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Agenus Submits Balstilimab Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer

Immuno-oncology company Agenus Inc. has submitted a Biologics License Application (BLA) to the U.S. FDA for the accelerated approval of its anti-PD-1 antibody, balstilimab, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The BLA updates data from Agenus’ pivotal Phase 2 single-arm clinical trial presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, together with preclinical data suggesting that balstilimab demonstrates differentiation from other anti-PD-1 antibodies. It also shows maturation of late patient responses, with overall data showing response rates of 20% in PD-L1 positive tumors, 15% in all tumors (PD-L1 positive and
negative), and a median duration of response of 15.4 months.

“Women with recurrent or metastatic cervical cancer have a very poor prognosis and limited treatment
options. Data suggest balstilimab may bring benefit to patients beyond what is available in this disease setting today.”

Jennifer Buell, PhD, President and Chief Operating Officer at Agenus

Fast Track designation was granted in April 2020 for balstilimab in recurrent or metastatic cervical cancer on the basis of its potential to benefit patients in serious need.

“We expect that the potential approval of balstilimab will enable us to better pursue our oncology combination strategy for our own extensive pipeline of agents as well as for existing and future partner products. In particular, we hope to use this potential approval to allow us to rapidly proceed with our anti-CTLA-4 combination strategy, which we believe can add significantly to the benefit provided by our anti-PD-1 agent. There are currently limited treatment options available for recurrent or metastatic cervical cancer patients, and our vision is to bring effective treatments to these patients.”

Steven O’Day, MD, Chief Medical Officer at Agenus

A global, randomized, Phase 3 confirmatory clinical trial in view of global registration is anticipated.

About Cervical Cancer
Cervical cancer is one of the world’s main causes of cancer death in women, claiming more than 300,000 lives each year despite advances in medical examinations and HPV vaccines. When left undetected, recurrent or metastatic cervical cancer develops, for which current therapies are limited and there is a low chance of survival.

About Balstilimab
Balstilimab 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 down-regulates the immune system and is a foundational target in 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 Agenus
Agenus is a clinical-stage immune-oncology company headquartered in Lexington, MA, that aims to discover and develop therapies aiding the body’s immune system to fight cancer. It envisions an expanded population of patients benefitting from cancer immunotherapy through a pursuit of combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its subsidiary, AgenTus Therapeutics), and proprietary cancer vaccine platforms. It has access to a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs.

(Source: Pipeline Review, 2021)