Category Archives: Stem Cell Therapy

BOSTON and LONDON, Sept. 28, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to OTL-203, aninvestigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy in development for the treatment of mucopolysaccharidosis type I (MPS-I) at the San Raffaele Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy.

We are encouraged by EMAs decision to grant PRIME designation to OTL-203, which was based on an initial clinical assessment of data supporting the potential benefit of our HSC gene therapy for patients with MPS-IH beyond the current standard of care, said Anne Dupraz-Poiseau, PhD., chief regulatory officer of Orchard. In 2021, we look forward to building upon the promising early data in the ongoing proof-of-concept study and plan to initiate a registrational trial to advance a potential new treatment for patients.

The PRIME program is designed to enhance regulatory support in the EU for the development of promising investigational medicines that, based on early clinical data, may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. PRIME aims to provide multiple benefits so that these medicines can reach patients earlier: enhanced interaction and early dialogue with EMA, guidance on the overall development plan and regulatory strategy, and the potential for accelerated assessment of the marketing authorization application. For more information please visit the EMA website at http://www.ema.europa.eu.

Additional interim data was recently presented from the ongoing proof-of-concept clinical trial evaluating the safety and efficacy of OTL-203 in the severe Hurler subtype of MPS-I. Eight patients have been treated in the study, which completed enrollment in December 2019. As of July 2020, all patients had been followed for a minimum of six months, with the longest follow-up extending out to 24 months. Orchard expects to release full proof-of-concept results at one year and initiate a registrational study for OTL-203 in 2021.

About OTL-203 and MPS-I Mucopolysaccharidosis type I (MPS-I) is a rare, inherited neurometabolic disease caused by a deficiency of the alpha-L-iduronidase (IDUA) lysosomal enzyme, which is required to break down sugar molecules called glycosaminoglycans (also known as GAGs). The accumulation of GAGs across multiple organ systems results in symptoms including neurocognitive impairment, skeletal deformity, loss of vision and hearing, and cardiovascular and pulmonary complications. MPS-I occurs at an overall estimated frequency of one in every 100,000 live births. There are three subtypes of MPS-I; approximately 60 percent of children born with MPS-I have the most severe subtype, called Hurler syndrome, and rarely live past the age of 10 when untreated. Treatment options for MPS-I include hematopoietic stem cell transplant and chronic enzyme replacement therapy, both of which have significant limitations. Though early intervention with enzyme replacement therapy has been shown to delay or prevent some clinical features of the condition, it has only limited efficacy on neurological symptoms. OTL-203 is an investigational ex vivo autologous hematopoietic stem cell gene therapy being studied for the treatment of MPS-I. Orchard was granted an exclusive worldwide license to intellectual property rights to research, develop, manufacture and commercialize the gene therapy program for the treatment of MPS-I developed by theSan Raffaele Telethon Institute for Gene TherapyinMilan, Italy.

About Orchard

Orchard Therapeuticsis a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSKs rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and theSan Raffaele Telethon Institute for Gene Therapy inMilan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters inLondonandU.S.headquarters inBoston. For more information, please visit http://www.orchard-tx.com, and follow us on Twitter and LinkedIn.

Availability of Other Information About Orchard

Investors and others should note that Orchard communicates with its investors and the public using the company website ( http://www.orchard-tx.com ), the investor relations website ( ir.orchard-tx.com ), and on social media ( Twitter and LinkedIn ), including but not limited to investor presentations and investor fact sheets,U.S. Securities and Exchange Commissionfilings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-Looking Statements

This press release contains certain forward-looking statements about Orchards strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by words such as anticipates, believes, expects, plans, intends, projects, and future or similar expressions that are intended to identify forward-looking statements. Forward-looking statements include express or implied statements relating to, among other things, Orchards business strategy and goals, the therapeutic potential of Orchards product candidates, including the product candidate referred to in this release, Orchards expectations regarding the timing of clinical trials for its product candidates, including the product candidate referred to in this release, the timing of interactions with regulators and regulatory submissions related to ongoing and new clinical trials for its product candidates, the timing of announcement of clinical data for its product candidates, and the likelihood that such data will be positive and support further clinical development and regulatory approval of these product candidates. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation: the severity of the impact of the COVID-19 pandemic on Orchards business, including on clinical development, its supply chain and commercial programs; the risk that Orchard will not realize the anticipated benefits of its new strategic plan or the expected cash savings associated with such plan; the risk that any one or more of Orchards product candidates, including the product candidate referred to in this release, will not be successfully developed, approved or commercialized; the risk of cessation or delay of any of Orchards ongoing or planned clinical trials; the risk that Orchard may not successfully recruit or enroll a sufficient number of patients for its clinical trials; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchards product candidates or that long-term adverse safety findings may be discovered; the delay of any of Orchards regulatory submissions; the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchards product candidates or the receipt of restricted marketing approvals; and the risk of delays in Orchards ability to commercialize its product candidates, if approved. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchards quarterly report on Form 10-Q for the quarter endedJune 30, 2020, as filed with theU.S. Securities and Exchange Commission(SEC), as well as subsequent filings and reports filed with theSEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Contacts

Investors Renee Leck Director, Investor Relations +1 862-242-0764 Renee.Leck@orchard-tx.com

Media Molly Cameron Manager, Corporate Communications +1 978-339-3378 media@orchard-tx.com

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Orchard Therapeutics Receives EMA PRIME Designation for OTL-203 for the Treatment of MPS-I - Northeast Mississippi Daily Journal

Acquisition to support accelerated commercialization of Koligos KYSLECEL,a personalized islet cell therapy available in the U.S. for chronic and recurrent acute pancreatitis

Goal to rapidly advance KT-PC-301, an autologous cell therapy under investigationfor the treatment of COVID-19-related Acute Respiratory Disease Syndrome (ARDS)

Orgenesis to leverage Koligos 3D-V bioprinting technology across its POCare Platform

GERMANTOWN, Md., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (Orgenesis or the Company), a global biotech company working to unlock the full potential of cell and gene therapies, and Koligo Therapeutics, Inc. (Koligo), a regenerative medicine company, today announced that the two companies have entered into a definitive merger agreement, subject to final closing conditions, with expected completion before year-end (Transaction).

Koligo is a leader in developing personalized cell therapies utilizing the patients own (autologous) cells. Koligo has successfully launched its first commercial product, KYSLECEL, and plans to commence a phase 2 trial of KT-PC-301 for COVID-19-related ARDS. Koligos development stage technology utilizes 3D bioprinting and vascularization with autologous cells (3D-V technology) to create biodegradable and shelf-stable three-dimensional cell and tissue implants. The 3D-V technology is being developed for diabetes and pancreatitis, with longer term applications for neural, liver, and other cell/tissue transplants.

Following closing of the Transaction, Orgenesis plans to accelerate the commercial scaleup of KYSLECEL throughout the United States and, subject to regulatory and logistical considerations, in international markets as well. After closing of the Transaction, and subject to FDA review and clearance of the Companys Investigational New Drug application, Orgenesis expects to start patient recruitment for a phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. Orgenesis also plans to leverage Koligos 3D-V bioprinting technology across its POCare platform.

Under the terms of the merger agreement, Orgenesis will acquire all of the outstanding stock of Koligo from its shareholders (the founders and staff of Koligo and a subsidiary of Bergen Special Opportunity Fund, LP, an institutional investor managed by Bergen Asset Management, LLC). The agreed consideration terms are an aggregate of $15 million in shares of Orgenesis common stock valued at $7.00 per share which shall be issued to Koligos accredited investors (with certain non-accredited investors to be paid solely in cash) and an assumption of $1.3 million in Koligos liabilities, estimated to be substantially all of Koligos liabilities. Additional details of the Transaction will be available in the Companys Form 8-K, which will be filed with the Securities and Exchange Commission, and will be available at http://www.sec.gov.

KYSLECELKoligos KYSLECEL is commercially available in the United States for chronic and recurrent acute pancreatitis in a surgical procedure commonly called Total Pancreatectomy with Islet Autologous-Transplant (TPIAT). TPIAT has been proven to provide significant pain relief, improved quality of life, and a reduction in the need for pain medication for patients suffering from chronic or recurrent acute pancreatitis. KYSLECEL infusion after a total pancreatectomy helps preserve insulin secretory capacity and reduce the risk of diabetic complications. KYSLECEL is made from a patients own pancreatic islets the cells that make insulin to regulate blood sugar.

Koligo has commenced its commercial pilot program for KYSLECEL at six U.S. hospitals, treating 40 patients to date. The KYSLECEL pilot program has generated approximately $2 million in sales revenue. KYSLECEL has also been shown to result in significant savings to payors over traditional chronic pancreatitis management. Following the closing of the Transaction, Orgenesis plans to make KYSLECEL available to an increasing number of hospitals throughout the United States through its POCare Network.

KT-PC-301Koligos lead clinical development program is for KT-PC-301, an autologous cell therapy under investigation for the treatment of COVID-19-related Acute Respiratory Disease Syndrome (ARDS). KT-PC-301 is comprised of autologous stromal and vascular fraction cells (SVF) derived from each patients adipose (fat) tissue. KT-PC-301 contains a population of mesenchymal stem cells, vascular endothelial cells, and immune cells which migrate to the patients lungs and other peripheral sites of inflammation. Nonclinical and clinical evidence demonstrate that KT-PC-301 may: (1) stabilize microcirculation to improve oxygenation; (2) maintain T and B lymphocytes to support antibody production; and (3) induce an anti-inflammatory effect.

Koligo has completed a pre-IND (Investigational New Drug) consultation with the U.S. Food and Drug Administration to start clinical trials of KT-PC-301 in COVID-19-related ARDS. Following the closing of the Transaction, and subject to FDA review and clearance of the Companys Investigational New Drug application, Orgenesis expects to start patient recruitment for a phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. As currently planned, the phase 2 trial is expected to enroll 75 patients and evaluate the safety and efficacy of KT-PC-301. Mohamed Saad, MD, Chief of Division of Pulmonary, Critical Care, and Sleep Disorders Medicine at the University of Louisville, will be the lead clinical investigator on the trial.

3D-V Technology Koligos 3D-V bioprinting technology is designed to support development of a number of product candidates for the treatment of diabetes, cancer, neurodegenerative disease, and other serious diseases. The 3D-V technology platform is able to print three-dimensional cell and tissue constructs with a vascular network. Key benefits of the 3D-V approach include: faster revascularization/inosculation of cell/tissue transplant to improve engraftment; host tolerance of the graft while minimizing need for immune suppressive drugs; better site of transplant administration of such products; and scaffolding to keep cell/tissue in place in vivo. These solutions are ideally suited for islet transplant and other cell/tissue transplant applications.

Koligo ManagementFollowing the closing of the Transaction, Koligos management team will be joining Orgenesis to continue commercial and development activities. Koligos CEO, Matthew Lehman, is an accomplished executive in the biotech and regenerative medicine fields. Prior to co-founding Koligo, he was CEO of Prima Biomed Ltd (now Immutep Ltd, a Nasdaq (IMMP) and ASX (IMM) listed biotech company). Stuart Williams, PhD, Chief Technology Officer, is a bioengineer and thought leader in regenerative medicine, with over 300 publications and 20 issued patents in the field. Dr. Williams has co-founded three other biotech companies and is an experienced academic-industry collaborator. Michael Hughes, MD, Chief Medical Officer, is a transplant surgeon who started the islet transplant program at University of Louisville which was the genesis of Koligos KYSLECEL program. He has successfully treated nearly 50 chronic pancreatitis patients with islet autologous transplant after pancreatectomy. Balamurugan Appakalai, PhD, has more than 20 years of islet isolation experience, having processed more than 800 human pancreases. He is a leader in the field of islet transplant with 100+ publications.

Vered Caplan, Chief Executive Officer of Orgenesis, stated, We are pleased to announce this transformative acquisition, which we expect will add broad capabilities to our therapeutic and technology platform, and will further our leadership in the cell and gene therapy field. Based on several phase 1 studies, Koligos KT-PC-301, using a patients own cells, has demonstrated safety and tolerability, and has shown signs of efficacy to support continued development in COVID-19-related ARDS. If successful for the treatment of COVID-19-related ARDS, KT-PC-301 is likely to have applications in other acute and chronic respiratory indications, areas that represent significant unmet medical need. In addition, we see significant potential in KYSLECEL, a commercial stage asset for the treatment of chronic and acute recurrent pancreatitis, which we plan to introduce through our global network of hospitals. Finally, Koligos 3D-V bioprinting technology is highly complementary to our POCare Platform, as we implement new technologies to improve efficacy and lower the costs of cell and gene therapies. I would like to personally welcome Matthew and the rest of the Koligo team to the Orgenesis organization when the Transaction closes. We believe that their skills and experience will be an important addition as we execute on our strategy to unlock the power of cell and gene therapies and make them accessible to all.

Matthew Lehman, Chief Executive Officer of Koligo Therapeutics, stated, The merger with Orgenesis marks a major milestone for our company and builds on our recent progress, including the Pre-IND package submitted to the U.S. FDA for KT-PC-301 and our pilot commercial program for KYSLECEL. The Orgenesis team brings extensive clinical, regulatory, and manufacturing expertise well suited to supporting Koligos goals. Orgenesis intellectual property is highly complementary to Koligos technology and the combined companies will work to advance a robust commercial and development product portfolio. Orgenesis POCare technologies are also ideally suited for low-cost and efficient production of autologous cell therapies at the point of care, which we believe will considerably enhance the delivery of these therapies to patients. Additionally, we believe Orgenesis global network of leading hospitals and healthcare institutions will enable us to accelerate the commercial rollout of KYSLECEL. We are quite encouraged by the outlook for the business and look forward to leveraging Orgenesis POCare Platform in order to accelerate the timeline to bringing our innovative cell therapies to market. Through this merger, we believe we can maximize value for all shareholders and we are grateful to Orgenesis for this opportunity.

Pearl Cohen Zedek Latzer Baratz LLP and KPMG advised Orgenesis on the Transaction. Maxim Group LLC acted as a finder and Nelson Mullins Riley & Scarborough, LLP advised Koligo on the Transaction.

About Koligo Therapeutics Koligo Therapeutics, Inc. is a US regenerative medicine company. Koligos first commercial product is KYSLECEL (autologous pancreatic islets) for chronic and acute recurrent pancreatitis. Koligos 3D-V technology platform incorporates the use of advanced 3D bioprinting techniques and vascular endothelial cells to support development of transformational cell and tissue products for serious diseases. More information is available at http://www.koligo.net.

About OrgenesisOrgenesis is a global biotech company working to unlock the full potential of celland gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis POCarePlatform is comprised of three enabling components: a pipeline of licensedPOCare Therapeuticsthat are processed and produced in closed, automatedPOCare Technologysystems across a collaborativePOCare Network. Orgenesisidentifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. Learn more about the work Orgenesis is doing atwww.orgenesis.com.

Notice Regarding Forward-Looking Statements The information in this release is as of September 29, 2020. Orgenesis assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments. This release contains forward looking statements about Orgenesis, Koligo, Koligos technology, and potential development and business opportunities of Koligo and Orgenesis following the closing of the Transaction, each of which involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of the Companys products; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any such regulatory authorities may approved the Companys development products, and, if approved, whether such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of the Companys products; uncertainties regarding the impact of COVID-19 on the Companys business, operations and financial results and competitive developments.

A further description of risks and uncertainties can be found in the Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov.

Contact for Orgenesis:Crescendo Communications, LLCTel: 212-671-1021ORGS@crescendo-ir.com

Read more:
Orgenesis Announces Agreement to Acquire Koligo Therapeutics, a Leader in Personalized Cell Therapies - GlobeNewswire

John M. Pagel, MD, PhD, discusses the utility of CAR T-cell therapy in patients with relapsed/refractory diffuse large B-cell lymphoma.

John M. Pagel, MD, PhD, chief of the Hematologic Malignancies Program, and directorof theHematopoietic Cell Transplantation Program at Swedish Cancer Institute inSeattle, Washington, discussesthe utility of CAR T-cell therapy in patients with relapsed/refractorydiffuse large B-cell lymphoma (DLBCL).

Althoughautologous stem cell transplant (ASCT)is still used in DLBCL, it is important to understand that it is not a viable treatment option for the vast majority of patients who relapse, says Pagel. For example, if 60 out of 100 patients are cured, that means 40 patients will relapse, adds Pagel; of those 40patients,approximatelyhalfwill receivean ASCT. Patients will not get a transplant if theyare not chemotherapy sensitive or they mayhave comorbidities that do not allow them toundergo the procedure.

Moreover, only about half of patients who under transplant will achieve cure, adds Pagel. Patients who are not cured up front or by transplant still needaneffective treatment option that can provide a significant benefit. To this end, some newer agents have emerged for patients with relapsed disease in recent years. The biggest development has beenCAR T-cell therapy, says Pagel. This approach provides curative potential to patients who failed a transplant; were never able to get to transplant because they are not sensitive to chemotherapy; or were high-risk and refractory to up-frontrituximab (Rituxan) plus cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisonechemoimmunotherapy.

CAR T-cell treatments are very important for those patients, adds Pagel, as this approach can provide long-term survival to some of these patients, concludes Pagel.

Read more here:
Dr. Pagel on the Utility of CAR T-Cell Therapy in Relapsed/Refractory DLBCL - OncLive

Introduction: Global Stem Cell Therapy Market

This well-composed research output tends to offer a highly resourceful outlook highlighting various facets that encourage remunerative business decisions in the Stem Cell Therapy market.The report is a quick reference point to make comply with reader understanding of the volatile market situations that collectively steer enormous growth opportunities in the global Stem Cell Therapy market.The global Stem Cell Therapy market research report is a well synchronized synopsis highlighting some of the most significant, real time research analysis that enable quick and efficient business discretion.The report fetches references of growth-specific business policies, approaches and preferences that help in maintaining the competitive momentum in global business decisions as well as comprises excerpts of dynamic segmentation that collectively ensure steady growth in the global Stem Cell Therapy market.

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This report studies the Stem Cell Therapy market status and outlook of Global and major regions, from angles of players, countries, product types and end industries; this report analyzes the top players in global market, and splits the Stem Cell Therapy market by product type and applications/end industries.Asia Pacific (APAC) is expected to grow at the highest CAGR during the forecast period, as most of the companies in APAC are encouraging the extensive adoption of mobile applications.

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The report offers updated financial information of the key competitors to offer accurate market insights and offers strategic recommendations. The study covers critical market trends along with an extensive analysis of emerging trends. The report covers a detailed examination of the market scenarios and trends on a regional and global level. The study covers the current competitive scenario with a special emphasis on the strategic initiatives taken by the prominent players of the industry.

Stem Cell Therapy Market Segmentation

Type Analysis of Stem Cell Therapy Market:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources

Applications Analysis of Stem Cell Therapy Market:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications

Report Offerings in BriefA rigorous, end-to-end review and analysis of the Stem Cell Therapy market events and their implicationsA thorough compilation of broad market segmentsA complete demonstration of best in-industry practices, mindful business decisions and manufacturer activities that steer revenue sustainability in the global Stem Cell Therapy marketA complete assessment of competition spectrum, inclusive of relevant details about key and emerging playersA pin-point review of the major dynamics and dominant alterations that influence growth in the global Stem Cell Therapy market

Key Player Analysis: Stem Cell Therapy Market1. The report precisely profiles leading players and their intricate marketing choices and best in industry performance that jointly inculcate remunerative business options in the Stem Cell Therapy market.2. For better and superlative comprehension of the Stem Cell Therapy market by leading market players and participants striving to strike a profitable growth trail in the Stem Cell Therapy market during 2020-27, this meticulous report composition houses critical developments, besides an extensive portfolio of leading players.

Understanding Regional Growth Prognosis: Global Stem Cell Therapy MarketFollowing sections of the report on global Stem Cell Therapy market includes vivid details about region specific developments, also including details about country-specific events that collectively influence optimistic growth.Furthermore, significant depiction on frontline market players have also been widely discussed in the report to imitate growth-oriented business discretion.

Gauging through Scope: Global Stem Cell Therapy Market, 2020-271. Intensive research suggests that the global Stem Cell Therapy market in the forthcoming years will see through a decent growth curve, registering a steady rise if xx million USD in 2020 and is further likely to ensure a spike of xx million USD by the end of 2027, clocking at a CAGR of xx% through 2020-27.2. Primary and secondary research also suggest that the steady growth trail in the global Stem Cell Therapy market will significantly emerge from the massive remunerative dip owing to the sudden pandemic, COVID-19 early this year that has proved highly detrimental for diverse businesses and industries, affecting growth.3. Further discussions in the report primarily adhere to the various events and developments dominant in the manufacturing space. The report is poised to undertake immersive study pertaining to dynamics identification and further analysis and evaluation to arrive at logical conclusions and touchpoint analysis.

Executive Summary1. Assumptions and Acronyms Used2. Research Methodology3. Stem Cell Therapy Market Overview4. Stem Cell Therapy Supply Chain Analysis5. Stem Cell Therapy Pricing Analysis6. Global Stem Cell Therapy Market Analysis and Forecast by Type7. Global Stem Cell Therapy Market Analysis and Forecast by Application8. Global Stem Cell Therapy Market Analysis and Forecast by Sales Channel9. Global Stem Cell Therapy Market Analysis and Forecast by Region10. North America Stem Cell Therapy Market Analysis and Forecast11. Latin America Stem Cell Therapy Market Analysis and Forecast12. Europe Stem Cell Therapy Market Analysis and Forecast13. Asia Pacific Stem Cell Therapy Market Analysis and Forecast14. Middle East & Africa Stem Cell Therapy Market Analysis and Forecast15. Competition Landscape

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Stem Cell Therapy Market Research, Technology, Demand, Analysis, Services, Type and Global Industry Forecast 2025 - The Daily Chronicle

The globalAdipose Tissue-derived Stem Cell Therapy Marketis carefully researched in the report while largely concentrating on top players and their business tactics, geographical expansion, market segments, competitive landscape, manufacturing, and pricing and cost structures. Each section of the research study is specially prepared to explore key aspects of the global Adipose Tissue-derived Stem Cell Therapy market. For instance, the market dynamics section digs deep into the drivers, restraints, trends, and opportunities of the global Adipose Tissue-derived Stem Cell Therapy market. With qualitative and quantitative analysis, we help you with thorough and comprehensive research on the global Adipose Tissue-derived Stem Cell Therapy market. We have also focused on SWOT, PESTLE, and Porters Five Forces analyses of the global Adipose Tissue-derived Stem Cell Therapy market.

Leading players of the global Adipose Tissue-derived Stem Cell Therapy market are analyzed taking into account their market share, recent developments, new product launches, partnerships, mergers or acquisitions, and markets served. We also provide an exhaustive analysis of their product portfolios to explore the products and applications they concentrate on when operating in the global Adipose Tissue-derived Stem Cell Therapy market. Furthermore, the report offers two separate market forecasts one for the production side and another for the consumption side of the global Adipose Tissue-derived Stem Cell Therapy market. It also provides useful recommendations for new as well as established players of the global Adipose Tissue-derived Stem Cell Therapy market.

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Major Players:

AlloCureMesoblastCelllerisAntriaIntrexonCelgene CorporationTissue GenesisCytori TherapeuticsCorestemPluristem TherapeuticsCyagenBioRestorative TherapiesLonzaPluristem TherapeuticsCelltex Therapeutics CorporationiXCells Biotechnologies

Segmentation by Product:

Autologous Stem CellsAllogeneic Stem Cells

Segmentation by Application:

Therapeutic ApplicationResearch Application

Regions and Countries:U.S, Canada, France, Germany, UK, Italy, Rest of Europe, India, China, Japan, Singapore, South Korea, Australia, Rest of APAC, Brazil, Mexico, Argentina, Rest of LATAM, Saudi Arabia, South Africa, UAE.

Report Objectives

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Table of Contents

Report Overview:It includes major players of the global Adipose Tissue-derived Stem Cell Therapy market covered in the research study, research scope, and Market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends:This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the global Adipose Tissue-derived Stem Cell Therapy market. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the global Adipose Tissue-derived Stem Cell Therapy market are discussed.

Market Share by Manufacturers:Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type:This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application:Besides an overview of the global Adipose Tissue-derived Stem Cell Therapy market by application, it gives a study on the consumption in the global Adipose Tissue-derived Stem Cell Therapy market by application.

Production by Region:Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region:This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles:Almost all leading players of the global Adipose Tissue-derived Stem Cell Therapy market are profiled in this section. The analysts have provided information about their recent developments in the global Adipose Tissue-derived Stem Cell Therapy market, products, revenue, production, business, and company.

Market Forecast by Production:The production and production value forecasts included in this section are for the global Adipose Tissue-derived Stem Cell Therapy market as well as for key regional markets.

Market Forecast by Consumption:The consumption and consumption value forecasts included in this section are for the global Adipose Tissue-derived Stem Cell Therapy market as well as for key regional markets.

Value Chain and Sales Analysis:It deeply analyzes customers, distributors, sales channels, and value chain of the global Adipose Tissue-derived Stem Cell Therapy market.

Key Findings:This section gives a quick look at important findings of the research study.

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Our research base consists of a wide spectrum of premium market research reports. Apart from comprehensive syndicated research reports, our in-house team of research analysts leverages excellent research capabilities to deliver highly customized tailor-made reports. The market entry strategies presented in our reports has helped organizations of all sizes to generate profits by making timely business decisions. The research information including market size, sales, revenue, and competitive analysis offered, is the product of our excellence in the market research domain.

More here:
Impact of Corona on Adipose Tissue-derived Stem Cell Therapy Market : What are the key opportunities? - The Market Chronicles

Brian T. Hill, MD, PhD, discussesthe role of CAR T-cell therapy in relapsed/refractory diffuse large B-cell lymphoma.

Brian T. Hill, MD, PhD, director of the Lymphoid Malignancies Program and staff physician, Taussig Cancer Institute, and assistant professor, Hematology and Oncology, Cleveland Clinic, discussesthe role of CAR T-cell therapy in relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

In October 2017,the FDA approved axicabtagene ciloleucel (axi-cel; Yescarta) for the treatment of adult patients with certain types of large B-cell lymphoma, including DLBCL, who have not responded to or who have relapsed after 2 or more treatments. Additionally, in May 2018, another CAR T-cell therapy product, tisagenlecleucel (Kymriah) was approved in a similar indication.

Prior to theseapprovals, therapeutic options were limited for patients who relapsed after autologous stem cell transplantor were ineligible for transplant.

However, the rate of durable remission is limited to 40% to 50% of patients with relapsed/refractory DLBCL. As such, there is a significant need to developadditional therapies in this space, Hill concludes.

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Dr. Hill on the Role of CAR T-Cell Therapy in Relapsed/Refractory DLBCL - OncLive

In nearly 40 years of the HIV epidemic, only two people have likely been cured of the virus. Both scenarios resulted from stem cell transplants needed to fight blood cancers such as leukemia. Inspired by these two cases, a team of scientists is studying a multipronged way to potentially control HIV without medication. It involves two different genetic alterations of immune cells and with a safer method of stem cell transplants, also referred to as bone marrow transplants, a procedure that is generally toxic and dangerous.

The research is being funded by a five-year $14.6 million grant from the National Institutes of Health. The scientists coleading the preclinical studies are Paula Cannon, PhD, a distinguished professor of molecular microbiology and immunology at the Keck School of Medicine of the University of Southern California, and Hans-Peter Kiem, MD, PhD, who directs the stem cell and gene therapy program at the Fred Hutchinson Cancer Research Center, also known as Fred Hutch. According to a Keck School of Medicine press release, the two other main partners are David Scadden, MD, a bone marrow transplant specialist and professor at Harvard University and the Harvard Stem Cell Institute, and the biotechnology company Magenta Therapeutics.

In the HIV cure scenariosinvolving the so-called Berlin and London patientsboth men received stem cell transplants from donors with a natural genetic mutation that made them resistant to HIV. Specifically, their genes resulted in immune cells that lack CCR5 receptors on their surface (HIV latches onto these receptors to infect cells). Unfortunately, this method isnt viable for the nearly 38 million people worldwide living with HIV. Not only is it expensive, toxic and riskyit involves wiping out the patients immune system and replacing it with the new immune cellsbut it also requires matched donors who are CCR5 negative. According to the press release, about 1% of the population have this mutation.

With funding from this new grant, researchers hope to overcome these challenges in several ways. First, Cannon has already developed a gene-editing method to remove the CCR5 receptors from a patients own stem cells. She now hopes to further genetically engineer stem cells so they release antibodies that block HIV.

Our engineered cells will be good neighbors, Cannon said in the press release. They secrete these protective molecules so that other cells, even if they arent engineered to be CCR5 negative, have some chance of being protected.

Fred Hutchs Kiem will use CAR-T therapya new method of genetically modifying immune cells that is emerging out of cancer researchwith the goal of creating T cells that attack HIV-infected cells.

In addition, other scientists involved in the federal grant aim to develop less toxic methods of bone marrow transplantationfor example, by reducing the amount of chemotherapy required and speeding up the process of creating the new immune system.

The research finding could translate to other illnesses, such as cancer, sickle cell anemia and autoimmune disorders.

A home run would be that we completely cure people of HIV, Cannon said. What Id be fine with is the idea that somebody no longer needs to take anti-HIV drugs every day because their immune system is keeping the virus under control so that it no longer causes health problems and, importantly, they cant transmit it to anybody else.

For the latest on the cure cases, see Famed London Man Probably Cured of HIV from earlier this year. And in related news, see $14M Federal Grant to Research CAR-T Gene Therapy to Cure HIV.

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$14.6M Grant to Explore a Therapy to Control HIV Without Meds - POZ

WALTHAM, Mass.--(BUSINESS WIRE)--TScan Therapeutics, a biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies in oncology, today announced plans to file two Investigational New Drug (IND) applications in their liquid tumor program in 2021. Their first product, TSC-100, targets HA-1 and is designed to treat patients receiving hematopoietic stem cell transplant therapy with the goal of preventing relapse, a high unmet need in this setting. TScan announced selection of their lead TCR and its advancement to IND-enabling activities. Simultaneously, TScan announced selection of their second target, HA-2, with plans to file a second IND in 2021. These products are the first two TCRs in a multi-TCR program designed to provide treatment options for the majority of patients receiving stem cell therapy.

We are excited to progress this T cell therapy solution for patients receiving stem cell transplant therapy, said David Southwell, Chief Executive Officer at TScan. TScans goal in both its liquid and solid tumor programs is to learn from patients who respond well to therapy to treat those who are less fortunate. This represents a significant step in the progression of TScan as a TCR therapy company. Our lead TCR, TSC-100, was discovered internally using our TCR discovery platform, R-Scan, and was significantly derisked using our proprietary genome-wide safety screening platform, T-Scan. By extending our liquid tumor program to also include HA-2, we are one step closer to providing a comprehensive solution for patients receiving stem cell therapy. We also remain on track to nominate solid tumor targets in 2021.

Leveraging its core TCR discovery platform, R-Scan, TScan identified its lead HA-1 TCR after screening over 100,000,000 T cells from HA-1-negative donors. In preclinical experiments, TSC-100 showed strong activity against HA-1-positive leukemia cells and a clean safety profile, with minimal off-target interactions or alloreactivity. TSC-100 will be used to engineer donor T cells in the context of a stem cell transplant, with the goal of preventing relapse in HA-1-positive patients with AML, MDS, or adult ALL. To expand this program to patients not expressing HA-1, TScan is developing a second TCR specific for HA-2, termed TSC-101.

Our goal is to provide a therapeutic option for every patient, said Gavin MacBeath, Chief Scientific Officer. Our discovery team is already identifying TCRs that will allow our products to address an even broader patient population. Expanding our repository of therapeutic TCRs also enables us to develop multiplexed TCR therapies, which better mimic natural immune responses and provide more robust treatments for heterogeneous cancers like AML, as well as a diverse range of solid tumors. Using our two core platforms, we remain on track to nominate our first solid tumor candidates in early 2021.

About HA-1

HA-1 is a well-characterized minor histocompatibility antigen that is expressed on all blood cells, including leukemia cells, but is not expressed at appreciable levels in other normal tissues. It is associated with clinical benefit by generating a graft vs. leukemia effect in the context of hematopoietic stem cell transplants in which the patient is HA-1-positive and the donor is HA-1-negative. Over half of all patients express the HA-1 target.

About HA-2

Similar to HA-1, HA-2 is a minor histocompatibility antigen expressed specifically on blood cells and is associated with clinical benefit through a graft vs. leukemia effect. Addition of TSC-101, an HA-2-specific TCR, will expand the pool of eligible patients for TScans liquid tumor program.

About TScan Therapeutics

TScan discovers and develops transformative T cell therapies (TCR-T) to treat liquid cancers, solid tumors, and other serious diseases. Our proprietary, high-throughput platform identifies previously uncharacterized, clinically-derived shared T cell antigens and all off-target TCR interactions, to enable the development of highly efficacious TCR-Ts with minimal off-target effects. Lead program TSC-100 is expected to enter clinical development for liquid cancers in 2021, and the Company is advancing additional TCR-Ts for solid cancers. TScan was co-founded by Chair Christoph Westphal (Partner, Longwood Fund) based on pioneering research from the Elledge Lab at Brigham and Womens Hospital. The Company has raised over $80 million to date from leading strategic collaborators and investors including Longwood Fund, Novartis Institutes for Biomedical Research, Astellas Venture Management, Novartis Venture Fund, Bessemer Venture Partners, GV, 6 Dimensions Capital, and Pitango Venture Capital.

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

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TScan Announces Targets for Two Planned INDs in 2021 to Treat Liquid Tumors - Business Wire

We know that dogs can be diagnosed with brain tumours however this is the first time we have reported on positive results in a preliminary brain cancer study for the treatment of dogs. Animal Life Sciences, Inc. (ALS), a pharmaceutical and nutritional development company announced that a comparative oncology trial being conducted using ALS101( a combination of two brain cancer drug candidates ALS licensed for use in animals) is showing promise in dogs suffering from malignant gliomas, including glioblastoma. Dogs suffer from these same types of aggressive tumours and treatment options, much like those for humans, are extremely limited. ALS have seen regression of tumour in a significant population of dogs treated in a formal Phase I clinical trial and while the tumour did not quite disappear, in some cases it shrank more than 95 percent and the animals lived longer.

News from Sweden now where a study has shown that one year after the diagnosis of low-grade malignant brain tumour just under three people in ten were in full-time employment. For this young patient group, returning to work is a key health factor however another year later, the proportion remained below half. For those of you unsure about the characterisation of a low grade, malignant tumour it is defined in this study as a low-grade glioma which is incurable and grows slowly but, thanks to modern treatments, its survival expectancy has successively increased. Given the patients' low age -- averaging 40 years when they fell ill -- their work capacity is seen as an especially important factor in quality of life. Being able to work again is, for many, a crucial aspect of returning to a normal life.

We have explained about orphan drug diagnosis in these updates before but to recap, in the US the Orphan Drug Act (ODA) provides for granting special status to a drug to treat a rare disease or condition. Benefits for a pharma company of having a drug given orphan designation include tax credits of 50% off the clinical drug testing cost awarded upon approval and eligibility for market exclusivity for 7 years post-approval.

Plus Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted the Company orphan drug designation for its lead investigational drug, Rhenium NanoLiposomes (RNL) for the treatment of patients with recurrent glioblastoma. RNL is designed to safely, effectively, and conveniently deliver a very high dose of radiation - up to 25 times greater concentration than currently used external beam radiation therapy - directly into the brain tumour for maximum effect. Dr. Marc Hedrick, President and Chief Executive Officer of Plus Therapeutics said: We believe RNL has the potential to prolong survival for patients with malignant brain tumours and that of other difficult to treat radiosensitive tumours.

In the fight against cancer, scientists have long grappled with the ambiguous nature of stem cells. GBM tumours consist of stem cells which have the ability to self-renew making these tumours notoriously hard to treat with targeted radiation therapy and difficult to permanently remove through surgery. However, could gene therapy provide a potential breakthrough in brain cancer treatment and put the invincibility of tumour stem cells into question. This recent paper details a new technique of sensitizing stem cells to radiation therapy, thereby increasing the therapys efficacy.

You may find this overview of dendritic cell vaccines for brain tumours is helpful reading before moving onto this paperOnce, Twice, Three Times a Finding: Reproducibility of Dendritic Cell Vaccine Trials Targeting Cytomegalovirus in Glioblastoma. John Sampson, M.D., Ph.D. from Duke University a leader in cancer immunotherapy for brain tumours commented on the paper saying These study results not only advance our understanding of a virus role in cancer, but they also signal tremendous hope to patients and their families suffering from this devastating disease

An optimistic-sounding end to this weeks worldwide research update.

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Treating dogs diagnosed with GBM, getting Swedish patients back to work, orphan designation for improved radiotherapy drug plus gene therapy - Brain...

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Reasons Industries to Thrive Post-Pandemic! Stem Cell Therapy for Osteoarthritis Market Report xyz Answers it Analysis by Key Companies Mesoblast,...