B-cell maturation antigen

SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Updates

Retrieved on: 
Tuesday, February 27, 2024

Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.

Key Points: 
  • Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.
  • Presented additional patient-reported outcome data from the Phase 3 DeFi trial at the 2023 Connective Tissue Oncology Society Annual Meeting.
  • Revenues: OGSIVEO net product revenues were $5.4 million in the fourth quarter of 2023, the first partial quarter of the U.S. launch.
  • Cash Position: Cash, cash equivalents and marketable securities were $662.6 million as of December 31, 2023.

TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma

Retrieved on: 
Tuesday, February 20, 2024

HORSHAM, Pa., Feb. 20, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of six months.1 There is a continued unmet need for patients with multiple myeloma and this approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • TECVAYLI® has been prescribed to more than 3,600 patients in the U.S. since approval.3
    This approval is based on results from the Phase 1/2 MajesTEC-1 study ( Phase 1: NCT03145181 ; Phase 2: NCT04557098 ).
  • Today's approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules," said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine.
  • "As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, TECVAYLI is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma."

Linvoseltamab Receives EMA Filing Acceptance for Treatment of Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Friday, February 2, 2024

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.
  • The MAA is supported by data from a Phase 1/2 pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM, which were last shared in December 2023.
  • A Phase 1 trial of linvoseltamab in combination with a CD38xCD28 costimulatory bispecific in MM is also planned.
  • Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Merck to Acquire Harpoon Therapeutics, Further Diversifying Oncology Pipeline

Retrieved on: 
Monday, January 8, 2024

“This agreement reflects the creativity and commitment of scientists and clinical development teams at Harpoon.

Key Points: 
  • “This agreement reflects the creativity and commitment of scientists and clinical development teams at Harpoon.
  • “At Harpoon, we have always been committed to advancing our cancer immunotherapy candidates to improve the lives of patients.
  • Under the terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Harpoon Therapeutics, Inc. for a price per share of $23.00 in cash.
  • Centerview Partners LLC acted as financial advisor to Harpoon and Goodwin Procter LLP acted as its legal advisor.

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

Retrieved on: 
Monday, January 8, 2024

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.

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

Retrieved on: 
Tuesday, December 19, 2023

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.

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

Retrieved on: 
Thursday, December 7, 2023

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.

Bristol Myers Squibb Announces Data at ASH 2023 from Diverse Multiple Myeloma Pipeline, Underscoring Range of Tailored Treatment Approaches to Address Unique Patient Needs

Retrieved on: 
Tuesday, December 12, 2023

Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.
  • These data were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, California.
  • While multiple myeloma remains a relentless disease, we continue to transform the multiple myeloma treatment paradigm by dramatically improving outcomes for every patient.
  • As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma

Retrieved on: 
Friday, December 8, 2023

Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).

Key Points: 
  • Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).
  • "More than 50,000 Europeans are diagnosed with multiple myeloma each year, and too often, they face relapse and treatment resistance,” said Chris Boshoff, Chief Oncology Research and Development Officer and Executive Vice President, Pfizer.
  • The conditional marketing authorization for ELREXFIO is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway.
  • This authorization follows the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation for a conditional marketing authorization on October 12, 2023.

Pfizer Highlights Scientific Advances from Growing Hematology Portfolio at American Society of Hematology Annual Meeting

Retrieved on: 
Thursday, November 2, 2023

Pfizer Inc. (NYSE: PFE) will present its latest data showcasing advances in the treatment of hemophilia, sickle cell disease, and blood cancers at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 9-12.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) will present its latest data showcasing advances in the treatment of hemophilia, sickle cell disease, and blood cancers at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 9-12.
  • “Pfizer has been advancing science in hematology for more than 30 years, starting with the introduction of recombinant factor replacement therapy, which became the standard of care for people living with hemophilia.
  • Fourteen abstracts focused on the treatment of SCD, including Phase 2a safety, efficacy, and pharmacodynamic data from the ongoing Phase 2/3 clinical trial study of GBT601.
  • Nineteen abstracts from our blood cancer portfolio, including six which continue to support the use of ELREXFIO, a B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody immunotherapy, in patients with RRMM.