Agenus Announces U.S. FDA Acceptance and Priority Review of Balstilimab Biologics License Application for the Treatment of Re...
June 17 2021 - 8:30AM
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an
extensive pipeline of agents which includes checkpoint antibodies,
cell therapies, adjuvants, and vaccines designed to activate immune
response to cancers and infections, today announced that the U.S.
Food and Drug Administration (FDA) has accepted Agenus’ Biologics
License Application (BLA) for balstilimab, an anti-PD-1 antibody,
for the treatment of recurrent or metastatic cervical cancer with
disease progression on or after chemotherapy. The FDA has granted
Priority Review to this submission, a designation for drugs which,
if approved, may provide significant improvements in the safety or
effectiveness of the treatment of serious conditions. Under the
Prescription Drug User Fee Act (PDUFA), the FDA has set a target
action date of December 16, 2021.
About Cervical CancerNearly 14,000 women are
expected to be diagnosed with invasive cervical cancer in the
United States this year and more than 4,000 are expected to die.1
Cervical cancer remains one of the leading causes of cancer death
in women globally, annually killing more than 300,000 women
worldwide.2 Despite advances in routine medical examinations and
HPV vaccines, cervical cancer remains prevalent. When left
undetected, recurrent or metastatic cervical cancer often develops,
for which there are limited treatment options and a low chance of
survival. Current therapies for recurrent or metastatic cervical
cancer are limited to a small subset of patients with limited
benefit.
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. Balstilimab is currently in clinical trials as monotherapy
and in combination with Agenus’ anti-CTLA-4, zalifrelimab, in an
ongoing Phase 2 study for recurrent/metastatic cervical cancer.
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 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.
ContactAgenus Investor
RelationsJan Medina,
CFAAgenus781-674-4490Jan.Medina@agenusbio.com
Agenus Media RelationsKimberly
HaKKH Advisors917-291-5744kimberly.ha@kkhadvisors.com
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1
https://www.cancer.org/cancer/cervical-cancer/about/key-statistics.html
2 https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660
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