Agenus Completes Enrollment in Randomized Phase 2 Clinical Trial of Botensilimab/Balstilimab in Advanced Colorectal Cancer
October 10 2023 - 7:30AM
Business Wire
Agenus Inc. (Nasdaq: AGEN), a leader in developing novel
immunological agents to treat various cancers today announced
completion of the planned patient enrollment in
ACTIVATE-Colorectal, a randomized Phase 2 trial in advanced
colorectal cancer (CRC) evaluating the efficacy and safety of
botensilimab (BOT) as monotherapy and in combination with
balstilimab (BAL) or standard of care in patients with metastatic
heavily pre-treated colorectal cancer.
The phase 2 study follows an expanded phase 1 study of over 100
patients with a median of four prior lines of therapy and with 25%
having failed previous immunotherapy. At ESMO GI earlier this year,
data from the phase 1 study were presented. Among the evaluable
patients (n=69) who did not have active liver metastases, a
confirmed objective response rate of 23% and a median overall
survival of 20.9 months were observed.
"There is a significant need for improved treatment options for
heavily pre-treated CRC patients and we anticipate data from
ACTIVATE-Colorectal will build upon the positive results from our
phase 1 study," said Chief Medical Officer, Dr. Steven O’Day. "Our
gratitude goes out to the patients, care partners, physicians, and
nurses involved in this trial, as we push forward with BOT/BAL to
bridge vital gaps in cancer care."
Agenus is exploring global accelerated approval strategies for
CRC. The totality of data from the phase 1 and 2 studies will
contribute to a planned Biologics License Application to the U.S.
FDA in 2024. The U.S. FDA has granted Fast Track designation for
BOT/BAL in patients with non-MSI-H/dMMR metastatic colorectal
cancer and no active liver involvement who are resistant or
intolerant to a fluoropyrimidine, oxaliplatin, and irinotecan, and
who have also received a VEGF inhibitor, an EGFR inhibitor and/or a
BRAF inhibitor, if indicated.
About Botensilimab
Botensilimab is an investigational multifunctional anti-CTLA-4
immune activator designed to boost both innate and adaptive
anti-tumor immune responses. Its novel design leverages mechanisms
of action to extend immunotherapy benefits to "cold" tumors which
generally respond poorly to standard of care or are refractory to
conventional PD-1/CTLA-4 therapies and other investigational
therapies. Botensilimab augments immune responses across a wide
range of tumor types by priming and activating T cells,
downregulating intratumoral regulatory T cells, activating myeloid
cells and inducing long-term memory responses.
Approximately 600 patients have been treated with botensilimab
in phase 1 and phase 2 clinical trials. Botensilimab alone, or in
combination with Agenus’ investigational PD-1 antibody,
balstilimab, has shown clinical responses across nine metastatic,
late-line cancers. For more information about botensilimab trials,
visit www.clinicaltrials.gov with the identifiers NCT03860272,
NCT05608044, NCT05630183, and NCT05529316.
Access to Investigational Medicines
Policy
Agenus is committed to making our investigational therapies
available to patients with cancer based upon advice of a treating
physician. Physicians and patients interested in accessing the
BOT/BAL combination for CRC should follow the compassionate use
policy available on the Agenus website.
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 relating to the anticipated
savings as a result of the strategic initiative, the timing of
potential regulatory applications, approval and commercialization
for BOT/BAL, the continued development of Agenus’ partnered
programs, the reactivation of certain pipeline programs, use of
botensilimab and balstilimab, for instance, statements regarding
therapeutic benefit and efficacy, mechanism of action (including
validation of mechanism of action), potency, durability, and safety
profile (including the absence of specific toxicities); 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 Quarterly Report on Form 10-Q or Annual Report on Form
10-K 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231010972883/en/
Investors 917-362-1370
investor@agenusbio.com
Media 781-674-4784
communications@agenusbio.com
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From Apr 2024 to May 2024
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From May 2023 to May 2024