Starton Therapeutics Inc. has reported findings from a preclinical efficacy study of STAR-LLD, a continuous delivery system of lenalidomide, in a lenalidomide-resistant animal model. The 28-day efficacy study evaluated STAR-LLD continuous subcutaneous (s.c.) infusion versus intraperitoneal (i.p.) lenalidomide in immunomodulatory drug (IMiD)-resistant RPMI CB.17 SCID mice.
Ichnos Sciences Inc. has presented data on the first-in-class trispecific BCMA and CD38 T-cell engager ISB-2001, which is based on the company’s TREAT (Trispecific Engagement by Antibodies based on the TCR) technology. The compound targets CD3 on T cells and cotargets BCMA and CD38 on multiple myeloma (MM) cells.
Arcellx Inc. signed a deal that could be worth almost $4 billion with Gilead Sciences Inc.’s unit Kite Pharma Inc. to push forward Arcellx's lead late-stage candidate CART-ddBCMA for relapsed or refractory multiple myeloma. The arrangement brings $225 million up front plus an equity investment of $100 million, along with as much as $3.9 billion in milestone payments. Arcellx CEO Rami Elghandour said the firm sorted through a number of suitors interested in the program. Data at the American Society of Clinical Oncology meeting “catalyzed a number of discussions and a broad set of interests. We felt of the possibilities out there, [Kite/Gilead is] the partner of choice in this space.”
Shares of Oncopeptides AB dropped 35% Dec. 7 on the U.S. FDA’s request to withdraw marketing authorization of Pepaxto (melflufen), a drug that had gained accelerated approval in early 2021 for use in relapsed/refractory multiple myeloma. The move followed a negative advisory committee vote in September 2022 and is based on the outcome of the confirmatory phase III Ocean study.
Sana Biotechnology Inc. has outlined the status of its pipeline following a portfolio prioritization. The company remains on track to file an IND this year for SC-291, the company's HIP-modified, CD19-targeted allogeneic chimeric antigen receptor (CAR) T therapy, with initial clinical data expected next year.
As GSK plc pulls Blenrep (belantamab mafodotin) from the U.S. market, the biotech giant will watch a lot of revenue go with it. Only two weeks ago a phase III confirmatory study data for the already-approved multiple myeloma drug fell short of meeting requirements for the U.S. FDA’s accelerated approval regulations, so the agency asked GSK to take the drug off the market.
There are doubts about the future of GSK plc’s multiple myeloma drug Blenrep (belantamab mafodotin) after it failed to meet its goal of improving progression-free survival compared with standard chemotherapy in a confirmatory trial, placing its conditional approvals in the U.S. and Europe at risk.
At the end of September, C4 Therapeutics Inc. disclosed the U.S. FDA’s green light for the phase I/II trial with CFT-1946 in solid tumors, but the firm has piqued Wall Street’s interest more with another program due to face off with Bristol Myers Squibb Co. (BMS) in multiple myeloma (MM) and non-Hodgkin lymphoma (NHL).
The U.S. FDA cleared teclistamab from Janssen Pharmaceutical Cos. as the first bispecific antibody for treating patients with relapsed or refractory multiple myeloma (MM), joining other BCMA-targeted drugs, including an antibody-drug conjugate and CAR T therapies.
