RRMM

ALX Oncology Announces Clinical Trial Collaboration with Sanofi to Evaluate Evorpacept in Combination with SARCLISA (isatuximab-irfc) in Patients with Multiple Myeloma

Retrieved on: 
Tuesday, April 25, 2023
CD38, CD47, Neoplasm, Multiple myeloma, Pharmacokinetics, Carfilzomib, Dexamethasone, Science, Patient, SAN, Sanofi, RRMM, Safety, Pharmaceutical industry

SARCLISA is approved in multiple countries, including the U.S., in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received > 2 prior therapies.

Key Points: 
  • SARCLISA is approved in multiple countries, including the U.S., in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received > 2 prior therapies.
  • Part 1 will evaluate dosing of evorpacept in combination with standard doses of SARCLISA and dexamethasone to identify a recommended dose.
  • ALX Oncology will supply evorpacept and Sanofi will supply SARCLISA for this study.
  • “We are excited about this clinical collaboration with ALX Oncology where we will be evaluating the combination of SARCLISA with evorpacept.”
    ALX Oncology owns worldwide commercial rights to evorpacept.

Gracell Biotechnologies Reports Fourth Quarter and Full Year 2022 Unaudited Financial Results, and Provides Corporate Update

Retrieved on: 
Monday, March 13, 2023
BCMA, Webcast, Research, EHA, Clinical trial, Graceling, IIT, TME, Investment, Cytokine release syndrome, Conference, Acute lymphoblastic leukemia, HLA, ORR, CD19, MRD, ASH, Patient, Lymphoid leukemia, Safety, SMART, FDA, SAN, ADS, Cancer, IND, B-ALL, Hematology, RRMM, Pharmaceutical industry, Vaccine, Medical device, Cryptocurrency, Broadcasting

Company-sponsored Phase 1b/2 clinical trial in US evaluating GC012F for the treatment of RRMM on track to initiate in the second quarter 2023.

Key Points: 
  • Company-sponsored Phase 1b/2 clinical trial in US evaluating GC012F for the treatment of RRMM on track to initiate in the second quarter 2023.
  • Company-sponsored Phase 1/2 clinical trial in China evaluating GC012F in RRMM expected to initiate in the third quarter 2023.
  • As of December 31, 2022, the Company had RMB1,458.2 million (US$211.4 million) in cash and cash equivalents and short-term investments.
  • As of December 31, 2022, 338,498,819 ordinary shares, par value of US$0.0001 per share, were issued and outstanding.

Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance

Retrieved on: 
Wednesday, February 22, 2023
FDA, Pharmaceutical, Health, Oncology, Pfizer, Safety, PFE, Survival, RRMM, Breakthrough therapy, Priority review, NYSE, European Medicines Agency, Maintenance, Multiple myeloma, BLA, MM, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PRIME, MHRA, Attention, Probability, Cytokine release syndrome, Hematology, Inc., Innovative Medicines Canada, Bispecific monoclonal antibody, Medicines and Healthcare products Regulatory Agency, EMA, MAA, CRS, BCMA, Orphan, CD3, Food, Society, Vaccine, Pharmaceutical industry

The company is working closely with the EMA to facilitate their review and will provide updates on timing as appropriate.

Key Points: 
  • The company is working closely with the EMA to facilitate their review and will provide updates on timing as appropriate.
  • In November 2022, Pfizer announced that elranatamab was granted Breakthrough Therapy Designation by the FDA.
  • In addition, elranatamab has been granted Orphan Drug Designation by the FDA and the EMA for the treatment of MM.
  • The FDA and EMA have also granted elranatamab Fast Track Designation and the PRIME scheme, respectively, for the treatment of patients with RRMM.

IASO Bio Announces CT103A Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations by the FDA

Retrieved on: 
Monday, February 13, 2023
FDA, SAN, Food, RRMM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BCMA, Pharmaceutical industry

SAN JOSE, Calif. and SHANGHAI and NANJING, China, Feb. 12, 2023 /PRNewswire/ -- IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, today announced that the U.S. Food and Drug Administration (FDA) has granted both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track (FT) designation to its investigational new drug BCMA CAR-T CT103A (Equecabtagene Autoleucel) for relapsed/refractory multiple myeloma (RRMM).

Key Points: 
  • SAN JOSE, Calif. and SHANGHAI and NANJING, China, Feb. 12, 2023 /PRNewswire/ -- IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, today announced that the U.S. Food and Drug Administration (FDA) has granted both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track (FT) designation to its investigational new drug BCMA CAR-T CT103A (Equecabtagene Autoleucel) for relapsed/refractory multiple myeloma (RRMM).

Gracell Biotechnologies Announces FDA Clearance of the IND Application for Phase 1b/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Friday, February 3, 2023
Safety, MRD, BCMA, CD19, Patient, Clinical trial, Food, IIT, Investigational New Drug, IND, FDA, SAN, Multiple myeloma, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, European Hematology Association, Cancer, Pharmacokinetics, Graceling, Pharmaceutical industry, RRMM

SAN DIEGO Calif., and SUZHOU and SHANGHAI, China, Feb. 3, 2023 /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 the U.S. Food and Drug Administration (FDA) has cleared Gracell's Investigational New Drug (IND) application and the Company can proceed to initiate a Phase 1b/2 clinical trial in the U.S. of GC012F, an autologous CAR-T therapeutic candidate, for the treatment of relapsed/refractory multiple myeloma (RRMM).

Key Points: 
  • In November 2021, the FDA granted GC012F Orphan Drug Designation for the treatment of multiple myeloma.
  • GC012F is currently being studied in multiple investigator-initiated trials (IIT) evaluating its safety and efficacy in RRMM, newly-diagnosed multiple myeloma, and B-cell non-Hodgkin's lymphoma.
  • Gracell plans to initiate a Phase 1b/2 clinical trial in the second quarter of 2023 in the U.S. to further evaluate GC012F in RRMM patients.
  • We look forward to initiating the Phase 1b/2 clinical trial and to bringing this promising therapeutic candidate one step closer to patients in need."

Harpoon Therapeutics Presents Updated Interim Results at ASH 2022 for Novel T Cell Engager HPN217 in Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Sunday, December 11, 2022
B-cell maturation antigen, SAN, Incidence, Cytokine release syndrome, Webcast, ASH, B cell, ORR, CRS, RRMM, MRD, Society, Therapy, BCMA, Patient, Pharmaceutical industry, Vaccine

Additionally, 86% (18/21) of responders remain on study treatment with sustained response, with many responders on treatment for over a year.

Key Points: 
  • Additionally, 86% (18/21) of responders remain on study treatment with sustained response, with many responders on treatment for over a year.
  • Three patients in the study were evaluated for minimal residual disease (MRD), and all three were MRD negative (
  • No Grade 3 or higher CRS or any immune effector cell associated neurotoxicity syndrome (ICANS) events have been observed.
  • In November 2019, Harpoon Therapeutics and AbbVie announced a licensing agreement and option to advance HPN217 and expand an existing discovery collaboration.

ICHNOS SCIENCES PRESENTS DATA SUPPORTING THREE ONCOLOGY ASSETS AT ASH 2022 ANNUAL MEETING

Retrieved on: 
Monday, December 12, 2022
BCMA, Daratumumab, Mouse, Oncology, T-cell acute lymphoblastic leukemia, MD, Infection, IND, Poster, Doctor of Philosophy, Multiple myeloma, CD38, Society, Patient, ISB, Treatment, Trace fossil classification, Research, HIV disease progression rates, Medicine, RRMM, Superior, MM, Antibody, Health, AML, Clinical trial, T-ALL, Relapse, Multimedia, Acute myeloid leukemia, CTN, Half-life, CRS, ASH, Risk, Vaccine, Pharmaceutical industry, Online shopping, NEW YORK, B cell

NEW YORK, Dec. 12, 2022 /PRNewswire/ -- Ichnos Sciences Inc., a global clinical-stage biotechnology company developing innovative multispecific immune cell engager antibodies in oncology, shared data during an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition supporting the advancement of its first-in-class TREAT™1 trispecific antibody, ISB 2001, to a first-in-human clinical trial. Both IND and CTN filings are planned during the first quarter of calendar year 2023 and preparations for a Phase 1 clinical trial in relapsed/refractory multiple myeloma (RRMM) are under way.

Key Points: 
  • Dual targeting with ISB 2001 may overcome escape mechanisms associated with BCMA and CD38 therapeutic antibodies, including approved T cell engagers.
  • In addition to the oral presentation on trispecific antibody ISB 2001 described above, Ichnos was selected for three poster presentations of data on other pipeline assets:
    1.
  • More information about the three oncology assets highlighted at the meeting, and the rest of Ichnos' pipeline can be found at this link .
  • With its patented BEATtechnology platform and pioneering teams, Ichnos Sciences has a mission to provide breakthrough, curative therapies that will extend and improve lives, writing a new chapter in healthcare.

CellCentric presents early clinical data at ASH: inobrodib (CCS1477), first in class p300/CBP bromodomain inhibitor treating relapsed refractory multiple myeloma

Retrieved on: 
Monday, December 12, 2022
R.J. Corman Railroad Group, Oncology, Hematology, Serum, CBP, Internal medicine, PR, Multiple myeloma, Drug discovery, Society, Endpoint security, Mayo Clinic College of Medicine and Science, Patient, DNA, Mayo Clinic, University of Cambridge, Cancer, Dana–Farber Cancer Institute, Oncogene, Research, Gurdon Institute, Partial-response maximum-likelihood, Takeda Pharmaceutical Company, Division, Disease, NHS foundation trust, MCRPC, Dexamethasone, RRMM, MYC, The Christie NHS Foundation Trust, Lymphatic system, Translation, University, IRF4, University of Manchester, Harvard Medical School, Gene, Toxic leukoencephalopathy, ASH, Cancer research, Medical imaging, Pharmaceutical industry, Medicine

Taken together, these findings provide clear encouragement for the further clinical development of this first in class drug."

Key Points: 
  • Taken together, these findings provide clear encouragement for the further clinical development of this first in class drug."
  • Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational
    CellCentric has developed inobrodib from concept through to clinical trials.
  • It is an oral, first in class small molecule inhibitor drug that targets twin cancer gene regulators p300 and CBP.
  • The company actively pursued multiple drug discovery programmes before prioritising p300/CBP inhibition and inobrodib.

CellCentric presents early clinical data at ASH: inobrodib (CCS1477), first in class p300/CBP bromodomain inhibitor treating relapsed refractory multiple myeloma

Retrieved on: 
Monday, December 12, 2022
R.J. Corman Railroad Group, Oncology, Hematology, Serum, CBP, Internal medicine, PR, Multiple myeloma, Drug discovery, Society, Endpoint security, Mayo Clinic College of Medicine and Science, Patient, DNA, Mayo Clinic, University of Cambridge, Cancer, Dana–Farber Cancer Institute, Oncogene, Research, Gurdon Institute, Partial-response maximum-likelihood, Takeda Pharmaceutical Company, Division, Disease, NHS foundation trust, MCRPC, Dexamethasone, RRMM, MYC, The Christie NHS Foundation Trust, Lymphatic system, Translation, University, IRF4, University of Manchester, Harvard Medical School, Gene, Toxic leukoencephalopathy, ASH, Cancer research, Medical imaging, Pharmaceutical industry, Medicine

Taken together, these findings provide clear encouragement for the further clinical development of this first in class drug."

Key Points: 
  • Taken together, these findings provide clear encouragement for the further clinical development of this first in class drug."
  • Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational
    CellCentric has developed inobrodib from concept through to clinical trials.
  • It is an oral, first in class small molecule inhibitor drug that targets twin cancer gene regulators p300 and CBP.
  • The company actively pursued multiple drug discovery programmes before prioritising p300/CBP inhibition and inobrodib.

Janssen Submits Biologics License Application to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Friday, December 9, 2022
Heart, Multiple myeloma, CD3, Society, Johnson & Johnson, Disease, Patient, Behavior, Metabolism, Biologics license application, Lymphatic system, Bone fracture, Royal commission, GPRC5D, American Cancer Society, Pain, Fatigue, Bone marrow, B cell, Pulmonary hypertension, Abstract, Security (finance), Food, Regulation of tobacco by the U.S. Food and Drug Administration, Science, Janssen Pharmaceuticals, RRMM, Breakthrough therapy, Risk, ASH, BLA, Orphan drug, Annual report, Research, FDA, Medicine, Blood, European Commission, Medication, Janssen, Vaccine, Pharmaceutical industry, Fine chemical, Oncology, Hematology, Neuroscience

RARITAN, N.J., Dec. 9, 2022 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for talquetamab forthetreatment of patients with relapsed or refractory multiple myeloma.

Key Points: 
  • RARITAN, N.J., Dec. 9, 2022 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for talquetamab forthetreatment of patients with relapsed or refractory multiple myeloma.
  • We look forward to working closely with the FDA in their review of the talquetamab submission."
  • In May 2021 and August 2021, talquetamab received an Orphan Drug designation for the treatment of multiple myeloma by the U.S. FDA and the European Commission, respectively.
  • Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.