Small-Cap Cancer Drug Developer Agenus' Highlights Encouraging Data From Colorectal Cancer, But Funding Concerns Loom
Friday, Agenus Inc (NASDAQ:AGEN) released updated results from its Phase 1 clinical trial of botensilimab and balstilimab (BOT/BAL) combination therapy for metastatic colorectal cancer (CRC) that is not microsatellite instability-high (MSS) or deficient mismatch repair (dMMR).
These findings build upon the compelling clinical activity demonstrated by BOT/BAL across nine different cancer types in Agenus’ broad clinical development program.
In the Phase 1 trial of 77 patients with refractory MSS-CRC without active liver metastases, a 23% overall response rate (ORR) was observed after a median follow up of 13.6 months at the data cutoff of March 1, 2024.
The median duration of response in 18 responders has not yet been reached. The estimated 12-month and 18-month overall survival (OS) rates were 71% and 62%, respectively. The median OS was 21.2 months.
The Phase 2 trial has completed enrollment and the company plans to discuss the interim results with the FDA.
Pending planned meetings with the FDA, Agenus plans to submit a Biologics License Application (BLA) for BOT/BAL in refractory MSS CRC later this year and plans to present detailed Phase 2 efficacy results, including response durability and updated Phase 1 survival data, at a major medical conference in the second half of 2024.
Also, Agenus’ one-for-twenty reverse stock split went into effect on Friday.
Last March, Agenus released results from a cohort of 24 evaluable patients in an expansion of its Phase 1b study of botensilimab/balstilimab combo therapy for recurrent platinum-resistant/refractory ovarian cancer.
The findings showed a 33% overall response rate. The disease control rate was 67%, and the median duration of response was not reached, with a manageable tolerability profile.
Despite positive clinical progress and Agenus adhering to timelines, William Blair notes that the company will require more funding soon.
The company ended 2023 with $76.1 million in cash and a $40.6 million cash burn as of 2023, plus a $25 million milestone from Bristol Myers Squibb & Co (NYSE:BMY).
William Blair sees potential in Agenus’s next-generation CTLA-4 antibody, botensilimab, particularly its efficacy in historically unresponsive tumor types.
The analyst maintains an Outperform rating on the stock and estimates a sales potential of $404 million in 2027 for balstilimab and botensilimab in metastatic CRC.
Price Action: AGEN shares are down 5.41% at $8.39 on the last check Friday.
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