Agenus Announces Updated Phase 1 Data and Progress on BOT/BAL Development in Metastatic MSS Colorectal Cancer
April 12 2024 - 6:30AM
Business Wire
- 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
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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