Category Archives: Cell Therapy

SOUTH SAN FRANCISCO, Calif. and BOSTON and SHANGHAI, China, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, and Overland Pharmaceuticals (Overland), a premier biopharmaceutical company backed by Hillhouse Capital, today announced the formation of Allogene Overland Biopharm (Allogene Overland). The joint venture will focus on the development, manufacturing and commercialization of AlloCAR T therapies for patients in greater China, Taiwan, South Korea and Singapore. Allogene Overland will have an exclusive license to develop, manufacture and commercialize specific Allogene candidates targeting BCMA, CD70, FLT3, and DLL3 in the licensed territories. The joint venture will also seek opportunities to advance the global development of AlloCAR T therapies against these targets.

We are excited to be the first allogeneic cell therapy company to establish a joint venture in China dedicated to making the potential benefits of an off-the-shelf cell therapy available to patients in China and other Asian Pacific markets, said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. Were looking forward to joining forces with Overland to build a leading cell therapy company focused on helping to accelerate the development of AlloCAR T therapies for blood cancers and solid tumors.

Overland has a strong operational presence in China backed by the Hillhouse Capital global biopharmaceutical ecosystem. Combined with Allogenes domain expertise, this positions Allogene Overland Biopharm to bring these important new therapies to patients and physicians fighting cancer across Asia and around the world, said Hua Mu, M.D., Ph.D., Co-Founder, Interim Chief Executive Officer and Chief Medical Officer of Overland Pharmaceuticals.

Allogene has an established track record of success in the design, manufacture and development of innovative cell therapies, added Ed Zhang, M.B.A., Co-Founder, Chief Operating Officer and Chief Business Officer of Overland Pharmaceuticals. Together, we establish a broad strategic partnership and will jointly move forward the development and global expansion of this cutting-edge technology platform.

Under the terms of the agreement, Allogene Overland will receive an exclusive license to AlloCAR T candidates directed at four targets, BCMA, CD70, FLT3, and DLL3, in the licensed territories. Overland will invest $117 million in capital, which includes an upfront payment of $40 million to Allogene and $77 million in capital to support joint venture operations. Overland and Allogene are the sole equity holders in Allogene Overland. Allogene will be eligible to receive a milestone payment per product for each first regulatory approval in China, as well as tiered royalties on net sales. Overland will provide development and operational support while Allogene will provide technical and manufacturing expertise. Allogene Overland will be governed by a Board of Directors with equal representation from Overland and Allogene.

Allogene has an exclusive license to the Cellectis technology for its allogeneic products and holds all global development and commercial rights for these investigational candidates.

About Overland PharmaceuticalsOverland Pharmaceuticals is building a fully integrated biopharma company with a mission to bring innovative medicines to underserved patients in Asia and around the world. By leveraging our resources, global network, and local expertise across the biopharma ecosystem in Asia, Overland is establishing a portfolio of differentiated therapeutic candidates in a few carefully selected therapeutic areas. Throughformative partnerships, Overland will move forward the development and commercialization of the most promising advances in medicine.www.overlandpharma.com

About Allogene TherapeuticsAllogene Therapeutics, with headquarters inSouth San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visitwww.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements for AllogeneThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability of the joint venture company to establish subsidiaries and operations in China and other Asian Pacific markets; the ability of the joint venture company to progress clinical trials, manufacture, or commercialize AlloCAR T therapies in China and other Asian Pacific markets; the potential for and ability to receive any payments from the joint venture company; and the potential benefits of AlloCAR T therapies. Various factors may cause differences between Allogenes expectations and actual results as discussed in greater detail in Allogenes filings with theSEC, including without limitation in its Form 10-Q for the quarter endedSeptember 30, 2020. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

AlloCAR T is a trademark of Allogene Therapeutics, Inc.

Allogene Media/Investor Contact:Christine CassianoChief Communications Officer(714) 552-0326Christine.Cassiano@allogene.com

Overland Pharmaceuticals Media Contact:Kari Watson or Madeline DavidshoferMacDougall kwatson@macbiocom.com or mdavidshofer@macbiocom.com781-235-3060

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Allogene Therapeutics and Overland Pharmaceuticals Form Joint Venture in Greater China to Develop and Commercialize AlloCAR T Cell Therapies -...

OSS, Netherlands, Dec. 17, 2020 /PRNewswire/ --Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic off-the-shelf Natural Killer (NK) cells, and Ghent University (UGent) have signed a license agreement for an innovative NK cell production technology. Ultimately, this agreement will bring significant benefit to targeted treatment of patients suffering from cancer. The agreement not only opens up new opportunities for development of NK-antibody combination therapies but also has significant positive impact on the production time of Glycostem's lead product oNKord and its second (CAR-NK) and third (TCR-NK) generation therapies viveNKTM.

"This license agreement offers new opportunities for more targeted treatment of cancer patients. By using UGent's technology we are able to increase the expression of CD16 receptors resulting in an increase of the NK-cell's activity and its antibody binding properties. When a patient's immunity is weak, administering NK-cells will boost the patient's immune system and increase the antibody's therapeutic effectiveness," explains Troels Jordansen, CEO at Glycostem.

Glycostem's NK-cell based therapies are manufactured in its in-house GMP licensed facility. "Ghent University's technology has the potential to almost halve the time needed for NK cell progenitor cells to differentiate into fully functional NK-cells. By incorporating this in our processes both our manufacturing time and cost-effectiveness will be affected very positively without negative effect on the potency of the NK cells. This is an important part of paving the way for further upscaling the production of our NK-cells," says Troels Jordansen.

"We are glad to see our research translated to a clinical setting as it is based on many years of fundamental research into NK cell biology," tells Prof. Georges Leclercq, head of the UGent research team and group leader in the Cancer Research Institute Ghent (CRIG). "We hope that with this collaboration, we can positively impact the lives of many patient's affected by difficult to treat cancers."

Dr. Dominic De Groote (UGent Business Development) further explains: "This partnership is the result of continuing efforts by Ghent University and Ghent University Hospital to become a leading academic and clinical center for cell-based therapies. This technology is part of our growing portfolio of oncology and Advanced Therapy Medicinal Products (ATMP) related assets that we are actively developing from the bench to the bedside through our translational platforms."

Taking cellular immunotherapy to the next level

Glycostem is focused on developing first, second and third generation cancer treatments based on NK-cells. This licensing deal will affect Glycostem's full portfolio. After a successful phase I study Glycostem initiated a first-of-its-kind pivotal trial in acute myeloid leukemia (AML) with in-house manufactured nonmodified NK cells (oNKord). Over the coming months, AML patients will receive this form of treatment as part of a phase I-IIa trial. A pivotal phase IIa trial for Multiple Myeloma (MM) patients is expected to start second half of 2021. This makes Glycostem one of the frontrunners in this promising field of cellular immunotherapy.

About Glycostem

Netherlands-based Glycostem Therapeutics BV, a clinical stage biotech company, develops allogeneic cellular immunotherapy to treat several types of cancer. By harnessing the power of stem cell-derived Natural Killer (NK) cells, Glycostem's products are a safe alternative to CAR-T-cells. Glycostem's lead product, oNKord, is manufactured from allogeneic raw material and is available off-the shelf. Thanks to its nine patent families, longstanding technical expertise and resources, as well as 'Orphan Drug Designation', Glycostem has secured a leadership position in the global NK-cell market.

oNKord is produced in a closed system (uNiKTM) in Glycostem's state-of-the-art and GMP (Good Manufacturing Practice) licensed production facility in the Netherlands, from which it can be distributed globally. The production technology includes ex vivo generation of high numbers of NK-cells with a high degree of purity for clinical applications. oNKord successfully passed phase I clinical trial (elderly and frail AML - Acute Myeloid Leukemia - patients), providing solid safety data and strong indication of clinical activity, including response on MRD (Minimal Residual Disease). Results indicate that oNKord may be safely infused in AML patients.

Glycostem is furthermore developing a range of CAR-NK and TCR-NK products in-house and in cooperation with global partners.

Glycostem Therapeutics BV http://www.glycostem.com

Foot note: "oNKord" is a registered trademark of Glycostem in the US and in Europe. Trademark registrations of "viveNK" and "uNiK" are pending.

About Ghent University

Ghent University (UGent) is a major Belgian university located in the heart of Europe. Our organization is dedicated to research and innovation with over 5,500 researchers active in a wide area of life, physical and social sciences. Strong partnerships with the Ghent University Hospital (1000+ beds), VIB, IMEC and global leaders in academia and pharma/biotech industry thrive life science innovation at our university and is part of the thriving Belgian biotech region. Our translational platforms such as CRIG (focus on cancer) and GATE (focus on advanced therapy medicinal products) facilitate to bring science to the patient.

Prof. Georges Leclercq has a longstanding and internationally recognized expertise in differentiation and function of NK cells. The recent focus of his research group is to reveal the role of several transcription factors in the differentiation of human hematopoietic stem cells into mature NK cells, and in the maintenance and function of these mature NK cells. The ultimate aim is to attribute to improved NK-based cancer immunotherapy.

Cancer Research Institute Ghent http://www.crig.ugent.be

SOURCE Glycostem

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Glycostem and Ghent University sign license agreement on NK cell therapy technology - PRNewswire

A new meta-analysis finds high rates of efficacy and high rates of toxicity in multiple myeloma patients treated with B-cell maturation agent (BCMA)-targeted chimeric antigen receptor (CAR)- T cells.

B-cell maturation agent (BCMA)-targeted chimeric antigen receptor (CAR) T-cell therapy is highly effective in treating multiple myeloma (MM), though it does come with significant toxicity, according to a new analysis.

CAR T cell therapy has become one of the most important innovations in cancer therapy in recent years, and BCMA has become one of the most promising myeloma target antigens under investigation, according to corresponding author Sbastien Anguille, MD, PhD, of the University of the University of Antwerp, and colleagues. However, the existing literature examining the use of BCMA-targeted CAR T-cell therapy in MM generally involves small-scale studies that make it difficult to extrapolate broad conclusions about efficacy.

Anguille and colleagues decided to address the problem by performing a meta-analysis of published literature, published this month in the Journal of Hematology & Oncology. They conducted searches of Web of Science and the PubMed/MEDLINE seeking studies involving BCMA and CAR T cells for MM. The studies captured in the searches were published between 2015 and 2020. Twenty-seven studies were located that met inclusion criteria. These studies comprised 640 unique patients, who received a total of 23 different CAR T-cell products.

The authors found a pooled overall response rate (ORR) of 80.5%, with 44.8% of patients achieving a complete response (CR). The pooled CR rate was much higher (71.9%) in studies that used alpaca/llama-based constructs; in studies that used retroviral vectors for CAR transduction, the CR rate was just 18.0%. The median progression-free survival (PFS) was 12.2 months, significantly higher than the 1.9-month PFS of the control groups in the studies, Anguille and colleagues said.

The low PFS in the control group is congruent with previous literature and illustrates the grim prognosis of the patients included so far in BCMA CAR T-cell studies, Anguille and colleagues wrote.

The investigators cautioned that while the therapy had high response rates, those responses were generally temporary and relapses were common.

Anguille and colleagues added that the improvement, albeit temporary, sparked by CAR T-cell therapy also came with significant toxicities.

Four out of 5 patients (80.3%) experienced cytokine release syndrome, and 1 in 10 (10.5%) had neurotoxicity. The authors said neurotoxicity was highest in more heavily pretreated patients compared with those who were not (19.1% versus 2.8%).

The rate of CRS was lower in studies that used murine single-chain variable fragment (scFv)-based CAR constructs, there was still a clear pattern between dosage and toxicity, the investigators said.

For example, with the bb2121 CAR-T product, which contains a murine anti-BCMA scFv, a CRS rate of 96.3% was noted at the recommended phase II dose of 450106 cells, whereas it was only 75.7% and 50.0% at the 300106 and 150106 dose levels, respectively, they said.

In their conclusion, the authors said the data clearly show that BCMA-targeted CAR T-cell therapy is effective, even in cases of advanced MM, but also comes with toxicity concerns. They said the heterogeneity of the data suggest that it might be possible to identify individual factors that can affect safety and efficacy. Such factors would need to be studied in more detail in order to optimize the results of BCMA-based CAR T-cell therapy.

Reference

Roex, G., Timmers, M., Wouters, K. et al. Safety and clinical efficacy of BCMA CAR-T-cell therapy in multiple myeloma. J Hematol Oncol. Published December 2, 2020. doi: 10.1186/s13045-020-01001-1

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B-cell maturation agent (BCMA)-targeted chimeric antigen receptor (CAR)-T-cell therapy: toxic but highly effective in multiple myeloma - AJMC.com...

About two and a half months after the FDA turned away their lead program, Mesoblast $MESO reported a Phase III miss Monday afternoon for their second clinical product. But the Australian biotech pointed toward data in a secondary endpoint it thinks the agency might find promising.

In a late-stage trial measuring rexlemestrocel-L in 537 patients, Mesoblast found that the experimental cell therapy did not significantly reduce hospitalizations over placebo in individuals with recurring heart failure. The program managed to hit secondaries in mortality-rate reduction for earlier stages of heart failure, and its here where Mesoblast hopes it can still pave a path toward accelerated approval should regulators prove receptive.

The hospitalizations in patients with chronic heart failure are really about their ability to handle volume loads and patients who are brittle are not able to handle volume loads very well, CEO Silviu Itescu said in a conference call Monday evening. It appears that our therapy does not have any impact on those types of outcomes.

Investors appeared skeptical of Mesoblasts claims as the companys shares fell after the bell Monday and continued to slide Tuesday morning to down about 17%.

The Phase III trial randomized patients evenly into the drug or placebo arms. Mesoblast enrolled 206 patients with Class II heart failure and 331 individuals who had progressed to Class III, a more severe form of the condition. In order to be included in the study, all patients needed to have been hospitalized for heart failure within nine months of starting treatment.

Mesoblast did not report any numbers or a p-value for the primary endpoint, only saying there was no reduction over placebo in hospitalizations for recurring non-fatal heart failure events.

Instead, the company revealed its positive secondary endpoint data. In all patients, rexlemestrocel-L showed a 60% reduction in heart attacks and stroke related to cardiac death, Mesoblast said, scoring a p-value of 0.002. The therapy also demonstrated a 60% reduction in death from any cause in the Class II population, good for a p-value of 0.037.

Rexlemestrocel-L also prevented such patients from progressing to severe disease but did not specify any numbers, the company said, only reporting a p-value of 0.004. Those in the control arm with maximum standard of care therapy progressed from Class II to Class III after an average of 20 months.

Its these data where Mesoblast now sees a potential path ahead. Itescu further told investors in Mondays call that rexlemestrocel-L could prove a complementary medicine to drugs that reduce hospitalizations but dont reduce mortality. He also said in previous meetings with the FDA that the agency has made clear it is focusing on mortality, despite hospitalization serving as primary.

When the company started its trial, Itescu said, the theory for the underlying mechanism was that the medicine could reduce inflammation in heart muscles, protect tissue from dying and prevent those muscles from becoming scar tissue.

The question then goes to why do we have this major benefit on mortality? Itescu said on the call. I think the data that weve seen here, where weve seen this dramatic reduction in mortality in patients who are at an advanced stage of disease but not yet so advanced that theyre not able to be rescued, suggests that this mechanism may be playing a key role.

Itescu also noted the programs benefits in less severe cases of heart failure, saying it could potentially be used to intervene before patients progress past Class II. The key moving forward will be meeting with regulators and figuring out exactly the right time to dose patients.

Mondays results follow the FDA handing Mesoblast a CRL for its acute graft-versus-host disease program, remestemcel-L, back in October. Regulators objected to the nature of the data package, with the company hoping to gain approval on the basis of only a single, open-label trial. Despite the rejection, Novartis partnered with the biotech last month in a $1.2 billion-plus deal, hoping to develop the candidate for ARDS, including cases related to Covid-19.

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Mesoblast spins a PhIII cell therapy miss in heart failure as a win, highlighting positive mortality data - Endpoints News

CAR T-Cell Therapy Saves Family

A young mom in England, Helen Wynne Hughes, 32, was diagnosed with Hodgkin lymphoma on Christmas Eve two years ago and was told to prepare her children for the worst. The mom, heartbreakingly, made memory boxes for her children, thinking that she didnt have many Christmases left, reported The Daily Mail.

Related: My Chemo Smirk! Radio Host Dan Bongino Shares Treatment Picture As He Fights Hodgkin Lymphoma

But thanks to CAR T-Cell therapy, the mom has made a full recovery and will hopefully have many more Christmases with her family.

Hughes was diagnosed with lymphoma during pregnancy after a scan showed a large mass on her chest. She began chemotherapy and then gave birth just 10 weeks later to a healthy baby girl. Thankfully, she qualified for CAR T-cell therapy. Hughes called it her last hope. Undergoing this therapy led to a full recovery.

Related: 7 Sneaky Symptoms of Hodgkin Lymphoma: Doctor Told One Teen Her Itchy Rash Later Diagnosed at Stage 4 Was Nothing to Worry About

Dr. Catherine Diefenbach, a Medical Oncologist at New York University Langone Health, spoke to us in an earlier interview about the possibility of lymphoma relapses. She said, There are over 68 kinds of lymphoma. For this reason, its very important that if you have a diagnosis of lymphoma, youre treated by a lymphoma specialist.

Related: CAR T-Cell Therapy: What You Should Know About Side Effects

She went on to explain,And we hope for all of our lymphoma patients that the first therapy you receive will be your last therapy. That is, that we can treat you and cure you with first line therapy. In general, non-Hodgkin lymphomas are divided into aggressive or indolent lymphomas. And the approach to these lymphomas is very different. Aggressive lymphomas are treatable and potentially curable. Indolent lymphomas are managed and dont always require treatment. However, they are not curable by conventional means of describing curability.

Could Your Lymphoma Come Back? What Happens When You Relapse

This mom of three was saved thanks to some incredible medical advancements in cancer treatment known as CAR T-Cell Therapy. Dr. Stephen Schuster, a Medical Oncologist at Penn Medicine, explained this type of therapy in a previous interview.

Once you transduced the patients T cells and this is done by taking the T cells outside the body, bringing them to the lab, using viral vectors to introduce these genes, and then giving the cells back to the patients and then they boom go to the tumor, expand, and amazingly wipe the tumor out. Its called cellular therapy. Or youll hear the term CAR T-cell therapy. CAR stands for chimeric antigen receptor modified T-cell therapy, said Dr. Schuster.

Related: CAR T-Cell Therapy: Making Your Body a More Efficient Cancer Fighter

And so what we were doing was making a gene that coded for chimeric receptor against this CD19 protein on the malignant B cells, and introducing into the normal T cells, giving them back those T cells to eradicate the cancer. Amazingly, it worked.

Why CAR T-Cell Therapy is So Exciting

Learn more about SurvivorNet's rigorous medical review process.

Related: My Chemo Smirk! Radio Host Dan Bongino Shares Treatment Picture As He Fights Hodgkin Lymphoma

Hughes was diagnosed with lymphoma during pregnancy after a scan showed a large mass on her chest. She began chemotherapy and then gave birth just 10 weeks later to a healthy baby girl. Thankfully, she qualified for CAR T-cell therapy. Hughes called it her last hope. Undergoing this therapy led to a full recovery.

Related: 7 Sneaky Symptoms of Hodgkin Lymphoma: Doctor Told One Teen Her Itchy Rash Later Diagnosed at Stage 4 Was Nothing to Worry About

Dr. Catherine Diefenbach, a Medical Oncologist at New York University Langone Health, spoke to us in an earlier interview about the possibility of lymphoma relapses. She said, There are over 68 kinds of lymphoma. For this reason, its very important that if you have a diagnosis of lymphoma, youre treated by a lymphoma specialist.

Related: CAR T-Cell Therapy: What You Should Know About Side Effects

She went on to explain,And we hope for all of our lymphoma patients that the first therapy you receive will be your last therapy. That is, that we can treat you and cure you with first line therapy. In general, non-Hodgkin lymphomas are divided into aggressive or indolent lymphomas. And the approach to these lymphomas is very different. Aggressive lymphomas are treatable and potentially curable. Indolent lymphomas are managed and dont always require treatment. However, they are not curable by conventional means of describing curability.

Could Your Lymphoma Come Back? What Happens When You Relapse

This mom of three was saved thanks to some incredible medical advancements in cancer treatment known as CAR T-Cell Therapy. Dr. Stephen Schuster, a Medical Oncologist at Penn Medicine, explained this type of therapy in a previous interview.

Once you transduced the patients T cells and this is done by taking the T cells outside the body, bringing them to the lab, using viral vectors to introduce these genes, and then giving the cells back to the patients and then they boom go to the tumor, expand, and amazingly wipe the tumor out. Its called cellular therapy. Or youll hear the term CAR T-cell therapy. CAR stands for chimeric antigen receptor modified T-cell therapy, said Dr. Schuster.

Related: CAR T-Cell Therapy: Making Your Body a More Efficient Cancer Fighter

And so what we were doing was making a gene that coded for chimeric receptor against this CD19 protein on the malignant B cells, and introducing into the normal T cells, giving them back those T cells to eradicate the cancer. Amazingly, it worked.

Why CAR T-Cell Therapy is So Exciting

Learn more about SurvivorNet's rigorous medical review process.

Read this article:
Mom of 3 Who Was Diagnosed with Terminal Lymphoma is Now Cancer-Free After CAR T-Cell Therapy - SurvivorNet

New York, Dec. 15, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cell and Gene Therapy Global Market Report 2020-30: COVID-19 Growth and Change" - https://www.reportlinker.com/p05996809/?utm_source=GNW

The global cell and gene therapy market is expected to decline from $6.68 billion in 2019 to $6.92 billion in 2020 at a compound annual growth rate (CAGR) of 3.61%. The slow growth is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The entire supply chain has been disrupted, impacting the market negatively. The market is then expected to recover and reach $13.23 billion in 2023 at a CAGR of 24.10%.

The cell and gene therapy market consists of sales of cell and gene therapies by entities (organizations, sole traders and partnerships) that develop cell and gene therapies. Cell therapy refers to the transfer of intact, live cells that are originated from autologous or allogenic sources and gene therapy refers to the introduction, removal, or change in the genome for treating diseases. The market consists of revenue generated by the companies developing cell and gene therapy products by the sales of these products.

North America was the largest region in the cell and gene therapy market in 2019. It is also expected to be the fastest-growing region in the forecast period.

In December 2019, Roche, a Swiss multinational healthcare company, acquired Spark Therapeutics for $4.3 billion. The acquisition supports the commitment of Roche to bring transformational therapies and innovative approaches to people with serious illnesses. Spark Therapeutics will continue to work within the Roche Group as an independent company. Spark Therapeutics, headquartered in Philadelphia, is a fully integrated commercial company involved in the discovery, production, and distribution of gene therapies for genetic disorders including blindness, hemophilia, lysosomal storage, and neurodegenerative diseases.

The cell and gene therapy market covered in this report is segmented by product into cell therapy; gene therapy and by application into oncology; dermatology; musculoskeletal; others.

Limited reimbursements preventing patients from receiving treatments are expected to limit the growth of cell and gene therapy (CGT market. In 2019, Trinity Life Sciences, a life sciences solution provider, researched national and large regional commercial health insurance plans in the US. It found that the confluence of increasing price, patient volume and number of CGTs on the market is likely to change the reimbursement model for CGTs and impact payer budgets by 5-10%. Payers realize that financing needs to be generated for cost management due to the uncertainty surrounding reimbursement of ancillary costs. Limited reimbursements and uncertain insurance plans are preventing patients from receiving high-cost CGT, which is expected to limit market growth.

Chimeric antigen receptor (CAR) T-cell therapy is shaping the cell and gene therapy (CGT) market. (CAR) T-cell therapy is a combination of cell and gene therapy in which T cells are collected from the patients blood and are genetically engineered to produce modified receptors at their surface, known as chimeric antigen receptors (CARs). These modified T cells with special structures (receptors) are reinfused into the patient. Then, the modified receptors of T cell help in targeting the surface antigen of the cancer cell that ultimately results in the killing of tumor cells in patients. In 2020, the US-FDA approved Bristol-Myers Squibbs two CAR-T cell therapies to treat lymphoma and multiple myeloma and is set to be launched. Currently, FDA approved CAR-T cell therapy treatments like Tisagenlecleucel for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in children and Axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

Steady investment and consolidation in cell and gene therapies contributed to the growth of the cell and gene therapy (CGT) market. After recognizing the potential of the CGT market, 16 out of the 20 largest biopharma companies by revenue, added CGT products to their portfolio. For instance, Merck invested $109 million in viral vector and gene therapy manufacturing in April 2020. Moreover, 12% of industrial clinical pipeline products and at least 16% of preclinical pipeline products consist of CGT. Steady investment and consolidation in CGT production capacity led to an increase in production capacity and also contributed to the growth of the market.Read the full report: https://www.reportlinker.com/p05996809/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Cell and Gene Therapy Global Market Report 2020-30: COVID-19 Growth and Change - GlobeNewswire

DetailsCategory: DNA RNA and CellsPublished on Friday, 18 December 2020 11:55Hits: 297

Proof-of-concept phase 1/2 trial to initiate in 2021 to treat severe respiratory viral infections in patients following hematopoietic stem cell transplantation

ALVR106 designed to target devastating diseases caused by four respiratory viruses: respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus

CAMBRIDGE, MA, USA I December 17, 2020 I AlloVir (Nasdaq: ALVR), a late clinical-stage cell therapy company, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ALVR106, an allogeneic, off-the-shelf virus-specific T cell therapy (VST) designed to target infections and diseases caused by respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV). The IND enables AlloVir to initiate a Phase 1/2 proof-of-concept clinical study in allogeneic and autologous hematopoietic stem cell transplant (HSCT) patients with respiratory infections caused by RSV, influenza, PIV or hMPV.

Respiratory viruses are a leading cause of morbidity and mortality in HSCT patients, and based on evidence from our preclinical studies, we believe ALVR106 could transform the treatment and prevention of respiratory infections and substantially reduce the associated morbidity and mortality of these infections in the future, said Ercem Atillasoy, M.D., Chief Regulatory and Safety Officer of AlloVir. The clearance of the IND for ALVR106 advances our third program into clinical trials further exploring the power of our proprietary virus-specific T cell therapy platform.

Respiratory tract infections due to RSV, influenza, PIV, and hMPV are a major public health concern and are detected in up to 40 percent of allogeneic HSCT patients. These viral infections can progress from upper respiratory tract infections to more serious lower respiratory tract infections, which are associated with mortality rates of 20-45 percent in HSCT patients.

As previously disclosed, this proof-of-concept clinical trial will initiate in 2021 as the company is assessing the impact of the COVID-19 pandemic on the incidence, diagnosis, and treatment of the respiratory viral infections which ALVR106 targets.

About ALVR106

ALVR106 is an allogeneic, off-the-shelf, multi-virus specific VST investigational therapy designed to target infections and diseases caused by the respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV). In vitro data demonstrate that ALVR106 has antiviral activity against each of the targeted viruses with minimal or no activity against non-virus-infected cells. This preclinical data supports the potential for antiviral benefit and safety of ALVR106 when administered to patients.

About AlloVir

AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with weakened immune systems. The companys innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVirs technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit http://www.allovir.com.

SOURCE: AlloVir

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AlloVir Announces FDA Clearance of Investigational New Drug Application for ALVR106, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T Cell Therapy...

GALWAY, Ireland, & SAN DIEGO, Calif.--(BUSINESS WIRE)--ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, today announced that it has secured three new exclusive option license agreements which strengthen its off-the-shelf, dual-targeted natural killer (NK) cell therapy platform and extend its pre-clinical pipeline to four programs across both hematological and solid tumors.

The first option agreement, with Cellerant Therapeutics, gives exclusive rights to a humanized CLEC12A scFv binder. CLEC12A is strongly expressed by blasts in the majority of AML patients. The option to license has enabled ONK to expand its pre-clinical product portfolio, launching a fourth program (ONKT104). This dual-targeted approach combines the CLEC12A CAR with a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting death receptor 4 (DR4).

While expressed on leukemic stem cells, CLEC12A is absent from normal hematopoietic stem cells and we thus expect that our dual-targeted NK cell therapy approach should enable safe targeting, with a reduced risk of prolonged aplasia in AML, said Prof Michael ODwyer MD, ONK Therapeutics co-founder, and CSO.

The second agreement in-licenses a humanized, tumor-specific antibody targeting an aberrantly glycosylated tumor-associated form of MUC1 (TA-MUC1) from Glycotope GmbH. Multiple solid tumor types express the mucin MUC1, including non-small cell lung cancer, breast cancer, and ovarian cancer. This antibody will be integrated into ONKs pre-clinical program ONKT103, for solid tumors.

Non-selective targeting of MUC1 could be problematic since the target is also expressed by healthy tissues, but ODwyer explains how ONKs dual-targeted approach can be used to address this. We have designed a CAR tailored to the glycosylation pattern distinct to tumor-associated MUC1 with specific recognition of the carbohydrate antigens Tn and T on MUC1, the expression of which is restricted to cancer cells. Glycotope has identified the glycosylation pattern as a way to unlock the potential of TA-MUC1 as a solid tumor target. ONK is thus set to bring the natural benefits of NK cells over T cells to bear on TA-MUC1, in a tumor-specific fashion, while also further boosting efficacy and countering resistance through the use of our TRAIL variant targeting DR5, he said.

ONKs unique platform approach combines the expression of a chimeric antigen receptor (CAR) and a high affinity, membrane-bound TRAILv. The incorporation of these two humanized scFvs has the potential to minimize the risk of immunogenicity in the allogeneic setting.

ONK is also exploring several innovative strategies to improve the homing of NK cells. This is an important consideration as ex-vivo expansion can lead to changes in chemokine receptor expression. Through this new license agreement with the NIH, ONK plans to enforce the expression of CCR7, which is downregulated on NK cell expansion. This may improve the homing of NK cells to lymph nodes and is expected to be particularly useful for ONKs off-the-shelf CD19 program targeting B cell lymphoma, ONKT101, which is partnered with Avectas.

ONK is making rapid progress since it announced its most recent financing in October. Chris Nowers, ex Kite Pharma Head of Europe, who joined at that time as Chief Executive Officer, said: The recent American Society of Hematology meeting highlighted the NK cell therapy area as offering great hope as the next generation of advanced cell therapies. We believe our best-in-class off-the-shelf, dual-targeted NK cell therapy platform has the potential to improve performance and overcome some of the shortcomings seen with earlier approaches. These new licensing activities strengthen and expand our programs and illustrate our ambition and strategy to become a leader in this exciting field.

The company recently expanded its operations into the USA, moving into JLABS @ San Diego, Johnson & Johnson Innovations flagship facility, at the heart of San Diegos precision medicine and cell therapy cluster. This represents a second facility that complements its main R&D team and operations in Galway, Ireland. The companys recruitment drive across both facilities has been rapid and the company continues to expand its capability in key areas, including NK cell biology, construct design, gene editing, and process development.

-Ends-

ONK Therapeutics http://www.onktherapeutics.com ONK Therapeutics Ltd is an innovative cell therapy company dedicated to developing the next generation of off-the-shelf, dual-targeted NK cell therapies targeting solid and hematological cancers.

The company was founded in 2015, by Prof. ODwyer MD, of NUI Galway, an expert in translational multiple myeloma research, the tumor microenvironment, and exploitation of NK cells as cellular immunotherapy. Its core proprietary platform is based on a dual-targeted NK cell expressing both a chimeric antigen receptor (CAR) targeting a known tumor antigen and a TNF-related apoptosis-inducing ligand variant (TRAILv) targeting the death receptor pathway (i.e. DR4 or DR5). This unique approach has the potential to enhance efficacy by addressing both intrinsic (e.g. CAR engagement of a tumor-specific antigen) and extrinsic (e.g. signaling through the death receptor pathway) apoptotic pathways and to reduce the susceptibility to possible target antigen escape through the engagement of tumor antigen-independent TRAILv.

Its pre-clinical pipeline comprises four programs;

In addition to the unique dual-targeted NK cell therapy platform, the company has a strong research focus on strategies to enhance homing and persistence, and overcome exhaustion, including the exploration of proprietary gene edits, such as the deletion of checkpoint inhibitory receptors in NK cells.

ONK Therapeutics is headquartered in the med-tech hub of Galway, Ireland, with a wholly-owned US subsidiary, ONK Therapeutics, Inc. based at JLabs @ San Diego. Shareholders include Acorn Bioventures, ALSHC (principally Seamus Mulligan), and Enterprise Ireland.

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About Avectas - http://www.avectas.com Avectas is a cell engineering technology business that has developed a unique delivery platform, Solupore to enable the ex vivo manufacture of cell therapy products, which have high in-vivo functionality.

Glycotope http://www.glycotope.com Glycotope is a biotechnology company utilizing a proprietary technology platform to develop highly tumor-specific monoclonal antibodies called GlycoBodies. GlycoBodies bind to targets (GlycoTargets) tumor-specific carbohydrate structure dependent, enabling the development of highly-specific immunotherapies across a broad range of cancer indications. Glycotope has to date discovered in excess of 150 GlycoTargets with GlycoBodies against eight of these targets currently under development.

Each GlycoBody can be developed in an array of modalities with different modes of action providing a unique offering in the (immuno) oncology space. Currently, six clinical and pre-clinical programs based on the GlycoBody technology are under development by Glycotope or its licensing partners.

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ONK Therapeutics Announces Three Exclusive Option License Agreements, Which Extend and Strengthen its Dual-Targeted NK Cell Therapy Pipeline -...

The research report on NK Cell Therapy and Stem Cell Therapy Market gives thorough insights regarding various key trends that shape the industry expansion with regards to regional perspective and competitive spectrum. Furthermore, the document mentions the challenges and potential restrains along with latent opportunities which may positively impact the market outlook in existing and untapped business spaces. Moreover, it presents the case studies, including the ones related to COVID-19 pandemic, to convey better understanding of the industry to all the interested parties.

The recent market trend of increasingly using NK Cell Therapy and Stem Cell Therapy for understanding the development of a disease extensively fuel the growth of this market in the coming years. Another trend that will aid the growth of the global NK Cell Therapy and Stem Cell Therapy market is the escalating demand for personalized medicine. Extensive investments are being made by various organizations, pharmaceutical companies, and governments for the research and development of drugs, and this is another trend that is benefiting the growth of the global NK Cell Therapy and Stem Cell Therapy market. This is because NK Cell Therapy and Stem Cell Therapy techniques enable researchers to compare NK Cell Therapy and Stem Cell Therapy changes between disease samples and normal samples. Public health can thus be analyzed as the changes in NK Cell Therapy and Stem Cell Therapy are influenced by internal biological system and environment directly.

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The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include: Osiris Therapeutics, Chiesi Pharmaceuticals, Molmed, Takeda Pharmaceutical, Medi-post, Chipscreen Biosciences, Affimed NV, JCR Pharmaceutical, Pharmicell, Innate Pharma SA, NuVasive, Anterogen, Altor BioScience Corporation.

NK Cell Therapy and Stem Cell Therapy Market Segmentation:

In market segmentation by types of NK Cell Therapy and Stem Cell Therapy, the report covers-

NK Cell TherapyStem Cell Therapy

In market segmentation by applications of the NK Cell Therapy and Stem Cell Therapy, the report covers the following uses-

Hospital & clinicsRegenerative medicine centersDiagnostic centersResearch institutesOthers

Regional Analysis for NK Cell Therapy and Stem Cell Therapy Market-:

1) North America- (United States, Canada)

2) Europe- (Germany, France, UK, Italy, Russia, Spain, Netherlands, Switzerland, Belgium)

3) Asia Pacific- (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Vietnam)

4) Middle East & Africa- (Turkey, Saudi Arabia, United Arab Emirates, South Africa, Israel, Egypt, Nigeria)

5) Latin America- (Brazil, Mexico, Argentina, Colombia, Chile, Peru)

The report provides insights on the following pointers :

Market Penetration: Comprehensive information on the product portfolios of the top players in the Supply Chain Analytics market.

Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the market

Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market

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

Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Supply Chain Analytics market

NOTE: Our analysis involves the study of the market taking into consideration the impact of the COVID-19 pandemic. Please get in touch with us to get your hands on an exhaustive coverage of the impact of the current situation on the market. Our expert team of analysts will provide as per report customized to your requirement.

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Table of Content

Chapter 1 NK Cell Therapy and Stem Cell Therapy Introduction and Market Overview

Chapter 2 Executive Summary

Chapter 3 Industry Chain Analysis

Chapter 4 Global NK Cell Therapy and Stem Cell Therapy Market, by Type

Chapter 5 NK Cell Therapy and Stem Cell Therapy Market, by Application

Chapter 6 Global NK Cell Therapy and Stem Cell Therapy Market Analysis by Regions

Chapter 7 North America NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 8 Europe NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 9 Asia Pacific NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 10 Middle East and Africa NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 11 South America NK Cell Therapy and Stem Cell Therapy Market Analysis by Countries

Chapter 12 Competitive Landscape

Chapter 13 Industry Outlook

Chapter 14 Global NK Cell Therapy and Stem Cell Therapy Market Forecast

Chapter 15 New Project Feasibility Analysis

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Global NK Cell Therapy and Stem Cell Therapy Market: Development, Current Analysis and Estimated Forecast to 2025 - The Courier

The CAR-T Cell Therapy Market research report helps the market players to execute phenomenal business techniques and therefore, it has featured driving contenders vital moves including acquisitions, business extension, mergers, joint efforts, adventures, limited time exercises, branding, and product dispatches. The SWOT analysis incorporates inner and outside variables, just as present and future capability of the market.

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Competitive Landscape and CAR-T Cell Therapy Market Share Analysis

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South America (Brazil, Argentina, Colombia, rest of countries etc.)

Middle East and Africa (Saudi Arabia, United Arab Emirates, Israel, Egypt, Nigeria and South Africa)

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Set of qualitative information that includes PESTEL Analysis, PORTER Five Forces Model, Value Chain Analysis and Macro-Economic factors, Regulatory Framework along with Industry Background and Overview

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Competitive rivalry:- The main driver is the number and capability of competitors in the market. Many competitors, offering undifferentiated products and services, will reduce market attractiveness.

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TABLE OF CONTENTS

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights

5 Market Overview and Industry Trends

6 CAR-T Cell Therapy Market, By Type

7 CAR-T Cell Therapy Market, By Organization Size

8 CAR-T Cell Therapy Market Analysis, By Region

9 Competitive Landscape

10 Company Profiles

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CAR-T Cell Therapy Market to gain significant revenue and Competitive Outlook UP To 2026 - SpinazzolaLive