerixafor. GENESIS Phase 3 trial patients were prospectively randomized (2:1) to receive either Motixafortide + G-CSF or placebo + G-CSF for HSPC mobilization. Demographically similar multiple myeloma patients undergoing mobilization with plerixafor + G-CSF prior to stem cell transplant were prospectively enrolled in a separate tissue banking protocol.

Extended CXCR4 inhibition with Motixafortide + G-CSF mobilized significantly higher numbers of combined CD34+ HSCs, MPPs and CMPs compared to plerixafor + G-CSF or G-CSF alone (p<0.05). Additionally, Motixafortide + G-CSF mobilized a 10.5 fold higher number of immunophenotypically primitive CD34+ HSCs capable of broad multilineage hematopoietic reconstitution compared to G-CSF alone (p<0.0001) and similar numbers compared to plerixafor + G-CSF. Furthermore, lack of CXCR4 inhibition resulted in mobilization of more-differentiated HCSs, whereas extended CXCR4 inhibition with Motixafortide + G-CSF (but not plerixafor + G-CSF) mobilized a unique MPP-III subset expressing genes specifically related to leukocyte differentiation.

Title: The High Affinity CXCR4 Inhibitor, BL-8040, Impairs the Infiltration, Migration, Viability and Differentiation of Regulatory T Cells

Date: Sunday, December 12, 2021

Time: 6:00 PM - 8:00 PM

This poster describes results of pre-clinical in-vivo and in-vitro studies demonstrating that Motixafortide potentially acts as an immunomodulator by affecting the biology of regulatory T cells. Motixafortide reduced the amount of infiltrating Tregs into the tumors, impaired the migration of Tregs toward CXCL12 and induced Tregs cell death. Furthermore, Motixafortide was found to inhibit the differentiation of nave CD4 T cells toward Tregs.

About BioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, has reported positive results from a pre-planned pharmacoeconomic study, and is currently in preparations for an NDA submission. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to Motixafortide), and is currently being studied in combination with LIBTAYO and chemotherapy as a first-line PDAC therapy.

BioLineRx is also developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

For additional information on BioLineRx, please visit the Company's website at http://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on February 23, 2021. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contact:

Tim McCarthyLifeSci Advisors, LLC+1-212-915-2564[emailprotected]

or

Moran MeirLifeSci Advisors, LLC+972-54-476-4945[emailprotected]

SOURCE BioLineRx Ltd.

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BioLineRx Announces an Oral Presentation and Three Poster Presentations at the 63rd American Society of Hematology (ASH) Annual Meeting &...

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- Updates from MANIFEST phase 2 trial in patients with myelofibrosis, including clinical updates on JAK nave patients treated with pelabresib in combination with ruxolitinib, including translational data- MANIFEST update on pelabresib monotherapy in patients with myelofibrosis- Expanded Real-World RE-MIND2 dataset comparing outcomes for tafasitamab plus lenalidomide versus pola-BR, R2, and CAR T in relapsed/refractory diffuse large B-Cell lymphoma

PLANEGG/MUNICH, GERMANY / ACCESSWIRE / November 4, 2021 / MorphoSys AG (FSE: MOR)(NASDAQ: MOR) today announced that new data on approved and clinical-stage therapeutics will be presented during the American Society of Hematology (ASH) Annual Meeting from December 11-14 in Atlanta, Georgia United States. Ten abstracts were accepted, including two oral presentations, from the comprehensive MorphoSys portfolio, including abstracts for the BET inhibitor pelabresib, which MorphoSys added to its pipeline through the acquisition of Constellation Pharmaceuticals.

"MorphoSys continues to contribute significantly to scientific advances in hematology-oncology with our cancer immunotherapy and our expanded portfolio including the development of epigenetic modifiers," said Malte Peters, MD, MorphoSys Chief Research and Development Officer. "The important data published in our ASH presentations show our commitment to finding cures that redefine how cancer is treated."

The MANIFEST and RE-MIND2 presentations at ASH 2021 are the culmination of a transformational year for MorphoSys. Through groundbreaking proprietary research in immunotherapy and the addition of Constellation Pharmaceuticals' high-potential product candidates, MorphoSys has bolstered its position as an emerging leader in hematology-oncology.

Highlights of presentations from the MorphoSys hematology-oncology portfolio include:

- An update of clinical and translational data from the ongoing MANIFEST trial for JAK nave patients treated with pelabresib (CPI-0610) in combination with ruxolitinib (study arm 3), representing the analysis for the primary endpoint SVR35

- An update of clinical and translational data from the ongoing MANIFEST trial for pelabresib (CPI-0610) monotherapy in patients with myelofibrosis

- Expanded Real-World RE-MIND2 dataset comparing tafasitamab and lenalidomide (Tafa+Len) outcomes to those observed in matched cohorts of 1) polatuzumab vedotin plus bendamustine and rituximab (pola-BR), 2) rituximab plus lenalidomide (R2); and 3) CAR-T therapies

Follow MorphoSys on Twitter via @MorphoSys and visit the MorphoSys ASH virtual booth at http://www.MorphoSysEvents.com

PELABRESIB ASH 2021 ACCEPTED ABSTRACTS

StudyAbstract TitleAuthorsStatus / Publication # /Session

MANIFEST

Pelabresib (CPI-0610) Monotherapy in Patients with Myelofibrosis - Update of Clinical and Translational Data from the Ongoing MANIFEST Trial

Marina Kremyanskaya, John Mascarenhas, Francesca Palandri, Alessandro M. Vannucchi, Srdan Verstovsek, Claire Harrison, Prithviraj Bose, Gary J. Schiller, Raajit K. Rampal, Mark W. Drummond, Vikas Gupta, Andrea Patriarca, Nikki Granacher, Joseph Scandura, Witold Prejzner, Lino Teichmann, Natalia Curto-Garca, Ronald Hoffman, Gozde Colak, Zheng Ren, Suresh Bobba, Jike Cui, Sergey Efuni, Moshe Talpaz

Oral Presentation#141Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Non-JAK inhibitor Therapies for Myelofibrosis Session Date: Saturday, December 11, 2021 Session Time: 12:00 PM - 1:30 PM Presentation Time: 12:30 PM Room: Georgia World Congress Center, A411-A412

Pelabresib Ph1

PK and PD Assessment of BET Inhibitor Pelabresib (CPI-0610) in Patients With Relapsed or Refractory Lymphoma: Findings from a Phase 1 Study

Kristie A. Blum, Jeffrey Supko, Michael Maris, Ian Flinn, Andre Goy, Anas Younes, Suresh Bobba, Adrian Senderowicz, Sergey Efuni, Ronda Rippley, Jeremy S. Abramson

POSTER

#1202Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster IDate: Saturday, December 11, 2021 Presentation Time: 5:30 PM - 7:30 PM Location: Georgia World Congress Center, Hall B5

MANIFEST

Disease-Modifying Potential of BET Inhibitor Pelabresib (CPI-0610) as Demonstrated by Improvements in Bone Marrow Function and Clinical Activity in Patients With Myelofibrosis - Preliminary Data

Srdan Verstovsek, Mohamed E. Salama, John Mascarenhas, Moshe Talpaz, Ruben Mesa, Alessandro M. Vannucchi, Raajit K. Rampal, Stephen Oh, Horatiu Olteanu, April Chiu, Dong Chen, Curtis A Hanson, Natalia Curto-Garca, Pietro Taverna, Jike Cui, Oksana Zavidij, Zehua Chen, Gozde Colak, Sergey Efuni, Patricia Keller, Patrick Trojer, Claire Harrison

Accepted as poster#2568Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II Date: Sunday, December 12, 2021 Presentation Time: 6:00 PM - 8:00 PM Location: Georgia World Congress Center, Hall B5

TAFASITAMAB ASH 2021 ACCEPTED ABSTRACTS

StudyAbstract TitleAuthorsStatus / Publication # /Session

RE-MIND2

Tafasitamab plus Lenalidomide versus pola-BR, R2, and CAR T: Comparing Outcomes from RE-MIND2, an Observational, Retrospective Cohort Study in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Grzegorz S. Nowakowski, Dok Hyun Yoon, Patrizia Mondello, Erel Joffe, Anthea Peters, Isabelle Fleury, Richard Greil, Matthew Ku, Reinhard Marks, Kibum Kim, Pier Luigi Zinzani, Judith Trotman, Lorenzo Sabatelli, Dan Huang, Eva E. Waltl, Mark Winderlich, Sumeet Ambarkhane, Nuwan C. Kurukulasuriya, Raul Cordoba, Georg Hess, Gilles Salles

Accepted as oral presentation#183Session Name: 905. Outcomes Research-Lymphoid Malignancies: Lymphoma/CLL Real-World DataSession Date: Saturday, December 11, 2021Session Time: 12:00 PM - 1:30 PMPresentation Time: 12:30 PMRoom: Georgia World Congress Center, Sidney Marcus Auditorium

Shared Decision Making in R/R DLBCL

Preferences and Perceptions Regarding Treatment Decision-Making For Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)

Mallory Yung, Frederick Schnell, Mirko Vukcevic, Nuwan C. Kurukulasuriya

Accepted as poster (collaboration with Avalere) #1928Session Name: 902. Health Services Research-Lymphoid Malignancies: Poster IDate: Saturday, December 11, 2021Presentation Time: 5:30 PM - 7:30 PMLocation: Georgia World Congress Center, Hall B5

inMIND (Incyte)

inMIND: A Phase 3 Study of Tafasitamab Plus Lenalidomide and Rituximab Versus Placebo Plus Lenalidomide and Rituximab for Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Sehn L, Luminari S, Salar A, Wahlin B, Gopal A, Bonnet C, Paneesha S, Trneny M, Manzke O, Seguy F, Li D, Hubel K, Scholz C

Accepted as posterSession Name: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster IIDate: Sunday, December 12, 2021Presentation Time: 6:00 PM - 8:00 PM

Tafasitamab + TAK981 preclinical

The SUMOylation Inhibitor TAK-981 in Combination with the CD19-Targeting Antibody Tafasitamab Shows Enhanced Anti-Tumor Activity in Preclinical B-Cell Lymphoma Models

Maria Patra-Kneuer, Akito Nakamura, Keli Song, Stephen Grossman, Andrea Polzer, Carmen Ginzel, Stefan Steidl, Allison J Berger, Igor Proscurshim, Christina Heitmller

Accepted as poster#2268Session Name: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster IIDate: Sunday, December 12, 2021Presentation Time: 6:00 PM - 8:00 PMLocation: Georgia World Congress Center, Hall B5

Tafasitamab + CAR-T preclinical

The Impact of Prior Treatment with a CD19 Targeting Monoclonal Antibody on Subsequent Treatment with CD19 Targeting CART Cell Therapy in Preclinical Models

Reona Sakemura, Claudia Manriquez Roman, Paulina Horvei, Ekene Ogbodo, Erin E. Tapper,Elizabeth L. Siegler, Carli M. Stewart, Kendall J. Schick, Ismail Can, Mohamad M. Adada, Evandro D. Bezerra, Lionel Aurelien A. Kankeu Fonkoua, Mehrdad Hefazi, Michael W. Ruff, Christian Augsberger, Jrgen Schanzer, Maria Patra-Kneuer, Christina Heitmller, Stefan Steidl, Jan Endell, Wei Ding, Sameer A. Parikh, Neil E. Kay, Greg Nowakowski, Michelle J. Cox, Saad S. Kenderian

Accepted as poster(collaboration with Mayo Clinic)#2412Session Name: 622. Lymphomas: Translational-Non-Genetic: Poster IIDate: Sunday, December 12, 2021Presentation Time: 6:00 PM - 8:00 PMLocation: Georgia World Congress Center, Hall B5

First-MIND

First-MIND: Primary Analysis from a Phase Ib, Open-Label, Randomized Study to Assess Safety of Tafasitamab or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma

David Belada, Katerina Kopeckova, Juan Miguel Bergua Burgues, Don Stevens, Marc Andr, Ernesto Perez Persona, Petra Pichler, Philipp Staber, Marek Trneny, Bettina Brackertz, Neha Shah, Andrea Sporchia, John M. Burke, Grzegorz S. Nowakowski

Accepted as poster#3556Session Name: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster IIIDate: Monday, December 13, 2021Presentation Time: 6:00 PM - 8:00 PMLocation: Georgia World Congress Center, Hall B5

First-MIND MRD Analysis

Disease kinetics measured by ctDNA correlates with treatment response after tafasitamab in combination with R-CHOP with or without lenalidomide in first line treatment of DLBCL

Mouhamad Khouja, Anke Schillhabel, Michaela Kotrova, Nikos Darzentas, Christian Kuffer, Derek Blair, Monika Brggemann, Christiane Pott

Accepted as poster with short presentation (collaboration with Univ. of Kiel) / #3498Session Name: 621. Lymphomas: Translational-Molecular and Genetic: Poster IIIDate: Monday, December 13, 2021Presentation Time: 6:00 PM - 8:00 PMLocation: Georgia World Congress Center, Hall B5

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi(R)(tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

In Europe, Minjuvi(R) (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi(R) and Monjuvi(R) are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi(R) in the U.S., and marketed by Incyte under the brand name Minjuvi(R) in the EU.

XmAb(R) is a registered trademark of Xencor, Inc.

About MANIFEST

MANIFEST is an open-label Phase 2 clinical trial of pelabresib (CPI-0610) in patients with myelofibrosis (MF), a rare cancer of the bone marrow that disrupts the body's normal production of blood cells. Constellation is evaluating pelabresib in combination with ruxolitinib in JAK-inhibitor-nave MF patients (Arm 3), with a primary endpoint of the proportion of patients with a >=35% spleen volume reduction from baseline (SVR35) after 24 weeks of treatment. Constellation Pharmaceuticals is also evaluating pelabresib either as a monotherapy in patients who are resistant to, intolerant of, or ineligible for ruxolitinib and no longer on the drug (Arm 1), or as add-on therapy in combination with ruxolitinib in patients with a sub-optimal response to ruxolitinib or MF progression (Arm 2). Patients in Arms 1 and 2 are being stratified based on transfusion dependent (TD) status. The primary endpoint for the patients in cohorts 1A and 2A, who were TD at baseline, is conversion to transfusion independence for 12 consecutive weeks. The primary endpoint for patients in cohorts 1B and 2B, who were not TD at baseline, is the proportion of patients with a >=35% spleen volume reduction from baseline after 24 weeks of treatment.

About MorphoSys

MorphoSys (FSE & NASDAQ: MOR) is a biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for people living with cancer and autoimmune diseases. Based on its leading expertise in antibody and protein technologies, MorphoSys is advancing its own pipeline of new drug candidates and has created antibodies that are developed by partners in different areas of unmet medical need. In 2017, Tremfya(R) (guselkumab) - developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc. for the treatment of plaque psoriasis - became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration granted accelerated approval of the company's proprietary product Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide for patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees. For more information visit http://www.morphosys.com or http://www.morphosys-us.com.Monjuvi(R) is a registered trademark of MorphoSys AG.

Tremfya(R) is a registered trademark of Janssen Biotech, Inc.

MorphoSys Forward-Looking Statements

This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys' expectations may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

For more information, please contact:

Media contacts:Thomas BiegiTel.: +49 (0)89 / 89927 26079Thomas.Biegi@morphosys.com

Jeanette BressiTel: +1 617-404-7816jeanette.bressi@morphosys.com

Investor Contacts:Dr. Julia NeugebauerTel: +49 (0)89 / 899 27 179julia.neugebauer@morphosys.com

Myles CloustonTel: +1-857-772-0240myles.clouston@morphosys.com

SOURCE: MorphoSys AG

View source version on accesswire.com: https://www.accesswire.com/671195/MorphoSys-to-Present-MANIFEST-and-RE-MIND2-Data-from-Expanded-Hematology-Oncology-Portfolio-at-the-2021-American-Society-of-Hematology-ASH-Annual-Meeting

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MorphoSys to Present MANIFEST and RE-MIND2 Data from Expanded Hematology-Oncology Portfolio at the 2021 American Society of Hematology (ASH) Annual...

EDIT-301 preclinical data support differentiated approach to develop a transformative medicine for people living with transfusion-dependent beta thalassemia

Preclinical data demonstrating proprietary CRISPR/Cas12a multiplexed editing of iPSCs enhances iNK tumor killing ability, supporting promise as a potential therapeutic approach for solid tumors

CAMBRIDGE, Mass., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today announced that two scientific abstracts have been accepted for presentation at the 63rd Annual Meeting and Exposition of the American Society of Hematology (ASH), being held in Atlanta and virtually, December 11-14, 2021. The two abstracts outline preclinical data from the Companys hemoglobinopathy and oncology programs. An additional oncology program abstract was published in Blood, the flagship journal of the American Society of Hematology.

Editas Medicine presentations at ASH will include preclinical data demonstrating that:

Edited peripheral blood CD34+ cells mobilized from transfusion-dependent beta thalassemia (TDT) patients demonstrated significantly improved red blood cell production and increased hemoglobin content, supporting the development of EDIT-301 for the treatment of TDT; and

Induced pluripotent stem cells (iPSC)-derived natural killer cells (iNKs), edited with proprietary CRISPR/Cas12a to double knock-out (DKO) CISH and TGFR2, demonstrated robust tumor reduction in vivo as compared to wild type iNKs, supporting the development of DKO iNKs as a potent allogeneic cell-based medicine for cancer.

At ASH, we will present preclinical data from our EDIT-301 program that reinforces our belief that our differentiated therapeutic strategy leveraging our highly-specific engineered Cas12a enzyme with more physiologic targeting has great potential for transfusion-dependent beta thalassemia. We believe that EDIT-301 has the potential to be an efficacious autologous cell therapy for TDT, and we remain on track to file an IND by year-end, said Mark S. Shearman, Ph.D., Chief Scientific Officer, Editas Medicine. We will also share early exciting preclinical data showcasing how we are using our proprietary gene editing tools to produce a customized iNK cell that we believe will have highly potent activity across multiple tumor cell killing mechanisms and superior persistence. These data reinforce our view that we have a unique and highly promising allogeneic approach with the potential to treat a wide range of solid tumors.

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The complete list of Editas Medicine presentations is below. Abstracts can be accessed on the ASH website and the presentations will be posted on the Editas Medicine website during the conference.

Poster Presentations:Title: Preclinical Development of EDIT301, an Autologous Cell Therapy Comprising AsCas12a-RNP Modified Mobilized Peripheral Blood-CD34+ Cells for the Potential Treatment of Transfusion Dependent Beta ThalassemiaDate and Time: Saturday, December 11, 2021, 5:30 p.m. 7:30 p.m. EST Session Name: 801. Gene Therapies: Poster I Location: Georgia World Congress Center, Hall B5

Title: Deletion of CISH and TGFR2 in iPSC-Derived NK Cells Promotes High Cytotoxicity and Enhances In Vivo Tumor KillingDate and Time: Sunday, December 12, 2021, 6:00 p.m. 8:00 p.m. ESTSession Name: 703. Cellular Immunotherapies: Basic and Translational: Poster II Location: Georgia World Congress Center, Hall B5

About EDIT-301EDIT-301 is an experimental, autologous cell therapy medicine under investigation for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). EDIT-301 is comprised of sickle patient (for SCD) or normal donor (for TDT) CD34+ cells genetically modified using a highly specific and efficient CRISPR/Cas12a (also known as Cpf1) ribonucleoprotein (RNP) that targets the HBG1 and HBG2 promoters in the beta-globin locus where naturally occurring fetal hemoglobin (HbF) inducing mutations reside. Red blood cells derived from EDIT-301 CD34+ cells demonstrate a sustained increase in HbF production, which has the potential to provide a one-time, durable treatment benefit for people living with sickle cell disease and TDT.

About Editas MedicineAs a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cas12a (also known as Cpf1) genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. For the latest information and scientific presentations, please visit http://www.editasmedicine.com.

Forward-Looking StatementsThis press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "target," "should," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of the Companys product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Companys foreseeable and unforeseeable operating expenses and capital expenditure requirements. These and other risks are described in greater detail under the caption Risk Factors included in the Companys most recent Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, as updated by the Companys subsequent filings with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.

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Editas Medicine to Present Data Demonstrating Progress Towards Transformative Gene Editing Medicines for the Treatment of Hemoglobinopathies and...

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- Enhanced Lymphodepletion Improved Overall Response Rate and Complete Response Rate Compared to Standard Lymphodepletion in Heavily Pretreated NHL and B-ALL Subjects with a Median of ~6 Prior Lines of Therapy

- Clinically Significant Activity in Subjects Previously Treated with Autologous CD19 Directed CAR T

- In B-ALL Subjects Enhanced Lymphodepletion or Higher Doses of PBCAR0191 Resulted in High Complete Response Rates Allowing the Potential to Bridge to Allogeneic Stem Cell Transplant

- Data Presented at ASH will be Updated to Include Subjects with >28 Day Follow up as of October 10, 2021

DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company using its ARCUS genome editing platform to develop allogeneic CAR T and in vivo gene editing therapies, today announced that investigators involved with the Phase 1/2a study of PBCAR0191 in Relapsed/Refractory (R/R) non-Hodgkins lymphoma (NHL) and B-cell acute lymphoblastic leukemia (B-ALL), will present new data during two oral presentations at the 63rd Annual Meeting of the American Society of Hematology (ASH) taking place December 11-14, 2021.

We are encouraged by the response rates seen in this heavily pre-treated patient population, and that a treatment strategy with enhanced lymphodepletion mitigated PBCAR0191 rejection and improved peak CAR T cell expansion and persistence, compared to standard lymphodepletion, with predictable toxicity, said Alan List, MD, Chief Medical Officer of Precision BioSciences. We look forward to sharing additional patient outcome, durability, and safety data for PBCAR0191 at the American Society of Hematology Annual Meeting.

The abstracts accepted by the ASH are now available at http://www.hematology.org, and will be presented during the following oral presentation sessions:

Session Name: 626, Abstract #302. Aggressive Lymphomas Prospective Therapeutic Trials: Challenging PopulationsOral Presentation Title: Allogeneic CAR-T PBCAR0191 with Intensified Lymphodepletion is Highly Active in Subjects with Relapsed/Refractory B-cell MalignanciesPresenting Author: Bijal Shah, M.D., Moffitt Cancer CenterDate/Time: Saturday, December 11, 2021 at 4:15 PM ETLocation: Georgia World Congress Center, B401-B402

Session Name: 704, Abstract #650 Cellular Immunotherapies: Allogeneic CARs and CARs for T Cell LymphomasOral Presentation Title: Preliminary Safety and Efficacy of PBCAR0191, an Allogeneic Off-the-Shelf CD19-Directed CAR-T for Patients with Relapsed/Refractory (R/R) CD19+ B-ALLPresenting Author: Nitin Jain, M.D., The University of Texas MD Anderson Cancer CenterDate/Time: Monday, December 13, 2021 at 10:45 AM ETLocation: Georgia World Congress Center, Sidney Marcus Auditorium

Published abstracts report on key interim clinical evaluations of CD19+ NHL or B-ALL subjects treated with PBCAR0191.

Abstract #302: For 21 subjects with Relapsed/Refractory (R/R) B-cell malignancies (16 NHL, 5 B-ALL) who received PBCAR0191 following enhanced lymphodepletion1 as of July 1, 2021:

Abstract #650: For 15 subjects with R/R B-cell acute lymphoblastic leukemia including 11 subjects who received PBCAR0191 Dose Level 3/4a3 and 4 subjects who received PBCAR0191 Dose Level 4b4 as of August 2, 2021:

About Precision BioSciences, Inc.

Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Companys pipeline consists of multiple off-the-shelf CAR T immunotherapy clinical candidates and several in vivo gene editing candidates designed to cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit http://www.precisionbiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding our clinical development pipeline and interim data announcements. In some cases, you can identify forward-looking statements by terms such as aim, anticipate, believe, could, expect, should, plan, intend, estimate, target, mission, goal, may, will, would, should, could, target, potential, project, predict, contemplate, potential, or the negative thereof and similar words and expressions. Forward-looking statements are based on managements current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments and effects of restrictions thereunder; risks associated with raising additional capital; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; our or our collaborators ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators development of product candidates; our or our collaborators ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; our or our collaborators ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to obtain an adequate supply of T cells from qualified donors; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators ability to enroll subjects; changes in interim top-line and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; the rate and degree of market acceptance of any of our product candidates; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate key executives and personnel; market and economic conditions; effects of system failures and security breaches; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events effects of the outbreak of COVID-19, or any pandemic, epidemic or outbreak of an infectious disease; insurance expenses and exposure to uninsured liabilities; effects of tax rules; risks related to ownership of our common stock and other important factors discussed under the caption Risk Factors in our Quarterly report on Form 10-Q for the quarterly period ended June 30, 2021, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SECs website at http://www.sec.gov and the Investors & Media page of our website at investor.precisionbiosciences.com.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

1 eLD = Fludarabine (30 mg/m/day for 4 days) and cyclophosphamide (1000 mg/m2/day for 3 days)2 sLD = Fludarabine (30 mg/m/day for 3 days) and cyclophosphamide (500 mg/m2/day for 3 days)3 3 x 10 cells/kg or equivalent following either standard or enhanced lymphodepletion4 Flat dose of 5 x 10 cells following standard lymphodepletion

View source version on businesswire.com: https://www.businesswire.com/news/home/20211104005345/en/

Investor Contact:Alex KellyChief Financial OfficerAlex.Kelly@precisionbiosciences.com

Media Contact:Maurissa MessierSenior Director, Corporate CommunicationsMaurissa.Messier@precisionbiosciences.com

Source: Precision BioSciences, Inc.

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Precision BioSciences Announces Two Oral Presentations Highlighting Updated Interim Data from Lead PBCAR0191 CAR T Immunotherapy for Relapsed and...

Abstract

Stem cells or mother or queen of all cells are pleuropotent and have the remarkable potential to develop into many different cell types in the body. Serving as a sort of repair system for the body, they can theoretically divide without limit to replenish other cells as long as the person or animal is alive. When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell. Stem cells differ from other kinds of cells in the body. All stem cells regardless of their source have three general properties:

They are unspecialized; one of the fundamental properties of a stem cell is that it does not have any tissue-specific structures that allow it to perform specialized functions.

They can give rise to specialized cell types. These unspecialized stem cells can give rise to specialized cells, including heart muscle cells, blood cells, or nerve cells.

They are capable of dividing and renewing themselves for long periods. Unlike muscle cells, blood cells, or nerve cells which do not normally replicate themselves - stem cells may replicate many times. A starting population of stem cells that proliferates for many months in the laboratory can yield millions of cells. Today, donated organs and tissues are often used to replace those that are diseased or destroyed. Unfortunately, the number of people needing a transplant far exceeds the number of organs available for transplantation. Pleuropotent stem cells offer the possibility of a renewable source of replacement cells and tissues to treat a myriad of diseases, conditions, and disabilities including Parkinsons and Alzheimers diseases, spinal cord injury, stroke, Cerebral palsy, Battens disease, Amyotrophic lateral sclerosis, restoration of vision and other neuro degenerative diseases as well.

Stem cells may be the persons own cells (a procedure called autologous transplantation) or those of a donor (a procedure called allogenic transplantation). When the persons own stem cells are used, they are collected before chemotherapy or radiation therapy because these treatments can damage stem cells. They are injected back into the body after the treatment.

The sources of stem cells are varied such as pre-implantation embryos, children, adults, aborted fetuses, embryos, umbilical cord, menstrual blood, amniotic fluid and placenta

New research shows that transplanted stem cells migrate to the damaged areas and assume the function of neurons, holding out the promise of therapies for Alzheimers disease, Parkinsons, spinal cord injury, stroke, Cerebral palsy, Battens disease and other neurodegenerative diseases.

The therapeutic use of stem cells, already promising radical new treatments for cancer, immune-related diseases, and other medical conditions, may someday be extended to repairing and replenishing the brain. In a study published in the February 19, 2002, Proceedings of the National Academy of Sciences, researchers exposed the spinal cord of a rat to injury, paralyzing the animals hind limbs and lower body. Stem cells grown in exponential numbers in the laboratory were then injected into the site of the injury. It was seen that week after the injury, motor function improved dramatically,

The following diseases have been treated by various stem cell practitioners with generally positive results and the spectrum has ever since been increasing.

Cerebral palsy is a disorder caused by damage to the brain during pregnancy, delivery or shortly after birth. It is often accompanied by seizures, hearing loss, difficulty speaking, blindness, lack of co-ordination and/or mental retardation. Studies in animals with experimentally induced strokes or traumatic injuries have indicated that benefit is possible by stem cell therapy. The potential to do these transplants via injection into the vasculature rather than directly into the brain increases the likelihood of timely human studies. As a result, variables appropriate to human experiments with intravascular injection of cells, such as cell type, timing of the transplant and effect on function, need to be systematically performed in animal models Studies in animals with experimentally induced strokes or traumatic injuries have indicated that benefit is possible with injury, with the hope of rapidly translating these experiments to human trials.(1)

Cerebral palsy produces chronic motor disability in children. The causes are quite varied and range from abnormalities of brain development to birth-related injuries to postnatal brain injuries. Due to the increased survival of very premature infants, the incidence of cerebral palsy may be increasing. While premature infants and term infants who have suffered neonatal hypoxic-ischemic (HI) injury represent only a minority of the total cerebral palsy population, this group demonstrates easily identifiable clinical findings, and much of their injury is to oligodendrocytes and the white matter (2)

Alzheimers is a complex, fatal disease involving progressive cell degeneration, beginning with the loss of brain cells that control thought, memory and language. The disease, which currently has no cure, was first described by German physician Dr. Alzheimer, who discovered amyloid plaques and neurofibrillary tangles in the brain of a woman who died of an unusual mental illness. A compound similar to the components of DNA may improve the chances that stem cells transplanted from a patients bone marrow to the brain will take over the functions of damaged cells and help treat Alzheimers disease and other neurological illnesses. A research team led by University of Central Florida professor Kiminobu Sugaya found that treating bone marrow cells in laboratory cultures with bromodeoxyuridine, a compound that becomes part of DNA, made adult human stem cells more likely to develop as brain cells after they were implanted in adult rat brains.

It has long been recognized that Alzheimers disease (AD) patients present an irreversible decline of cognitive functions as consequence of cell deterioration in a structure called nucleus basalis of Meynert The reduction of the number of cholinergic cells causes interference in several aspects of behavioral performance including arousal, attention, learning and emotion. It is also common knowledge that AD is an untreatable degenerative disease with very few temporary and palliative drug therapies. Neural stem cell (NSC) grafts present a potential and innovative strategy for the treatment of many disorders of the central nervous system including AD, with the possibility of providing a more permanent remedy than present drug treatments. After grafting, these cells have the capacity to migrate to lesioned regions of the brain and differentiate into the necessary type of cells that are lacking in the diseased brain, supplying it with the cell population needed to promote recovery. (3)

Malignant multiple sclerosis (MS) is a rare but clinically important subtype of MS characterized by the rapid development of significant disability in the early stages of the disease process. These patients are refractory to conventional immunomodulatory agents and the mainstay of their treatment is plasmapheresis or immunosuppression with mitoxantrone, cyclophosphamide, cladribine or, lately, bone marrow transplantation. A report on the case of a 17-year old patient with malignant MS who was treated with high-dose chemotherapy plus anti-thymocyte globulin followed by autologous stem cell transplantation. This intervention resulted in an impressive and long-lasting clinical and radiological response (4).

In other experiment treatment of 24 patients (14 women, 10 men) with relapsing-remitting Multiple Sclerosis, in the course of 28 years was done For treatment, used were embryonic stem cell suspensions (ESCS) containing stem cells of mesenchymal and ectodermal origin obtained from active growth zones of 48 weeks old embryonic cadavers organs. Suspensions were administered in the amount of 13 ml, cell count being 0,1-100x105/ml. In the course of treatment, applied were 24 different suspensions, mode of administration being intracavitary, intravenous, and subcutaneous. After treatment, syndrome of early post-transplant improvement was observed in 70% of patients, its main manifestations being decreased weakness, improved appetite and mood, decreased depression. In the course of first post-treatment months, positive dynamics was observed in the following aspects: Nystagmus, convergence disturbances, spasticity, and coordination. In such symptoms as dysarthria, dysphagia, and ataxia, positive changes occurred at much slower rate. In general, the treatment resulted in improved range and quality of motions in the extremities, normalized muscle tone, decreased fatigue and general weakness, and improved quality of life. Forth, 87% of patients reported no exacerbations, no aggravation of neurological symptoms, and no further progression of disability. MRI performed in 12 years after the initial treatment, showed considerable subsidence of focal lesions, mean by 31%, subsidence of gadolinium enhanced lesions by 48%; T2-weighted images showed marked decrease of the focis relative density.

Doctors firstly isolated adult stem cells from the patients brain, they were then cultured in vitro and encouraged to turn into dopamine-producing neurons. As soon as tests showed that the cells were producing dopamine they were then re-injected into the mans brain. After the transplant, the mans condition was seen to improve and he experienced a reduction in the trembling and muscle rigidity associated with the disease. Brain scans taken 3-months after the transplant revealed that dopamine production had increased by 58%, however it later dropped but the Parkinsons symptoms did not return. The study is the first human study to show that stem cell transplants can help to treat Parkinsons.

The use of fetal-derived neural stem cells has shown significant promise in rodent models of Parkinsons disease, and the potential for tumorigenicity appears to be minimal. The authors report that undifferentiated human neural stem cells (hNSCs) transplanted into severely Parkinsonian 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-treated primates could survive, migrate, and induce behavioral recovery of Parkinsonian symptoms, which were directly related to reduced dopamine levels in the nigrostriatal system(5). Working with these cells, the researchers created dopamine neurons deficient in DJ-1, a gene mutated in an inherited form of Parkinsons. They report that DJ-1-deficient cells -- and especially DJ-1-deficient dopamine neurons -- display heightened sensitivity to oxidative stress, caused by products of oxygen metabolism that react with and damage cellular components like proteins and DNA. In a second paper, they link DJ-1 dysfunction to the aggregation of alpha-synuclein, a hallmark of Parkinsons neuropathology. (6,7)

In summary most of studies using aborted human embryonic tissue indicate that:

Clinical benefit does occur; however, the benefit is not marked and there is a delay of many months before the clinical change.

Postmortem examinations show that tissue grafts do survive and innervate the striatum.

PET scans show that there is an increase in dopamine uptake after transplantation.

Followup studies show that long term benefit does occur with transplantation.(8)

During and after a stroke, certain cellular events take place that lead to the death of brain cells. Compounds that inhibit a group of enzymes called histone deacetylases can modulate gene expression, and in some cases produce cellular proteins that are actually neuroprotective -- they are able to block cell death. Great deal of research has gone into developing histone deacetylase inhibitors as novel therapeutics (9)

One Mesenchymal stem cell (MSC) transplantation improves recovery from ischemic stroke in animals. The Researchers examined the feasibility, efficacy, and safety of cell therapy using culture-expanded autologous MSCs in patients with ischemic stroke. They prospectively and randomly allocated 30 patients with cerebral infarcts within the middle cerebral arterial territory Serial evaluations showed no adverse cell-related, serological, or imaging-defined effects. In patients with severe cerebral infarcts, the intravenous infusion of autologous MSCs appears to be a feasible and safe therapy that may improve functional recovery.(10)

Early intravenous stem cell injection displayed anti-inflammatory functionality that promoted neuroprotection, mainly by interrupting splenic inflammatory responses after intra cranial Haemorrage.

In summary, early intravenous NSC injection displayed anti-inflammatory functionality that neural stem cell (NSC) transplantation has been investigated as a means to reconstitute the damaged brain after stroke. In this study, however, was investigated the effect on acute cerebral and peripheral inflammation after intracerebral haemorrhage (ICH). STEM CELLS from fetal human brain were injected intravenously (NSCs-iv, 5 million cells) or intracerebrally (NSCs-ic, 1 million cells) at 2 or 24 h after collagenase-induced ICH in a rat model. Only NSCs-iv-2 h resulted in fewer initial neurologic deteriorations and reduced brain edema formation, inflammatory infiltrations and apoptosis. (11)

Emerging cell therapies for the restoration of sight have focused on two areas of the eye that are critical for visual function, the cornea and the retina. The relatively easy access of the cornea, the homogeneity of the cells forming the different layers of the corneal epithelium and the improvement of cell culture protocols are leading to considerable success in corneal epithelium restoration. Rebuilding the entire cornea is however still far from reality. The restoration of the retina has recently been achieved in different animal models of retinal degeneration using immature photoreceptors (12)

Bone marrow contains stem cells, which have the extraordinary abilities to home in on injuries and possibly regenerate other cell types in the body. In this case, the cells were transplanted to confirm that bone marrow does regenerate the injured RPE. Damage to RPE is present in many diseases of the retina, including age-related macular degeneration, which affects more than 1.75 million people in the United States. (13)

Neural stem cells (NSCs) offer the potential to replace lost tissue after nervous system injury. Thus, stem cells can promote host neural repair in part by secreting growth factors, and their regeneration-promoting activities can be modified by gene delivery.

Attempted repair of human spinal cord injury by transplantation of stem cells depends on complex biological interactions between the host and graft

Extrapolating results from experimental therapy in animals to humans with spinal cord injury requires great caution.

There is great pressure on surgeons to transplant stem cells into humans with spinal cord injury. However, as the efficacy of and exact indications for this therapy are still uncertain, and morbidity (such as rejection or late tumour development) may result, only carefully designed studies based on sound experimental work which attempts to eliminate placebo effects should proceed.

Premature application of stem cell transplantation in humans with spinal cord injury should be discouraged. 14, 15, 16)

Attempted repair of human spinal cord injury by transplantation of stem cells depends on complex biological interactions between the host and graft

Extrapolating results from experimental therapy in animals to humans with spinal cord injury requires great caution.

There is great pressure on surgeons to transplant stem cells into humans with spinal cord injury. However, as the efficacy of and exact indications for this therapy are still uncertain, and morbidity (such as rejection or late tumour development) may result, only carefully designed studies based on sound experimental work which attempts to eliminate placebo effects should proceed.

Premature application of stem cell transplantation in humans with spinal cord injury should be discouraged.

Mesenchymal stem cells have also been identified and are currently being developed for bone, cartilage, muscle, tendon, and ligament repair and regeneration. These MSCs are typically harvested, isolated, and expanded from bone marrow or adipose tissue, and they have been isolated from rodents, dogs, and humans. Interestingly, these cells can undergo extensive sub cultivation in vitro without differentiation, magnifying their potential clinical use.(17) Human MSCs can be directed toward osteoblastic differentiation by adding dexamethasone, ascorbic acid, and -glycerophosphate to the tissue culture media. This osteoblastic commitment and differentiation can be clearly documented by analyzing alkaline phosphatase activity, the expression of bone matrix proteins, and the mineralization of the extracellular matrix.(18)

Children with Battens disease suffer seizures, motor control disturbances, blindness and communication problems. As many as 600 children in the US are currently diagnosed with the condition.(19)

Death can occur in children as young as 8 years old. The children lack an enzyme for breaking down complex fat and protein compounds in the brain, explains Robert Steiner, vice chair of paediatric research at the hospital. The material accumulates and interferes with tissue function, ultimately causing brain cells to die. Tests on animals demonstrated that stem cells injected into the brain secreted the missing enzyme. And the stem cells were found to survive well in the rodent brain. Once injected, the purified neural cells may develop into neurons or other nervous system tissue, including oligodendrocytes, or glial cells, which support the neurons(20).

In a study that demonstrates the promise of cell-based therapies for diseases that have proved intractable to modern medicine, a team of scientists from the University of Wisconsin-Madison has shown it is possible to rescue the dying neurons characteristic of amyotrophic lateral sclerosis (ALS), a fatal neuromuscular disorder also known as Lou Gehrigs disease. Previously there was no effective treatments for ALS, which afflicts roughly 40,000 people in the United States and which is almost always fatal within three to five years of diagnosis. Patients gradually experience progressive muscle weakness and paralysis as the motor neurons that control muscles are destroyed by the disease

In the new Wisconsin study, nascent brain cells known as neural progenitor cells derived from human fetal tissue were engineered to secrete a chemical known as glial cell line derived neurotrophic factor (GDNF), an agent that has been shown to protect neurons but that is very difficult to deliver to specific regions of the brain. The engineered cells were then implanted in the spinal cords of rats afflicted with a form of ALS. The implanted cells, in fact, demonstrated an affinity for the areas of the spinal cord where motor neurons were dying. The cells after being injected to the area of damage where they just sit and release GDNF. At the early stages of disease, almost 100 percent protection of motor neurons was seen. (21)

In other study MSCs were isolated from bone marrow of 9 patients with definite ALS. Growth kinetics, immunophenotype, telomere length and karyotype were evaluated during in vitro expansion. No significant differences between donors or patients were observed. The patients received intraspinal injections of autologous MSCs at the thoracic level and monitored for 4 years. No significant acute or late side effects were evidenced. No modification of the spinal cord volume or other signs of abnormal cell proliferation were observed. The results seem to demonstrate that MSCs represent a good chance for stem cell cell-based therapy in ALS and that intraspinal injection of MSCs is safe also in the long term. A new phase 1 study is carried out to verify these data in a larger number of patients. (22)

Stem-cell-based technology offers amazing possibilities for the future. These include the ability to reproduce human tissues and potentially repair damaged organs (such as the brain, spinal cord, vertebral column the eye), where, at present, we mainly provide supportive care to prevent the situation from becoming worse. This potential almost silences the sternest critics of such technology, but the fact remains that the ethical challenges are daunting. It is encouraging that, in tackling these challenges, we stand to reflect a great deal about the ethics of our profession and our relationships with patients, industry, and each other. The experimental basis of stem-cell or OEC transplantation should be sound before these techniques are applied to humans with neurological disorders.

1. Stem cell therapy for cerebral palsy. Bartley J, Carroll JE. Department of Pediatrics of the Medical College of Georgia, Augusta, Georgia, USA

8. Department of Neurology, Mt. Sinai School of Medicine, New York, NY, Medscape journal. Stem Cell Transplantation for Parkinsons Disease

9. Journal of Medicinal Chemistry. Future Therapies For Stroke May Block Cell Death 16 Jun 2007

10. Neurosurg Focus. 2005;19(6) 2005 American Association of Neurological Surgeons

11. Brain Advance Access originally published online on December 20, 2007 Brain 2008 Anti-inflammatory mechanism of intravascular neural stem cell transplantation in haemorrhagic stroke.

13. University of Florida(2006, June 8). Bone Marrow May Restore Cells Lost In Vision Diseases. ScienceDaily.

18. Autologous mesenchymal stem cell transplantation in stroke patients Oh Young Bang, MD, PhD 1, Jin Soo Lee, MD Department of Neurology, School of Medicine, Ajou University, Suwon, South Korea Brain Disease Research Center, School of Medicine, Ajou University, Suwon, South Korea.

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Role of Stem Cells in Treatment of Neurological Disorder

The longest-lived leaves in the plant kingdom can be found only in the harsh, hyperarid desert that crosses the boundary between southern Angola and northern Namibia.

A desert is not, of course, the most hospitable place for living things to grow, let alone leafy greens, but the Namib Desert the worlds oldest, with parts receiving less than 2 inches of precipitation a year is where Welwitschia calls home.

In Afrikaans, the plant is named tweeblaarkanniedood, which means two leaves that cannot die. The naming is apt: Welwitschia grows only two leaves and continuously in a lifetime that can last millenniums.

Most plants develop a leaf, and thats it, says Andrew Leitch, a plant geneticist at Queen Mary University of London. This plant can live thousands of years, and it never stops growing. When it does stop growing, its dead.

Some of the largest plants are believed to be more than 3,000 years old, with two leaves steadily growing since the beginning of the Iron Age, when the Phoenician alphabet was invented and David was crowned King of Israel.

By some accounts, Welwitschia is not much to look at. Its two fibrous leaves, buffeted by dry desert winds and fed on by thirsty animals, become shredded and curled over time, giving Welwitschia a distinctly octopus-like look. One 19th-century director of Kew Gardens remarked, It is out of the question the most wonderful plant ever brought to this country and one of the ugliest.

But since it was first discovered, Welwitschia has captivated biologists including Charles Darwin and botanist Friedrich Welwitsch, after whom the plant is named; it is said that when Welwitsch first came across the plant in 1859, he could do nothing but kneel down on the burning soil and gaze at it, half in fear lest a touch should prove it a figment of the imagination.

When we see that the plant can live in this environment for so long and preserve its DNA and proteins, I feel like we can find hints for how to improve agriculture

In a study published recently in Nature Communications, researchers report some of the genetic secrets behind Welwitschias unique shape, extreme longevity and profound resilience.

Jim Leebens-Mack, a plant biologist at the University of Georgia not involved in the study, says it gives us a foundation for better understanding how Welwitschia does all the crazy stuff that it does.

The Welwitschia genome reflects the plants arid and nutrient-poor surroundings. And its genetic history seems to correspond with environmental history.

Approximately 86 million years ago, after a mistake in cell division, the entire Welwitschia genome doubled during a time of increased aridity and prolonged drought in the region and possibly the formation of the Namib Desert itself, says Tao Wan, a botanist at the Fairy Lake Botanical Garden in Shenzhen, China, and lead author of the study. He says that extreme stress is often associated with such genome duplication events.

Leitch, a co-author of the study, adds that duplicated genes are also released from their original functions, potentially taking on new ones.

However, having more genetic material comes with a cost, Wan says.

The most basic activity for life is DNA replication, he says, so if you have a big genome, it is really energy-consuming to maintain life, especially in such a harsh environment.

To make matters worse, a large amount of Welwitschias genome is junk self-replicating DNA sequences called retrotransposons.

Now that junk needs to be replicated, repaired, Leitch says.

The researchers detected a burst of retrotransposons activity 1 to 2 million years ago, most likely because of increased temperature stress. But to counteract this, the Welwitschia genome underwent widespread epigenetic changes that silenced the junk DNA through a process called DNA methylation.

This process, along with other selective forces, drastically pared down the size and energetic maintenance cost of Welwitschias duplicated library of DNA, Wan says, giving it a very efficient, low-cost genome.

The plants leaves pour out of its base

(Getty/iStock)

The study also found that Welwitschia had other genetic tweaks hidden up its leaves.

The average plant leaf grows from the plants apexes, or the tippy-tops of its stem and branches. But Welwitschias original growing tip dies, and leaves instead pour out of a vulnerable area of the plants anatomy called the basal meristem, which supplies fresh cells to the growing plant, Wan says. A large number of copies or increased activity of some genes involved with efficient metabolism, cell growth and stress resilience in this area may help it continue to grow under extreme environmental stress. In a warming world, the genetic lessons that Welwitschia has to offer may help humans breed hardier, less thirsty crops.

When we see that the plant is able to live in this environment for so long and preserve its DNA and its proteins, I really feel like we can find hints for how to improve agriculture, Leebens-Mack says.

The study also underscores the importance of curiosity-driven research. When you encounter two leaves growing in a desert against all odds, kneel down in the burning soil and take a closer look.

From weird things, you discover weird things that help you understand things that you didnt know you didnt understand, Leitch says.

This article originally appeared in The New York Times

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A plant that 'cannot die' reveals its genetic secrets - The Independent

Kimberley Miner: https://www.ifthencollection.org/kimberleyrClimate Scientist and Research Assistant ProfessorLos Angeles, CA

From mountaintops to the depths of the seas, American women scientists are tackling global problems.

In the past, there were very few women in science, technology, engineering and math (STEM) jobs, but today women hold nearly 3 in 10 of those jobs.

The United Nations has designated February 11 the International Day of Women and Girls in Science. Thanks toinitiatives like IF/THEN, launched by the Lyda Hill Philanthropies and the American Association for the Advancement of Science, 125 women are mentoring girls who will join them as the scientific leaders of tomorrow. ShareAmerica talked to four of thesescience ambassadors.

Climate scientist and professor Kimberley Miner lets girls in on a secret. You dont have to be inherently good at science or math to be a scientist. With hard work, dedication and perseverance, you can succeed at STEM, said Miner, of NASAs Jet Propulsion Laboratory in the Los Angeles area.

Miner has sailed around Antarctica, gazed at the beauty of the northern lights in Alaska and led a team cataloging pollution all the way up Mount Everest. She loves exploration and advocates for preserving the sites she explores.

The world around us revolves around scientific principles. Understanding how and why it works is like the key to the kingdom it allows you to become whatever you want to be in life! Miner said. She has worked with various school groups, in virtual classrooms and with the Girls Scouts of America to help them find keys to the natural world.

Lataisia Jones is a cell nerd. A Ph.D. in biomedical science, she loves the artistry of seeing cells of different colors under her microscope as she experiments, trying to understand cell division, diabetes and brain development. She works as a scientist at the American Society for Microbiology in Washington.

She also founded Young Scientist Wednesday to teach patients at Childrens National Hospital in Washington. Females, she likes to remind girls, have superpowers. Not only are we intelligent, work hard and contribute on a wide scale to society, we are also capable of relating to the emotional sides of every situation and creating a well-rounded solution, she said.

As a Black woman, Jones sees theimportance of women and minorities entering STEM fields. STEM advances only when people from different backgrounds, cultures, ethnic groups, genders and identities come together to work on the worlds greatest mysteries, she said.

When Erin Smith talks about experiments she did in her kitchen as a girl, shes not exactly talking about ancient history. Smith is just 21 years old and a member of the Stanford University undergraduate class of 2023. Shes not waiting for a degree to start making a difference.

As a high school student, she co-founded a steminists group to teach coding to middle school girls.

She directs her mastery of technology toward the human brain, looking for ways to detect and monitor Parkinsons disease. She is developing FacePrint, an application that uses video technology to detect facial-expression impairments or behavioral indicators associated with the early stages of Parkinsons. FacePrint is in clinical trials with Stanford Medical School and the Michael J. Fox Foundation. I hope to help build a future where brain health is objective, personalized and preemptive, she said.

Smith hopes girls and women can develop a deeper sense of belonging in STEM fields, to share the full extent of their ideas and work, she said.

Katy Croff Bell changed the face of oceanography when she led the Nautilus Exploration Program, which probes the ocean floor and livestreams the spectacular view globally. When she took over the program, just 17 percent of the science and operations team was female. When she left 18 years later in 2017, the representation was 43 percent.

When ocean exploration is accessible to all talented people, she said, it will allow us to make wise decisions regarding the use, management and protection of the ocean, resulting in humankind thriving.

Bell grew up in San Diego loving the water. She went on to study ocean engineering, maritime archeology and geological oceanography. Today, she directs the Open Ocean Initiative at MIT Media Lab and is a fellow at the National Geographic Society.

As children, she said, one of the first questions we ask is Why? because we are trying to understand the world: Why is the sky blue? That same Why? drives science, because as adults we are still trying to understand the world [though] on a deeper level and how we can make the world a better place.

By U.S. Embassy Tbilisi | 9 February, 2021 | Topics: Gender Issues, History, News, Science & Tech | Tags: girls' education, mentorship, science, STEM, women in the workforce

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Exploring science with a new generation of girls - US Embassy in Georgia

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COVID-19 has spread around the planet, sending billions of people into lockdown as health services struggle to cope. The statistics are startling global cases stand at 23,139,628 and with a total death toll of 801,795 and new daily cases rising (John Hopkins University data 23 Aug 2020), the outbreak has thrown an unprecedented challenge to the world and its citizens. So far, there is no approved treatment or vaccine.

While researchers around the world continue to explore different ways in combating COVID-19, some are looking into how cannabis derived CBD can offer benefits for those suffering from severe forms of this infection.

One recent study from the Dental College of Georgia and Medical College of Georgiashowed high CBD formulations could be effective in the treatment of acute respiratory distress syndrome, or ARDS. The condition, also known as a cytokine storm, has been seen in serious cases of coronavirus, and even affects patients with other viruses or autoimmune diseases. With ARDS, the patients own hyperactive autoimmune system inundates organs with cytokines, resulting in dangerous inflammation. This reaction can cause lung damage and eventual death in COVID-19 victims.

The study model showed CBD down-regulated the cytokines, which helped improve oxygen levels and supported recovery of damaged lung tissues. The researchers also intend to perform similar studies to understand how CBD might help other organs recover from the effects of the virus. Researchers from University of Nebraska and the Texas Biomedical Research Institute also took part. In apeer-reviewed article in Brain, Behaviour, and Immunity, the authors said further research is needed to understand if CBD can help patients infected by the virus.

Now early results from an ongoing Israeli study is adding to the growing evidence that cannabis ingredients could be a game changing treatment in the fight against COVID-19. The new terpene study is being performed by two Israeli research and development companies,Eybnawhich specializes in terpene based medicines, and CannaSoul Analytics. The study looks at a proprietary terpene formulation called NT-VRL, which was created by Eybna to treat inflammatory conditions such as the cytokine storm syndrome found in COVID-19 patients. The formulation contains 30 individual terpenes that are potential anti-inammatory agents all working together to create a positive impact.

While results are ongoing and are yet to be completed, peer reviewed or published, these are positive steps that warrants further investigation into the application of CBD.

This is far from the only investigation into CBD medical benefits.

Researchers at the University of Lethbridge in Alberta,Canada, revealed at the beginning of July that certain kinds of high CBD strains could help treat people infected with the virus or even prevent it from developing in the first place by managing to reduce virus receptors.

Study authors found extract from high CBD strains could help to regulate an enzyme that coronavirus attaches to thereby blocking the viruss ability to infect cells. Results were published on peer review website Preprints.

In Israel, there are several companies and trials underway on how CBD can be used to battle COVID-19. One such example is the partnership of InnoCan Pharma and Tel Aviv University who are working on a new treatment for COVID-19 using exosomes loaded with CBD. Exosomes are small particles created when stem cells multiply. The method will utilise the exosomes as homing missiles, as they can uniquely target cell organs that have been damaged.

As it stands, CBD is still an area under development for the treatment of COVID-19. While there have been some promising results on CBDs anti-inflammatory properties, more studies are needed before leading into clinical trials to test effectiveness. This can take anywhere from months to years.

Speed, agility, and innovation are required from governments, businesses, and society in crafting responses to cope with this evolving new normal. In this period of uncertainty, every therapeutic opportunity and avenue must be considered. CBD opens the door to various exciting possibilities.

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COVID is shifting the conversation about the medical application of CBD - Open Access Government