"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, EpiThany's founder, president and CEO, said in a press release. The vaccine is currently being evaluated in a Phase 1 trial (NCT02157051) for patients with HER2-negative advanced breast cancer. The new Phase 2 trial will assess EP-101's immunological efficacy, clinical activity and safety in combination with Bavencio and standard-of-care therapies, as a neoadjuvant therapy — meanin
EpiThany says it will test its multi-antigen vaccine EP-101 STEMVAC — in combination with the PD-L1 antibody Bavencio (avelumab) — as a neoadjuvant therapy in breast cancer patients, under a three-way agreement with Pfizer and Merck KGaA (known as EMD Serono in the U.S. and Canada). The combination therapy will be assessed in a randomized, double-blind, placebo-controlled Phase 2 trial. EP-101 contains pieces of the CD105, Yb-1, SOX2, CDH2 and MDM2 proteins, and is designed to activate robust T-cell responses against cancer cells expressing these proteins.