LEXINGTON, Mass., April 7, 2020 /PRNewswire/ -- Agenus Inc.
(NASDAQ: AGEN), an immuno-oncology company with an extensive
pipeline of agents designed to activate immune response to cancers,
today announced that the U.S. Food and Drug Administration (FDA)
has granted Agenus Fast Track designation for investigation of
balstilimab (anti-PD-1) for the treatment of cervical cancer. This
designation was based on comprehensive data that support the
potential for balstilimab to address a significant unmet medical
need. Agenus expects to file 2 BLAs this year for accelerated
approval of the combination of balstilimab and zalifrelimab and
balstilimab monotherapy in metastatic cervical cancer.
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"We are pleased to have now been granted Fast Track designation
by FDA for both balstilimab as a monotherapy and in combination
with zalifrelimab (anti-CTLA-4) in recognition of the high unmet
medical need in second line cervical cancer," said Dr. Anna Wijatyk, Head of Clinical Development,
Agenus. "The Fast Track designation confers important benefits,
including the potential eligibility for a Priority Review, and we
are excited to work with the FDA to quickly advance novel agents
for women who suffer from metastatic cervical cancer."
Agenus has updated data from a pre-planned interim analysis
revealing robust and durable activity for balstilimab and
zalifrelimab in patients with relapsed or refractory metastatic
cervical cancer. The data for the combination demonstrated 26.5%
objective response rates (ORR) (4 CRs, 5 PRs) which are
durable (median not yet reached) and for balstilimab
monotherapy, a 14.3% ORR (1 CR, 5 PRs) in an all-comer,
non-biomarker selected population of patients with refractory
cervical cancer who have failed prior platinum chemotherapy with or
without bevacizumab.
Fast Track designation1 is granted by the FDA for
products that are intended for the treatment of serious or
life-threatening disease or conditions, which demonstrate the
potential to address an unmet medical need. The designation offers
the opportunity for frequent interactions with the FDA to discuss
the drug's development plan and ensure collection of appropriate
data needed to support drug approval, as well as eligibility for
rolling submission of a Biologic Licensing Application (BLA).
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. 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 AgenTus
Therapeutics subsidiary), 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 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 Agenus' anticipated BLA filings and the
anticipated benefits of Fast Track designation. 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.
Contact:
Agenus Inc.
Jennifer S. Buell, PhD
781-674-4420
Jennifer.Buell@agenusbio.com
1.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
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SOURCE Agenus Inc.