BioNTech fails to impress with early CAR T data at SITC
BioNTech reported initial first-in-human data from several cancer programs at SITC, and so far, investors aren’t impressed by the mRNA company’s cancer data. The real proof of concept for one of its cancer platforms may not come until the company presents updated data at the conference. In an abstract released ahead of SITC, BioNTech reported highly anticipated initial data for BNT211, the company’s CAR T cell therapy targeting CLDN6 in solid tumors. The earliest data show a best response of stable disease among the first treated patients. What the abstract lacks are data for BNT211 plus CARVac, which is expected to give the CAR T cell a much-needed efficacy boost for solid tumor indications. CARVac is an mRNA vaccine administered after the CAR T cell therapy that’s designed to increase expansion of the therapeutic cells.
FDA extends review of Legend’s CAR T ciltacabtagene autoleucel
FDA has set a new PDUFA date of Feb. 28, 2022, for CAR T therapy ciltacabtageneautoleucel (JNJ-68284528). The extension is meant to give FDA sufficient time to review information recently submitted pertaining to an updated analytical method following an FDA information request, but the agency is not requesting additional data for the BCMA-targeting therapy. The prior date had been Nov. 29.
Poseida Therapeutics to focus on allogeneic CAR-T therapies
Poseida would focus on advancing P-BCMA-ALLO1, the company’s first fully-allogeneic CAR-T product candidate. P-BCMA-ALLO1 is in development as a potential treatment for patients with relapsed/refractory multiple myeloma. In August, FDAgreenlit the company’s IND application for P-BCMA-ALLO, which marked the strategic shift toward allogeneic CAR-T programs. The company is not closing allits autologous programs, though. Poseida continues to see promise with P-PSMA-101, a solid tumor autologous CAR-T product candidate. P-PSMA-101, a Phase 1 study, is being developed as a potential treatment for metastatic castrate-resistant prostate cancer patients.