Agenus Inc. ( AGEN ) stock is trading lower on Thursday, with a session volume of 6.29 million, according to data from Benzinga Pro.

The company announced the results of its end-of-Phase 2 (EOP2) meeting with the FDA to advance its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for adult patients with relapsed/refractory microsatellite-stable colorectal cancer (r/r MSS CRC) with no active liver metastases (NLM).

The FDA discouraged the accelerated approval pathway and advised against submitting these results to support an Accelerated Approval based on its view that objective response rates may not translate to survival benefits.

Agenus ( AGEN ) previously disclosed data from the Phase 1 trial, which showed an overall response rate (ORR) of 23% in the 77 MSS mCRC patients without active liver metastases, with a median follow-up of 13.6 months.

The estimated 6-month, 12-month, and 18-month overall survival (OS) rates were 86%, 71%, and 62%, respectively. The estimated median OS was 21.2 months.

Topline interim data from the Phase 2 trial show trends consistent with the Phase 1 study, including an ORR of 19.4% and a 6-month survival rate of 90% for the BOT 75mg/BAL combination.

The safety profile was manageable, and no new signals were observed.

Agenus ( AGEN ) plans to explore opportunities to partner in the U.S. to accomplish a successful Phase 3 trial.

In addition to the progress in the U.S., Agenus ( AGEN ) is advancing its efforts to bring BOT/BAL to patients in Europe.

Engagements with the European Regulatory Authority to explore registration paths are scheduled for later this summer.

These discussions aim to align on the regulatory path for approval of the BOT/BAL combination in Europe.

Agenus ( AGEN ) continues to pursue opportunities for BOT/BAL development in earlier lines of CRC and other tumor types where BOT/BAL has demonstrated clinical activity, such as lung, melanoma, and pancreatic cancers.

The company expects to present data from some of these programs at future medical congresses, including BOT/BAL in sarcoma at the European Society for Medical Oncology in September 2024.

Price Action: AGEN shares are down 53.20% at $8.27 at the last check on Thursday.

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