Astellas’ zolbetuximab approved in Japan for treatment of gastric cancer

CLINICAL AND REGULATORY

Astellas’ zolbetuximab approved in Japan for treatment of gastric cancer

The approval is based on results from the Phase 3 SPOTLIGHT and GLOW trials for first-line treatment in patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors were CLDN18.2 positive. The SPOTLIGHT study evaluated Vyloy plus mFOLFOX6 compared to placebo plus mFOLFOX6. The GLOW study evaluated Vyloy plus CAPOX compared to placebo plus CAPOX. Both trials met their primary endpoint, PFS, as well as a key secondary endpoint, OS, showing statistical significance in patients treated with Vyloy plus chemotherapy compared to placebo plus chemotherapy. The most frequent treatment-emergent adverse events for Vyloy in combination with mFOLFOX6 or CAPOX were nausea, vomiting, decreased appetite, neutropenia, and decreased weight. In clinical trials, adverse reactions were managed by antiemetics, dose interruptions, and infusion rate adjustments.

Biontech demonstrated that its personalized neoantigen vaccines are durable

Biontech announced three-year follow-up data from a Phase 1 trial with the mRNA-based individualized neoantigen-specific immunotherapy candidate autogene cevumeran (also known as BNT122) in patients with resected pancreatic ductal adenocarcinoma (PDAC). The data show that in 8 out of 16 patients autogene cevumeran elicited an immune response up to three years post administration measured by activated T cells. The persistence of T cels was associated with a longer median recurrence-free survival in cancer vaccine responders. A randomized Phase 2 trial with autogene cevumeran in patients with resected PDAC is currently enrolling patients at clinical trial sites in the United States, with additional sites planned to open globally.

Gritstone disappoints with Phase 2 portion of Phase 2/3 of its personalized cancer vaccine

Gritstone shares lost 49% after the company reported that personalized neoantigen cancer vaccine GRANITE showed an early PFS trend (HR=0.82), and no difference in short-term ctDNA response in the Phase 2 portion of a Phase 2/3 colorectal cancer study. GRANITE was generally well-tolerated with manageable adverse events; no patients have discontinued GRANITE due to adverse events. The study evaluated the cancer vaccine in combination with a checkpoint inhibitor and chemotherapy against chemotherapy alone in 104 patients with microsatellite instability-high colorectal cancer. Gritstone noted that the treatment arm led to a greater difference in median PFS in a high-risk subgroup of patients, most of whom had liver metastases. The treatment led to 12 months of PFS vs. 7 months in the control arm (HR=0.52). Mature PFS data are expected in the third quarter of 2024; overall survival data expected in 1H 2025.

DEALS AND FINANCING

Invenra announced research collaboration with Astellas to develop bispecific antibodies

Invenra, an innovative leader in bispecific antibody technology, is pleased to announce a strategic research agreement with Astellas. This agreement will leverage Invenra’s cutting-edge B-Body bispecific antibody platform to support Astellas’ focused research and development initiatives. Under the agreement, Astellas will have access to Invenra’s B-Body technology, marking a thoughtful step toward advancing their bispecific therapeutic research. At the conclusion of the research, Astellas will have the option to negotiate future licenses.

Aethon and Revolution Medicines announced collaboration on novel antibody programs

Aethon Therapeutics has entered into a collaboration agreement with Revolution Medicines, under which Aethon will use its HapImmune platform to discover novel bispecific antibodies to mount an immune attack directed towards cancer cells hit by Revolution Medicines’ RAS(ON) inhibitors, with the goal of fueling tumor clearance and helping to establish immune memory. The terms of the agreement provide for a multi-year collaboration under which Aethon is responsible for conducting preclinical work, with full reimbursement by Revolution Medicines. Revolution Medicines has an option to conduct any clinical development of products that may arise from the collaboration. The arrangement provides for both upfront and potential downstream payments covering future development and commercialization activities should Revolution Medicines exercise its option.