BCMA

EQS-News: Heidelberg Pharma granted orphan drug designation by FDA for its proprietary ATAC candidate HDP-101

Retrieved on: 
Wednesday, April 10, 2024
ODD, Diagnosis, RRMM, BCMA, Patient, Multiple myeloma, Spacecraft, Amanitin, AACR, Antibody, Safety, HPHA, FDA, B-cell maturation antigen, ATAC, Food, Pharmaceutical industry

Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.

Key Points: 
  • Ladenburg, Germany, 27 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101.
  • Heidelberg Pharma is investigating the candidate in a clinical Phase I/IIa study for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “We are delighted that our proprietary ATAC candidate HDP-101 has been granted Orphan Drug Designation by the FDA, providing further validation of its potential benefit as a therapeutic for patients with multiple myeloma.
  • The designation provides significant incentives to promote the development of the drug including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.

EQS-News: Heidelberg Pharma announces progress into Cohort 6 with its proprietary ATAC candidate HDP-101 in Phase I/IIa multiple myeloma study

Retrieved on: 
Wednesday, April 10, 2024
Multiple myeloma, Bone marrow, Cohort, Infection, Incidence, BCMA, Patient, Plasma cell, Mortality, B cell, Spacecraft, AACR, Annual report, Antibody, The Annual Report, Safety, Pharmacokinetics, HPHA, FDA, ATAC, Food, Pharmaceutical industry

Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow and can affect more than one part of the body.

Key Points: 
  • Multiple myeloma is a type of blood cancer that develops from plasma cells in the bone marrow and can affect more than one part of the body.
  • Plasma cells are a type of blood cell that makes antibodies to fight infection, created by bone marrow.
  • Heidelberg Pharma’s Phase I/IIa clinical study is an ongoing, non-randomised, open label study which is actively enrolling patients with relapsed or refractory multiple myeloma or other plasma cell disorders expressing BCMA.
  • Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, said: “Our proprietary ATAC candidate HDP-101 is showing exciting potential for treating multiple myeloma.

Linvoseltamab Pivotal Data Presented at AACR Reinforce High Response Rate that Deepens Over Time in Patients with Heavily Pre-Treated Multiple Myeloma

Retrieved on: 
Sunday, April 7, 2024
Regeneron Pharmaceuticals, Multiple myeloma, BCMA, Patient, AACR, FDA, B-cell maturation antigen, Pharmaceutical industry

Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

Key Points: 
  • Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
  • “In clinical trials, linvoseltamab treatment led to responses that occurred early, were durable and deepened over time – all critical efficacy measures for this heavily pre-treated patient population.
  • Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
  • The Phase 3 confirmatory trial for linvoseltamab in patients with R/R MM (LINKER-MM3) is underway.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
Saturday, April 6, 2024
Guillain–Barré syndrome, Bone marrow, Medical College of Wisconsin, Encephalopathy, Survival, Immunotherapy, BCMA, Patient, Hypotension, Mortality, B-cell maturation antigen, Edema, Periodic breathing, Associate professor, Dexamethasone, Certification, Neutropenia, Dizziness, Risk, Headache, Chills, Myelodysplastic syndrome, Coagulopathy, DPD, Johnson & Johnson, Immune system, Effect, Fatigue, Thrombocytopenia, Food, Disease, Drive, Appetite, Lymphocytopenia, JNJ, Constipation, Multiple myeloma, Acute myeloid leukemia, CRS, Death, Hypersensitivity, Cytopenia, Cytokine release syndrome, ASCO, Use, Hematology, FDA, PVD, Annual general meeting, T cell, DSM-IV codes, Incidence, Tachycardia, Bortezomib, Diarrhea, Viral, Hope, United, Cough, Daratumumab, Nausea, Society, Division, Physician, Pharmaceutical industry

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

Autolus Therapeutics Reports Full Year 2023 Financial Results and Business Updates

Retrieved on: 
Thursday, March 14, 2024
Nucleus, Bone marrow, BCMA, BioNTech, B-ALL, Patient, ALL, SLE, Engineering, Minocycline, European Medicines Agency, Therapy, Research, Canadian Aviation Regulations, Flow cytometry, ASH, General counsel, Immunotherapy, SVP, EMA, Legal Affairs, Trial of the century, GMP, SME, BLA, Nature Communications, Development, UCL, Biologics license application, Multiple myeloma, MIA, University College London, Senior, TRBC, GD2, ASCO, FDA, CD19, Conference call, Conference, MAA, EHA, ADS, MHRA, T cell, ACS Chemical Biology, PDUFA, Autoimmune disease, Pharmaceutical industry

“For now, we remain fully focused on preparing for a potential obe-cel launch and successfully transitioning Autolus to a commercial stage company.

Key Points: 
  • “For now, we remain fully focused on preparing for a potential obe-cel launch and successfully transitioning Autolus to a commercial stage company.
  • In February 2024, Autolus promoted Dr. Chris Williams to Chief Business Officer and Alex Driggs to Senior Vice President, Legal Affairs and General Counsel.
  • Dr. Leiderman brings extensive transactional and financial expertise, and Mr. Azelby brings more than 30 years of biopharmaceutical leadership and commercial experience to Autolus’ Board.
  • Financial Results for the Year Ended December 31, 2023

2seventy bio Announces Completion of Oncology and Autoimmune Pipeline Divestiture to Regeneron

Retrieved on: 
Monday, April 1, 2024
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, LVV, BCMA, Patient, Sale, Multiple myeloma, BMS, Cancer, Bristol Myers Squibb, APA, Pharmaceutical industry

(Nasdaq: TSVT), announced today the completion of the asset purchase agreement (“APA”) by Regeneron Pharmaceuticals, Inc.

Key Points: 
  • (Nasdaq: TSVT), announced today the completion of the asset purchase agreement (“APA”) by Regeneron Pharmaceuticals, Inc.
  • Under the terms of the APA, Regeneron has acquired all oncology and autoimmune research and development programs and has hired approximately 160 employees from 2seventy bio as part of their newly launched cell medicines business.
  • “With the completion of the Regeneron transaction, 2seventy officially embarks on our new strategic path forward to focus on unlocking the value of Abecma,” said Chip Baird, CEO.
  • With the resulting cost savings from reduced headcount and the sale of the pipeline assets to Regeneron, 2seventy bio has extended cash runway beyond 2027.

Kelonia Therapeutics Appoints Kristen Hege, M.D., and Mathai Mammen, M.D., Ph.D., to Board of Directors

Retrieved on: 
Thursday, March 28, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Oncology, Harvard Medical School, Flexner Report, Organization, Bone marrow, Internal medicine, UCSF, Hematology, Science, HST, Massachusetts Institute of Technology, BCMA, Patient, HIV, Dartmouth College, BMS, Cancer, Bristol Myers Squibb, Doctor of Philosophy, Daratumumab, Biochemistry, Chemistry, Therapy, Harvard University, Hospital, Johnson & Johnson, Drug development, FDA, Pharmaceutical industry

Kelonia Therapeutics , a biotech company revolutionizing in vivo gene delivery, today announced the appointments of global leaders in cell therapy and drug development, Kristen Hege, M.D., and Mathai Mammen, M.D., Ph.D., to its board of directors.

Key Points: 
  • Kelonia Therapeutics , a biotech company revolutionizing in vivo gene delivery, today announced the appointments of global leaders in cell therapy and drug development, Kristen Hege, M.D., and Mathai Mammen, M.D., Ph.D., to its board of directors.
  • Furthermore, some patients never receive their autologous CAR-T products due to disease progression or clinical deterioration during the manufacturing window.
  • In addition, the field of cell and gene therapy has gained tremendous expertise and insight into the manufacturing of lentiviral vectors at commercial scale.
  • from the Harvard Medical School and Massachusetts Institute of Technology (HST) and a Ph.D. in chemistry from Harvard University.

Slingshot Unveils a Novel Cell Therapy-Focused Portfolio to Streamline Development while Improving Manufacturing and Clinical Trial Capabilities

Retrieved on: 
Tuesday, March 26, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, BCMA, Quality control, Plague, Patient, Lymphocyte, Cell, CD19, Fine chemical

In response to strong customer demand, Slingshot Biosciences is introducing a groundbreaking portfolio of products that will transform the landscape of analytical precision in cell therapy.

Key Points: 
  • In response to strong customer demand, Slingshot Biosciences is introducing a groundbreaking portfolio of products that will transform the landscape of analytical precision in cell therapy.
  • Its first products in this category are aimed at solving quality control challenges that plague current cell therapy development and manufacturing processes.
  • In the evolving field of cell therapy, the development and delivery of potent and effective products are heavily dependent on precise analytical methodologies.
  • We are dedicated to enhancing cell therapy research and manufacturing precision through our commitment to excellence and strategic global partnerships.”

Merck Completes Acquisition of Harpoon Therapeutics, Inc.

Retrieved on: 
Monday, March 11, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, MSD, Glomus tumor, Carcinoma, EPS, BCMA, Patient, Neoplasm, Merck & Co., Acquisition, Cancer, Epithelial cell adhesion molecule, DLL3, MRK, Safety, Pharmacokinetics, B-cell maturation antigen, SCLC, Food, Pharmaceutical industry

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of Harpoon Therapeutics, Inc. (Nasdaq: HARP).

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of Harpoon Therapeutics, Inc. (Nasdaq: HARP).
  • Harpoon is now a wholly-owned subsidiary of Merck, and Harpoon’s common stock will no longer be publicly traded or listed on the Nasdaq Stock Market.
  • “We continue to augment and diversify our oncology pipeline with innovative approaches to help people with cancer worldwide,” said Dr. Dean Y. Li, president, Merck Research Laboratories.
  • Under the terms of the merger agreement, Merck, through a subsidiary, has acquired all outstanding shares of Harpoon.

IASO Bio Announces U.S. FDA Approval of Investigational New Drug Application for BCMA CAR-T Equecabtagene Autoleucel for Generalized Myasthenia Gravis

Retrieved on: 
Thursday, April 4, 2024
Vital capacity, MuSK protein, Glucocorticoid, NMPA, Hormone, GMG, Disease, Chinese, MRS, BCMA, Nervous system, Patient, SAN, Enzyme inhibitor, History, Female, Multiple myeloma, CRS, B cell, Biotechnology, IND, Phenotype, Investigational New Drug, QMG, Safety, Thymectomy, FDA, Food

The Chinese IND for this indication of Equecabtagene Autoleucel was approved by the NMPA in January this year.

Key Points: 
  • The Chinese IND for this indication of Equecabtagene Autoleucel was approved by the NMPA in January this year.
  • The 2 subjects were treated with a single infusion of Eque-cel at the doses of 1.0×106 CAR-T/Kg, respectively.
  • No immunomodulatory therapy other than low dose pyridostigmine (90 mg/day and 60 mg/day, respectively) was used during the follow-up period.
  • Anti-AChR antibodies, anti-Titin antibodies, and anti-MuSK antibodies decreased rapidly and maintained at very low levels in both subjects after infusion.