Presentations will showcase new data
reinforcing BOT/BAL’s potential across different lines of treatment
in colorectal cancer, including the neoadjuvant setting
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today
announced five presentations featuring botensilimab (BOT, an
Fc-enhanced anti-CTLA-4 antibody) plus balstilimab (BAL, an
anti-PD-1 antibody) at the upcoming American Society of Clinical
Oncology Gastrointestinal Cancers (ASCO GI) Symposium. The
conference will take place on January 23-25, 2025, in San
Francisco, California.
The presentations will showcase BOT/BAL's activity across three
distinct colorectal cancer settings—late-line metastatic,
first-line, and neoadjuvant treatment. The studies demonstrate
BOT/BAL’s consistent activity in microsatellite stable (MSS)
colorectal cancer (CRC), which accounts for over 80% of CRC cases
and has limited treatment options, as well as its efficacy in
microsatellite instability-high (MSI-H) CRC. Additionally, one
presentation will feature BOT/BAL and invariant natural killer T
cells (iNKTs) in patients with refractory gastric cancer.
“These presentations will highlight BOT/BAL’s potential to
benefit patients across colorectal cancer treatment settings,
including the neoadjuvant, late-line, and first-line settings,”
said Dr. Garo Armen, Chairman and CEO of Agenus. “We aim to
transform outcomes at every stage of disease and deliver renewed
hope for patients worldwide.”
Presentation Details
Abstract Title: Preliminary results from a randomized,
open-label, phase 2 study of botensilimab (BOT) with or without
balstilimab (BAL) in refractory microsatellite stable metastatic
colorectal cancer with no liver metastases (MSS mCRC NLM)*
Abstract Number: 23 Presenting Author: Dr. Marwan
Fakih Session: Rapid Oral Abstract Session C: Cancers of the
Colon, Rectum, and Anus Session Date and Time: 1/25/2025,
9:15 AM-10:00 AM PST
Abstract Title: Preoperative botensilimab (BOT) with or
without balstilimab (BAL) for patients with resectable locally
advanced pMMR or dMMR colon cancer: Results from the UNICORN trial
by GONO Abstract Number: 158 Presenting Author: Dr.
Filippo Ghelardi Session: Poster Session C: Cancers of the
Colon, Rectum, and Anus Session Date and Time: 1/25/2025,
7:00 AM-7:55 AM PST
Abstract Title: A phase II study of agenT-797 (invariant
natural killer T-cells), botensilimab (Fc-enhanced CTLA-4
inhibitor) and balstilimab (anti-PD-1) in patients with advanced,
refractory gastroesophageal adenocarcinoma Abstract Number:
TPS515 Presenting Author: Dr. Samuel Cytryn Session:
Trials in Progress Poster Session A: Cancers of the Esophagus and
Stomach and Other Gastrointestinal Cancers Session Date and
Time: 1/23/2025, 11:30 AM-1:00 PM PST
Abstract Title: Neoadjuvant botensilimab (BOT) plus
balstilimab (BAL) in resectable mismatch repair proficient (pMMR)
and deficient (dMMR) colorectal cancer (CRC): NEST clinical trial
update Abstract Number: 207 Presenting Author: Dr.
Erika Hissong Session: Poster Session C: Cancers of the
Colon, Rectum, and Anus Session Date and Time: 1/25/2025,
7:00 AM-7:55 AM PST
Abstract Title: A phase 1 trial of folinic acid,
fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab
(FOLFOX-3B) in microsatellite stable metastatic colorectal cancer.
Abstract Number: 180 Presenting Author: Dr. Marwan
Fakih Session: Poster Session C: Cancers of the Colon,
Rectum, and Anus Session Date and Time: 1/25/2025, 7:00
AM-7:55 AM PST
Complete abstracts will be released at 5:00 PM ET on January
21st, 2025. Data presented at the conference will be available to
view in the publications section of the Agenus website
(https://agenusbio.com/publications) following the ASCO GI
Meeting.
*Agenus Sponsored Study
About Agenus
Agenus is a leading immuno-oncology company targeting cancer
with a comprehensive pipeline of immunological agents. The company
was founded in 1994 with a mission 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 has robust end-to-end development
capabilities, across commercial and clinical cGMP manufacturing
facilities, research and discovery, and a global clinical
operations footprint. 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.
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking
antibody 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 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 1,100 patients have been treated with botensilimab
and/or balstilimab 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.
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 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 2023, 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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