Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive
pipeline of checkpoint antibodies, cell therapies, adjuvants, and
vaccines designed to activate immune response to cancers and
infections, today announced a strategic decision to withdraw its
Biologics License Application (BLA) for balstilimab, its PD-1
inhibitor. The decision to withdraw the BLA does not change the
development plans for balstilimab combinations.
Following the full approval of pembrolizumab, announced four
months earlier than the FDA goal date, the U.S. Food and Drug
Administration (FDA) no longer considered it appropriate to review
the BLA for accelerated approval and recommended Agenus withdraw.
The BLA submission for balstilimab received Fast Track and Priority
Review designation from the FDA, with a target action date of
December 16, 2021. As part of the BLA review process, Agenus
successfully completed 3 FDA inspections with no cited issues,
concerns, or Form-483s.
As previously reported, in the largest single-arm trial to date
in this population (140 evaluable patients), balstilimab
demonstrated objective responses in both PD-L1 positive and
negative patients, with an objective response rate (ORR) of 20% and
8% respectively1. Pembrolizumab has demonstrated an ORR of 14% and
0% in PD-L1 positive and negative patients respectively, which led
to its accelerated approval in 2018. Balstilimab has shown superior
killing of PD-L1 negative tumors compared to other anti PD-1
therapies, including pembrolizumab, suggesting a broader mechanism
consistent with balstilimab’s clinical activity in both PD-L1
positive and negative cervical cancer2.
Concurrent with the withdrawal, Agenus will discontinue its
ongoing confirmatory trial (BRAVA) in this population, which is
expected to reduce R&D expenses by over $100M. However, given
the clinical benefit demonstrated by balstilimab, Agenus plans to
launch expanded access programs to give patients and doctors access
to balstilimab in several countries, including the US, pending
regulatory processes.
“While the commercial market for balstilimab monotherapy in
second line cervical cancer was always anticipated to be small,
Agenus’ priority remains developing balstilimab as a necessary
component of highly effective and affordable combination therapies,
both with its own portfolio and with partners, including in
combination with Agenus’ next-generation CTLA-4, AGEN1181,” said
Garo Armen, CEO and Chairman of Agenus.
“Balstilimab has demonstrated meaningful clinical activity and
an excellent safety profile in second-line cervical cancer,
including in PD-L1 negative patients, who are ineligible to receive
standard of care anti-PD-1 therapy, which makes the decision to
withdraw so difficult for us,” said Steven O’Day, MD, Chief Medical
Officer of Agenus. “Balstilimab remains a critical component of our
combination regimens, including with our next-generation CTLA-4
agent, AGEN1181. Concomitant with presentation of new data at SITC
next month, we continue to accelerate development of AGEN1181 in
combination with balstilimab in trials designed to rapidly support
full or accelerated approval in multiple tumor types.”
Agenus executives will host a conference call to discuss this
update at 8:30AM ET today.
Conference CallDial-in numbers: (833) 614-1394
(US) or (914) 987-7115 (International); Conference ID: 5399638.
WebcastA live webcast and replay of the
conference call will be accessible from the Events &
Presentations page of the Company’s website at
https://investor.agenusbio.com/events-and-presentations and via
https://edge.media-server.com/mmc/p/2p8yio6u.
References1. D.M. O'Malley, A. Oaknin, B.J.
Monk, et al., Phase II study of the safety and efficacy of the
anti-PD-1 antibody balstilimab inpatients with rec..., Gynecologic
Oncology, https://doi.org/10.1016/j.ygyno.2021.08.0182. C. Joyce,
D. Chand et al., Differentiated activity profile for the PD-1
inhibitor balstilimab. Journal of Clinical Oncology 39, no.
15_suppl (May 20, 2021) 5529-5529.
About BalstilimabBalstilimab is a novel, fully
human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1
(programmed cell death protein 1) from interacting with its ligands
PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation
that is considered a foundational target within the immuno-oncology
market.
About AgenusAgenus 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. 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 affiliate MiNK Therapeutics), adjuvants, and
proprietary cancer vaccine platforms. 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 StatementsThis 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 therapeutic candidates
balstilimab and AGEN 1181, for instance, statements regarding
therapeutic benefit and efficacy, mechanism of action, potency,
durability, and safety profile of the therapeutic candidates, both
alone and in combination with each other and/or other agents;
future clinical and regulatory development plans for balstilimab
alone and in combination with other agents, including AGEN1181; our
ability to obtain regulatory approval for balstilimab, alone and in
combination with other agents, including AGEN1181, including the
timing (including the possibility of accelerated review) and scope
of any such regulatory approval; future commercial plans, including
pricing, for balstilimab, alone and in combination with other
agents; and any other statements containing the words "may,"
"believes," "expects," "anticipates," "hopes," "intends," "plans,"
"forecasts," "estimates," "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. 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.
ContactAgenus Inc.Divya
Vasudevan, PhD781-674-4571divya.vasudevan@agenusbio.com
Agenus Media RelationsKimberly HaKKH
Advisors917-291-5744kimberly.ha@kkhadvisors.com
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