FDA approves checkpoint therapy Imfinzi for metastatic NSCLC

CLINICAL AND REGULATORY

FDA approves checkpoint therapy Imfinzi for metastatic NSCLC

It was approved in late October for unresectable hepatocellular carcinoma, the most common type of liver cancer. The combination is under review for the NSCLC indication in the EU, Japan and other countries.

Keytruda meets its endpoints in the gastric cancer Phase 3 trial

Merck & Co. will submit to regulatory authorities topline data from the Phase 3 KEYNOTE-859 trial of Keytruda plus chemotherapy as first-line therapy for HER2-negative advanced gastric or gastroesophageal junction cancer patients, a setting in which the combination improved outcomes regardless of PD-L1 expression. Merck said it observed improvements in overall survival, progression-free survival, and overall response rate in patients receiving the combination versus chemotherapy alone. The PD-1 mAb already has accelerated approval as a first-line treatment of HER-positive GEJ cancer.

Apexigen’s CD40 mAb shows promise in investigator-initiated study

Phase 1/2 data for sotigalimab from Apexigen suggests intratumor injection may avoid the safety issues arising from systemic delivery of anti-CD40 mAbs, and when combined with Keytruda, could lead to efficacy that rivals standard of care in first-line melanoma. At SITC, Apexigen presented data from a Phase 2 investigator-sponsored study showing that intratumoral administration of sotigalimab plus Keytruda led to a 47% ORR in 32 previously untreated melanoma patients, and a 50% ORR in the 24 patients treated at the recommended Phase 2 dose. In contrast, Opdualag nivolumab/relatlimab, which combines mAbs against PD-1 and LAG-3, led to a 43% ORR.

Affimed and Artiva will take their cell combination therapy to IND

Affimed and Artiva Biotherapeutics are planning a 1H23 IND application for a combination therapy comprising AFM13, Affimed’s bispecific innate cell engager, and AB-101, Artiva’s non-CAR, non-genetically modified NK cell product, to treat CD30-positive lymphoma patients. Affimed will receive 67% of the combination therapy revenues, and Artiva is to receive 33%. In an abstract released ahead of December’s American Society of Hematology meeting, Affimed disclosed that the combination of AFM13 and allogeneic NK cells demonstrated a complete response rate of up to 71% and an OS of 83% at a median follow-up of eight months (range 1-23) in 30 patients with relapsed or refractory CD30-positive lymphoma. Shares of Affimed rose $0.16 to $1.85.

Oncorus pulls plug on Phase 1 program, narrowing focus

Oncolytic virus developer Oncorus is terminating its ONCR-177 program, which had reached Phase 1 testing to treat solid tumors, and focusing its efforts on its self-amplifying viral RNA platform, positioning new lead candidate ONCR-021 for an IND submission by mid-2023. ONCR-177 was derived from the biotech’s oncolytic HSV-1 platform for intratumoral administration; ONCR-021 is an IV treatment that delivers an optimized strain of Coxsackievirus A21.

Epcoritamab secures priority review for large B-cell lymphoma

Genmab and AbbVie are looking ahead to a May 21, 2023, PDUFA date for subcutaneous epcoritamab to treat relapsed/refractory large B-cell lymphoma after FDA accepted a BLA and granted priority review to the CD20 X CD3 bispecific. The news comes five months after the partners reported the therapy led to an overall response rate of 63% and complete response of 39% in the Phase I/II EPCORE NHL-1 trial. Roche’s mosunetuzumab, another CD20 X CD3 bispecific, is also under FDA priority review, but for a different indication: relapsed/refractor follicular lymphoma. Mosunetuzumab’s PDUFA date is Dec. 29.

DEALS AND FINANCING

After Roche-Good deal, Bonum Therapeutics raises $93M series A

An investor syndicate that backed Good Therapeutics prior to its acquisition by Roche has contributed to a $93 million in series A funding for spinout company Bonum Therapeutics. The start-up will develop conditionally activated cancer immunotherapies based on the same platform with which Good created a PD-1-regulated, IL-2-targeting program. New investor Vivo Capital joined the syndicate, which included Good backers Rivervest Venture Partners, Roche Venture Fund, Digitalis Ventures, 3x5 Partners, and Codon Capital.