Agenus Posts Early Data For CTLA-4 Drug Candidate Across Tumor Types

In a Phase I study across nine tumor types, Agenus Inc’s AGEN CTLA-4 drug AGN1181 posted one complete response and three partial responses (PRs) as a monotherapy, according to data presented t SITC.
The three responders expressed the low-affinity FcγRIIIA receptor, Agenus said, which is associated with a lack of response to first-generation CTLA-4 inhibitors.
The Phase I study mainly enrolled heavily pretreated patients.
As part of a combo with balstilimab, AGN1181 showed three confirmed PRs and one unconfirmed PR in 20 patients with microsatellite stable colorectal cancer.
In nine patients with ovarian cancer, the combo posted three confirmed PRs, with other responses in microsatellite stable endometrial cancer and non-small cell lung cancer, visceral angiosarcoma, and leiomyosarcoma.
Agenus also touted AGN1181’s safety profile, with no hypophysitis, pneumonitis, or high-grade hepatitis side effects reported.
The Company plans to move ahead with Phase 2/3 studies for AGN1181 as both monotherapy and in combination with balstilimab in MSS-CRC and gynecological cancers.
In October, the Company pulled its FDA application for balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.
Price Action: AGEN shares are down 8.57% at $3.89 during the market session on the last check Friday.