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Clinical collaboration to evaluate avelumab, EP-101 for breast cancer
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EpiThany entered into a clinical collaboration with Merck KGaA and Pfizer to conduct a trial that will evaluate avelumab in combination with EP-101 STEMVAC for the treatment of breast cancer.
The double blind, placebo-controlled, randomized phase 2 trial will assess the immunological efficacy, clinical activity and safety of EP-101 (EpiThany) — a multiantigen, polyepitope vaccine — in combination with standard-of-care therapy and avelumab (Bavencio; EMD Serono, Pfizer), a human anti–PD-L1 antibody, as neoadjuvant therapy in approximately 84 women with breast cancer.
“The evaluation of our lead product candidate, EP-101, in combination with avelumab in this randomized phase 2 trial will build upon our compelling preclinical and early clinical data highlighting the potential benefits of Th-1 selective vaccination in women with breast cancer,” Bill Watt, PhD, founder, president and CEO of EpiThany, said in a company-issued press release. “We look forward to completing our phase 1 trial, with the goal of advancing this phase 2 program with Merck KGaA ... and Pfizer.”
The trial is expected to begin next year.
“Despite advances in treatment for these patients over recent years, response rates remain low and chance of recurrence is high,” Alise Reicin, MD, head of global clinical development in the biopharma business of Merck KGaA, which operates in the United States as EMD Serono, said in the release. “This collaboration with EpiThany to evaluate a Th-1 selective vaccine in combination with avelumab allows us to explore a potential synergistic immuno-oncology treatment regimen that may provide improved outcomes for women with this common form of breast cancer.”