AgenusNews • Vol. 4 • Issue 2 • Jan 26, 2021

Cervical Cancer Awareness Month: Agenus’ Breakthrough Treatments and Technologies for Cervical Cancer

Experts Discuss their Shared Commitment to Defeat This Deadly Disease

Another year of important advances preceded this month’s cervical cancer awareness month, the fourth most common cancer in women, with ~300,000 annual deaths worldwide. Agenus’ treatments have offered life changing experiences to many women enrolled in our trials. We look to extend their experience to scores of other cervical cancer patients with advanced disease as we get ready to file our first BLA ahead of our planned balstilimab (anti-PD-1) launch. While this is the first step to offer a better choice to these women, we will be working with the FDA to bring about more choices to doctors and patients with the offering of zalifrelimab (anti-CTLA-4) as a combination therapy for improved responses.

We have diligently pursued cures for cancers since our founding 26 years ago. Today, Agenus is set up to achieve this goal with one of the most extensive pipelines of immuno-oncology agents in the industry. Our arsenal of anti-cancer agents includes antibodies, cell therapies, vaccines, and adjuvants. For cervical cancer in particular, our therapies balstilimab (anti PD-1) +/- zalifrelimab (anti CTLA-4) have shown major benefit to patients. We have seen response rates of ~22% with our combination in patients regardless of histology and biomarker status. The only immunotherapy currently approved have shown a response rate of ~14%.

In today’s newsletter, you will hear from Agenus and a team of the top experts in the field. They express the challenges faced by cervical cancer patients, today’s treatment landscape, and the potential of immune based transformative treatment options. Featured speakers include Dr. Leslie Randall (Gynecologic Oncologist, Virginia Commonwealth University), Dr. Bradley Monk (Professor of the Division of Gynecologic Oncology at University of Arizona College of Medicine, Medical Director US Oncology Research Network, Co-Director of GOG Partners) and Dr. David O’Malley (Professor of Obstetrics and Gynecology at the Ohio State University College of Medicine and the Director of Gynecologic Oncology at the James Cancer Center of Ohio State University).

In 2018, ~570,000 women were diagnosed with cervical cancer worldwide despite preventative measures including HPV vaccination and pap smears. Without early detection, patients often develop advanced cervical cancer, which is difficult to treat as the cancer has spread to other areas of the body. Dr. Randall discusses the difficulty of treating this disease. Dr. Monk notes that when a patient develops metastatic or recurrent cervical cancer, they have a low chance of survival. The crucial hope for these women is immunotherapy.

Today, multiple approved immunotherapies have changed the way physicians treat most major tumor types. Agenus’ immunotherapy trials evaluating balstilimab +/- zalifrelimab are the largest clinical studies in I-O with available data in second-line cervical cancer. Dr. O’Malley, the principal investigator on these clinical trials, discusses how patients treated with our therapies have responded well to date. He also describes how immunotherapy has changed the landscape of cervical cancer treatment.

Given these encouraging outcomes, Agenus is dedicated to ensuring all cervical cancer patients who need our therapies have access to them. We anticipate the completion of our BLA filing for balstilimab monotherapy in second line cervical cancer later this year. We will strive to deliver affordable access to our treatments to women in need. Further, eligible patients can already access these therapies through our RaPiDS trial, which is actively enrolling at sites across the United States. In this trial, patients are randomized to receive balstilimab alone or in combination with zalifrelimab. We continue our commitment to advance our quest for cures with our next-generation CTLA-4 antibody (AGEN1181), which is currently advancing in the clinic in combination with balstilimab. Our deep portfolio also includes our conditional CD137 agonist (AGEN2373), which is proceeding towards the clinic for combination studies with balstilimab. Our TIGIT bispecific (AGEN1777) and iNKT cell therapy program (AgenT-797) have generated some of our most exciting data and are progressing into the clinic this year. We look forward to sharing additional updates from these programs in the future. 

Forward-Looking Statements: This Agenus Newsletter includes forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Agenus’ planned BLA filing and commercial launch of balstilimab, the potential for balstilimab to change the landscape of cervical cancer treatment, Agenus’ goal of delivering affordable access to treatments for women in need, and clinical development plans and timelines for additional candidates. These statements are subject to risks and uncertainties, including those described in our SEC filings.