BCMA

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

Retrieved on: 
Martedì, Dicembre 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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Martedì, Dicembre 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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Martedì, Dicembre 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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Lunedì, Dicembre 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

Immix Biopharma 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

Retrieved on: 
Lunedì, Dicembre 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

LOS ANGELES, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, today announced new clinical data from its Phase 1b/2a NEXICART-1 (NCT04720313) study of novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, in patients with relapsed/refractory AL Amyloidosis (R/R ALA) at an oral presentation by study investigator Moshe E. Gatt, MD at the 65th American Society of Hematology (ASH) Meeting being held in San Diego, CA. The updated results include follow-up and clinical data from one new patient. All patients were relapsed/refractory to standard-of-care Dara-CyBorD (daratumumab combined with cyclophosphamide, bortezomib, and dexamethasone) and had experienced a median of 6 prior lines of therapy that failed to stop worsening of disease prior to receiving NXC-201.

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., Chief Executive Officer of Immix Biopharma.
  • 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

Initial Phase 1 Dose Escalation Data for ORIC-533 in Relapsed/Refractory Multiple Myeloma Demonstrates Clinical Activity and Strong Safety Profile Supporting Potential for Combination Development

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Lunedì, Dicembre 11, 2023
PRC2, Partnership, Survival, Bone marrow, Plasma, Lung cancer, Multiple myeloma, Prostate cancer, BCMA, SAN, Half-life, Society, Pharmacokinetics, Serum, Q&A, ASH, Knowledge, CD73, Toxicity, Webcast, Patient, Safety, NK, Pharmaceutical industry

The primary objectives of the trial are safety and determination of the recommended Phase 2 dose (RP2D).

Key Points: 
  • The primary objectives of the trial are safety and determination of the recommended Phase 2 dose (RP2D).
  • As of November 28, 2023, a total of 23 patients with multiple myeloma received doses ranging from 400 mg to 2400 mg once daily.
  • ORIC-533 also demonstrated strong inhibition of soluble CD73 enzymatic activity across all dose levels, highlighting good target engagement, including in the bone marrow.
  • Soluble BCMA levels have been reported to correlate with clinical response on treatment and predict progression free survival of various therapies.

Autolus Therapeutics Presents Clinical Data Updates at the American Society of Hematology (ASH) Annual Meeting 2023

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Domenica, Dicembre 10, 2023
Associate, Food, Bone marrow, MRD, FDA, Royal College of Pathologists, CRi, Cancer Institute, Multiple myeloma, BCMA, EMD, Doctor of Philosophy, Society, Biologics license application, Therapy, ASH, EFS, University College London, Toxicity, CRS, Webcast, Patient, CD19, Safety, ALL, B-ALL, UCL, BLA, Pharmaceutical industry

Finally, in an oral presentation pre-clinical and Phase I clinical data from AUTO8, a BCMA/CD19 co-targeting CAR T cell candidate, evaluated in patients with refractory multiple myeloma.

Key Points: 
  • Finally, in an oral presentation pre-clinical and Phase I clinical data from AUTO8, a BCMA/CD19 co-targeting CAR T cell candidate, evaluated in patients with refractory multiple myeloma.
  • “The FELIX study, with 127 patients, is one of the largest CAR T cell studies in adults with r/r B-ALL.
  • A high proportion of patients responded, with many responses sustained, particularly in patients with low or intermediate disease-burden at lymphodepletion.
  • Cellular kinetic data shows high expansion and long-term persistence of CAR T cells in most responders.

Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients with Heavily Pre-Treated Multiple Myeloma

Retrieved on: 
Giovedì, Dicembre 7, 2023
Telephone, Regeneron Pharmaceuticals, Food, Translation, Aes, B-cell maturation antigen, Death, FDA, Cytokine release syndrome, Disease, Multiple myeloma, BCMA, Society, ASH, Hematology, African Americans, ID, Infection, CRS, Webcast, Patient, Safety, Senior, Pharmaceutical industry

TARRYTOWN, N.Y., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the primary endpoint analysis from the pivotal trial (LINKER-MM1) investigating linvoseltamab demonstrated high rates of deep and durable responses in patients with relapsed/refractory (R/R) multiple myeloma (MM). These Phase 1/2 results are planned to be submitted to regulatory authorities, including to the U.S. Food and Drug Administration (FDA) this year. Linvoseltamab is an investigational BCMAxCD3 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: 
  • ET
    TARRYTOWN, N.Y., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the primary endpoint analysis from the pivotal trial (LINKER-MM1) investigating linvoseltamab demonstrated high rates of deep and durable responses in patients with relapsed/refractory (R/R) multiple myeloma (MM).
  • Linvoseltamab is an investigational BCMAxCD3 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 the U.S., linvoseltamab has been granted Fast Track Designation for multiple myeloma by the FDA.
  • A replay of the conference call and webcast will be archived on the company's website for at least 30 days.

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

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Lunedì, Novembre 27, 2023
Quality of life, Food, Autoimmune disease, Autoantibody, Immune system, IND, FDA, SLE, IIT, Tissue, BCMA, Society, Cancer, Pharmacokinetics, Standard of care, B cell, Neurotoxicity, NHL, RRMM, Patient, CD19, Safety, Vaccine

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Nov. 27, 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 U.S. Food and Drug Administration (FDA) has cleared Gracell’s Investigational New Drug (IND) application, allowing the Company to initiate a Phase 1/2 clinical trial of FasTCAR-T GC012F in the United States for the treatment of refractory systemic lupus erythematosus (rSLE).

Key Points: 
  • “We are excited to expand the clinical development of our lead FasTCAR asset, GC012F, for treatment of rSLE in the United States,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell.
  • “This progress marks the second U.S. IND clearance for GC012F, a notable milestone.
  • Systemic lupus erythematosus (SLE) is a B-cell-mediated autoimmune disease, in which autoantibodies produced by the immune system attack the patient’s own tissues, causing multi-organ damage.
  • Further, in preclinical studies, GC012F has shown a more effective elimination of antibody secreting cells compared to CD19 single-targeted CAR-T therapy.

Immix Biopharma to Host KOL Event to Discuss its BCMA-Targeted CAR-T Cell Therapy Candidate NXC-201 for Relapsed/Refractory AL Amyloidosis

Retrieved on: 
Mercoledì, Novembre 22, 2023
University of Alabama, IND, FDA, Multiple myeloma, BCMA, ODD, Society, Amyloidosis, University, AL amyloidosis, Hematology, Poster, Patient, KOL, Assistant professor, Pharmaceutical industry

To register for the event, click here.

Key Points: 
  • To register for the event, click here.
  • NXC-201 is a BCMA-targeted investigational CAR-T cell therapy.
  • NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma.
  • A live question and answer session will follow the formal presentations.