Agenus Receives Fast Track Designation for Botensilimab and Balstilimab in Colorectal Cancer
April 17 2023 - 7:30AM
Business Wire
Agenus Inc. (Nasdaq: AGEN), a leading immuno-oncology company
specializing in immunological agents for cancer and infectious
diseases, has been granted Fast Track Designation from the US Food
and Drug Administration (FDA) for the investigation of the
combination of botensilimab (AGEN1181) and balstilimab (AGEN2034).
The designation is for patients with non-microsatellite
instability-high (MSI-H)/deficient mismatch repair (dMMR)
metastatic colorectal cancer with no active liver involvement.
Patients targeted with this designation are heavily pretreated 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. The company is
conducting a global, randomized Phase 2 trial of botensilimab in
combination with balstilimab compared to standard of care in
non-microsatellite instability-high (non-MSI-H) colorectal cancer
patients.
"We are pleased that the FDA has granted Fast Track designation
for the combination of botensilimab with balstilimab in patients
with non-MSI-H colorectal cancer, recognizing the high unmet
medical need in this population," said Dr. Steven O’Day, Chief
Medical Officer of Agenus. "The Fast Track designation offers
important benefits, including the potential eligibility for a
Priority Review, and we will be working with the FDA and all key
stakeholders to rapidly advance the botensilimab/balstilimab
combination in colorectal cancer as well as other solid tumor
indications.”
During the American Society of Clinical Oncology –
Gastrointestinal Cancers Symposium in January 2023, Agenus
presented positive results from its ongoing clinical trials of the
botensilimab/balstilimab combination in patients with non-MSI-H
colorectal cancer. The combination therapy showed an overall
response rate of 23% and a 12-month survival rate of 63%, which
compares to very limited activity of 1-2% overall response rate and
~25% 12-month survival rate reported for the standard of care.
Responses to the botensilimab/balstilimab therapy have been
durable, with 69% ongoing at data cut-off, and median overall
survival not reached.
About Botensilimab
Botensilimab is a novel, multifunctional CTLA-4 investigational
antibody that has been designed to extend clinical benefits to
“cold” tumors that have not historically responded to standard of
care or investigational therapies. In addition to binding to the
CTLA-4 receptor, its Fc-enhanced structure induces a memory immune
response, downregulates regulatory T cells, and delivers better
priming and activation of T cells, thereby amplifying immune
responses.
In a Phase 1b clinical study of more than 350 patients,
botensilimab has demonstrated clinical responses in nine,
previously IO unresponsive, solid tumor cancers, either alone or in
combination with Agenus’ PD-1 antibody, balstilimab (data presented
at ASCO GI 2023, SGO 2023, CTOS 2022, SITC 2022). Agenus is
conducting global, randomized Phase 2 trials in non-MSI-H
colorectal cancer, pancreatic cancer, and melanoma as part of its
ACTIVATE trial programs. Additional information about these
botensilimab trials can be found at www.clinicaltrials.gov under
the identifiers NCT05608044, NCT05630183, and NCT05529316,
respectively. A global Phase 3 trial in non-MSI-H CRC is expected
to launch in 2023.
About Agenus Agenus is a
clinical-stage immuno-oncology company focused on the discovery and
development of therapies that engage the body's immune system to
fight cancer and infections. The Company's vision is to expand the
patient populations benefiting from cancer immunotherapy by
pursuing combination approaches that leverage a broad repertoire of
antibody therapeutics, adoptive cell therapies (through its
subsidiary MiNK Therapeutics), and adjuvants (through its
subsidiary SaponiQx). The Company is equipped with a suite of
antibody discovery platforms and a state-of-the-art GMP
manufacturing facility with the capacity to support clinical
programs. Agenus is headquartered in Lexington, MA. For more
information, please visit www.agenusbio.com and our Twitter handle
@agenus_bio. Information that may be important to investors will be
routinely posted on our website and Twitter.
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 our technologies,
therapeutic candidates, and capabilities, for instance, statements
regarding therapeutic benefit and efficacy, mechanism of action,
potency, durability, and safety and tolerability profile of our
therapeutic candidates, both alone and in combination with each
other and/or other agents; statements regarding future plans,
including research, clinical, regulatory, and commercialization
plans; and any other statements containing the words "may,"
"believes," "expects," "anticipates," "hopes," "intends," "plans,"
"will" 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 and
available on our website: www.agenusbio.com. 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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version on businesswire.com: https://www.businesswire.com/news/home/20230417005330/en/
Zack Armen Head of Investor Relations 917-362-1370
zack.armen@agenusbio.com
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