BCMA

Century Therapeutics Strengthens Position in Autoimmune Disease with Strategic Pipeline Expansion Supported by $60 Million Private Placement and Acquisition of Clade Therapeutics

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목요일, 4월 11, 2024
NK, Sale, Cancer, LLP, Lazard, Investment, News, Safety, Security (finance), Ink, Myasthenia gravis, Research, Exchange, Haematopoiesis, Lymphoma, IPSC, CD19, Autoimmune disease, Patient, Acquisition, Pharming, NHL, Inflammation, BofA Securities, SLE, Clinical trial, Therapy, Lymphoid leukemia, Autoimmunity, BCMA

PHILADELPHIA, April 11, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory diseases, today announced plans to expand clinical development for its lead program, CNTY-101, a CD19-targeting iNK cell therapy, into additional autoimmune disease indications. CNTY-101 is currently being evaluated in a clinical trial in B-cell malignancies (ELiPSE-1) as well as a planned clinical trial in systemic lupus erythematosus (SLE) (CALiPSO-1), which is on track to be initiated in the first half of 2024. Century plans to pursue additional autoimmune disease indication regulatory filings in 2024. Century’s increased research and development activities in autoimmune diseases are further supported by a $60 million private placement of its common stock to certain institutional investors. Concurrently, Century announced pipeline and platform enhancements through the acquisition of Clade Therapeutics, Inc. (“Clade”), a privately-held biotech company focused on discovering and delivering engineerable, off-the-shelf, scalable, and consistent stem cell-based medicines, with a focus on iPSC-derived αβ T cells. The acquisition brings additional iPSC-focused pipeline programs and technology to Century spanning across cancer and autoimmune diseases.

Key Points: 
  • Century plans to pursue additional autoimmune disease indication regulatory filings in 2024.
  • Century’s increased research and development activities in autoimmune diseases are further supported by a $60 million private placement of its common stock to certain institutional investors.
  • The acquisition brings additional iPSC-focused pipeline programs and technology to Century spanning across cancer and autoimmune diseases.
  • With support from a distinguished group of investors, coupled with the acquisition of Clade, we are poised for continued success,” said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century.

Cartesian Therapeutics to Present at the ASGCT 27th Annual Meeting

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월요일, 4월 22, 2024
Biotechnology, Health, Clinical Trials, Messenger, Annual general meeting, Therapy, Gene, Cell, Society, BCMA, Patient

Cartesian Therapeutics, Inc. (NASDAQ:RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that recently reported twelve-month follow-up data from its Phase 2a trial of Descartes-08 in patients with generalized myasthenia gravis will be featured during an oral presentation at the upcoming American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting being held May 7-11, 2024 in Baltimore, MD.

Key Points: 
  • Cartesian Therapeutics, Inc. (NASDAQ:RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that recently reported twelve-month follow-up data from its Phase 2a trial of Descartes-08 in patients with generalized myasthenia gravis will be featured during an oral presentation at the upcoming American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting being held May 7-11, 2024 in Baltimore, MD.
  • Descartes-08, the Company’s lead product candidate, is an autologous anti-B cell maturation antigen (BCMA) mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T).
  • Details of the presentation are as follows:

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

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수요일, 4월 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

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수요일, 4월 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

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일요일, 4월 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

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토요일, 4월 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

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목요일, 3월 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

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월요일, 4월 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

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목요일, 3월 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

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화요일, 3월 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.”