CD38

Takeda Announces Positive Topline Results from Phase 2 Study Evaluating Mezagitamab (TAK-079), a Potential Best-in-Class Anti-CD38 Monoclonal Antibody, for Primary Immune Thrombocytopenia

Retrieved on: 
Wednesday, March 13, 2024
Neurology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Fast track (FDA), Psoriasis, Cell, Disease, Risk, Patient, Megakaryocyte, Immunoglobulin G, ITP, B cell, Quality of life, Platelet, Autoantibody, Gastrointestinal tract, CD38, Bleeding, Safety, Dravet syndrome, Blood, Lennox–Gastaut syndrome, Fatigue, Fiscal, Food, Autoimmune disease, Pharmaceutical industry

Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP).
  • An interim analysis of the ongoing Phase 2 study demonstrated positive safety and efficacy results.
  • Based on these positive results, and following consultation with global health authorities, Takeda plans to initiate a global Phase 3 trial of mezagitamab in ITP in fiscal year 2024.
  • Results from the Phase 2 trial have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2024 (Fiscal Year 2023).

IGM Biosciences Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 7, 2024
CD20, Progression-free survival, PFS, Myopathy, Research, Immunoglobulin M, Investment, FDA, Research and development, IGM, FOLFIRI, Myositis, Bevacizumab, Lupus, GAAP, Rheumatoid arthritis, Administration, Patient, Clinical trial, Survival, CD38, SLE, G&A, IND, Colorectal cancer, Pharmaceutical industry

MOUNTAIN VIEW, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments.

Key Points: 
  • MOUNTAIN VIEW, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on recent developments.
  • Collaboration Revenue: For the fourth quarter and year ended 2023, collaboration revenues were $0.7 million and $2.1 million, respectively, compared to $0.4 million and $1.1 million for the fourth quarter and year ended 2022, respectively.
  • Research and Development (R&D) Expenses: For the fourth quarter and year ended 2023, R&D expenses were $54.2 million and $215.5 million, respectively, compared to $45.0 million and $179.3 million for the fourth quarter and year ended 2022, respectively.
  • General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2023, G&A expenses were $11.6 million and $50.1 million, respectively, compared to $11.6 million and $49.7 million for the fourth quarter and year ended 2022, respectively.

Summary of opinion: Abecma, 25/01/2024 Positive

Retrieved on: 
Sunday, February 4, 2024
Marketing, European Commission, EEIG, CD38, Civil service commission, Patient, Committee, CHMP, Medication package insert, Idecabtagene vicleucel, Pharmaceutical industry

On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Abecma.

Key Points: 
  • On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Abecma.
  • The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
  • The CHMP adopted an extension to the existing indication to include treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies.
  • 1New text in bold, removed in strikethrough

Summary of opinion: Abecma, 25/01/2024 Positive

Retrieved on: 
Sunday, February 4, 2024
Marketing, European Commission, EEIG, CD38, Civil service commission, Patient, Committee, CHMP, Medication package insert, Idecabtagene vicleucel, Pharmaceutical industry

On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Abecma.

Key Points: 
  • On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Abecma.
  • The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
  • The CHMP adopted an extension to the existing indication to include treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies.
  • 1New text in bold, removed in strikethrough

Summary of opinion: Abecma, 25/01/2024 Positive

Retrieved on: 
Monday, January 29, 2024
Medication package insert, Committee, Idecabtagene vicleucel, Patient, Marketing, CHMP, Civil service commission, European Commission, EEIG, CD38, Pharmaceutical industry

On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Abecma.

Key Points: 
  • On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Abecma.
  • The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
  • The CHMP adopted an extension to the existing indication to include treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies.
  • 1New text in bold, removed in strikethrough

Wugen Presents Latest Data from First-In-Human Phase 1/2 Trial of WU-CART-007 in Patients with Difficult-to-Treat Blood Cancers at American Society of Hematology Annual Meeting

Retrieved on: 
Monday, December 11, 2023
Patient, Quality of life, Division, Death, Relapse, Pancytopenia, Cytokine release syndrome, Disease, LBL, Blood, EMD, SAN, Gene, Graft-versus-host disease, EMRA, CRC, ASH, CD38, Oncology, M.D, CRS, T-ALL, Fungal infection, Cell, Medicine, Phenotype, Pharmaceutical industry

“For a disease that disproportionately affects younger individuals, the need to find better treatments feels especially urgent,” said Armin Ghobadi, M.D, associate professor of medicine and clinical director of Center for Gene and Cellular Immunotherapy (CGCI) in the Division of Medical Oncology at the Washington University School of Medicine in St. Louis. “It’s encouraging to see positive momentum -- with favorable tolerability and efficacy data continuing to be reported as the study has expanded to include more patients with such difficult-to-treat blood cancers.”

Key Points: 
  • An investigational allogeneic CAR-T cell therapy, WU-CART-007 is being studied for the treatment of patients with relapsed or refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL).
  • In the latest update, an additional 13 patients were treated with WU-CART-007, which showed clinically acceptable safety profiles and preliminary evidence of anti-leukemic activity, demonstrating a notable clinical improvement.
  • Positive and consistent data from the WU-CART-007 Phase 1/2 trial collectively underscore its potential to address unmet medical needs for difficult-to-treat blood cancers as it advances to the next crucial phase of development.
  • In evaluable patients at DL≥ 2 (18/22), the Composite Complete Remission Rate (CRc) in patients was 67%.

IGM Biosciences Announces Strategic Pipeline Prioritization and Cash Runway Extension

Retrieved on: 
Tuesday, December 5, 2023
Workforce, DR5, Sanofi, IND, Antibody, FDA, Colorectal cancer, FOLFIRI, CD20, SLE, IGM, Clinical trial, Rheumatoid arthritis, Inflammation, Investigational New Drug, Lupus, CD38, Bevacizumab, Myopathy, Myositis, Patient, Immunoglobulin M, Vaccine

In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent.

Key Points: 
  • In conjunction with this strategic refocusing, the Company will be reducing its workforce by approximately 22 percent.
  • As a result of these actions, IGM expects to extend its cash runway into the second quarter of 2026.
  • “IGM continues to have a tremendous opportunity to transform a variety of disease areas using an entirely new class of antibody medicines,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences.
  • As a part of this strategic refocusing, the Company will halt the following clinical development activities:

Molecular Templates, Inc. Reports Third Quarter 2023 Financial Results and Business Update

Retrieved on: 
Monday, November 13, 2023
CD38, Malignancy, PD-L1, Immunomodulatory imide drug, Neck, Bristol Myers Squibb, Research, Head, Alveolar soft part sarcoma, HIV disease progression rates, Patient, Part, ETB (company), TME, Therapy, Immunoglobulin A, Cancer, Symantec Endpoint Protection, BCMA, CMV, CPS, Biology, Pharmaceutical industry, Nursing, Vaccine, Medical imaging, Engineered wood

The net loss attributable to common shareholders for the third quarter of 2023 was $4.2 million, or $0.82 per basic share and per diluted share.

Key Points: 
  • The net loss attributable to common shareholders for the third quarter of 2023 was $4.2 million, or $0.82 per basic share and per diluted share.
  • Revenues for the third quarter of 2023 were $6.8 million, compared to $4.2 million for the same period in 2022.
  • Total research and development expenses for the third quarter of 2023 were $7.6 million, compared with $22.0 million for the same period in 2022.
  • Total general and administrative expenses for the third quarter of 2023 were $4.3 million, compared with $5.9 million for the same period in 2022.

IGM Biosciences Announces Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
Myositis, CD38, Safety, Food, Treatment, Progression-free survival, Colorectal cancer, Acute myeloid leukemia, Myopathy, Bevacizumab, IND, Investment, Immunoglobulin G, Clinical trial, Net, Administration, Patient, Research, Lupus, Rheumatoid arthritis, FDA, Autoimmune disease, American College, G&A, Bispecific monoclonal antibody, FOLFIRI, SLE, Immunoglobulin M, GAAP, CD20, R, Antibody, Research and development, IGM, Azacitidine, Pharmaceutical industry, Vaccine, Sanofi

MOUNTAIN VIEW, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the quarter ended September 30, 2023.

Key Points: 
  • MOUNTAIN VIEW, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its financial results for the quarter ended September 30, 2023.
  • “During the third quarter, we continued to execute across our clinical development pipeline,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences.
  • Collaboration Revenue: For the third quarter of 2023, collaboration revenues were $0.5 million, compared to $0.3 million for the same period in 2022.
  • Research and Development (R&D) Expenses: For the third quarter of 2023, R&D expenses were $54.8 million, compared to $48.2 million for the same period in 2022.

Notable Labs Announces JCO Precision Oncology Publication Demonstrating PPMP Potential to Identify Novel Drug Combinations in JMML

Retrieved on: 
Thursday, November 9, 2023
EHA, CD38, Associate, UCSF Benioff Children's Hospital, European Hematology Association, Juvenile myelomonocytic leukemia, Transplant, Disease, Database, UCSF, Patient, ASCO, Hematopoietic stem cell transplantation, APL, AZA, Blood, Cytarabine, FLA, Cancer, Tretinoin, Acute promyelocytic leukemia, Trial of the century, Malignancy, Society, Physician, Cell, Bone marrow, Drug combination, Pharmaceutical industry, JMML

FOSTER CITY, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Notable Labs, Inc. (“Notable”) (Nasdaq: NTBL), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, today announced the publication of data from an ex vivo study demonstrating the potential for its Predictive Precision Medicine Platform (PPMP) to identify more effective pre-hematopoietic stem cell transplantation (pre-HSCT) regimens for the treatment of juvenile myelomonocytic leukemia (JMML) in the November 9th Issue of the American Society of Clinical Oncology (ASCO) Journal JCO Precision Oncology. Part of this data was recently presented at the European Hematology Association (EHA) Hybrid Congress held in Frankfurt, Germany on June 8 – 15, 2023. Details of that presentation can be found on the Company’s website at https://notablelabs.com/.

Key Points: 
  • JMML is a rare, aggressive pediatric malignancy for which curative treatment is restricted to hematopoietic stem cell transplantation.
  • Pre-HSCT therapies, i.e., therapies prior to transplantation, include moderately intensive chemotherapy (particularly fludarabine and cytarabine in combination (FLA)) and azacytidine (AZA) monotherapy.
  • Applying its proprietary PPMP technology to blood or bone marrow samples from JMML patients, Notable screened 130 drug combinations and discovered that 27 of these combinations (26 dual-, 1 triple-combination) were more effective ex vivo than the components of these combinations tested individually.
  • “This publication marks the culmination of a multi-year collaboration between UCSF and Notable Labs,” remarked Dr. Stieglitz.