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Category Archives: Cell Therapy

Catamaran Bio Launches with $42 Million Financing to Develop OfftheShelf CAR-NK Cell Therapies to Treat Solid Tumors – BioSpace

Posted: November 25, 2020 at 11:54 pm

In assembling the founding team at Catamaran, we saw an opportunity to pioneer a highly differentiated approach to develop allogeneic cell therapies using CAR-NK cells, said Houman Ashrafian, Managing Partner, SV Health Investors and a founder of Catamaran. To date, the success of autologous CAR T-cell therapies in hematological malignancies has opened the door to the breakthrough potential of cell therapies for cancer, and Catamaran is now well positioned to improve upon this groundwork by developing off-the-shelf CAR-NK cell therapies capable of reaching solid tumors.

A novel approach to developing off-the-shelf cell therapies to address solid tumors

Catamarans TAILWIND Platform integrates proprietary capabilities to create novel, allogeneic CARNK cell therapies by harnessing the natural cancer-fighting properties of natural killer (NK) cells and enhancing them with the power of synthetic biology and innovative NK cell engineering and manufacturing. With the TAILWIND Platform, CAR-NK cells are programmed with NK cell-specific CAR architectures and potency-boosting switches to neutralize the hostile tumor microenvironment and enable efficacy against diverse cancer types, especially solid tumors. Additionally, the TAILWIND Platform includes proprietary, non-viral NK cell engineering technology for efficient modification of NK cells with customized genetic programs enabled by synthetic biology. Catamarans CAR-NK cell therapies use healthy donor cells that are engineered and manufactured for offtheshelf use, unlike current CAR-T cell therapies that use a patients own genetically modified T cells and require a customized, multi-week manufacturing process.

Catamaran is focused on expanding the frontier of cell therapies to treat solid tumors and provide transformative benefit to cancer patients. We are doing this by creating allogeneic cell therapies that harness the innate cancer-fighting power of NK cells and enhancing them with new biologically-powerful attributes from our leading-edge technologies all originating from our custom-built TAILWIND Platform for designing, engineering and manufacturing off-the-shelf CAR-NK cell therapies, said Vipin Suri, PhD, MBA, Chief Scientific Officer of Catamaran.

During Catamarans stealth period, the start-up team assembled key components of the TAILWIND Platform and related intellectual property, including a set of potency-boosting cellular switches to enable therapeutic action in the immunosuppressive tumor microenvironment of solid tumors, and it generated early proof of concept using a non-viral transposon system to efficiently deliver large genetic cargos into NK cells. Based on this early work, the company has rapidly advanced two lead CAR-NK cell therapy programs to lead optimization stage.

With its holistic and cutting-edge approach, Catamaran stands out in the rapidly-evolving NK cell field with a platform that addresses the full complement of capabilities necessary to develop CAR-NK cell therapies, while focusing on the high-impact technologies of synthetic biology and innovative gene delivery systems that can enable these new cell therapies to offer extraordinary value in the field of cancer treatment, said Maina Bhaman, Partner, Sofinnova Partners.

Scientific founders and leadership team

Catamarans scientific founders are pioneers in NK cell biology, engineering, manufacturing and clinical application and are proven innovators in the cell therapy field:

Additional founders of Catamaran are Kevin Pojasek, PhD, and Tim Harris, PhD, through their roles as venture partners with SV Health Investors.

The leadership team at Catamaran Bio has deep expertise in cell therapy research and product development, and the team includes: Vipin Suri, PhD, MBA, Chief Scientific Officer, who has more than 20 years of biopharmaceutical experience, including as a co-founder of Obsidian Therapeutics and Serien (formerly Raze) Therapeutics, and earlier in R&D roles at GSK, Pfizer and Wyeth; Mark Boshar, JD, Chief Operating Officer, who has more than 25 years of leadership experience spanning legal, business development, financings and operations for biotechnology companies, including as VP, Legal Affairs at Rubius Therapeutics, Associate General Counsel at Millennium Pharmaceuticals, a senior advisor to a range of venture-backed start-up companies, and earlier as a life sciences attorney with WilmerHale; Chris Carpenter, MD, PhD, Chief Medical Officer, who has 20 years of clinical and laboratory experience in oncology, including as CMO of Rubius Therapeutics, SVP and Head of Cancer Epigenetics Discovery at GSK, and roles at Merck and Harvard Medical School/Beth Israel Deaconess Medical Center; Celeste Richardson, PhD, Senior VP of Research, who has 16 years of experience in research and drug discovery in biotechnology and pharmaceutical companies, including at Obsidian Therapeutics and Novartis; and Bharat Reddy, PhD, MPhil, MA, Senior Director of Business Development, who has served as director of business development at bluebird bio, as well as roles at SV Health Investors and ClearView Healthcare Partners.

Catamaran is positioned to open up new territory for cancer treatments with highly potent CAR-NK cell therapies, and we are confident in the experienced leadership team and the scientific expertise that is propelling the companys research and development, said Caroline Gaynor, Principal, Lightstone Ventures.

Concurrent with the Series A financing, Maina Bhaman of Sofinnova Partners, Caroline Gaynor of Lightstone Ventures and Rob Woodman of Takeda Ventures join Houman Ashrafian and Kevin Pojasek on the Catamaran board of directors.

About Catamaran Bio

Catamaran Bio is developing novel, off-the-shelf CAR-NK cell therapies designed to treat a broad range of cancers, including solid tumors. Our proprietary capabilities enable us to harness the natural cancer-fighting properties of NK cells and enhance and tailor their effectiveness with the power of synthetic biology and innovative non-viral cell engineering. We are using our TAILWINDTM Platform, an integrated suite of technologies, to specifically address the end-to-end methods of engineering, processing and manufacturing NK cells and rapidly advance our pipeline of CAR-NK cell therapy programs.

Our team combines experienced biopharmaceutical leadership with founding scientists who are pioneers in NK cell biology, engineering, manufacturing and clinical application. Catamaran is backed by leading financial and corporate investors, including SV Health Investors, Sofinnova Partners, Lightstone Ventures, Takeda Ventures and Astellas Venture Management. For more information, please visit http://www.catamaranbio.com and follow us on LinkedIn and @CatamaranBio on Twitter.

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Catamaran Bio Launches with $42 Million Financing to Develop OfftheShelf CAR-NK Cell Therapies to Treat Solid Tumors - BioSpace

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Growing at an annualized rate of over 16.5%, the cell therapy manufacturing market is estimated to reach close to USD 11 Billion by 2030, claims Roots…

Posted: November 25, 2020 at 11:54 pm

iCrowdNewswire Nov 25, 20202:28 PM ET

The approval of KYMIRAH, YESCARTA, Alofisel and Zyntelgo has increased the interest of pharma stakeholders in cell therapies; further, owing to the technical challenges in this field, outsourcing manufacturing operations has become a necessity

Roots Analysis has announced the addition of Cell Therapy Manufacturing Market (3rd Edition), 2019 2030 report to its list of offerings.

Owing to various reasons, the demand for cell therapies is anticipated to increase over the coming years. Therefore, both therapy developers and contract service providers may need to strengthen their capabilities and expand available capacity. In this context, automation is expected to be a key enabler within the cell therapy manufacturing and contract services industry.

To order this 550+ page report, which features 160+ figures and 250+ tables, please visit this link

Key Market Insights

More than 160 organizations claim to be engaged in cell therapy manufacturing

The market landscape is dominated by industry players, representing more than 60% of the total number of stakeholders. Amongst these, over 55 are large or mid-sized firms (having more than 50 employees).

100+ players focused on T-cell and stem cell therapies

Most of these players are focused on manufacturing T-cell therapies, including CART, TCR or TILs. It is worth highlighting that more than 35 organizations claim to have necessary capabilities for the manufacturing of both types of therapies.

Presently, 70+ companies have commercial scale capacity

As majority of the cell therapy products are in clinical trials, the demand is high at this scale. However, it is worth noting that several players (~50%) have already developed commercial scale capacity for cell therapies.

Europe is currently considered a current hub for cell therapy production

More than 220 manufacturing facilities have been established by various players, worldwide; of these, 35% are in Europe, followed by those based in North America. Other emerging regions include Australia, China, Japan, Singapore, South Korea and Israel.

50+ facility expansions reported between 2015-2019

More than 85% of the expansions are related to setting up of new facilities across different regions. Maximum expansion activity was observed in the US and in certain countries within the Asia Pacific regions.

20+ companies offer automated solutions to cell therapy developers

Players that claim to offer consultancy services related to automation include (in alphabetical order) Berkeley Lights, Cesca Therapeutics, Ferrologix, FluDesign Sonics, GE Healthcare and Terumo BCT. Further, we identified players,namely (in alphabetical order) Fraunhofer Institute for Manufacturing Engineering and Automation IPA, Invetech, KMC Systems, Mayo Clinic Center for Regenerative Medicine and RoosterBio, that offer consultancy solutions related to automation.

Partnership activity has grown at an annualized rate of 16%, between 2014 and 2018

More than 200 agreements have been inked in the last 5 years; majority of these were focused on the supply of cell-based therapy products for clinical trials. Other popular types of collaboration models include manufacturing process development agreements (16%), services agreements (12%) and acquisitions (10%).

By 2030, developed geographies will capture over 60% of the market share

Asia Pacific is anticipated to capture the major share (~36%) of the market by 2030. It is also important to highlight that financial resources, technical expertise and established infrastructure is likely to drive cell therapy manufacturing market in Europe, which is estimated to grow at a CAGR of ~26%.

To request a sample copy / brochure of this report, please visit this link

Key Questions Answered

The USD 11 billion (by 2030) financial opportunity within the cell therapy manufacturing market has been analyzed across the following segments:

The report features inputs from eminent industry stakeholders, according to whom the manufacturing of cell therapies is largely being outsourced due to exorbitant costs associated with the setting-up of in-house expertise. The report includes detailed transcripts of discussions held with the following experts:

The research covers profiles of key players (industry and non-industry) that offer manufacturing services for cell-based therapies, featuring a company overview, information on manufacturing facilities, and recent collaborations.

For additional details, please visit

https://www.rootsanalysis.com/reports/view_document/cell-therapy-manufacturing/285.html or email [emailprotected]

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Contact:Gaurav Chaudhary+1 (415) 800 3415[emailprotected]

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Roots AnalysisA430, 4th Floor,Bestech Business Towers, Sector 66, Mohali, India[emailprotected]+1 (415) 800 3415+44 (122) 391 1091Web: https://www.rootsanalysis.com/LinkedIn: https://in.linkedin.com/company/roots-analysisTwitter: https://twitter.com/RootsAnalysis

Keywords:cell therapy manufacturing, car-t manufacturing, car t cell therapy cost, gene therapy manufacturing, Roots Analysis, Pharma, Analysis, Research, Report,

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Growing at an annualized rate of over 16.5%, the cell therapy manufacturing market is estimated to reach close to USD 11 Billion by 2030, claims Roots...

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CAR T-Cell Therapy creates individualized treatment opportunities in MCL – Credence Turbine

Posted: November 25, 2020 at 11:54 pm

Treatment decisions in mantle cell lymphoma (MCL) have become more nuanced since the FDA approval of the CAR T-cell therapy brexucabtagene autoleucel (Tecartus) in the relapsed/refractory setting, explained Alan P. Z. Skarbnik, MD.

Previously, the treatment of choice for patients who recurred after high-dose therapy and transplant had been 1 of the 3 FDA-approved BTK inhibitors: ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa). Now, there is a decision-making process between BTK inhibitors and CAR T-cell therapy, which is driven by the time to relapse, disease burden, and overall performance status of the patient.If the patient recurs 8 or 9 years after transplantation and does not have a lot of disease, the BTK inhibitor may be a better choice at that point. This way, you can protect the risks of CAR T-cell therapy at a later time. I have a number of patients in this setting who have very long remissions or disease control with BTK inhibitors, said Skarbnik. Patients who recur shortly after transplantation who have a larger proportion of the disease and are more symptomatic may be better candidates for CAR T-cell therapy.In an interview with OncLive, Skarbnik, a hematologist/oncologist with Novant Health, discussed the data with available treatment options for relapsed/refractory MCL and shared some of the treatment options.

OncLive: How do you approach the treatment selection of 3 FDA-approved BTK inhibitors in MCL?Skarbnik: We did not have a head-to-head comparison trial between the three agents. All three agents are available and efficient. All we have is cross-trial comparison. The duration of the [DOR] response in the acalabrutinib trial appears to be longer. However, patients were in earlier treatment lines; the median number of previous treatment lines was 2 vs. 3 in the ibrutinib trial. This may contribute to the DOR difference. Zanubrutinib has a very good DOR and a deep response.

All three drugs seem to be safe and well tolerated. They have different safety profiles, which is not to say] that one is better than the other but [rather] that you have to determine what adverse effects [AEs] are best tolerated in a particular patient.

Head-to-head comparisons are made between zanubrutinib and ibrutinib in Waldenstrm macroglobulinemia. As far as the safety profile is concerned, zanubrutinib appears to be better tolerated in that particular trial and in that particular disease. You can extrapolate this to other conditions of the disease, because the mechanism of action of the drugs is the same throughout. Newer second-generation BTK inhibitors may be better tolerated than the first-generation BTK inhibitor ibrutinib, but we cant say that with certainty. All three drugs are great. [The decision will come down to the choice of a physician.

How has the paradigm been affected by CAR T-cell therapy?Brexucabtagene autoleucel was recently approved in MCL based on data from the ZUMA-2 study, which evaluated this treatment in patients with recurrent, relapsed/refractory MCL who had previously been exposed to a BTK inhibitor. However, approval did not require patients to be exposed to a BTK inhibitor in a commercial setting. It is now approved for second-line or [later] use which is appropriate at this point, because although BTK inhibitors are a great treatment option for patients with relapsed MCL, the best DOR we have seen so far is close to 26 months, which is certainly not ideal.

We try to treat MCL more aggressively in the frontline setting with high-dose cytarabine-containing induction regimens followed by high-dose chemotherapy and autologous stem cell transplantation or rescue. This appears to give patients a longer remission and progression-free survival than other frontline treatment approaches.

The main concern here is for patients who recur shortly after this intensive treatmentthose with recurrent disease 1 to 3 years after a stem cell transplant. These patients are at higher risk of resistance to second-line therapy and are at higher risk of early progression following second-line therapy. Until now the treatment of choice has been BTK inhibitors, which are easy to take and readily available. The AEs are well tolerated and [patients] have a response [to this type of treatment].

The length of the response here is the issue. We now have the option of CAR T-cell therapy in this setting. Again, this will depend on how soon the patient relapses after the transplant and their disease burden. We also need to consider the overall performance status of the patient. Will they be a good candidate to withstand the AEs of CAR T-cell therapy, or will they be a better candidate for a BTK inhibitor?

We have not yet had long-term follow-up to the [ZUMA-2] trial. The true long-term efficacy and disease effect of CAR T-cell therapy is not yet known. We dont know if using CAR T-cell therapy before a BTK inhibitor changes the response rate or DOR. We dont have that kind of data. Its something that were going to have to look back at retrospectively and try to compare as best we can.

Certainly, I would be more likely to use CAR T-cell therapy in a younger patient who has early recurrence after frontline induction, especially if they are transplanted, and certainly for those who recur after BTK inhibitors. Very few agents are able to save a patient [after that]. In terms of chemotherapy, [rituximab/bendamustine with low-dose cytarabine] appears to be a chemotherapy regimen with better response rates in the BTK inhibitor-refractory or relapsed setting. However, CAR T-cell therapy has been specifically studied in this setting, so it is a good option for those patients.

Ref: onclive.com

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CAR T-Cell Therapy creates individualized treatment opportunities in MCL - Credence Turbine

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CAR-T Therapy Treatment Market 2020 Industry Share, Size, Growth, Segments, Revenue, Statistics, Bus – PharmiWeb.com

Posted: November 25, 2020 at 11:54 pm

Global CAR-T therapy treatment marketis rising gradually with a substantial CAGR in the forecast period of 2019-2026. Growing prevalence of cancer worldwide where CAR-T cell therapies act as a dominant treatment and new launches of the product are the key factors for market growth.

Few of the major competitors currently working in the globalCAR-T therapy treatment marketareNovartis AG, Gilead Sciences, Inc, AbbVie Inc, Adaptimmune, Amgen Inc, Atara Biotherapeutics., Aurora Biopharma, Autolus, Bellicum Pharmaceuticals, Inc, BioAtla LLC., bluebird bio, Inc, CELGENE CORPORATION, CARINA BIOTECH, CARsgen Therapeutics, Cartherics Pty ltd, Cellectis, Ziopharm Oncology, Inc, Xyphos, TrakCel, Tmunity Therapeutics, Tessa Therapeutics Ltd, TC BioPharm Limited, Sorrento Therapeutics, Inc and others.

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Market Definition: Global CAR-T Therapy Treatment Market

Chimeric Antigen Receptor T(CAR-T) cell therapy is a type of immunotherapy treatment that utilizes patients T cells a part of immune system cell to fight against cancer. It is developed in the structured laboratory by collecting a sample of a patients T cells and modified in the laboratory to develop special structures called chimeric antigen receptors (CARs) on their surface when infused into patients, these cells get multiple and in turn boost a patients immune system.

According to the statistics published in The Global Cancer Observatory, Globocan 2018, it is estimated that the total incident population of Non-Hodgkin lymphoma and breast cancer worldwide were 509,590 and 2,088,849 respectively. This growing incidence of cancer globally and increase in deal between the companies are acts as market drivers.

Browse Detailed TOC Herehttps://www.databridgemarketresearch.com/toc?dbmr=global-car-t-therapy-treatment-market

Segmentation:Global CAR-T Therapy Treatment Market

CAR-T Therapy Treatment Market : By Therapeutic Application

CAR-T Therapy Treatment Market : By Development Processes

CAR-T Therapy Treatment Market : By Structure

CAR-T Therapy Treatment Market : By Targeted Antigens

CAR-T Therapy Treatment Market : By Drugs

CAR-T Therapy Treatment Market : By End-Users

CAR-T Therapy Treatment Market : ByGeography

Key Developments in the CAR-T Therapy Treatment Market :

CAR-T Therapy Treatment Market Drivers

CAR-T Therapy Treatment Market Restraints

This CAR-T Therapy Treatment Market report includes a wide-ranging evaluation of the markets growth prospects and restrictions. The CAR-T Therapy Treatment Market report provides estimations about the growth rate and the market value in industry based on market dynamics and growth inducing factors. Global CAR-T Therapy Treatment Market report studies the industry abilities for each geographical region based on the customer purchasing patterns, macroeconomic parameters, development rate, and market demand and supply states. In addition, this CAR-T Therapy Treatment Market report also endows with top to bottom estimation of the market with respect to income and developing business sector.

For market segmentation study performed in this CAR-T Therapy Treatment Market report, a market of potential customers is classified into groups or segments based on different characteristics such as application of product, deployment model, end user and geographical region etc. The report contains a number of market drivers and restraints which are obtained from SWOT analysis and all the CAGR projections for the historic year 2018, base year 2019, and forecast period of 2020-2027. The report also highlights the reviews about key players, major collaborations, merger & acquisitions along with trending innovation and business policies. It is also assured that the report provides precise market segmentation and insights for the success of business.

CAR-T Therapy Treatment Market Reports Table of Contents

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CAR-T Therapy Treatment Market 2020 Industry Share, Size, Growth, Segments, Revenue, Statistics, Bus - PharmiWeb.com

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Fred Hutch at ASH: Fauci fireside chat, latest on cell therapies, repairing immune function, COVID and clots and more – Newswise

Posted: November 25, 2020 at 11:54 pm

Newswise SEATTLE Nov. 18, 2020 Fred Hutchinson Cancer Research Centers latest findings on cell therapies, repairing immune function, and more will be featured at the 62nd American Society of Hematology Annual Meeting & Exposition, to be held virtually Dec. 5 8.

Dr. Stephanie Lee, ASH president and Fred Hutch physician-scientist will kick off the meeting with a fireside chat with Dr. Anthony Fauci. She will also chair ASHs annual E. Donnall Thomas Lecture, named for the Hutchs Nobel laureate Dr. Thomas, who would have turned 100 this year. This lectureship recognizes pioneering research achievements.

Lee shared other meeting highlights:

Follow Lee on Twitter: @StephanieLeeMD.

See below for selected presentations by Fred Hutch researchers, along with Fred Hutch experts to follow on Twitter. Presentations times are in the Pacific time zone.

REPAIRING IMMUNE FUNCTION

Damage-Induced Pyroptotic Cell Death Facilitates Regeneration of the Thymus

As a small but mighty butterfly shaped gland in the chest, the thymus is the training ground for T cells to mature into disease-killing machines in the body. But over time, the thymus wears out from stress, infection and age. Finding ways to help repair it could have broad implications for preventing and treating cancer. Dr. Sinead Kinsella, a researcher in the lab of Dr. Jarrod Dudakov, will present findings on a new way of thymus regeneration in which a cell death process called pyroptosis is critical in releasing large numbers of signaling molecules that can trigger the thymus to repair itself. Abstract No. 735 (oral presentation) Monday, Dec. 7, 2020: 2:45 p.m. On Twitter: Dr. Sinead Kinsella: @shinkinsella Dr. Jarrod Dudakov: @Dudakov_lab

T CELL RECEPTOR THERAPY

The immune system plays a key role in detecting tumor antigens and killing cancer cells. But immune response to tumor antigens varies and is often insufficient to prevent tumor growth and relapse. Fred Hutch physician-scientists have identified specific tumor antigens that can be targeted to trigger a potent immune response. The team is creating immunotherapy using genetically modified T cells, called TCR T-cell immunotherapy, to augment these responses in patients.

Phase I Study of Adoptive Immunotherapy with HA-1-Specific CD8+ and CD4+ Memory T Cells for Children and Adults with Relapsed Acute Leukemia after Allogeneic Hematopoietic Stem Cell Transplantation (HCT): Trial in Progress Dr. Elizabeth Krakowwill present a Phase I trial in progress. It uses a T-cell receptor therapy developed byDr. Marie Bleakleyto treat adult and pediatric patients who have relapsed after receiving a stem cell (blood and marrow) transplant for leukemia or other related conditions. Abstract No. 492 (oral presentation) Sunday, Dec. 6, 2020: 2:15 p.m.

A d SF3B1 Neoantigen Is Presented on Primary Malignant Cells and Induced Pluripotent Stem Cell-Derived Hematopoietic Lines

Neoantigens, tiny markers that arise from cancer mutations, flag cells as cancerous and could lead to more targeted precision immunotherapies. But, because hundreds of mutations exist on a tumor, targeting the right neoantigen is crucial to trigger an immune response. Dr. Melinda Biernacki, working with the Hutchs Dr. Marie Bleakley, will present findings that identify a specific neoantigen, SF3B1, present in Myelodysplastic Syndromes (MDS), secondary acute myeloid leukemia (AML) and advanced chronic lymphocytic leukemia (CLL), as a promising target for treatment with immunotherapy. Abstract No. 3265 (poster presentation) Monday, Dec. 7, 2020, 7:00 a.m. 3:30 p.m.

CD19 CAR T-CELL THERAPY

Hutch scientists continue to take deep dives into understanding how CD19 CAR T-cell therapy works and how to make it work better for more patients.

Age, performance status, and comorbidities in relation to IEC-associated toxicities (including ICANS) followed by live Q&A panel discussion Scientific Workshop Thursday, Dec. 3, 2020, 2:45 p.m. 3:17 p.m. To be presented by Jordan Gauthier, MD On Twitter: Dr. Jordan Gauthier: @drjgauthier

High IL-15 Serum Concentrations Are Associated with Response to CD19 CAR T-Cell Therapy and Robust In Vivo CAR T-Cell Kinetics Findings by Dr. Jordan Gauthier, a clinician-scholar at Fred Hutch, suggest that high levels of IL-15 could improve CD19 CAR T-cell efficacy and in vivo persistence. Abstract No. 1442 (poster presentation) Saturday, Dec. 5, 2020, 7:00 a.m. 3:30 p.m. ASH Virtual Poster Walk Thursday, Dec. 10, 2020, 7 a.m. On Twitter: Dr. Jordan Gauthier: @drjgauthier

Patient-Reported Outcomes at Time of CAR-T Cell Therapy Abstract No. 3485 (poster presentation) Monday, Dec. 7, 2020, 7:00 a.m. 3:30 p.m. To be presented by Erin Mullane, DNP

CD20 CAR T-CELL THERAPY

Third Generation CD20 Targeted CAR T-Cell Therapy (MB-106) for Treatment of Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma Researchers at Fred Hutch have developed a CAR T-cell therapy targeting CD20, a specific protein marker in blood cancers, for treating patients with B-cell non-Hodgkin lymphoma who have relapsed or previously been non-responsive to treatment. Dr. Mazyar Shadman will early results from the ongoing trial taking place at the Seattle Cancer Care Alliance, the Hutchs clinical-care partner. Abstract No. 1443 (poster presentation) Saturday, Dec. 5, 2020, 7:00 a.m. 3:30 p.m. On Twitter: Dr. Mazyar Shadman: @mshadman

CAR T for AML

Therapeutic Targeting of Mesothelin in Acute Myeloid Leukemia with Chimeric Antigen Receptor T Cell Therapy Abstract No. 1959 (poster presentation) Sunday, Dec. 6, 2020, 7:00 a.m. 3:30 p.m. To be presented by Quy Le, PhD

MORE CELL THERAPY

Challenges in Cell Therapy: Relapse and Toxicities Live Q&A Even as a growing number of cancer patients benefit from advances in immunotherapy, relapse and toxic side effects from the treatment remain challenging. Dr. Aude Chapuis will discuss new strategies using genetically modified immune cells to improve the next generation of adoptive T cell therapies in the treatment of solid tumor and blood cancers. Scientific Program, Live Q&A Saturday, December 5, 2020, 9:30 a.m. 10:15 a.m.

PRECISION MEDICINE AND AML

Researchers from the lab ofDr. Soheil Meshinchi, a pediatric oncologist and acute myeloid leukemia specialist, are mapping genetic mutations to how well a patient will respond to various treatments. Their presentations show that ongoing genomic profiling work can help guide targeted treatments for patients with AML, which is the deadliest leukemia among children and young adults.

Genome and Transcriptome Profiling of Monosomy 7 AML Defines Novel Risk and Therapeutic Cohorts Abstract No. 274, (oral presentation) Saturday, Dec. 5, 2020, 2:30 p.m. To be presented by Rhonda E. Ries, MA

Clinical Benefit and Tolerability of Crenolanib in Children with Relapsed Acute Myeloid Leukemia Harboring Treatment Resistant FLT3 ITD and Variant FLT3 TKD Mutations Treated on Compassionate Access Abstract No. 1973, (poster presentation) Sunday, December 6, 2020, 7:00 a.m. 3:30 p.m. To be presented by Katherine Tarlock, MD

Mesothelin Expression Is Associated with Extramedullary Disease and PromotesIn VivoLeukemic Growth in Acute Myeloid Leukemia Abstract No. 1993, (poster presentation) Sunday, Dec. 6, 2020, 7:00 a.m. 3:30 p.m. To be presented by Katherine Tarlock, MD

Target-Informed Repurposing of Immunotherapies in AML a Transcriptome Based Approach for Identifying Immediately Available Therapeutics Abstract No. 2003, (poster presentation) Sunday, Dec. 6, 2020, 7:00 a.m. 3:30 p.m. To be presented by Amanda R. Leonti, MS

BLOOD CLOTS AND CANCER, COVID-19

Dr. Gary Lyman, a medical oncologist, hematologist and public health researcher, has helped develop treatment guidelines for managing blood clots in cancer patients and more recently in COVID-19 patients. His colleagues will present on the COVID-19 findings at this years ASH. Dr. Lyman is available to speak with media. On Twitter: Dr. Gary Lyman: @gary_lyman

Severity of Sars-Cov-2 Infection in Patients with Hematologic Malignancies: A COVID-19 and Cancer Consortium (CCC19) Registry Analysis Abstract No. 1632 (poster presentation) Saturday, Dec. 5, 2020, 7:00 a.m. 3:30 p.m.

Incidence of and Risk Factors for Venous Thromboembolism Among Hospitalized Patients with Cancer and COVID-19: Report from the COVID-19 and Cancer Consortium (CCC19) Registry Abstract No. 204; Session No. 701 (oral presentation) Monday, Dec. 7, 2020: 2:45 PM

HEALTHCARE ECONOMICS

Comparison of Outcomes and Utilization of Therapy in Multiple Myeloma Patients in the USA and Alberta, Canada Abstract No. 2516 (poster presentation) Sunday, Dec. 6, 2020, 7:00 a.m. 3:00 p.m. To be presented by Andrew J. Cowan, MD On Twitter: Dr. Andrew Cowan: @andrewcowanmd Co-author Dr. Veena Shankaran: @ShankaranVeena

CELL BIOLOGY

Distinct Transcriptional signatures distinguish the emergence of multipotent progenitors and hematopoietic stem cells from endothelial precursors in the murine embryo Abstract No. 908, (poster presentation) Saturday, Dec. 5, 2020, 7:00 a.m. 3:30 p.m. To be presented by Tessa Dignum, BS

Note: Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

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At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nations first National Cancer Institute-funded cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network.

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Fred Hutch at ASH: Fauci fireside chat, latest on cell therapies, repairing immune function, COVID and clots and more - Newswise

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Celularity Announces Dosing of First Patient in Phase I Study of Human Placental Hematopoietic Stem Cell-Derived Natural Killer Cells (CYNK-001) in…

Posted: November 25, 2020 at 11:54 pm

DetailsCategory: DNA RNA and CellsPublished on Wednesday, 25 November 2020 12:03Hits: 308

FLORHAM PARK, NJ, USA I November 24, 2020 I Celularity, Inc., a clinical-stage cell therapeutics company focused on the development of innovative allogeneic placenta-derived cellular therapies, announced today that the first patient was dosed in its Phase 1 clinical study of human placental hematopoietic stem cell-derived natural killer cells (CYNK-001) in adults with recurrent glioblastoma multiforme.

"Celularity is committed to the development of innovative therapeutic tools to treat serious diseases, particularly targeting diseases with unmet medical needs that have a devastating impact on patients and families.As testimony to this commitment, we are extremely excited to announce the dosing of our first patient in our first clinical trial for, glioblastoma multiforme (GBM). Through the study team's diligent efforts, we were able to rapidly complete the start-up activities and to accelerate the commencement of patient screening, enrollment, and first dosing in this important study," said Robert J. Hariri, M.D., Ph.D., Celularity's Founder, Chairman and Chief Executive Officer.

This study (ClinicalTrials.gov Identifier:NCT04489420) will determine the maximum safe dose (MSD) of CYNK-001 which are culture-expanded NK cells derived from human placental CD34+ cells. The intravenous (IV) cohort will receive repeat administration of CYNK-001 cells after lymphodepleting chemotherapy. The intratumoral (IT) cohort will not receive lymphodepletion. The safety of this treatment will be evaluated, as researchers investigate the role of NK cells in the treatment of recurrent glioblastoma.

"Glioblastoma patients have poor survival and novel treatments are urgently needed for this patient population," said Nazanin Majd, M.D., Ph.D., assistant professor of Neuro-Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study. "Placental-derived NK cells are a promising approach in treatment of GBM patients as these cells have been shown to kill GBM tumor cells in pre-clinical animal studies. This trial offers an innovative immunotherapy approach where exogenously manufactured NK cells will be administered to GBM patients with the goal of shrinking the tumor and improving outcomes."

In a related development, the Company also announced that its abstract highlighting the details of this Phase 1 study was accepted for a poster presentation at the 25thAnnual Meeting and Education Day of the Society for Neuro-Oncology (SNO) which will occur November 19-21, 2020.

About CYNK-001CYNK-001 is an investigational cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

About CelularityCelularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf allogeneic cellular therapies. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the postpartum placenta. Through nature's immunotherapy engine the placenta Celularity is leading the next evolution of cellular medicine with placenta-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com.

SOURCE: Celularity

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Celularity Announces Dosing of First Patient in Phase I Study of Human Placental Hematopoietic Stem Cell-Derived Natural Killer Cells (CYNK-001) in...

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Scientists Reveal a New Drug That Directs Stem Cells To Desired Sites – Science Times

Posted: November 25, 2020 at 11:54 pm

Researchers at Stanford Burnham Prebys Medical Discovery Institute recently developed a drug that can lure stem cells to impaired tissue and enhance the efficacy of treatment.

This is considered a "scientific first," not to mention a major advance for the field of regenerative drugs. Such a discovery, which theProceedings of the National Academy of Sciences or PNASpublished could enhance the present stem cell treatments developed to cure such neurological disorders like stroke, spinal cord injury, ALS or other amyotrophic lateral sclerosis, as well as other neurodegenerative diseases -- and have their use expanded to new conditions such as arthritis or heart disease.

In the study, toxic or green cells disappeared when mice with a neurodegenerative condition were given both therapeutic or red cells and the drug SDV1a, which matched with delayed onset of symptoms and longer lives.

(Photo : Stem Cell Research via Getty Images)In this undated handout photo released by the Institute for Stem Cell Research in 2005, neurons (red) and astrocytes (green), which can be made from neural stem cells, are seen.

Results Suggesting Efficacy of the Drug

The study results proposed that SDV1a can be used to enhance the stem cell treatments' efficacy. According to Evan Snyder, MD, PhD, theCenter for Stem Cells & Regenerative Medicine at Stanford Burnham Prebysprofessor and director, "the ability to instruct a stem cell where to go in the body, or to a particular region of a given organ is the 'Holy Grail' for regenerative medicine.

Snyder, who's also the senior author of the study, added, now, for the first time, stem cells can be directed to a desired area and focus its therapeutic effect.

Almost a decade-and-a-half back, the senior author, together with his team, found that stem cells are drawn to infection, a biological 'fire alarm' indicating that damage has taken place.

Nevertheless, using inflammation as a healing appeal is not possible since an inflammation environment can be dangerous to the body. Hence, researchers have been searching for mechanisms to help in the migration of stem cells or 'home' to the body's desired areas.

Such a mechanism or tool, according to reports on this new finding, would be a great contributor for disorders in which preliminary inflammatory indicators disappear over time, like chronic spinal cord injury or stroke, and conditions where the inflammation's role is not clearly understood, like heart disease, for one.

Fortunately, after decades of investing in stem cell science, scientists are now making "tremendous progress," saidCalifornia Institute for Regenerative Medicine or CIRMpresident and CEO Maria Millan, MD said, in their understanding of the manner such cells work and the manner they can be attached to help reverse disease or an injury.

The CIRM partially funded this new study. Millan also said, Snyder's group has identified a medicine that could enhance "the ability of neural stem cells to home to sites of injury and initiate repair."

More so, the president and CEO also explained, the drug candidate could help fast-track the stem cell treatments' development, specifically for conditions including Alzheimer's disease and spinal cord injury.

In the research, study investigators modified an inflammatory molecule called CXCL12, which the Snyder's group discovered previously, could guide healing stem cells to areas that need repair to develop the SDV1a.

As such, this new medicine works by improving stem cell binding and minimizing inflammatory indicating and can be injected anywhere to attract stem cells to a particular site without causing any inflammation.

Since such inflammation can be dangerous, Snyder explained, they modified CXL12 by "tripping away the risky beat and maximizing the good bit."

Now, he added, they have a drug, drawing stem cells to an area of pathology, but not creating or worsening the unwanted infection.

"Now, we have a drug that draws stem cells to a region of pathology, but without creating or worsening unwanted inflammation."

Furthermore, to present that the new medication can improve the effectiveness of stem cell therapy, the scientists implanted SDV1a and human neural stem cells into the brains of mice thatSandhoff disease, a neurodegenerative disease.

The scientists have already started testing the ability of SDV1a to enhance stem cell therapy in a mouse model of Lou Gehrig's disease, also known as ALS, which results from progressive loss of motor neurons in the brain.

Snyder said they are optimistic that the mechanism of action of this new drug may potentially benefit various neurodegenerative disorders and non-neurological conditions like arthritis, heart disease, and even brain cancer.

Interestingly, he also explained, since CXL12 and its receptor is said to be implicated in cytokine storm that exemplifies severeCOVID-19, some of their understandings of how to constrain infection without controlling other normal procedures selectively may be helpful in that field, as well.

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Cell Therapy Market Will Generate New Growth Prospects In The Next Upcoming Years With The Huge Demand, Business Strategies and High CAGR By 2026 -…

Posted: November 25, 2020 at 11:54 pm

AMR information of the Global Cell Therapy Market report will surely grow business and improve return on investment (ROI). The report has been prepared by taking into account several aspects of marketing research and analysis which includes market size estimations, market dynamics, company & market best practices, entry level marketing strategies, positioning and segmentations, competitive landscaping, opportunity analysis, economic forecasting, industry-specific technology solutions, roadmap analysis, targeting key buying criteria, and in-depth benchmarking of vendor offerings. This Cell Therapy Market research report gives CAGR values along with its fluctuations for the specific forecast period.

Major Market Key Players: Cell Therapy Market

JCR Pharmaceuticals Co., Ltd., Kolon TissueGene, Inc.; and Medipost and many more.

Download Exclusive Sample (350 Pages PDF) Report: To Know the Impact of COVID-19 on this Industry @ https://www.adroitmarketresearch.com/contacts/request-sample/611

Cell Therapy Market research report encompasses a far-reaching research on the current conditions of the industry, potential of the market in the present and the future prospects. By taking into account strategic profiling of key players in the industry, comprehensively analyzing their core competencies, and their strategies such as new product launches, expansions, agreements, joint ventures, partnerships, and acquisitions, the report helps businesses improve their strategies to sell goods and services. This AMR research report is sure to help grow your business in several ways. Hence, the Cell Therapy Market report brings into the focus, the more important aspects of the market or industry.

The Global Cell Therapy Market Accounted For XXX USD Billion In 2017 And Is Projected To Grow At A CAGR Of XX% The Forecast Period Of 2018 To 2025. The Upcoming Market Report Contains Data For Historic Years 2016, The Base Year Of Calculation Is 2017 And The Forecast Period Is 2018 To 2025.

This Free report sample includes:

1.A brief introduction to the Cell Therapy Market research report.2.Graphical introduction of the regional analysis.3.Top players in the Cell Therapy Market with their revenue analysis.4.Selected illustrations of Cell Therapy Market insights and trends.5.Example pages from the Cell Therapy Market

The Cell Therapy Market report provides insights on the following pointers:1.Market Penetration: Comprehensive information on the product portfolios of the top players in the Cell Therapy Market.

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4.Market Development: Comprehensive information about emerging markets. This report analyses the market for various segments across geographies.

5.Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Cell Therapy Market.

Table of Contents: Cell Therapy Market*Cell Therapy Market Overview*Global Economic Impact on Industry*Global Market Competition by Manufacturers*Global Production, Revenue (Value) by Region*Global Supply (Production), Consumption, Export, Import by Regions*Global Production, Revenue (Value), Price Trend by Type*Global Market Analysis by Application*Manufacturing Cost Analysis*Industrial Chain, Sourcing Strategy and Downstream Buyers*Marketing Strategy Analysis, Distributors/Traders*Market Effect Factors Analysis*Global Cell Therapy Market Forecast

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Cell Therapy Market Segmentation

Type Analysis of Cell Therapy Market:

By Use & Type Outlook, (Clinical-use,By Cell Therapy Type,,Non-stem Cell Therapies,Stem Cell Therapies,BM, Blood, & Umbilical Cord-derived Stem Cells,Adipose derived cells,Others), By Therapeutic Area, (Malignancies,Muscoskeletal Disorders,Autoimmune Disorders,Dermatology,Others,Research-use), By Therapy Type, (Allogenic Therapies,Autologous Therapies)

Some of the key questions answered in these Cell Therapy Market reports:

*What will the market growth rate, growth momentum or acceleration market carries during the forecast period?*Which are the key factors driving the Cell Therapy Market?*What was the size of the emerging Cell Therapy Market by value in 2019?*What will be the size of the emerging Cell Therapy Market in 2025?*Which region is expected to hold the highest market share in the Cell Therapy Market?*What trends, challenges and barriers will impact the development and sizing of the Global Cell Therapy Market?*What is sales volume, revenue, and price analysis of top manufacturers of Cell Therapy Market?*What are the Cell Therapy Market opportunities and threats faced by the vendors in the global Cell Therapy Market Industry?

With tables and figures helping analyze worldwide Global Cell Therapy Market growth factors, this research provides key statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market.

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1.The report offers statistical data in terms of value (US$) as well as Volume (units) till 2027.

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4.The data analysis present in the Cell Therapy report is based on the combination of both primary and secondary resources.

5.The report helps you to understand the real effects of key market drivers or retainers on Cell Therapy business.Significant highlights covered in the Global Cell Therapy market include:

*In-depth market analysis, including information about current Cell Therapy market drivers and challenges

*An exhaustive study on the expected trends, changing market dynamics, and market intelligence

*Porters Five Forces analysis discussing the potentiality of buyers and sellers operating in the market, which is likely to help in developing efficient strategies

*Detailed analysis of the changing competitive scenario and thorough vendor analysis

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We will provide you an analysis of the extent to which the global Cell Therapy acquires commercial characteristics along with examples or instances of information that helps you to understand it better.

We will also help to identify customary/ standard terms and conditions, as like offers, worthiness, warranty, and others for the Cell Therapy industry.

Also, this report will help you to identify any trends to forecast Cell Therapy growth rates.

The analysed report will forecast the general tendency for supply and demand in Cell Therapy market.

Thanks for reading this article you can also get individual chapter wise section or region wise report version like North America, Europe, MEA or Asia Pacific.

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Adroit Market Research is an India-based business analytics and consulting company incorporated in 2018. Our target audience is a wide range of corporations, manufacturing companies, product/technology development institutions and industry associations that require understanding of a markets size, key trends, participants and future outlook of an industry. We intend to become our clients knowledge partner and provide them with valuable market insights to help create opportunities that increase their revenues. We follow a code Explore, Learn and Transform. At our core, we are curious people who love to identify and understand industry patterns, create an insightful study around our findings and churn out money-making roadmaps.

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Cell Therapy Market Will Generate New Growth Prospects In The Next Upcoming Years With The Huge Demand, Business Strategies and High CAGR By 2026 -...

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CAR T-cell therapy treatment helps cancer patient beat near impossible odds – ABC News

Posted: November 25, 2020 at 11:54 pm

A cancer patient who was given less than a two per cent chance of survival has beaten the odds thanks to a new treatment that alters patient's immune cells to recognise and fight cancer.

Troy Daley was the first person in Australia to trial CAR T-cell therapy to treat mantle cell lymphoma.

The 45-year-old's ordeal began when he discovered a lump in his groin during a shower in 2014 and went to his GP.

"The next thing I knew I was on the operating table having biopsies done and scans done," he said.

About a week later, he was diagnosed with Mantle cell lymphoma a rare type of non-Hodgkin lymphoma.

When Mr Daley was initially diagnosed, his GP told him there was a 98 per cent chance he would be dead within the next six months.

"Telling the family's probably the hardest thing I've ever had to do," he said.

"I had a bit of a slack night that night and the next day I woke up and decided I was too young to fall over and got the gloves on."

Mr Daley was admitted to the Lismore Base Hospital for chemotherapy and received a stem cell transplant in Brisbane, but the treatments were not match for the aggressive cancer.

"(It) came back pretty quick, within sort of six to eight months it was a bit of a shock to everybody," he said.

Mr Daley's haematologist, Dr Dan Scott said he was put on cancer drug Ibrutinib, which worked initially, but after two-and-a-half years his condition progressed.

The next step would have been a bone marrow transplant, but despite a world-wide pool of donors no suitable match could be found.

With almost all the options exhausted, Mr Daley was registered with a clinical trial being done at the Peter MacCallum Cancer Centre in Melbourne.

"It was at a stage where we've got to have a go at something," he said.

"We're not going to sit back here and let the gods come and get me."

CAR T-cell therapy is a new form of immunotherapy that uses specially altered T-cells to directly and precisely target cancer cells.

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Dr Scott said the CAR T-cell trial was used in conjunction with ibrutinib to treat Mr Daley's cancer.

"That's what's been exciting and different about Troy's case is he's had access to this therapy, which is relatively unusual in this disease," he said.

Dr Scott said the results have far exceeded expectations.

He said a recent PET CT scan showed "no evidence of lymphoma".

"We've also done a bone marrow biopsy recent where we look under a microscope and look for any evidence of residual lymphoma and there was no evidence in Troy's case," Dr Scott said.

A third test, which involves looking for traces of lymphoma beyond a microscopic level, has also come back clear.

"At this point in time the results are as good as we could have ever hoped for," Dr Scott said.

Mr Daley said the results were "10 times better" than anyone could have predicted.

"Within 28 days we've had more success than we've had in five years," he said.

"We don't exactly know what the future holds but at this stage, for what I've been through I couldn't be any better."

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CAR T-cell therapy treatment helps cancer patient beat near impossible odds - ABC News

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CARsgen Therapeutics to Present Multiple Myeloma Cell Therapy Data at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition in…

Posted: November 25, 2020 at 11:54 pm

SHANGHAI, Nov. 20, 2020 /PRNewswire/ -- CARsgen Therapeutics, a clinical-stage biopharmaceutical company, today announced that data from its global multiple myeloma program will be presented, including two oral presentations and one poster session, at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place virtually December 5-8, 2020.

Presentations will include updated safety and efficacy results from investigator-initiated clinical studies of CT053 and preliminary data from the ongoing Phase 1 and 1b/2 clinical studies of CT053 in China (LUMMICAR STUDY 1) and the United States (LUMMICAR STUDY 2). CT053 is an investigational anti-BCMA (B cell maturation antigen) autologous chimeric antigen receptor (CAR) T-cell product for the treatment of adult patients with relapsed and/or refractory multiple myeloma.

Results from LUMMICAR-1: A Phase 1 Study of Fully Human B-Cell Maturation Antigen-Specific CAR T Cells (CT053) in Chinese Subjects with Relapsed and/or Refractory Multiple MyelomaPresenting Author:Wenming Chen, MD, PhD, Beijing Chao-Yang Hospital of Capital Medical University, Beijing, ChinaDate/Time:Poster #1396, Saturday, December 5, 2020: 7:00 AM-3:30 PM PST

Results from LUMMICAR-2: A Phase 1b/2 Study of Fully Human B-Cell Maturation Antigen-Specific CAR T Cells (CT053) in Patients with Relapsed and/or Refractory Multiple MyelomaPresenting Author:Shaji K. Kumar, MD, Division of Hematology, Mayo Clinic, Rochester, MNDate/Time:Oral #133, Saturday, December 5, 2020: 9:30 AM-11:00 AM PST

Two-Year Follow-up of Investigator-Initiated Phase 1 Trials of the Safety and Efficacy of Fully Human Anti-BCMA CAR T Cells (CT053) in Relapsed/Refractory Multiple MyelomaPresenting Author:Siguo Hao, MD, PhD, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, ChinaDate/Time:Oral #132, Saturday, December 5, 2020: 9:30 AM-11:00 AM PST

About CT053 and LUMMICAR

CT053 is a CAR T-cell therapy that targets B-cell maturation antigen (BCMA), a protein expressed on the surface of malignant and normal plasma cells. The CT053 construct utilizes a fully human anti-BCMA scFv domain, hypothesized to reduce immunogenicity and improve safety. CT053 T cells are proposed to recognize, bind, and eradicate multiple myeloma cells that express BCMA.

CT053 has received regenerative medicine advanced therapy (RMAT) and orphan drug designations from the U.S. Food and Drug Administration and PRIority MEdicines (PRIME) and orphan drug designations from the European Medicines Agency.

CARsgen Therapeutics' clinical development program for CT053 includes the clinical studies: LUMMICAR STUDY 1 (NCT03975907 Phase 1, China) and LUMMICAR STUDY 2 (NCT03915184 Phase 1b/2, United States and Canada). These are open-label, multicenter studies evaluating the safety and efficacy of CT053 in adult patients with relapsed and/or refractory multiple myeloma. CT053 studies also include three investigator-initiated trials (NCT03380039; NCT03716856; NCT03302403). For more information, visit clinicaltrials.gov.

About CARsgen Therapeutics

CARsgen Therapeutics is a clinical-stage immuno-oncology company committed to the development of first-in-class and best-in-class CAR T-cell and antibody therapeutics.

Founded in 2014, CARsgen is based in Shanghai, with operations in both China and the United States. CARsgen has established a broad pipeline of CAR T-cell product candidates covering several solid and blood tumors in areas of significant unmet medical need. The company has launched several first-in-class CAR T-cell clinical trials for the treatment of relapsed/refractory tumors, including CAR-claudin18.2 for gastric and pancreatic cancer, CAR-GPC3 for hepatocellular carcinoma (HCC) and squamous lung cancer and CAR-EGFR/EGFRvIII for glioblastoma. CARsgen also has ongoing clinical CAR T-cell programs with a humanized CAR-CD19 for leukemia and lymphoma.

For more information, please visit: http://www.carsgen.com

SOURCE CARsgen Therapeutics Co. Ltd.

http://www.carsgen.com

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CARsgen Therapeutics to Present Multiple Myeloma Cell Therapy Data at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition in...

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