Botensilimab/Balstilimab Breakthrough Data Presented at ASCO-GI Shows Unprecedented Tumor Shrinkage and Robust Biomarker Response in Prevalent Colorectal Cancer Population
22 Janeiro 2024 - 11:59AM
Business Wire
- Botensilimab/Balstilimab (BOT/BAL) shows major tumor regression
in 67.5% of Patients with Localized MSS Colorectal Cancer (CRC), a
tumor typically unresponsive to IO therapy
- The study achieved durable elimination of ctDNA, a critical
biomarker for cancer clearance and long-term disease-free
survival
Agenus Inc. (Nasdaq: AGEN), a leader in developing immunological
cancer treatments, today announced results from the NEST-1 study,
an investigator-sponsored trial (IST) evaluating the combination of
botensilimab and balstilimab (BOT/BAL) in the neoadjuvant setting
for colorectal cancer (CRC), both those with Microsatellite Stable
(MSS) CRC and Microsatellite Instability High (MSI-H) CRC. Dr.
Pashtoon Kasi, M.D., Director of Colon Cancer Research at
Weill-Cornell Medicine, presented these findings at the ASCO-GI
conference.
"BOT/BAL's potential impact on colorectal cancer is
groundbreaking. The study's findings, particularly the significant
tumor regression after only a single dose of BOT and two doses of
BAL, and the complete elimination of ctDNA in 100% of patients
tested, offer a potentially transformative treatment approach for
CRC patients diagnosed with early stage and locally advanced colon
and rectal cancers. These results hold great promise for patients
and providers as a framework for reduced reliance on chemotherapy
and/or surgical resection," said Dr. Pashtoon Kasi, M.D., Director
of Colon Cancer Research at Weill-Cornell Medicine and lead
investigator of the NEST-1 study.
Study Highlights:
- Treatment Protocol: Patients received a single dose of BOT and
two doses of BAL between diagnosis and surgery, which was
approximately a four-week period.
- Impressive Pathologic Response: Tumor shrinkage of ≥50% was
observed in 67.5% of patients in the Microsatellite Stable (MSS)
CRC cohort and 100% in the Microsatellite Instability-High
(MSI-High) CRC cohort.
- Surgery Without Delays: Treatment with BOT/BAL did not cause
any postponements in surgical procedures, with only two instances
of Grade 3 Treatment-Related Adverse Events (TRAEs) observed.
- BOT/BAL Eliminates Circulating Tumor DNA (ctDNA): patients in
the NEST-1 study were tested for ctDNA, a biomarker closely
associated with long-term Disease-Free Survival (DFS).
- In a separate, independent observational study of 1,792
patients (NCT04264702;
https://meetings.asco.org/abstracts-presentations/228848), also led
by Dr. Kasi and presented at the ASCO-GI meeting on January 20th,
showed a correlation between ctDNA clearance and improved
disease-free survival (DFS) rates. Patients who remained ctDNA
negative post-treatment exhibited better 2-year DFS as compared to
ctDNA-positive patients.
Dr. Steven O’Day, Chief Medical Officer of Agenus, stated, “The
NEST-1 trial results are remarkable. Neoadjuvant BOT/BAL in both
MSS and MSI-H CRC resulted in marked tumor regression and robust
immune cell infiltration in a very short interval. These results in
MSS CRC (90% of all CRC) are particularly compelling and may lead
to an unprecedented shift away from invasive and morbid standard
treatments in the future.”
NEST-1 data presented at the conference is available to view in
the publications section of the Agenus website
(https://agenusbio.com/publications).
About Botensilimab
Botensilimab is an investigational multifunctional anti-CTLA-4
immune activator (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 750 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.
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 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) of the
Company’s therapeutic candidates; 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.
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