LEXINGTON, Mass., March 12, 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 [PD-1] in combination with zalifrelimab [CTLA-4] for
the treatment of patients with relapsed or refractory metastatic
cervical cancer. This designation was based on comprehensive data
that support the potential for balstilimab and zalifrelimab 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.
![Agenus Logo Agenus Logo](https://mma.prnewswire.com/media/403578/Agenus_Logo.jpg)
"We are pleased that balstilimab and zalifrelimab have been
granted Fast Track designation by FDA in recognition of the high
unmet medical need in second line cervical cancer. The Fast Track
designation confers important benefits, including the potential
eligibility for a Priority Review,"
said Dr. Jennifer Buell, President
and COO, Agenus. "We are excited about the prospect of making these
novel agents available to women who suffer from metastatic cervical
cancer. We look forward to continuing to work with FDA as we
advance new treatment options for patients with cancer."
Agenus has reported updated data from a pre-planned interim
analysis revealing robust and durable activity of balstilimab and
zalifrelimab in patients with relapsed or refractory metastatic
cervical cancer. The data demonstrated 26.5% objective response
rates (ORR) (4 CRs, 5 PRs, 8 SD) which are
durable (median not yet reached) 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 designation 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.
Regina Grebla, PhD
781-674-4495
Regina.Grebla@agenusbio.com
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SOURCE Agenus Inc.