Agenus Inc. (NASDAQ:AGEN) has announced the commencement of the rolling submission of a Biologics License Application (BLA) to the FDA for balstilimab for treating metastatic/recurrent cervical cancer.
Agenus presents its Phase 2 study results at ESMO
The immune-oncology company presented data from its largest second phase study of anti-PD-1 in refractory cervical cancer patients at the Virtual European Society of Medical Oncology (ESMO) Congress. The data shows that over 160 patients who received balstilimab monotherapy attained 19% response rates in PD-L1 positive patients and 14% of all the treated patients. This data will support Agenus’s balstilimab BLA submission. Balstilimab is Agenus’ proprietary anti-PD-1 human monoclonal antibody that has shown promising clinical benefit as a second-line cervical cancer treatment,
Dr. Jennifer Buell, the COO and President of Agenus, stated that the commencement of the rolling Biologics License Application is a huge step for the company as it is moving closer to commercial production of its therapies for cervical cancer patients that have few available treatment alternatives. She further indicated that the company has continued to partner with top KOLs and the US FDA to make the therapies available to patients.
Rolling BLA to enable review of each section as Agenus submits it
The advantage of a rolling BLA submission is that the company will submit every section of the BLA as it completes its. This enables continuous review if the sections by the FDA concerning the progress of the remaining BLA application. There is a need for a treatment alternative for this patient population, and the American Cancer Society approximates that there are close to 14,000 new invasive cervical cancer cases that have been reported this year with close to 4,300 death.
Therefore there is an urgent need to provide new therapies that can offer clinical benefits to this patient population. Agenus is focused on expanding its patient population that benefits from its cancer immunotherapy through a combination of approaches leveraging a wide range of adoptive cell therapies, antibody therapeutics, and novel cancer vaccine platforms.