Agenus Announces Updated Phase 1 Data and Progress on BOT/BAL Development in Metastatic MSS Colorectal Cancer

Rhea-AI Summary

Agenus Inc. (AGEN) announces updated Phase 1 data showing a 71% 12-month overall survival rate and 62% 18-month overall survival rate for BOT/BAL combination therapy in metastatic colorectal cancer (CRC) patients. The company plans to discuss Phase 2 interim results with the FDA and submit data to a major medical conference in the second half of 2024.

Oncology Medical Research Analyst

The survival rates reported for the BOT/BAL combination therapy in metastatic colorectal cancer (CRC) are promising, with a 12-month overall survival (OS) of 71% and an 18-month OS of 62%. For context, metastatic CRC has historically had poor prognoses, with five-year survival rates hovering around 14% according to the American Cancer Society. The observed overall response rate (ORR) of 23% is also notable, particularly given that the trial involved patients with refractory MSS-CRC, which is often more challenging to treat due to its lack of response to certain immunotherapies.

From a medical research perspective, the median duration of response not being reached suggests that the treatment could offer sustained benefits, which is a critical factor in cancer care. The upcoming discussions with the FDA and the potential submission of a Biologics License Application (BLA) indicate that the therapy may soon transition into a new treatment option for patients, subject to regulatory approval. This could eventually impact the standard of care in metastatic CRC, particularly for those with MSS-CRC subtype.

Healthcare Industry Market Analyst

The positive clinical trial results for Agenus Inc.’s BOT/BAL therapy could have significant market implications. The metastatic CRC therapeutic area is in need of innovative treatments and BOT/BAL's potential to improve survival outcomes could position Agenus as a key player in this space. As the second leading cause of cancer mortality in the U.S., CRC represents a substantial market with high unmet medical needs.

Should the FDA discussions lead to a successful BLA submission and eventual approval, Agenus could see a substantial increase in its market valuation. The decision to present detailed Phase 2 efficacy results at a major medical conference also suggests a strategic move to build anticipation and credibility within the oncology community, potentially influencing future adoption rates among healthcare providers. Furthermore, the expansion of the treatment landscape for MSS-CRC could drive partnerships, licensing agreements, or even acquisition interest from larger pharmaceutical companies seeking to bolster their oncology portfolios.

Biotech Financial Analyst

The interim results from Agenus' clinical trials could be a strong indicator of future financial performance, particularly if the BOT/BAL combination therapy gains FDA approval. Agenus' stock (NASDAQ: AGEN) may react positively to the news of the high survival rates in the Phase 1 trial, as investors often look for such breakthroughs in biotech as potential growth drivers. The company's proactive approach to meeting with the FDA and the planned BLA submission are likely to be viewed favorably by the market.

Investors should monitor the progress of these regulatory discussions and the impact of the detailed Phase 2 results presentation. However, it's important to consider the inherent risks in biotech investing, such as regulatory hurdles and the potential for adverse findings in later-stage trials. Additionally, Agenus' financial health, cash burn rate and ability to secure sufficient funding until the potential product launch should be scrutinized to assess long-term viability.

• Updated Phase 1 data demonstrate a 12-month overall survival (OS) of 71% and 18-month OS of 62%
• Company plans to discuss encouraging Phase 2 interim results with the FDA
• Company plans to submit Phase 2 data to a major medical conference in the second half of 2024

LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (NASDAQ: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced updated results from its Phase 1 clinical trial of BOT/BAL combination therapy in patients with metastatic 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 was not yet reached. The estimated 12-month and 18-month 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 encouraging interim results with the U.S. Food and Drug Administration (FDA).

“These results underscore the potential of BOT/BAL in metastatic CRC, the second leading cause of cancer mortality in the U.S.,” said Steven O’Day, M.D., Chief Medical Officer at Agenus. “We continue to work expeditiously to bring this promising combination to patients in need.”

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. This growing body of clinical evidence underscores the significant potential of BOT/BAL to transform the treatment landscape for difficult-to-treat solid tumors.

About Agenus

Agenus is a leading immuno-oncology company targeting cancer and infectious diseases with a comprehensive pipeline of immunological agents. The company’s mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding a its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2022, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

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Source: Agenus Inc.

What are the updated overall survival rates for the Phase 1 clinical trial of BOT/BAL combination therapy in refractory MSS-CRC patients?

The 12-month overall survival rate is 71%, and the 18-month overall survival rate is 62%.

What is the overall response rate observed in the Phase 1 trial of BOT/BAL combination therapy?

A 23% overall response rate (ORR) was observed in the Phase 1 trial.

What are the future plans regarding Phase 2 data for BOT/BAL combination therapy?

The company plans to discuss the encouraging Phase 2 interim results with the FDA and submit data to a major medical conference in the second half of 2024.

Who is the Chief Medical Officer at Agenus Inc.?

Steven O’Day, M.D. is the Chief Medical Officer at Agenus Inc.

What application does Agenus plan to submit for BOT/BAL in refractory MSS CRC?

Agenus plans to submit a Biologics License Application (BLA) for BOT/BAL in refractory MSS CRC later this year.