Category Archives: Stem Cell Therapy

When Dan Kemp was plottinghis next move after Takeda, he was blown away by data from Wugen, a biotech working on off-the-shelf natural killer (NK) cell therapies. Now, after four months in the CEO seat, hes ready to take those treatments to the next level with a $172 million financing.

The proceeds will bankroll the development of the companys memory NK cell platform and advance its lead program, WU-NK-101, through a phase 1/2 trial in acute myeloid leukemia (AML) and into new studies in solid tumors. The funding will also support Wugens broader pipeline, including an allogeneic CAR-T treatment for T-cell leukemia and lymphoma.

Wugen is one of several biotechs pursuing NK cell therapies to go where CAR-T treatments cannot. Despite its success in blood cancers, CAR-T has faced challenges in solid tumors. And all four of the FDA-approved CAR-T treatments are autologous, meaning theyre made from a patients own cells, which stops them from being widely available.

RELATED: Catamaran Bio sets sail with $42M to create off-the-shelf CAR-NK treatments

The biggest differentiator [of NK cell treatments] from CAR-T is the fact that there is this continual concern around safety. Cytokine release syndrome or neurotoxicity appear to be unavoidable consequences of CAR-T cell therapy, Kemp said, referring to side effects of CAR-T that happen when the treatment activates the immune system too strongly.

T-cell therapy developers have learned to expect these effects and try to manage them rather than avoid them. But NK cell treatments may become a safer alternative.

On the NK side of things, weve seen no toxicity at all; its a pristine safety profile, Kemp said. Thats consistent with other NK cell products that are in the clinic as well.

And thats not allWugen reckons its approach could have an advantage over other NK cell treatments. Its platform generates memory NK cells, which are better at killing cancer cells and last longer in the body than conventional NK cells.

RELATED: Sanofi inks $358M Kiadis takeover to acquire NK-cell platform

Conventional NK cells, like those derived from stem cells, cord blood or peripheral blood, must be engineered to provide sufficient potency to drive any clinical efficacy, Kemp said. Memory NK cells and WU-NK-101 have shown significant efficacy in AML without any engineering at all.

We essentially prime the cells into a superpotent phenotype and expand them so we can actually leverage the innate ability of NK cells themselves to have true clinical potency, he added.

That said, the company plans to combine its NK cell treatments with other cancer-fighting drugs and make engineered NK cell products that could work even better, Kemp said.

Moving forward, Wugen will start a global, multicenter study for WU-NK-101 and file an IND for its CAR-T program in T-cell leukemia and lymphoma later this year, Kemp said. Trials of WU-NK-101 in solid tumors will follow in 2022. As it ramps up its pipeline, the company will aggressively build its team. It currently has 40 staffers across sites in St. Louis and San Diego.

See the original post:
New CEO, check. $172M round, check. Wugen's off-the-shelf cell therapies are ready for takeoff - FierceBiotech

CAMBRIDGE, Mass., July 19, 2021 /PRNewswire/ -- BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly owned subsidiary of Bayer AG, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DA01 for advanced Parkinson's disease (PD). DA01, BlueRock's pluripotent stem cell-derived dopaminergic neuron therapy, is under evaluation in a Phase 1 study.

BlueRock Therapeutics (PRNewsfoto/BlueRock Therapeutics)

The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation may be eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for accelerated approval and priority review.

"Receiving Fast Track Designation from the FDA is an important step, which will help us further accelerate clinical development of our DA01 cell therapy approach for Parkinson's disease," says Joachim Fruebis, Ph.D., BlueRock's Chief Development Officer. "This is another critical step in the BlueRock mission to create authentic cellular medicines to reverse devastating diseases, with the vision of improving the human condition."

About the TrialThe trial will enroll ten patients in the United States and Canada. The primary objective of the Ph1 study is to assess the safety and tolerability of DA01 cell transplantation at one-year post-transplant. The secondary objectives of the study are to assess the evidence of transplanted cell survival and motor effects at one- and two-years post-transplant, to evaluate continued safety and tolerability at two years, and to assess feasibility of transplantation.

More information about this trial is available at clinicaltrials.gov (NCT#04802733).

About Parkinson's DiseaseParkinson's disease is a progressive neurodegenerative disorder caused by nerve cell damage in the brain, leading to decreased dopamine levels. The worsening of motor and non-motor symptoms is caused by the loss of dopamine-producing neurons. At diagnosis, it is estimated that patients have already lost 60-80% of their dopaminergic neurons. Parkinson's disease often starts with a tremor in one hand. Other symptoms are rigidity, cramping and dyskinesias. Parkinson's disease is the second most common neurodegenerative disorder, impacting more than 7.5 million people, including 1.3 million people in North America.

Story continues

About BlueRock TherapeuticsBlueRock Therapeutics is an engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. The company's cell+gene platform enables the creation, manufacture, and delivery of authentic cell therapies with engineered functionality by simultaneously harnessing pluripotent cell biology and genome editing. This enables an approach where, in theory, any cell in the body can be manufactured and any gene in the genome can be engineered for therapeutic purposes. The platform is broadly applicable, but the company is focused today in neurology, cardiology, immunology, and ophthalmology. In August 2019, the company was acquired by Bayer Pharmaceuticals, for an enterprise value of $1B in upfront and milestone payments. For BlueRock this marks the next step in the journey to prove degenerative disease is reversible, and to bring our revolutionary new medicines to the patients who desperately need them. For more information, visit http://www.bluerocktx.com.

About BayerBayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability, and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to http://www.bayer.com.

Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. These forward-looking statements are based on BlueRock's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing of our clinical trial for DA01; our results regarding the safety, tolerance and efficacy of DA01 cell transplantation for patients with Parkinson's disease; and ongoing FDA and other regulatory requirements regarding the development of DA01. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Except as expressly required by law, BlueRock does not undertake an obligation to update or revise any forward-looking statement. All of the Company's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

Cision

View original content to download multimedia:https://www.prnewswire.com/news-releases/bluerock-therapeutics-receives-fda-fast-track-designation-for-da01-in-the-treatment-of-advanced-parkinsons-disease-301336295.html

SOURCE BlueRock Therapeutics

The rest is here:
BlueRock Therapeutics Receives FDA Fast Track Designation for DA01 in the Treatment of Advanced Parkinson's Disease - Yahoo Finance

PHOENIX, July 20, 2021 /PRNewswire/ -- (OTC CELZ)Creative Medical Technology Holdings Inc. announced today the launching of its second Regenerative Immunology product, MyeloCelz.

In contrast to the Company's ImmCelz product, which utilizes primarily T cells and B cells to induce activation of the body's own stem cells and healing processes, MyeloCelz utilizes the innate immune system, particularly cells of the monocyte/macrophage lineage.

"Immunotherapy is the future of medicine. In the field of oncology immunotherapy it has saved thousands of lives and resulted in the Nobel Prize in Medicine." Said Thomas Ichim, Ph.D, Chief Scientific Officer, and Co-Founder of the Company. "We believe that in using ImmCelz and MyeloCelz, we are in the position to advance immunotherapy for treatment of degenerative conditions, an approach that we term "Regenerative Immunotherapy". This is a first-in-class therapeutic direction that leverages the specificity, amplification, and memory of the immune system in order to accelerate the body to restore its function."

"The unique thing about MyeloCelz, like ImmCelz, is that the cellular product is personalized and the patient is receiving their own cells back into themselves. This not only significantly increases the safety of the procedure, but also conceptually may increase efficacy because the body's own cells know best how to interact with the body." Said Dr. Courtney Bartlett, Director of Clinical Development.

"Having recently joined the Scientific Advisory Board of the Company, I am astonished at the expedience, innovation, and productivity of the team assembled by Dr. Thomas Ichim, Chief Scientific Officer of the Company." Said Dr. Camillo Ricordi. "MyeloCelz, which is a parallel immunotherapy approach to ImmCelz, is another paradigm shifting product and to my knowledge, is covered by one of the most comprehensive patent applications in cell therapy."

The Company's first regenerative immunotherapy product, ImmCelz was demonstrated effective in numerous animal models of autoimmunity and is the subject of a filed and pending FDA IND for use in stroke. ImmCelz was featured at the international stem cell conference, The World Stem Cell Summit, with the presentation available at this link https://www.youtube.com/watch?v=LTHUxz_xN5w .

"I am grateful for our team of scientific advisors and collaborators, who have worked diligently and ingeniously to develop a cellular therapy that leverages aspects of the innate immune system in stimulating the body to heal itself naturally. The addition of MyeloCelzto our Regenerative Immunotherapy portfolio, which includes ImmCelz and multiple patent filings on the treatment of specific indications, clearly demonstrates our dedication to the immunotherapy space." Said Timothy Warbington, President and CEO of the Company.

About Creative Medical Technology HoldingsCreative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative medicine/stem cell technology in the fields of immunotherapy, urology, neurology and orthopedics and is listed on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking StatementsOTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at http://www.sec.gov.

Creativemedicaltechnology.comwww.StemSpine.comwww.Caverstem.comwww.Femcelz.com http://www.MyeloCelz.comwww.OvaStem.comwww.ImmCelz.com

SOURCE Creative Medical Technology Holdings, Inc.

http://creativemedicaltechnology.com

Read this article:
Creative Medical Technology Holdings Announces MyeloCelz The Company's Second Regenerative Immunotherapy Product - PRNewswire

Acquisition Advances Transformation Into Platform Company Focused on Cell, Gene Editing and Cytokine Therapy

Company to hold Conference Call Today, July 19, 2021, at 4:15PM ET to Discuss the Transaction and Future Plans

NEW YORK, July 19, 2021 (GLOBE NEWSWIRE) -- Brooklyn ImmunoTherapeutics, Inc. (NYSE American: BTX) (Brooklyn), a biopharmaceutical company focused on exploring the role that cytokine and gene editing/cell therapy can have in treating patients with cancer, blood disorders, and monogenic diseases, today announced that it had completed, on July 16, 2021, its acquisition of Novellus Therapeutics Limited (Novellus). Novellus is developing next-generation engineered mesenchymal stem cell (MSC) therapies using extensively patented mRNA-based cell reprogramming and gene editing technologies licensed from Factor Bioscience (Factor). The transaction advances Brooklyns evolution into a platform company with a pipeline of next-generation engineered cellular, gene editing and cytokine programs.

Key Transaction Highlights:

We are confident that the Novellus transaction will provide significant forward momentum in the gene editing and mRNA spaces, said Brooklyns Chief Executive Officer and President Howard J. Federoff, M.D., Ph.D. The addition of Novellus will accelerate our research and development efforts, potentially facilitating faster development of clinical products for orphan diseases such as sickle cell anemia, familial amyloidosis and cell therapies for cancer. We believe the transaction makes it possible for us to enter first-in-human trials as early as 2023 and positions Brooklyn to become a leader in stem cell therapies, gene editing and mRNA therapeutics, with the ability to develop multiple therapeutic candidates rapidly.

We look forward to continuing to update our stockholders on our progress and to speaking with them to provide additional details on this transformative transaction, concluded Dr. Federoff.

Brooklyn will be conducting a conference call at 4:15PM ET on July 19, 2021 to discuss the transaction and future plans. Participants can register for the call here and will receive dial-in information to put them directly into the call. Those who are unable to register may access the conference by calling 1-866-777-2509 (toll free U.S.) or 1-412-317-5413 (internationally) and then asking the operator to join them into the Brooklyn ImmunoTherapeutics conference call. The conference will also be webcast, which can be accessed here. A replay of the call will be available via the webcast link as well as on Brooklyns website in the investor relations section, for one week following the call.

About Brooklyn ImmunoTherapeutics

Brooklyn is focused on exploring the role that cytokine, gene editing, and cell therapy can have in treating patients with cancer, blood disorders, and monogenic diseases.

Brooklyns most advanced program is IRX-2, a human cell-derived cytokine therapy, studying the safety and efficacy of IRX-2 in patients with head and neck cancer in Phase 2B. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.

Brooklyn has multiple next-generation cell and gene-editing therapies in preclinical development for various indications including acute respiratory distress syndrome, solid tumor indications, as well as in vivo gene-editing therapies for rare genetic diseases. For more information about Brooklyn and its clinical programs, please visit http://www.BrooklynITx.com.

Forward-Looking Statements

The third bullet under, and the paragraph immediately following, Key Transaction Highlights contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are any statements that are not statements of historical fact and may be identified by terminology such as believe, plan, possible, potential, project, or will or other similar words. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those stated or implied in any forward-looking statement as a result of various factors, including, but not limited to, uncertainties related to: (i) the evolution of Brooklyns business model into a platform company focused on cellular, gene editing and cytokine programs; (ii)Brooklyns ability to successfully, cost-effectively and efficiently develop its technology and products; (iii)Brooklyns ability to successfully commence clinical trials of any products on a timely basis or at all; (iv)Brooklyns ability to successfully fund and manage the growth of its development activities; (v)Brooklyns ability to obtain regulatory approvals of its products for commercialization; and (vi) uncertainties related to the impact of the COVID-19 pandemic on the business and financial condition of Brooklyn, including on the timing and cost of its clinical trials. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this communication speak only as of the date on which they were made, and Brooklyn does not undertake any obligation to update the forward-looking statements contained herein to reflect events that occur or circumstances that exist after the date hereof, except as may be required by applicable law or regulation.

Investor Relations Contact:CORE IR516-222-2560investors@brooklynitx.com

Media Contact:Jules AbrahamCORE IR917-885-7378julesa@coreir.com

Continue reading here:
Brooklyn ImmunoTherapeutics Completes Acquisition of Novellus Therapeutics - GlobeNewswire

After closing a merger with GX Acquisition Corp., Celularity Inc., a clinical-stage cellular medicine company, is taking the next step in its evolution to enable further development of novel, off-the-shelf allogeneic placentaderived cellular therapies.1

Celularity aims to transform the way we approach the treatment of cancer and other diseases by harnessing the versatility, unique immune biology, and innate stemness of placental-derived cells, Robert J. Hariri, MD, PhD, found, chairperson, and chief executive officer of Celularity, stated in a press release. We are immensely proud of our clinical development results so far as well as the state-of-the-art manufacturing capabilities we built to support rapid scaling and a competitive cost structure for our placental-derived cell therapeutics. We believe off-the-shelf, allogeneic cell therapies will drive a paradigm shift in how clinicians approach the treatment of cancer and other serious diseases.

CYNK-001, the companys lead product candidate, is the only cryopreserved, allogeneic, off-the-shelf natural killer (NK) cell therapy to be developed from placental hematopoietic stem cells. The agent expresses perforin and granzyme B, has showcased cytotoxic activity against hematological tumors and solid tumor cell lines, and can secrete immunomodulatory cytokines in the presence of tumor cells.

The novel therapy is under investigation as a potential option in multiple myeloma, acute myeloid leukemia (AML), and glioblastoma multiforme; it is also being evaluated in infectious diseases like COVID-19 (NCT04365101).

An ongoing, open-label, multi-dose, phase 1 trial (NCT04310592) is examining the maximum-tolerated dose (MTD) or maximum planned dose of CYNK-001 in an estimated 22 patients with acute myeloid leukemia (AML).2 To participate, patients need to have primary or secondary AML and be in first or second morphological clinical response (CR), morphological CR with incomplete hematologic recovery, or a morphologic leukemia-free state per European LeukemiaNet recommendations for AML Response Criteria.

Patients also need to have MRD positivity, be aged between 18 and 80 years old, have an ECOG performance status of 0 to 2, and be able to be off immunosuppressive therapy for at least 3 days before infusion with the therapy. Patients who previously had central nervous system involvement are allowed to enroll if they had been treated and their cerebral spinal fluid is clear for at least 2 weeks before undergoing lymphodepletion.

Exclusion criteria include significant medical conditions, laboratory abnormalities, bi-phenotypic acute leukemia, acute promyelocytic leukemia, unacceptable organ function, autoimmune disease, uncontrolled graft-vs-host disease (GVHD), and GVHD that requires corticosteroids.

Participants are first given cyclophosphamide plus fludarabine. Then, they are administered CYNK-001 at 3 varying dose levels1.8 billion, 3.6 billion, and 5.4 billion CYNK-001 cellson days 0, 7, and 14. The primary objectives of the research include dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), and frequency and severity of adverse effects. Important secondary objectives include the number of patients who convert from MRD-positive to -negative status; time to, and duration of, MRD response; progression-free survival; time to progression; duration of morphologic complete remission; and overall survival.

In June 2021, the study was expanded to include patients with relapsed/refractory AML following a case of conversion to MRD negativity, when the therapy was delivered at its highest dose level.3

The decision to expand the trial followed observations of a patient with NPM-1positive, FLT3-negative AML and good-risk cytogenetics who had been administered 5.4 billion CYNK-001 cells. The patient converted from MRD-positive to -negative status, without experiencing any DLTs.

For this patient, primary induction treatment with 7+3 chemotherapy had failed, and so they had gone on to receive second induction therapy followed by high-dose cytarabine consolidation. At this time point, the patient achieved a complete CR, but MRD was found to be persistent; it did not clear following 4 months of treatment with azacitidine. MRD positivity was confirmed on a marrow biopsy.

The patient went on to enter the phase 1 trial, where they received lymphodepletion, and then received 1.8 billion CYNK-001 cells on days 0, 7, and 14 in the outpatient setting, which totaled to 5.4 billion CYNK-001 cells. On day 28, the patient had converted from MRD positivity to negativity. CYNK-001 cells were present in both the peripheral blood and bone marrow.

Notably, no DLTs have been observed with the therapy at any of the dose levels examined thus far.

The company also shared plans to continue dose escalation with the therapy in the MRD indication up to 9.0 billion CYNK-001 cells. To strengthen the persistence of the treatment, the expansion arms of MRD and relapsed/refractory AML will include an augmented lymphodepletion protocol comprised of cyclophosphamide at 3600 mg and fludarabine at 120 mg over 4 days vs cyclophosphamide at 900 mg plus fludarabine at 75 mg over 3 days.

In April 2021, the FDA granted an orphan drug designation to CYNK-001 as a potential therapeutic option for patients with malignant gliomas.4 As such, the therapy is also under investigation in patients with glioblastoma multiforme as part of another phase 1 trial (NCT04489420).5

To be eligible for enrollment, patients need to have historically confirmed disease at first or second relapse, measurable disease, a Karnofsky performance status of 60 or higher, and acceptable organ function, among other criteria.

Patients who previously received radiation within 12 weeks of their screening MRI; those who were on growth factors with less than 4 weeks of a washout period; those treated with radiotherapy, chemotherapy, or other investigational drugs within 4 weeks; those who received prior cellular or gene therapy; and those with active autoimmune disease, were excluded.

Cohort 1A of the trial will enroll up to 6 patients with recurrent glioblastoma multiforme who will receive intravenous CYNK-001 at a dose of 1.2 x 109 cells on days 0, 7, and 14. From the initial infusion of therapy, patients will be followed for a 42-day DLT period. No other interventions are planned between the last day of treatment.

If DLTs are experienced, cohort 1C, the de-escalation cohort, will include up to 6 patients with recurrent glioblastoma multiforme who will receive the therapy at a dose of 600 x 106 cells on days 0, 7, and 14. These patients will also be followed for DLTs for 42 days post infusion. Cohort 1B, the surgical cohort, will also enroll up to 6 patients, who will be given CYNK-001 at a maximum safe dose of either 1.2 x 109 cells or 600 x 106 cells at days 0, 7, and 14. Patients in this cohort will undergo resection following the last dose of the therapy in the DLT period.

Treatment of cohorts 2A or 2C will only begin after the safety data from cohorts 1A or 1C are determined to be acceptable. Here, patients will first have the Ommaya catheter placement in accordance with institutional policy within 1 week before CYNK-001 infusion on day 0. Cohort 2A will enroll up to 6 patients with recurrent glioblastoma multiforme who will be given the therapy at a dose of 200 x 106 cells +/- 50 x 106 cells intratumorally on day 0, 7, and 14.

Cohort 2C will also include up to 6 patients with recurrent disease who will receive the product at a dose of 200 x 106 cells +/- 50 x 106 cells intratumorally on day 0 and day 7. Lastly, cohort 2B, the surgical intratumoral cohort, will include 6 patients with glioblastoma multiforme who will receive the cellular therapy at a maximum safe dose of either 200 x 106 cells +/- 50 x 106 cells on day 0 and 7.

The primary objectives of the trial are to examine the number of patients who report DLTs with the therapy and toxicities. Important secondary objectives are to evaluate the overall response rate, duration of response, progression-free survival, time to progression, and overall survival.

The safety and efficacy of the cell therapy is also being explored in newly diagnosed patients with multiple myeloma after autologous stem cell transplant, as part of another phase 1 trial (NCT04309084).6 The objective of the program is to achieve durable responses with the therapy in these patients with multiple myeloma who are eligible for transplant in the first-line setting.

Another novel agent in the pipeline is CYNK-101, which is manufactured from NK cells extracted from postpartum placentas. The cells are then genetically engineered to boost cell-killing activity when given with a monoclonal antibody.7 Preclinical data with the product in combination with an antibody showed that the regimen resulted in cell-killing activity when administered to lymphoma cells in vitro.

Additionally, CYNK-CAR products are being developed as allogeneic, off-the-shelf strategies by modifying genes of the human placental hematopoietic stem cellderived NK cells. Several CAR constructs that are designed to target hematologic and solid tumor indications are currently under investigation.

Read the original here:
Developmental Interest in Allogeneic PlacentaDerived Cell Therapies Expands - OncLive

The report published on the Stem Cell Therapy Market Analysis of Key Players, End User, Demand and Consumption By 2026 by Zion Market Research facilitates a closer outlook on opportunities, revenue growth, and current market trends. The report is focused to offer qualitative and quantitative analysis of dynamics and market opportunities prevailing during the forecast period. Also, the report encompasses an in-depth study on the prominent leaders in theStem Cell Therapy Market.

The Leading Market Players Covered in this Report are:

Anterogen Co., Ltd., RTI SurgicalInc., Pharmicell Co., Ltd., MEDIPOST Co., Ltd., JCR Pharmaceuticals Co., Ltd., Holostem Terapie Avanzate S.r.l., NuVasiveInc., and AlloSource.

The market report additionally gives a to-the-point evaluation of the techniques and plans of action that are being executed by the players and companies to contribute to the global Stem Cell Therapy Market growth. Some of the most conspicuous measures taken by the organizations are partnerships, mergers & acquisitions, and collaborations to extend their overall reach. The players are likewise presenting newer product varieties in the market to improve the product portfolio by embracing the new innovation and carrying out it in their business.

Get Sample PDF Brochure @https://www.zionmarketresearch.com/sample/stem-cell-therapy-market

The report provides extensive insights into the key strategies and market development dynamics along with the macro and micro factors in the current market landscape. Also, the report comprises the Covid-19 and post-Covid-19 market landscape to let users identify the upcoming patterns and trends in the global Stem Cell Therapy Market. Our analysts have prepared the report as an indispensable guide for enabling our customers to take qualitative decisions and reap the best results out of it.

The report is segregated into different sections of which few are overview, growth factors, segmentation, regional analysis, and competitive analysis. The only aim to bifurcate the report into different sections is to put forth an in-depth assessment of each parameter and let our users understand the most probable and even the finest trend prevailing in the current landscape. Also, the structure of a report is curated to reveal the future trends and opportunities in the global Stem Cell Therapy Market in the forthcoming years.

This Research Help Grow Your Business [Download free Sample PDF of Research Report]

The overview section reveals the potential, opportunities, and scope of the Stem Cell Therapy Market along with its market size and volume. Also, the section encompasses an in-depth study on value chain analysis and the core working of the market. The growth factor segment elaborates the financial position, technology dynamics, and product portfolio expected in the forthcoming year. Also, the segmentation section bifurcates the whole market landscape into different classes to identify the market size and volume of each segment. However, the regional analysis segment reveals the extensive potential of each region in the global Stem Cell Therapy Market along with its size and volume.

Our analysts have tried to maintain the highest level of transparency and accuracy in the report. Also, the report offers business intelligence solutions for helping our clients to achieve a competitive edge in the global Stem Cell Therapy Market. Moreover, it will help our users to curate effective business strategies to promulgate the growth rate of their business in the forthcoming years. However, all the statistical and quantitative analysis mentioned in the report reflects the real-time data. It covers all the market landscapes to help users understand the present positioning of the global Stem Cell Therapy Market along with the probable market trends in the future.

Inquire More about Report:https://www.zionmarketresearch.com/inquiry/stem-cell-therapy-market

Moving to the drivers and restraints, one will be given all factors that are indirectly or directly helping the development of the global Stem Cell Therapy Market. To get to know the markets development measurements, it is important to evaluate the drivers of the market. Furthermore, the report likewise analyses the current patterns alongside new and plausible growth openings for the global market. Additionally, the report incorporates the components that can restrict the market growth during the forecast period. Understanding these elements is also mandatory as they help in grasping the markets shortcomings.

Primary and secondary methodologies are being utilized by the research analysts to gather the information. Along these lines, this global Stem Cell Therapy Market report is planned at guiding the readers to a superior, clearer viewpoint and information about the global market.

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

More here:
Stem Cell Therapy Market Analysis of Key Players, End User, Demand and Consumption By 2026 26 Sports - 2x6 Sports

Newswise BUFFALO, N.Y. A research team led by Fumito Ito, MD, PhD, FACS, of Roswell Park Comprehensive Cancer Center reports new data on the promise of combining standard treatment for breast cancer with a particular form of cancer immmunotherapy dendritic-cell (DC) treatment vaccines. This study, published in the Journal for ImmunoTherapy of Cancer, is the first to demonstrate that in situ dendritic-cell vaccines can improve the effectiveness of radiation therapy for some aggressive and treatment-resistant forms of breast cancer.

Although immunotherapy with primary conventional dendritic cells is a promising approach, obtaining a sufficient number of circulating conventional dendritic cells has proved difficult, says Dr. Ito, who is Associate Professor of Surgical Oncology at Roswell Park. Use of induced pluripotent stem cells (iPSCs) has been proposed to overcome that limitation, but the feasibility of this approach had not previously been demonstrated.

The teams results show that intratumoral administration of iPSC-DCs significantly enhanced antitumor efficacy of local irradiation, which is commonly incorporated into treatment plans for patients with breast cancer.To better understand the potential of this approach, Dr. Ito and colleagues conducted laboratory studies to assess the antitumor efficacy of intratumoral injection of iPSC-DCs, or dendritic cells derived from iPSCs, and radiotherapy in models of triple-negative breast cancer that have shown resistance to anti-PD-L1 checkpoint inhibition immunotherapy.

The researchers demonstrate that radiation therapy increased the trafficking of intratumorally injected iPSC-DCs to the tumor-draining lymph nodes and augmented the activation of tumor-specific T cells. Their work shows that this multimodal intralesional therapy can control growth of distant tumors and render some breast cancers responsive to anti-PD-L1 therapy

While our work to develop this strategy is at an early stage and will need to be studied further, we show that these two approaches, radiotherapy and intratumoral iPSC-DC administration, can work synergistically to control not only local tumor growth but also distant tumors. And we saw evidence of systemic tumor-specific immunological memory, suggesting a potential for long-term tumor control, says Dr. Ito.

This study sheds light on the antitumor efficacy of in situ administration of iPSC-DCs when integrated with radiotherapy against poorly immunogenic tumors. These findings align with another study from Dr. Ito and his team, recently published in Nature Communications, that showed potent systemic antitumor immunity caused by combinational multimodal intralesional therapy.

Currently, efficacy of immunotherapy against breast cancer is limited, adds Dr. Ito. Our hope is to improve clinical outcomes for patients with advanced unresectable and metastatic breast cancer.

This work, In situ delivery of iPSC-derived dendritic cells with local radiotherapy generates systemic antitumor immunity and potentiates PD-L1 blockade in preclinical poorly immunogenic tumor models, was supported by several grants from the National Cancer Institute (project numbers P30CA016056, K08CA197966, and R50CA211108), as well as the Melanoma Research Alliance, Sarcoma Foundation of America and Uehara Memorial Foundation.

###

For an online version of this release, please visit: https://www.roswellpark.org/newsroom/202107-roswell-park-team-shows-dendritic-cell-vaccines-can-be-paired-standard-therapy

Roswell Park Comprehensive Cancer Center is a community united by the drive to eliminate cancers grip on humanity by unlocking its secrets through personalized approaches and unleashing the healing power of hope. Founded by Dr. Roswell Park in 1898, it is the only National Cancer Institute-designated comprehensive cancer center in Upstate New York. Learn more at http://www.roswellpark.org, or contact us at 1-800-ROSWELL (1-800-767-9355) or [emailprotected].

Read the original:
Roswell Park Team Shows Dendritic-Cell Vaccines Can Be Paired With Standard Therapy for Breast Cancer - Newswise

Danish pharma company Novo Nordisk has announced a new collaboration and licence agreement with Japans Heartseed to develop the companys investigational cell therapy HS-001 for heart failure.

HS-001, Heartseeds lead asset, is an investigational cell therapy using purified cardiomyocytes derived from induced pluripotent stem cells (iPSC). The therapy is currently being developed as a treatment for heart failure.

Heartseed is already planning to launch a phase 1/2 study of HS-001 in Japan in the second half of 2021, which will evaluate the safety and efficacy of the therapy for the treatment of heart failure caused by ischaemic heart disease.

Under the terms of their agreement, Novo Nordisk will gain exclusive rights to develop, manufacture and commercialise HS-001 globally, excluding Japan where Heartseed will retain the rights to solely develop the therapy.

However, Novo Nordisk has the rights to co-commercialise HS-001 with Heartseed in Japan, with equal profit and cost sharing.

In return, Heartseed is eligible to receive up to a total $598m, with $55m earmarked in upfront and near-term milestone payments.

The Japanese biotech company is also eligible to receive tiered high single-digit to low double-digit royalties of annual net sales on the product outside Japan.

"We are delighted to have a company with the expertise and resources of Novo Nordisk as our partner for development and commercialisation of HS-001, and are also honoured that Novo Nordisk has recognised the innovativeness and high potential of our technology," said Keiichi Fukuda, chief executive officer of Heartseed.

"We believe that the partnership with Novo Nordisk is very valuable as we seek to disseminate our Japan-origin innovation globally as early as possible, he added.

Through this important collaboration with Heartseed, we aim to pioneer novel treatment solutions for people with cardiovascular disease, said Marcus Schindler, chief scientific officer, EVP research and early development at Novo Nordisk.

We [will] gain access to an innovative clinical asset, underlying technology and deep expertise within the field of iPSC biology and cardiac cell transplantation, which can be combined with our knowledge and capabilities in stem cell biology and manufacturing, he added.

Follow this link:
Novo Nordisk partners with Heartseed on heart failure cell therapy - PMLiVE

WWE Hall of Famer Diamond Dallas Page and his girlfriend, Payge McMahon, announced they are heading to Bio Excellorator in Colombia to receive total body stem cell therapy.

The WWE Hall of Famer posted a video on his Twitter, revealing he is looking to get stem cell therapy for his neck, back, shoulders, and knees.

Hey guys its me, Diamond Dallas Page, WWE Hall Of Famer. After years of pro wrestling beating up my body, I cant tell you how excited I am to be heading to Medellin, Colombia to see my good friends at BIO Excellorator, DDP said.

Because they are gonna hook me up with some serious stem cells, in my neck, in my back, in my shoulders, and in my knees. I am looking for bio accelerator to take me from 65 years old to 65 years young. And thats a fact.

DDP also posted a photo at the airport as he and his girlfriend began their trip to Columbia.

Visit link:
WWE Hall Of Famer To Receive Stem Cell Therapy - Wrestling Inc.

Advancing Next Generation Cell And Gene Therapy

Cancer doesnt stop for COVID-19 or anything else, says Jay Feinberg and neither does he.

The founder of the nonprofit Gift of Life Marrow Registry in Boca Raton is determined to democratize and redefine cell and gene therapy to save lives.

A leading global stem cell donor registry with three decades of experience curing cancers like leukemia with stem cell transplants, Gift of Life will launch a new, for-profit biotech subsidiary this year: Gift of Life Biologics. Groundbreaking innovations in this field have led to a significant demand from biopharmaceutical firms for these same donor stem cells, useful as building blocks for next generation living drugs to treat cancer and other life-threatening diseases.

Our goal is to be a single source for the new era of therapeutics by tapping into our donor registry, collection center, cell therapy laboratory, quality systems and information technology all housed under one roof at Gift of Lifes 32,000 square-foot headquarters, says Feinberg.

Companies creating revolutionary treatments will find a tremendous resource in Gift of Life Biologics, which will deliver high-quality cell products and solutions advancing medical therapies at any stage of development from research through commercialization.

While many advancements have been made in cellular therapy treatments, certain critical barriers still impede success for patients, said Feinberg, who survived leukemia thanks to a bone marrow transplant 25 years ago.

As a majority owner of the Biologics company, Gift of Life will use revenues earned to fund the growth of the registry in order to save even more lives. Biologics is seeking impact investors in an initial raise of $5 million to help start the venture.

In November 2020, the organization also launched the nonprofit Gift of Life Center for Cell and Gene Therapy. The laboratory processes and freezes donor stem cells in a BioBank making them available off the shelf for faster transplants.

Our goal is to ensure that every patient has an equal opportunity to receive a transplant and other lifesaving therapies, says Feinberg, who is constantly looking for new ways to help patients in need, and procuring charitable funding to grow the donor registry and additional operations.

Gift of Life Biologics, 5901 Broken Sound Parkway N.W., Ste. 600, Boca Raton, FL 33487, 561-982-2900, giftoflifebio.org

Power Players Special Advertising Section

See the original post:
Gift of Life Biologics - The Boca Raton Observer