Small-Cap Cancer Drug Developer Agenus' Highlights Encouraging Data From Colorectal Cancer, But Funding Concerns Loom

Friday, Agenus Inc 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 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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