BCMA

Cartesian Therapeutics Announces Positive Long-Term Follow-Up Data from Phase 2a Study of Lead mRNA Cell Therapy Candidate Descartes-08 in Patients with Myasthenia Gravis

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월요일, 1월 8, 2024
Lancet Neurology, Patient, Quality of life, Acetylcholine receptor, Peer review, Food, Autoimmune disease, Risk, IND, Messenger, Cytokine release syndrome, The Lancet, Data, Fatigue, Lupus, BCMA, Muscle weakness, Orphan, Therapy, Clinical trial, Investigational New Drug, Quality, Pharmacokinetics, Neurotoxicity, Manuscript, Month, MedRxiv, Autoimmunity, Pharmaceutical industry

GAITHERSBURG, Md., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC), (“the Company”) a clinical-stage biotechnology company pioneering mRNA cell therapies for autoimmune diseases, today announced positive twelve-month follow-up data from its Phase 2a trial of Descartes-08 in patients with generalized myasthenia gravis (MG), a chronic autoimmune disorder that causes disabling muscle weakness and fatigue. The manuscript titled, “Twelve-Month Follow-Up of Patients With Generalized Myasthenia Gravis Receiving BCMA-Directed mRNA Cell Therapy,” has been submitted for peer-review and can be accessed on the online preprint server, medRxiv.

Key Points: 
  • The manuscript titled, “Twelve-Month Follow-Up of Patients With Generalized Myasthenia Gravis Receiving BCMA-Directed mRNA Cell Therapy,” has been submitted for peer-review and can be accessed on the online preprint server, medRxiv.
  • Descartes-08, Cartesian’s lead mRNA cell therapy candidate and a potential first-in-class mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T), is an autologous anti-B-cell maturation antigen (BCMA) mRNA CAR-T.
  • “Notably, most patients maintained robust, clinically meaningful improvements across all four standard MG severity scores approximately 10 months after the last infusion.
  • Enrollment is ongoing in a Phase 2b randomized, double-blind, placebo-controlled trial (NCT04146051) in patients with MG. Topline results are expected in mid-2024.

SpringWorks Therapeutics Highlights 2023 Accomplishments and Anticipated Milestones for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference

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월요일, 1월 8, 2024
Regeneron Pharmaceuticals, Initiate, Conference, AACR, Orange Book, MAPK, Amgen, IND, B-cell maturation antigen, FDA, EMA, BeiGene, EGFR, MAA, Pain, Multiple myeloma, NDA, BCMA, Therapy, Cancer, Investigational New Drug, Event, First grade, Standard of care, TEAD, Neoplasm, Plantar fibromatosis, European Medicines Agency, RAF, European Hematology Association, CD3, MEK, Webcast, NRAS, RAS, Patient, Panitumumab, Pharmaceutical industry

Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.

Key Points: 
  • Ahead of the presentation, the Company highlighted its 2023 accomplishments and announced its anticipated key milestones for 2024.
  • These presentations demonstrated rapid, sustained and consistent improvements in pain and functional status in patients receiving OGSIVEO using multiple assessment tools.
  • Initiate Phase 1 trial of SW-682, SpringWorks’ TEAD inhibitor, in Hippo mutant solid tumors in the first half of 2024.
  • A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

AbelZeta Announces Formation of Scientific Advisory Board to Support Inflammatory and Immunological Diseases

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수요일, 1월 3, 2024
Arthritis, Quality of life, University, Canadian Aviation Regulations, Honorary, CD20, SLE, SAB, Society, Innovation, Cancer, Autoimmune disease, UCSF, Skin condition, Hospital for Special Surgery, B cell, Weill Cornell Medicine, Safety, Journal, Lupus nephritis, Human musculoskeletal system, Biomarker, Arthritis Foundation, Intramural sports, Patient, Hospital, Preventive healthcare, Division, Research, Jean, BCMA, Postgraduate education, Catholic League (German), Rheumatoid arthritis, Lupus Research Alliance, Conditional sentence, Bangladesh Technical Education Board, American College, Cell, CD19, Lee, Culture, Pharmaceutical industry

These four industry experts are distinguished scientific leaders with vast experience in the autoimmune disease field."

Key Points: 
  • These four industry experts are distinguished scientific leaders with vast experience in the autoimmune disease field."
  • Members of the SAB include:
    Peter Lipsky, M.D., served on the Board of Directors of the American College of Rheumatology.
  • She was President of the American College of Rheumatology, President of the Henry Kunkel Society, and Chair of the Scientific Advisory Board of the Lupus Research Alliance.
  • "AbelZeta is advancing promising new therapies for inflammatory and immunological diseases through innovative cell therapy platforms that provide custom-tailored treatment for each individual patient.

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

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화요일, 1월 2, 2024
People, Marketing, INN, Risk, Leukopenia, Hypophosphatemia, Hypotension, Pneumonia, Potassium, Nausea, Cancer, Myenteric plexus, Infection, Anatomy, Cough, IIA, Multiple myeloma, Chills, Consciousness, Diarrhea, Fever, Fatigue, Bone marrow, ATC, Pharyngitis, Pain, Platelet, Disease, Nose, Edema, Neutrophil, Speech, Depression, Appetite, Writing, Lymphocyte, Safety, Water, Tachycardia, Anemia, Neurological disorder, Hypocalcemia, Sepsis, Hypokalemia, Patient, Medical Subject Headings, Febrile neutropenia, Lymphocytopenia, Cytokine release syndrome, International, Encephalopathy, Neutropenia, Blood, Language, Thrombocytopenia, Neurotoxicity, Select, Medicine, Vomiting, Upper respiratory tract infection, Headache, Hospital, BCMA, Confusion, European Medicines Agency, Cell, Medical device

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Gracell Biotechnologies to be acquired by AstraZeneca, furthering cell therapy ambition across oncology and autoimmune diseases

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화요일, 12월 26, 2023
ADS, CVR, AstraZeneca, LLP, Acquisition, AllBright Law Offices, SLE, Centerview Partners, Maples Group, Multiple myeloma, BCMA, Cancer, Lupus, Harney Westwood & Riegels, Investment, Patient, CD19, Bone marrow, VWAP, Cooley LLP, Vaccine

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 26, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative cell therapies for the treatment of cancer and autoimmune diseases, today announced it has entered into a definitive agreement to be acquired by AstraZeneca.

Key Points: 
  • Autologous CAR-T is a type of cell therapy created by reprogramming a patient’s immune T cells to target disease-causing cells, and the manufacturing process for this type of treatment is complex and time-consuming.
  • Gracell’s FasTCAR next-day manufacturing platform significantly shortens manufacturing time, enhances T cell fitness and will potentially improve the effectiveness of autologous CAR-T treatment in patients.
  • AllBright Law Offices is acting as PRC legal advisor to Gracell, and Harney Westwood & Riegels is acting as Cayman Islands legal advisor to Gracell.
  • RuiMin is acting as PRC legal advisor to AstraZeneca, and Maples Group is acting as Cayman Islands legal advisor to AstraZeneca.

Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Refractory Systemic Lupus Erythematosus

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목요일, 12월 21, 2023
Autoimmune disease, CDE, SLE, IIT, Trial of the century, BCMA, Society, Cancer, Investigational New Drug, B cell, NMPA, NHL, National Medical Products Administration, RRMM, CD19, Patient, Vaccine

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has cleared Gracell's Investigational New Drug (IND) application for GC012F, an autologous CAR-T therapeutic candidate, for the treatment of refractory systemic lupus erythematosus (rSLE).

Key Points: 
  • Under the IND, Gracell plans to initiate a Phase 1/2 clinical study in China to further evaluate GC012F in rSLE patients.
  • As announced Nov. 27, the Company will also commence Phase 1/2 clinical study in the U.S. An IIT is underway to evaluate GC012F for the treatment of rSLE.
  • “This milestone marks our rapid progress in advancing development of GC012F in rSLE, an autoimmune disease with high unmet need,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.
  • GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19 and utilizes Gracell’s proprietary FasTCAR next-day manufacturing platform.

Galapagos announces start of PAPILIO-1 Phase 1/2 multiple myeloma study of point-of-care manufactured BCMA CAR-T candidate, GLPG5301

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화요일, 12월 19, 2023
Prognosis, Galapagos NV, Euronext, Patient, B-cell maturation antigen, Multiple myeloma, Safety, Quality of life, BCMA

This is Galapagos’ third oncology CAR-T program in clinical development.

Key Points: 
  • This is Galapagos’ third oncology CAR-T program in clinical development.
  • GLPG5301 is an autologous, second-generation/4-1BB B-cell maturation antigen (BCMA)-directed CAR-T product candidate, administered as an intravenous infusion of a fresh product in a single fixed dose, at point-of-care.
  • “Patients living with relapsed/refractory multiple myeloma have a very poor prognosis and a significant high unmet medical need for novel treatment options.
  • “We are very pleased that the first patient with rrMM in PAPILIO-1 has been dosed with our BCMA CAR-T candidate, GLPG5301.

C4 Therapeutics Announces Positive Data from CFT7455 Phase 1 Trial in Relapsed/Refractory Multiple Myeloma

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화요일, 12월 12, 2023
Well, Patient, CCCC, Leukopenia, Protein, Immunology, Aes, Arm, Completeness, Dexamethasone, Plasma, Anemia, Disease, Neutropenia, Multiple myeloma, Half-life, BCMA, Therapy, Infrared spectroscopy correlation table, SCR, Combination therapy, NHL, MWF, Webcast, Safety, Pharmaceutical industry

C4T also continues to enroll patients in the Phase 1 dose escalation trial exploring CFT7455 as a monotherapy for NHL patients.

Key Points: 
  • C4T also continues to enroll patients in the Phase 1 dose escalation trial exploring CFT7455 as a monotherapy for NHL patients.
  • C4T expects to present the following data on CFT7455 in 2024:
    Complete Phase 1 dose escalation data from the ongoing Phase 1/2 clinical trial in R/R MM.
  • Complete Phase 1 dose escalation data from the ongoing Phase 1/2 clinical trial in NHL.
  • C4T will host an investor webcast today, December 12, 2023, at 4:30 pm Eastern Time, to discuss the CFT7455 Phase 1 clinical data in relapsed/refractory multiple myeloma.

Harpoon Therapeutics Presents HPN217 Phase 1 Clinical Data in Relapsed/Refractory Multiple Myeloma (RRMM) at ASH 2023 and Announces Selection of Recommended Phase 2 Dose (RP2D)

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화요일, 12월 12, 2023
Therapeutic index, Associate, MTD, Oncology, Symantec Endpoint Protection, Index, Banner, FDA, Cytokine release syndrome, Hematology, BCMA, Incidence, SAN, Society, Therapy, Publication, Lymphoma, ASH, CRS, RRMM, Patient, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, today reported data from the Phase 1 study of HPN217 in patients with RRMM in an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego. Harpoon also announced the selection of 12 mg as the HPN217 RP2D.

Key Points: 
  • Harpoon also announced the selection of 12 mg as the HPN217 RP2D.
  • During the trial, 97 patients with RRMM who had received at least three prior therapies were enrolled across 15 dose escalation cohorts and three expansion regimens.
  • As of the data cut-off of October 17, 2023, the data demonstrated:
    Clinical activity across a wide dose range (2.15 mg to 24 mg).
  • The maximum tolerated dose (MTD) was not reached at the target dose using a step up approach.

Nexcella Announces 100% Overall Response Rate (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2023

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월요일, 12월 11, 2023
Patient, Bone marrow, MGUS, Cyclophosphamide, IND, Prevalence, Disease, NYHA, BCMA, MD, Daratumumab, Society, Standard of care, AL amyloidosis, ASH, Dexamethasone, LOS, Bortezomib, Hematopoietic stem cell transplantation, Treatment, CRS, Heart failure, Pharmaceutical industry

“We continue to be encouraged by NXC-201’s 100% overall response rate, including in this 10th relapsed/refractory AL amyloidosis patient.”

Key Points: 
  • “We continue to be encouraged by NXC-201’s 100% overall response rate, including in this 10th relapsed/refractory AL amyloidosis patient.”
    “We believe NXC-201 is the first and only CAR-T in clinical development for AL amyloidosis.
  • With our recent IND clearance, we are thrilled to be now activating sites to bring this first-of-a-kind study to U.S. relapsed/refractory AL Amyloidosis patients,” said Ilya Rachman, M.D., Ph.D., Executive Chairman of Nexcella.
  • Patients were infused with CAR+T cells at doses of 150 x 106 (n=1), 450 x 106 (n=2), and 800 x 106 (n=7).
  • MGUS, Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: From Light Chain to Fibril-Novel Diagnostics to Treatments for Amyloidosis