Affimed’s recent string of positive data for AFM13 continued with an impressive early efficacy report for the bispecific Innate Cell Engager in Hodgkin lymphoma patients, but investors still want to learn more about the treatment’s durability. Affimed reported that AFM13, a bispecific NK cell engager targeting CD30 on tumor cells and CD16A on NK cells, conjugated to allogeneic NK cells, led to a 100% ORR with five complete responses (42%) among the first 12 patients treated at the recommended Phase 2 dose in an open-label Phase 1/2 study. The trial enrolled patients with NHL and HL; 11 of the 12 patients in the highest dose cohort had Hodgkin lymphoma. Patients had progressed on a median of six prior lines of therapy. The data represent responses after the first of two planned cycles of treatment, which involved an infusion of the pre-complexed innate cell engager and NK cells, followed by weekly infusions of the innate cell engager alone for three weeks.
Affimed’s NK cell engager impresses on response rates
CLINICAL
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.
DEALS AND FINANCING
Blackstone to invest up to $250 million in Autolus to develop obe-cel in ALL
Autolus and Blackstone Life Sciences announced that the two companies have entered into a strategic collaboration and financing agreement under which funds managed by Blackstone will provide up to $250 million in equity and product financing to support Autolus’ advancement of its CD19 CAR T cell investigational therapy product candidate, obecabtageneautoleucel (obe-cel), as well as next generation product therapies of obe-cel in B-cell malignancies.As part of this $250 million transaction, Blackstone is committing to invest $150 million in product financing to support obe-cel development and commercialization, with $50 million payable upon closing of the transaction and the remainder payable based on certain development and regulatory achievements. Blackstone has also agreed to purchase $100 million of Autolus’ American Depositary Shares (ADS) in a private placement, which is subject to customary closing conditions. In connection with the collaboration, Blackstone received the right to nominate a member to Autolus’ board of directors.
Marengo closes $80 million A round to harness novel antibody-mediated T-cell activation
Marengo Therapeuticsis deploying a tumor-infiltrating subpopulation of T cells, which can be activated by a newly identified, antibody-based mechanism. The company is taking forward a scientific concept that has been germinating for several years at founding investor and company creator ATP, which has now launched the firm with an $80 million series A round. Marengo is gearing up for a first clinical trial in 2022.
