Dispatch Biotherapeutics Inc. has obtained IND clearance from the FDA for DISP-10, enabling the initiation of a phase I study in patients with solid tumors. Initial clinical evaluation will begin in gastrointestinal cancers, with plans to expand into multiple additional solid tumor indications following clinical proof of concept.
Mixed opinions from the U.S. FDA’s Oncology Drugs Advisory Committee last month didn’t stop the agency from green-lighting an expanded label for Abecma (idecabtagene vicleucel) to include adults with relapsed or refractory multiple myeloma (r/r MM) after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
The U.S. FDA’s Oncology Drugs Advisory Committee, in two separate sessions, took up the matters of Carvykti (ciltacabtagene autoleucel) from Johnson & Johnson and the Bristol Myers Squibb Co. product Abecma (idecabtagene vicleucel) – specifically, whether the benefits of each CAR T therapy outweigh the risks in relapsed or refractory multiple myeloma (MM).
2seventy bio Inc. shares (NASDAQ:TSVT) rose 15% or 52 cents, to close Jan. 30 at $4.01 on word that the Cambridge, Mass.-based firm is selling its R&D pipeline to Regeneron Pharmaceuticals Inc., which will move the work forward by way of a new company called Regeneron Cell Medicines.
DUBLIN – In a busy week at the EMA, its Committee on Human Medicinal Products (CHMP) nodded through eight marketing applications at its June meeting. The haul included a chimeric antigen receptor T-cell (CAR T) therapy, three antibodies, including a biosimilar, and two new small-molecule drugs, as well as two generics.
While acknowledging the net health benefit over standard of care in heavily pretreated multiple myeloma patients, CAR T-cell therapies Abecma (idecabtagene vicleucel) and ciltacabtagene autoleucel (cilta-cel) represent low long-term value at their current pricing levels, according to the Institute for Clinical and Economic Review (ICER) in a final evidence report released May 11.
The first BCMA-targeted CAR T therapy, idecabtagene vicleucel, cleared FDA approval for use in adults with multiple myeloma (MM) who have received four or more prior lines of therapy. Developed by partners Bluebird Bio Inc. and Bristol Myers Squibb Co., the drug, branded Abecma, is also the first CAR T drug indicated for MM. It is designed for use as a one-time infusion, with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. The personalized therapy will be produced at BMS’ cellular manufacturing facility in Summit, N.J. Bluebird developed the lentiviral vector used in Abecma.
As the March 27 PDUFA date nears for idecabtagene vicleucel (ide-cel, also known as BB-2121), the B-cell maturation antigen (BCMA)-directed chimeric antigen receptor CAR T-cell therapy from Bristol Myers Squibb Co. and Bluebird Bio Inc., investors are looking with increased favor on the approach.
Bluebird Bio Inc. CEO Nick Leschly conceded that it’s “hard for folks on the outside looking in” to understand why the firm would cleave its severe genetic disease (SGD) and oncology efforts into two independently traded public companies, but said the Cambridge, Mass.-based firm is making the change by the end of this year in order “to make sure we can basically fall down and get back up and learn everything we can in the most disciplined manner,” he said.
