RRMM

Poseida Therapeutics to Present Early Data from Phase 1 Trials of P-MUC1C-ALLO1 and P-BCMA-ALLO1 at ESMO Immuno-Oncology 2022 Annual Congress

Retrieved on: 
Tuesday, December 6, 2022
Therapy, BCMA, Security (finance), Oncology, European Society for Medical Oncology, Lung, Therapeutic index, B-cell maturation antigen, MUC1, Diagnosis, Epithelium, Patient, University of Maryland Medical Center, Cancer, Degenerative disease, Toxicity, Assistant professor, Roche, Breast cancer, GVHD, Safety, RRMM, University of California, ESMO, Efficacy, Multimedia, Infrared spectroscopy correlation table, University, Breast, Cytokine release syndrome, SAN, CRS, Febrile neutropenia, Vaccine, Pharmaceutical industry, Medical imaging, Risk management, Takeda

SAN DIEGO, Dec. 6, 2022 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced it will present early clinical results from its Phase 1 clinical trials of P-MUC1C-ALLO1 and P-BCMA-ALLO1 at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) 2022 Annual Congress, taking place in Geneva, Switzerland and online from December 7-9, 2022.

Key Points: 
  • "While it is still quite early in both trials, we have seen encouraging responses in both P-MUC1C-ALLO1 and P-BCMA-ALLO1 at the lowest doses as well as favorable tolerability.
  • Poseida has demonstrated the elimination of tumor cells to undetectable levels in preclinical models of both breast and ovarian cancer.
  • Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated cell and gene therapies with the capacity to cure certain cancers and rare diseases.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

COTA, Inc. Announces Seven Upcoming Poster Presentations at the 2022 American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, December 1, 2022
Multiple myeloma, B-cell lymphoma, AML, 2021 Essex County Council election, Food, University, CLL, Cancer, Acute myeloid leukemia, Partnership, MM, Patient, Excellence, Hematological Cancer Research Investment and Education Act, Society, RWD, ASH, COTA, Physical Sciences-Oncology Centers, Research, Chronic lymphocytic leukemia, Health care, DLBCL, RRMM, Lymphatic system, Pharmaceutical industry, Medical imaging, Medicine

NEW YORK, Dec. 1, 2022 /PRNewswire/ -- COTA, Inc. ,an oncology real-world data and analytics company, announced that seven abstracts leveraging COTA's oncology real-world data (RWD) will be presented at the 64th American Society of Hematology (ASH) Annual Meeting taking place in New Orleans, Louisiana, from December 1013, 2022.

Key Points: 
  • NEW YORK, Dec. 1, 2022 /PRNewswire/ -- COTA, Inc. ,an oncology real-world data and analytics company, announced that seven abstracts leveraging COTA's oncology real-world data (RWD) will be presented at the 64th American Society of Hematology (ASH) Annual Meeting taking place in New Orleans, Louisiana, from December 1013, 2022.
  • "There is a continuous need to better understand how emerging therapies are impacting patients in everyday healthcare settings," said C.K.
  • COTA co-authored three of the seven abstracts accepted for poster presentation at the ASH conference.
  • The accepted poster presentations leveraging COTA's oncology real-world data include:

Gracell Biotechnologies Reports Third Quarter 2022 Unaudited Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 14, 2022
Clinical trial, CAR, Federal Reserve Board of Governors, HVG, Multiple myeloma, Persephone Borrow, ASH, Cancer, Security (finance), RRMM, Webcast, Investment, ORR, ADSS, Conference, Research, Lymphoid leukemia, Graft-versus-host disease, American Society for Investigative Pathology, EHA, Holm–Bonferroni method, SMART, Annual report, T cell, BCMA, IND, RMB, Gene editing, B-ALL, TME, IIT, MRD, Graceling, Translation, HLA, SAN, Patient, CD19, Pharmaceutical industry, Vaccine, Medical device, Medical imaging, Mobile phone, Cryptocurrency, Broadcasting, Renminbi

ET today

Key Points: 
  • ET today
    SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (NASDAQ: GRCL) (Gracell or Company), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, today reported third quarter unaudited financial results for the period ended September 30, 2022, and provided corporate updates.
  • First clinical data from ongoing IIT evaluating GC012F in NDMM patients to be presented as oral session at ASH 2022.
  • On track to submit the IND applications in the U.S. and China in the fourth quarter 2022 to evaluate GC012F for the treatment of RRMM.
  • Gracell specifically disclaims any obligation to update any forward-looking statement, whether due to new information, future events, or otherwise.

Gracell Biotechnologies Wins 2022 Fierce Life Sciences Innovation Award

Retrieved on: 
Wednesday, November 16, 2022
SAN, Multiple myeloma, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, IIT, SVP, ORR, Security (finance), RRMM, Annual report, Safety, Risk, Efficiency, Industry, Society, Cancer, European Hematology Association, Technology, Patient, CD19, NASDAQ, Form 20-F, BCMA, SMART, MRD, Food, B-cell maturation antigen, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Development, Fine chemical, Vaccine, Pharmaceutical industry, Research, Graceling

SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, Nov. 16, 2022 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that its FasTCAR Autologous CAR-T Platform was named the winner of the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Awards.

Key Points: 
  • SAN DIEGO, Calif. and SUZHOU and SHANGHAI, China, Nov. 16, 2022 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that its FasTCAR Autologous CAR-T Platform was named the winner of the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Awards.
  • The Fierce Life Sciences Innovation Awards identify and showcase outstanding innovation that is driving improvements and transforming the industry.
  • "We are honored that the FasTCAR next-day manufacturing platform has been recognized by the prestigious Fierce Life Sciences Innovation Awards," said Dr. Cao.
  • Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies.

Harpoon Therapeutics to Present Interim Results from Phase 1 Clinical Trial of T Cell Engager HPN217 at the 64th ASH Annual Meeting and Exposition

Retrieved on: 
Thursday, November 3, 2022
Protein, B-cell maturation antigen, Lymphatic system, Private Securities Litigation Reform Act, Neoplasm, SAN, Society, AbbVie, BCMA, GLOBE, FDA, Cytokine release syndrome, Safety, Poster, ASH, Therapy, COVID-19, RRMM, U.S. Securities and Exchange Commission, Forward-looking statement, Half-life, Antigen, Time, Patient, Cancer, Vaccine, Pharmaceutical industry, Harpoon

The updated interim results from the Phase 1 trial establish clinical proof of concept of HPN217 in heavily pretreated relapsed/refractory multiple myeloma and provide further clinical validation of our proprietary TriTAC T cell engager platform, said Julie Eastland, President and Chief Executive Officer of Harpoon Therapeutics.

Key Points: 
  • The updated interim results from the Phase 1 trial establish clinical proof of concept of HPN217 in heavily pretreated relapsed/refractory multiple myeloma and provide further clinical validation of our proprietary TriTAC T cell engager platform, said Julie Eastland, President and Chief Executive Officer of Harpoon Therapeutics.
  • At ASH 2022, we look forward to presenting updated clinical results from the ongoing HPN217 trial in patients with RRMM, including additional safety, efficacy and pharmacodynamic data from patients enrolled at higher dose levels.
  • For more details about the ASH Annual Meeting, please visit: https://www.hematology.org/meetings/annual-meeting
    In November 2019, Harpoon Therapeutics and AbbVie announced a licensing agreement and option to advance HPN217 and expand an existing discovery collaboration.
  • Under the terms of the agreement, AbbVie may exercise its option to license HPN217 after completion of the Phase 1/2 clinical trial.

Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Thursday, November 3, 2022
FDA, Fitness & Nutrition, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Oncology, Patient, Science, Medicines and Healthcare products Regulatory Agency, Society, EMA, PRIME, European Medicines Agency, FDA, CD3, YouTube, U.S. Securities and Exchange Commission, Clinical trial, Disease, Melanoma, B-cell maturation antigen, Food, NYSE, SC, Breakthrough, Multiple myeloma, ASH, RRMM, Vaccine, Cancer, Blood, ORR, Research, Bone marrow, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough therapy, Breast, COVID-19, CCO, Bispecific monoclonal antibody, PFE, B cell, Hematology, Antigen, Immunotherapy, Survival, News, Lymphatic system, BCMA, Antibody, Probability, Inc., Cytokine release syndrome, Safety, CRS, Orphan, MHRA, Innovative Medicines Initiative, Risk, Causality, ASCO, Pharmaceutical industry, Medical device, Pfizer

Pfizer Inc. (NYSE:PFE) today announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of people with relapsed or refractory multiple myeloma (RRMM).

Key Points: 
  • Pfizer Inc. (NYSE:PFE) today announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of people with relapsed or refractory multiple myeloma (RRMM).
  • This marks Pfizers twelfth FDA Breakthrough Therapy Designation in Oncology, a testament to our relentless commitment to developing transformational cancer medicines in areas of high unmet need.
  • In addition to the Breakthrough Therapy Designation, elranatamab has been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA) for the treatment of MM.
  • The FDA and EMA have granted elranatamab Fast Track Designation and the PRIME scheme, respectively, for the treatment of patients with RRMM.

Poseida Therapeutics to Present at the ESMO Immuno-Oncology 2022 Annual Congress

Retrieved on: 
Thursday, November 3, 2022
Security (finance), Safety, Oncology, SAN, ESMO, RRMM, U.S. Securities and Exchange Commission, Transposase, European Society for Medical Oncology, B-cell maturation antigen, Neoplasm, Genetic engineering, MUC1, 2021 Essex County Council election, Cancer, Private Securities Litigation Reform Act, Efficacy, BCMA, Patient, Epithelium, Breast, Relapse, Therapy, Multiple myeloma, Lung, Roche, Multimedia, Nasdaq, AAV, Vaccine

SAN DIEGO, Nov. 3, 2022 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced the acceptance of two poster presentations at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) 2022 Annual Congress, taking place in Geneva, Switzerland and online from December 7-9, 2022.

Key Points: 
  • SAN DIEGO, Nov. 3, 2022 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced the acceptance of two poster presentations at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) 2022 Annual Congress, taking place in Geneva, Switzerland and online from December 7-9, 2022.
  • The full abstracts will be made available on the ESMO website on December 1, 2022 at 12:05 AM CET.
  • Poseida has demonstrated the elimination of tumor cells to undetectable levels in preclinical models of both breast and ovarian cancer.
  • Poseida Therapeutics is a clinical-stage biopharmaceutical company dedicated to utilizing our proprietary genetic engineering platform technologies to create next generation cell and gene therapeutics with the capacity to cure.

Oncopeptides provides an update from the meeting with FDAs advisory committee ODAC

Retrieved on: 
Friday, September 23, 2022
Adult, European Economic Area, OS, Q&A, FDA, Food, Corporate communication, Multiple myeloma, RRMM, European Commission, Company, Population, Nasdaq Stockholm, Survival, Patient, Capital, CEO, ODAC, ITT, Progression-free survival, Nasdaq, CET, Melphalan, Science, PDC, Failure, Hematologic disease, Heart, Research, US Foods, Royal commission, Dexamethasone, Union, PFS, HIV disease progression rates, Disease, Transplant, Pharmaceutical industry, Melphalan flufenamide

A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population.

Key Points: 
  • A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population.
  • In a 14 to 2 vote, the ODAC answered no to the question.
  • The FDA will not issue a final determination on the issues discussed until input from the advisory committee process has been considered and all reviews have been finalized.
  • Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ)
    The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation.

Oncopeptides provides an update from the meeting with FDAs advisory committee ODAC

Retrieved on: 
Friday, September 23, 2022
Adult, European Economic Area, OS, Q&A, FDA, Food, Corporate communication, Multiple myeloma, RRMM, European Commission, Company, Population, Nasdaq Stockholm, Survival, Patient, Capital, CEO, ODAC, ITT, Progression-free survival, Nasdaq, CET, Melphalan, Science, PDC, Failure, Hematologic disease, Heart, Research, US Foods, Royal commission, Dexamethasone, Union, PFS, HIV disease progression rates, Disease, Transplant, Pharmaceutical industry, Melphalan flufenamide

A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population.

Key Points: 
  • A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population.
  • In a 14 to 2 vote, the ODAC answered no to the question.
  • The FDA will not issue a final determination on the issues discussed until input from the advisory committee process has been considered and all reviews have been finalized.
  • Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ)
    The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation.

Briefing Book for ODAC meeting on benefit/risk profile of Pepaxto now published

Retrieved on: 
Tuesday, September 20, 2022
Adult, European Economic Area, MD, FDA, Food, Corporate communication, RRMM, Company, Population, OCEAN, European Commission, Immunotherapy, Nasdaq Stockholm, Survival, Patient, Capital, CEO, ODAC, Nasdaq, CET, Doctor of Philosophy, Science, PDC, NASDAQ, Hematologic disease, Research, US Foods, Royal commission, Dexamethasone, Union, PFS, EMA, Oncology Drug Advisory Committee, Pharmaceutical industry, Medical device, Melphalan flufenamide

The purpose of the meeting is to obtain the advisory committee's input regarding the benefit/risk of Pepaxto(melphalan flufenamide, also called melflufen) for the currently indicated patient population.

Key Points: 
  • The purpose of the meeting is to obtain the advisory committee's input regarding the benefit/risk of Pepaxto(melphalan flufenamide, also called melflufen) for the currently indicated patient population.
  • "Oncopeptides is committed to enhancing treatment success in patients with RRMM treated with Pepaxto," says Klaas Bakker, MD, PhD, Executive Vice President and Chief Medical Officer.
  • The briefing book contains background information prepared by the FDA and Oncopeptides for the panel members of the ODAC.
  • This may be affected by issues not discussed at the ODAC meeting.