EpiThany established a collaboration agreement with Merck KGaA and Pfizer, through which the tumor vaccines firm will carry out a Phase II study evaluating its multiantigen polyepitope vaccine EP-101 STEMVAC in combination with Merck KGaA and Pfizer’s anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) Bavencio® (avelumab) in women with breast cancer.

EP-101 STEMVAC is a T-helper type 1 (Th1)-selective, multiantigen DNA vaccine designed to trigger a targeted antitumor immune response. The vaccine is currently being evaluated in a Phase I dose-ranging study in HER2 advanced-stage breast cancer patients. EpiThany claims the candidate could have applications in the treatment of other tumors of epithelial origin.

The Phase II study combining EP-101 with avelumab is projected to start during Q1 2018 and will enroll approximately 84 breast cancer patients, randomized to receive EP-101 combined with standard-of-care and avelumab as neoadjuvant therapy. Financial details of the agreement were not disclosed.

“The evaluation of our lead product candidate EP-101 in combination with avelumab in this randomized Phase II 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,” said Bill Watt, Ph.D., EpiThany founder, president, and CEO. “We look forward to completing our Phase I trial, with the goal of advancing this Phase II program with Merck KGaA, Darmstadt, Germany, and Pfizer.”

“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,” added Alise Reicin, M.D., head of global clinical development for biopharma at Merck KGaA.

The agreement among the three firms follows FDA’s accelerated approval yesterday of Merck KGaA and Pfizer’s Bavencio for treating locally advanced or metastatic urothelial carcinoma.

Founded in 2014 by researchers at the University of Washington's Tumor Vaccine Group, EpiThany is developing a pipeline of multiantigen, Th1-selective vaccines for the potential treatment of a range of solid tumors. The company’s pipeline is headed by EP-101 STEMVAC, and EP-201, a single-antigen candidate for ovarian cancer, which is expected to start in Phase II trials during 2017.

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