Botensilimab

A phase one trial combining botensilimab and balstilimab shows promise for treating 'cold tumors' like sarcomas, particularly angiosarcoma, with a 44% response rate. The study aims to extend immunotherapy's reach to tumors not well recognized by the immune system, potentially leading to future trials and approvals for other sarcoma types.

Agenus Inc. executives and directors misled the public about clinical trials for their cancer treatment, breaching fiduciary duties, according to a shareholder derivative suit. The false statements involved a combination therapy for metastatic colorectal cancer, which Agenus promoted until the FDA advised against submitting trial results.

Gastric cancer affects 26,890 people annually in the US, with 10,880 expected deaths in 2024. Risk factors include smoking, age, diet, and stomach inflammation. Cell therapy, particularly CAR-T, is a focus for new treatments. CARsgen completed patient enrollment for its CLDN18.2-targeting CAR-T therapy satri-cel in China. The first patient with refractory gastroesophageal cancer was dosed in a phase 2 trial combining iNKT cell therapy agenT-797 with immune checkpoint inhibitors. Triumvira’s TAC01-CLDN18.2 is set for a phase 1/2 trial for solid tumors. Biosyngen’s TCR-T therapy BRL03 received FDA clearance for trials in lung and gastric cancers.

Pomerantz LLP announces a class action lawsuit against Agenus Inc. and certain officers, alleging false and misleading statements regarding the effectiveness of botensilimab and balstilimab combination therapy. The lawsuit seeks damages for shareholders who purchased Agenus securities between January 23, 2023, and July 17, 2024. Shareholders have until November 5, 2024, to join the lawsuit.

Botensilimab and balstilimab combo showed deep, durable responses in refractory metastatic sarcoma, with 23% ORR and 21.7 months median DOR. Notably, 39% ORR in angiosarcoma, including 44% in visceral subtype, challenging historical treatment difficulties.

Experts highlight emerging sarcoma therapies at 2024 ESMO Congress, including palbociclib plus retifanlimab in dedifferentiated liposarcoma, regorafenib maintenance in non-adipocytic soft tissue sarcomas, and botensilimab plus balstilimab in relapsed/refractory metastatic sarcoma.

The Portnoy Law Firm advises Agenus Inc. investors of a class action representing those who bought securities between January 23, 2023, and July 17, 2024. The lawsuit alleges Agenus made false or misleading statements about the effectiveness of its immuno-oncology treatments, balstilimab and botensilimab. On July 18, 2024, Agenus revealed the FDA advised against using these treatments for Accelerated Approval, leading to a 59% stock price drop.