Recent word that Johnson & Johnson submitted the BLA for teclistamab may have reminded Wall Street that a combo-therapy face-off is in progress between the big pharma firm – with partner Springworks Therapeutics Inc. – and Novartis AG, paired with Ayala Therapeutics Inc.
There was no slowing of biopharma innovation in 2021, even as industry directed significant resources to, while feeling the impact of, the ongoing COVID-19 pandemic. The year saw big wins for developers of DNA vaccines and biosimilars, while CAR T expanded its reach and a drug target once considered undruggable was finally conquered. And as 2021 gives way to 2022, other potentially game-changing technologies and therapeutics are waiting in the wings.
CAR T specialist Carsgen Therapeutics Holdings Ltd.’s shares started trading on the Hong Kong Stock Exchange on June 18, helping the company raise HK$3.1 billion (US$400 million) from an IPO that will allow it to advance its phase II-stage BCMA CAR T therapy candidate, CT-053, in multiple markets.
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.
With Glaxosmithkline plc (GSK) having sailed through an FDA advisory panel meeting July 14 centered on its belantamab mafodotin (belantamab), an antibody-drug conjugate (ADC) for multiple myeloma (MM), others in the B-cell maturation antigen (BCMA) space such as Legend Biotech Corp. are further piquing Wall Street’s interest.
American depositary shares in CAR T-focused Legend Biotech Corp. (NASDAQ:LEGN), offered in a red hot IPO at $23 each, took off Friday, rising 60.9% to close at $37 per share. Other offerings June 5, a buoyant day for U.S. markets after a surprising drop in unemployment, raised $154 million for cellular trafficking specialist Applied Molecular Transport Inc. and $90 million for Calliditas Therapeutics AB, the developer of an oral formulation of the corticosteroid budesonide.
American depositary shares in CAR T-focused Legend Biotech Corp. (NASDAQ:LEGN), offered in a red hot IPO at $23 each, took off Friday, rising 60.9% to close at $37 per share. Other offerings June 5, a buoyant day for U.S. markets after a surprising drop in unemployment, raised $154 million for cellular trafficking specialist Applied Molecular Transport Inc. and $90 million for Calliditas Therapeutics AB, the developer of an oral formulation of the corticosteroid budesonide.
BEIJING – Cell therapies specialist Nanjing Iaso Biotherapeutics Co. Ltd. pocketed $60 million in a series funding B round to advance its CT-103A, an anti-BCMA CAR T therapy candidate for multiple myeloma, among other plans.
As attendees of last year’s American Society of Hematology (ASH) meeting heard, B-cell maturation antigen (BCMA)-targeting therapies are steadily gaining ground on various fronts, even as companies such as Springworks Therapeutics Inc. bring forward candidates that might boost activity of the class.
