Category Archives: Stem Cell Therapy

The novel triplet combination with polatuzumab vedotin (Polivy), rituximab, and lenalidomide was safe while improving overall and complete responses for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), according to data presented at the 2021 ASCO Annual Meeting.

In this first report of a triplet combination of polatuzumab, rituximab and lenalidomide, the triplet combination showed notable efficacy in a challenging-to-treat relapsed and refractory diffuse large B-cell lymphoma population, said Catherine S.M. Diefenbach, MD, associate professor of medicine, translational director of hematology and director of clinical lymphoma at Perlmutter Cancer Center at NYU Langone Health, during the virtual presentation.

In this phase 1b/2 trial, researchers analyzed the safety of this combination in 57 patients (median age, 71 years; 67% men) with relapsed/refractory diffuse large B-cell lymphoma, were ineligible for or failed prior autologous stem cell transplantation and were treated with at least one prior anti-CD20-containing chemo-immunotherapy regimen. Efficacy of the treatment was assessed in 49 patients (median age, 72 years; 63% men).

The median age was 71, as is typical for this lymphoma, but the age range was from between 28 and 92 years, Diefenbach said.

Most patients in the safety and efficacy groups (86% and 84%, respectively) had stage 3 to 4 disease, nearly a quarter had two lines of therapy (28% and 27%) and nearly a third had three or more lines of therapy (33% and 31%). In addition, some patients underwent previous CAR T-cell therapy (5% and 6%, respectively) or prior bone marrow transplant (11% and 12%).

At induction, all patients received induction during 6 28-day cycles with 1.8 mg/kg of intravenous polatuzumab vedotin, 375 mg/m2 of intravenous rituximab and either a dose escalation of oral lenalidomide (between 10 mg and 20 mg) or the recommended daily dose of the drug on days 1 through 21. Patients who responded to the treatment at the end of induction received 6 months consolidation of 10 mg of lenalidomide (days 1 through 21, monthly) and 375 mg/m2 of rituximab (day 1 every 2 months).

Primary endpoints for this trial included the safety and tolerability of this triplet combination, in addition to complete response rates at the end of induction as assessed by positron emission tomography (PET) scans. Follow-up was conducted for a median of 9.7 months in the safety population and for 9.5 months in the efficacy population.

In the safety population, 75% of patients experienced grade 3 to 4 adverse events, with the most common including neutropenia (58%), thrombocytopenia (14%) and infections (14%). Adverse events led to 26% of patients undergoing a lenalidomide dose reduction and 67% had treatment interruption. One grade 5 adverse event related to the treatment neutropenic sepsis was reported.

The additional (adverse events) were not considered related to study drug, Diefenbach said. For example, a patient who had a fatal gastric hemorrhage who had been enrolled but not yet treated, and a patient with COVID-19 who contracted this disease 167 days after his last dose of the study therapy.

In the efficacy population, the overall response rate was 39% with a complete response rate of 29%. Ten percent of patients had a partial response. Median progression-free survival for the entire population was 6.3 months (95% CI, 4.5-9.7) with a median duration of remission of 8.1 months (95% CI, 4.7-not evaluated) and a median overall survival of 10.9 months (95% CI, 10.9-not evaluated).

However, for the patients who obtained a (complete response) this is 13 patients who were evaluable, the median progression-free survival at 9 months had not been reached, nor has the median overall survival, Diefenbach said. Nearly all patients remain in complete remission.

Additional follow-up is needed to assess the impact of consolidation therapy on the duration of long-term response, Diefenbach said. In summary, the triplet combination of polatuzumab, rituximab and lenalidomide represents a potential novel regimen for patients with transplant-ineligible relapsed and refractory diffuse large B-cell lymphoma and is worthy of further study.

Reference

Magid Diefenbach CS, Abrisqueta P, Gonzalez-Barca E, et al. Polatuzumab vedotin (Pola) + rituximab (R) + lenalidomide (Len) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Primary analysis of a phase 1b/2 trial. J Clin Oncol. 2021;39(suppl 15):Abstract 7512.

See more here:
Triplet Combo of Polatuzumab Vedotin, Rituximab and Lenalidomide Safe, Effective to Treat Relapsed/Refractory DLBCL - Cancer Network

In patients with relapsed/refractory diffuse large B-cell lymphoma treated with the triplet combinaton of polatuzumab vedotin (Polivy), rituximab and lenalidomide, therapy was considered to be safe and effective, according to data presented at the 2021 ASCO Annual Meeting.

In this first report of a triplet combination of polatuzumab, rituximab and lenalidomide, the triplet combination showed notable efficacy in a challenging-to-treat relapsed and refractory diffuse large B-cell lymphoma population, said Catherine S.M. Diefenbach, MD, associate professor of medicine, translational director of hematology and director of clinical lymphoma at Perlmutter Cancer Center at NYU Langone Health, during the virtual presentation.

In this phase 1b/2 trial, researchers analyzed the safety of this combination in 57 patients (median age, 71 years; 67% men) with relapsed/refractory diffuse large B-cell lymphoma, were ineligible for or failed prior autologous stem cell transplantation and were treated with at least one prior anti-CD20-containing chemo-immunotherapy regimen. Efficacy of the treatment was assessed in 49 patients (median age, 72 years; 63% men).

The median age was 71, as is typical for this lymphoma, but the age range was from between 28 and 92 years, Diefenbach said.

Most patients in the safety and efficacy groups (86% and 84%, respectively) had stage 3 to 4 disease, nearly a quarter had two lines of therapy (28% and 27%) and nearly a third had three or more lines of therapy (33% and 31%). In addition, some patients underwent previous CAR T-cell therapy (5% and 6%, respectively) or prior bone marrow transplant (11% and 12%).

At induction, all patients received induction during 6 28-day cycles with 1.8 mg/kg of intravenous polatuzumab vedotin, 375 mg/m2 of intravenous rituximab and either a dose escalation of oral lenalidomide (between 10 mg and 20 mg) or the recommended daily dose of the drug on days 1 through 21. Patients who responded to the treatment at the end of induction received 6 months consolidation of 10 mg of lenalidomide (days 1 through 21, monthly) and 375 mg/m2 of rituximab (day 1 every 2 months).

Primary endpoints for this trial included the safety and tolerability of this triplet combination, in addition to complete response rates at the end of induction as assessed by positron emission tomography (PET) scans. Follow-up was conducted for a median of 9.7 months in the safety population and for 9.5 months in the efficacy population.

In the safety population, 75% of patients experienced grade 3 to 4 adverse events, with the most common including neutropenia (58%), thrombocytopenia (14%) and infections (14%). Adverse events led to 26% of patients undergoing a lenalidomide dose reduction and 67% had treatment interruption. One grade 5 adverse event related to the treatment neutropenic sepsis was reported.

The additional (adverse events) were not considered related to study drug, Diefenbach said. For example, a patient who had a fatal gastric hemorrhage who had been enrolled but not yet treated, and a patient with COVID-19 who contracted this disease 167 days after his last dose of the study therapy.

In the efficacy population, the overall response rate was 39% with a complete response rate of 29%. Ten percent of patients had a partial response. Median progression-free survival for the entire population was 6.3 months (95% CI, 4.5-9.7) with a median duration of remission of 8.1 months (95% CI, 4.7-not evaluated) and a median overall survival of 10.9 months (95% CI, 10.9-not evaluated).

However, for the patients who obtained a (complete response) this is 13 patients who were evaluable, the median progression-free survival at 9 months had not been reached, nor has the median overall survival, Diefenbach said. Nearly all patients remain in complete remission.

Additional follow-up is needed to assess the impact of consolidation therapy on the duration of long-term response, Diefenbach said. In summary, the triplet combination of polatuzumab, rituximab and lenalidomide represents a potential novel regimen for patients with transplant-ineligible relapsed and refractory diffuse large B-cell lymphoma and is worthy of further study.

Reference

Magid Diefenbach CS, Abrisqueta P, Gonzalez-Barca E, et al. Polatuzumab vedotin (Pola) + rituximab (R) + lenalidomide (Len) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Primary analysis of a phase 1b/2 trial. J Clin Oncol. 2021;39(suppl 15):Abstract 7512.

More:
Polatuzumab With Rituximab and Lenalidomide Shown Safe and Effective for Relapsed/Refractory DLBCL - Targeted Oncology

SAN DIEGO, June 1, 2021 /PRNewswire/ --ViaCyte, Inc., a clinical-stage regenerative medicine company focused on developing cell therapies that provide a functional cure for patients with diabetes announced today presentation of a late-breaking ePoster with commentary on behalf of the study by Manasi Sinha Jaiman, M.D., M.P.H., Vice President, Clinical Development, at the upcoming American Diabetes Association's Virtual 81st Scientific Sessionsto be held on June 25-29, 2021.

The ePoster, "Stem Cell-Derived Islet Replacement Therapy (VC-02) Demonstrates Production of C-Peptide in Patients with Type 1 Diabetes (T1D) and Hypoglycemia Unawareness" will be available for conference attendees to view and submit questions on Friday, June 25, 2021, at 11:30 a.m. ET.

"We believe that the data presented at ADA from our stem cell-derived islet replacement therapy program brings us one step closer to delivering a functional cure for type 1 diabetes," said Dr. Jaiman. "Our mission is to re-define the way in which diabetes is managed today by eliminating the burden of constant insulin administration with a therapy designed to deliver physiological regulation of blood glucose, thus enabling better health outcomes for patients."

After the conference, the ePoster will be available at the journal Diabetes website.

About ViaCyte

ViaCyte is a privately held regenerative medicine company developing novel cell replacement therapies based on two major technological advances: cell replacement therapies derived from pluripotent stem cells and medical device systems for cell encapsulation and implantation. ViaCyte has the opportunity to use these technologies to address critical human diseases and disorders that can potentially be treated by replacing lost or malfunctioning cells or proteins. The company's first product candidates are being developed as potential long-term treatments for patients with type 1 diabetes to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. To accelerate and expand the company's efforts, ViaCyte has established collaborative partnerships with leading companies, including CRISPR Therapeutics and W.L. Gore & Associates. ViaCyte is headquartered in San Diego, California. For more information, please visit http://www.viacyte.com and connect with ViaCyte on Twitter, Facebook, and LinkedIn.

About PEC-Direct (VC-02)

ViaCyte's PEC-Direct (VC-02) product candidate is being developed for treatment of patients with type 1 diabetes who have hypoglycemia unawareness and/or extreme glycemic lability. It is an investigational cell replacement therapy comprised of pancreatic islet progenitor cells in a non-immunoprotective pouch, which allows direct vascularization of the implanted cells. VC-02 is designed to enable production of both insulin and glucagon to modulate blood glucose, improve time in range, and ameliorate or prevent complications associated with type 1 diabetes. Phase 2 clinical studies to evaluate the safety and efficacy of VC-02 are ongoing (clinical trial identifier: NCT03163511).

About the ADA's Scientific Sessions

The American Diabetes Association's (ADA) 81st Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention, and care, will be held virtually June 25-29, 2021. Leading physicians, scientists, and health care professionals from around the world will unveil cutting-edge research, treatment recommendations and advances toward a cure for diabetes. Attendees will receive exclusive access to all virtual content for 90-days after the event, with access ending September 29, 2021.For more information, visit https://professional.diabetes.org/scientific-sessions.

SOURCE ViaCyte, Inc.

https://viacyte.com/

See more here:
ViaCyte to Present Late-Breaking Data at the American Diabetes Association's 81st Scientific Sessions - PRNewswire

Development of advanced genomic analysis techniques, the introduction of effective guidelines for cell therapy manufacturing, a vast amount of research by cancer societies, and the proven effectiveness of transplants are some of the primary growth stimulants for the market. Certain manufacturing and pharmacological issues and regulatory hurdles are hindering the growth of the market.

The report offers an industry-wide and economy-wide analysis of the market along with supply and demand dynamics, sales, and production and manufacturing capacity. It also reviews the rate of production and consumption, sales network and distribution channel, pricing analysis, profit margins, cost and demand volatility, import/export, gross revenue, among others. Financial difficulties brought by the pandemic have slowed down the progression of the businesses, and disruptions in the supply chains have been seen. The report assesses the comprehensive impact of the pandemic on the overall growth of the Stem Cell Therapy market and offers a future impact assessment.

Download the report description: https://www.emergenresearch.com/request-sample/83

COVID Analysis

The research report draws focus on the impact of the COVID-19 pandemic on the market and its crucial segments. It offers insights into the effects of the pandemic on the global economic scenario and business sphere. The report evaluates the key market influencing factors and considers the COVID-19 pandemic as one of the contributing elements.

With a major focus on the growth trajectories of each segment of the market, the report inspects the operating patterns of each market contender, for instance, partnerships & collaborations, mergers & acquisitions, and new product launches, in a detailed manner.

The Stem Cell Therapy market intelligence report exhaustively examines the market value, share, demand, growth prospects, latest and historical trends, manufacturers, gross revenue collection, competitive terrain, market growth forecast, available products, and end-use applications.

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REGULATED INFORMATION

Strong clinical progress especially in JTA-004 Phase III study thanks to high patient compliance and retention

Process development partnership and appointment of cell therapy expert Anthony Ting as CSO to further strengthen product pipeline

Gosselies, Belgium, 26May 2021, 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces its business update for the first quarter, ended 31 March 2021.

Bone Therapeutics has continued the strong momentum into 2021, said Miguel Forte, MD, PhD, CEO of Bone Therapeutics. Bone Therapeutics mid-late stage clinical programs continue to advance largely on schedule, including the Phase IIb trial of the allogenic cell therapy platform ALLOB in difficult-to-heal tibial fractures and the Phase III trial of the enhanced viscosupplement JTA-004 in knee osteoarthritic pain. Alongside this, Bone Therapeutics has strengthened its manufacturing and R&D capabilities by signing a process development partnership with Rigenerand. It has also appointed the industry veteran Tony Ting as our new Chief Scientific Officer. Building on these achievements, Bone Therapeutics will be able to continue significant clinical and commercial advancements as we move towards the topline data of our JTA-004 Phase III study; a potential key inflection point for Bone Therapeutics.

Operational highlights

Financial highlights

Outlook for the remainder of 2021

(1) Unaudited number

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in Phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Read more from the original source:
Bone Therapeutics Provides First Quarter 2021 Business Update - GlobeNewswire

Report Introduction

The report entitled, Global Stem Cell Therapy Market is a unique market study that offers the latest in-depth information and comprehensive analysis of the market. It provides a complete overview of the market with detailed insights on key aspects including the current market situation, potential size, volume, and dynamics of the market. This research report makes a thorough assessment of the COVID-19 pandemic and its impact on the current market and evaluates the possible outcome of the market during the forecast period, 2021 2028.

Competitors Landscape

Key players in the market include

Osiris TherapeuticsNuVasiveChiesi PharmaceuticalsJCR PharmaceuticalPharmicellMedi-postAnterogenMolmedTakeda (TiGenix)Stem Cell Therap

This report offers a comprehensive view regarding the competitive landscape of the Stem Cell Therapy market and includes a broad description of performance by some of the key global players completing in the market. It offers a list of latest updates of several business strategies including mergers, acquisitions, partnerships, product launch, expansion of production units, and collaborations adopted by these major global players. The report provides a clear picture regarding R&D investment from key players and adoption of innovative technologies to widen their consumer base and expand the existing competitive position. Moreover, the report offers a detailed information about the position, scope of growth, and opportunities of new entrants or players in the market.

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Keeping a view to grasp the overall prospect of the market, the report explains key drivers, opportunities, restraints, and challenges focusing on the current market trend and evaluates the prospects of the future market. The report offers an extensive study of the market segments and sub-segments with a clear explanation of which segment is expected to dominate the market during the forecast period.

To assist clients in arriving informed decision about their business investment plans and strategies of the market, the report provides a broad information about the performance of regional markets and competitors analysis. The report analyses the latest development and profiles of the major global players competing in the market to understand their positions and expansion capacity.

Segments Insight

The global Stem Cell Therapy market is divided into

AutologousAllogeneicStem Cell Therap

The report includes key insights regarding segments and sub-segments of the market. It covers a detailed information regarding the performance and market valuation of each segment along with the expected CAGR including various sub-segments of the market during the forecast period. Additionally, the report offers insight about key driving factors that help to expand the segment as well as major challenges that can hamper the growth of segments during the projected period to understand the clear picture of the overall expansion scope of the market.

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Applications

The global Stem Cell Therapy market is categorized into

Musculoskeletal DisorderWounds & InjuriesCorneaCardiovascular DiseasesOthers

The report lists a wide range of applications of Stem Cell Therapy and covers the major industries that extensively use the product for their various applications. A detailed explanation is provided in the report about the areas of applications describing where the product is adopted by key industries to leverage their business portfolio. It also provides information about factors that help expand market scope of some of the key applications, their revenue share of each application, and their segment parameters to grasp a complete sense of the segment.

Regional Analysis

The global Stem Cell Therapy market is classified as

Asia Pacific

Europe

North America

Latin America

Middle East & Africa

This research report widely covers the revenue share, potential growth opportunities, and projected growth rate focusing on five major regions namely Asia Pacific, Europe, North America, Latin America, and Middle East & Africa. Additionally, the report includes a broad analysis of which sub-regions and countries within a region, which are expected to dominate the regional market during the forecast period. The report provides vital information regarding socio-economic and political factors that can influence the overall performance and growth rate of the respective regional markets. A special chapter is reserved in the report for the COVID-19 pandemic and its impacts on the regional market and further explains how this pandemic is projected to influence consumers behavior of the Stem Cell Therapy market in the coming years. The report also focuses on elaborating the roles and impacts of the existing regional trade regulations and government policies & regulations that can either boost or hinder the regional market expansion.

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Some Major TOC Points:

Chapter 1. Report Overview

Chapter 2. Global Growth Trends

Chapter 3. Market Share by Key Players

Chapter 4. Breakdown Data by Type and Application

Chapter 5. Market by End Users/Application

Chapter 6. COVID-19 Outbreak: Stem Cell Therapy Industry Impact

Chapter 7. Opportunity Analysis in Covid-19 Crisis

Chapter 8. Market Driving Force

And Many More

Reasons to Buy the Report

Contact Info: Name: Alex MathewsAddress: 500 East E Street, Ontario,CA 91764, United States.Phone No: USA: +1 909 414 1393Email: [emailprotected]Website: https://industrygrowthinsights.com

Link:
Stem Cell Therapy Industry 2021 Insights. A Detailed Research Report Covering Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCR...