- Agreement reached with the FDA on Phase 3 dose for the BOT/BAL
combination
- Accelerated approval pathway discouraged by FDA
- Preliminary Phase 2 data tracks with Phase 1 BOT/BAL clinical
activity in MSS mCRC (ORR ~19.4% and 90% alive at 6 months)
- Strategic meeting with the European agency scheduled for Q3
2024 to explore additional regulatory opportunities
Agenus Inc. (NASDAQ: AGEN), a leader in developing novel
immunological agents to treat various cancers, today announced the
results of its end-of-Phase 2 (EOP2) meeting with the U.S. Food and
Drug Administration (FDA), for the advancement of its immunotherapy
combination, botensilimab (BOT) and balstilimab (BAL), for the
treatment of adult patients with relapsed/refractory microsatellite
stable colorectal cancer (r/r MSS CRC) with no active liver
metastases (NLM).
Key Outcomes of the EOP2 Meeting:
- Dosing Regimen: Agenus gained agreement on the proposed
BOT/BAL combination dosing regimen of 75mg BOT once every 6 weeks
for up to 4 doses in combination with 240mg BAL once every 2 weeks
for up to 2 years.
- Randomized Phase 2 Interim Data: Topline interim data
suggest best activity seen at 75 mg BOT/240mg BAL combination (ORR
19.4%; 6-month survival rate of 90%; data continues to
mature).
- Accelerated Approval: FDA advised against submission of
these results in support of an Accelerated Approval based on their
view that objective response rates may not translate to survival
benefit.
- Phase 3 Protocol Design: The FDA recommended the
inclusion of a BOT monotherapy arm at Agenus’ discretion in the
Phase 3 study.
Dr. Steven O’Day, Agenus’ Chief Medical Officer, stated, “Based
on the high level of enthusiasm from significant numbers of global
clinical experts and the promising clinical activity we have seen
in the Phase 1 and 2 studies, our commitment to seek all possible
pathways to make BOT/BAL available to patients is unwavering. This
includes exploring opportunities to partner in the U.S. to
accomplish a successful Phase 3 trial.”
Agenus previously disclosed data from the Phase 1 trial, which
showed an overall response rate (ORR) of 23% in the 77 MSS mCRC
patients without active liver metastases, with a median follow up
of 13.6 months. The estimated 6-month, 12-month and 18-month
overall survival (OS) rates were 86%, 71%, and 62%, respectively.
The estimated median OS was 21.2 months.
Topline interim data (below) from the Phase 2 trial are showing
trends consistent with the Phase 1 study, including an ORR of 19.4%
and 6-month survival rate of 90% for the BOT 75mg/BAL combination.
The safety profile was manageable and no new signals were observed.
Agenus plans to continue future discussions with FDA as the Phase 2
data mature and will present these data in totality at an upcoming
medical conference.
Topline
Interim Phase 2 Data
BOT + BAL
75 mg
(n= 62)
BOT+BAL
150 mg
(n=61)
BOT
75 mg
(n=38)
BOT
150 mg
(n=40)
SOC
(n=33)
ORR %
(95% CI)
n/nn
19.4*
(10.4, 31.4)
12/62
8.2
(2.7, 18.1)
5/61
0
(0.0, 9.3)
0/38
7.5
(1.6, 20.4)
3/40
0
(0.0, 10.6)
0/33
Follow-Up (m)
Mean (SD)
Range
9.5
(2.77)
1.2, 15.7
9.1
(3.25)
0.1, 16.6
7.8
(4.37)
0.2, 14.8
8.2
(4.53)
0.7, 17.1
5.5
(5.30)
0.0, 13.0
*Pending confirmation of two additional
responses in 75mg BOT + BAL arm. No responses are pending
confirmation in other arms.
These results are particularly meaningful, as the landscape of
MSS colorectal cancer treatment has seen little advancement leaving
a significant gap in effective therapies for patients.
“MSS colorectal cancer, representing approximately 95% of
colorectal cancer cases, remains a disease setting with substantial
unmet need and is considered to be one of the most challenging
types of cancer due to its high incidence and mortality rates,”
said Michael Sapienza, Chief Executive Officer of Colorectal Cancer
Alliance. “The rapidly growing number of diagnoses in younger
individuals is particularly alarming. There is an urgent need for
new treatment options that can transform the trajectory of MSS
colorectal cancer and provide lasting benefits for patients.”
In addition to the progress in the U.S., Agenus is advancing its
efforts to bring BOT/BAL to patients in Europe. Engagements with
the European Regulatory Authority to explore registration paths are
scheduled for later this summer. These discussions aim to align on
the regulatory path for approval of the BOT/BAL combination in
Europe.
Other areas of BOT/BAL clinical development:
Agenus continues to pursue opportunities for BOT/BAL development
in earlier lines of CRC and other tumor types where BOT/BAL has
demonstrated clinical activity, such as lung, melanoma, and
pancreatic cancers. The company expects to present data from some
of these programs at future medical congresses, including BOT/BAL
in sarcoma at European Society for Medical Oncology (ESMO) in
September 2024.
About Botensilimab
Botensilimab 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 1100 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 Colorectal Cancer
Colorectal cancer (CRC) is the second leading cause of cancer
death in the United States, and is estimated to be the number one
killer of men aged 50 and above and second leading killer of women
in the same age category. Microsatellite stable (MSS) colorectal
cancer is the most prevalent form of the disease, representing
approximately 95% of patients with colorectal cancer. Survival
remains poor for advanced disease, and the burden is shifting to a
younger population. Alarmingly, from 1995 to 2019, the number of
patients under the age of 55 who were diagnosed with CRC in the
United States nearly doubled.
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 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 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.
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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