EpiThany Announces Clinical Collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer to Evaluate Combination of Avelumab and EP-101 STEMVAC in Breast Cancer

SEATTLE, May 10, 2017 /PRNewswire/ -- EpiThany today announced that they have entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono, and Pfizer to evaluate avelumab*, a human anti-PD-L1 antibody, and EP-101 STEMVAC, a multi-antigen, polyepitope vaccine, in a Phase 2 trial in women with breast cancer. Avelumab is currently under clinical evaluation across a broad range of tumor types by the global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer. This is an exclusive agreement between EpiThany and the alliance to evaluate the combination of these investigational agents in breast cancer. Under the terms of the agreement, EpiThany will be responsible for conducting the Phase 2 clinical trial in 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," said Bill Watt, Ph.D., Founder, President and Chief Executive Officer of EpiThany. "We look forward to completing our Phase 1 trial, with the goal of advancing this Phase 2 program with Merck KGaA, Darmstadt, Germany, and Pfizer."

The randomized, double-blind, placebo-controlled Phase 2 trial will evaluate the immunological efficacy, clinical activity and safety of EP-101 administered in combination with standard-of-care therapeutics and avelumab as neoadjuvant therapy in women with breast cancer. Patients will be randomized to receive EP-101 or placebo in combination with the other two agents. Approximately 84 patients will be enrolled in the trial, which is targeted to begin during the first quarter of 2018.

"Despite advances in treatment for these patients over recent years, response rates remain low and chance of recurrence is high," said Alise Reicin, M.D., Head of Global Clinical Development in the biopharma business of Merck KGaA, Darmstadt, Germany. "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."

"A key focus of our clinical development program for avelumab is to evaluate the role and potential of combination therapy in immuno-oncology," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-oncology, Early Development and Translational Oncology, Pfizer Global Product Development. "Through this collaboration with EpiThany, we look forward to assessing and understanding the benefits that the combination of avelumab and EP-101 may offer as a treatment option for patients with breast cancer."

*Avelumab is under clinical investigation for treatment of breast cancer and has not been demonstrated to be safe and effective for this indication. There is no guarantee that avelumab will be approved for breast cancer by any health authority worldwide.

About Breast Cancer

The breast cancer patients in this study represent the majority of newly diagnosed cases, and receive neoadjuvant aromatase inhibitor therapy as the current standard of care prior to surgical resection. Despite such treatment, surgical pathological complete response (pCR) rates are low (5–12%),^1-7 and patients remain at high risk of recurrence. Successful immunotherapy for these patients may require tumor-antigen-specific generation of T-helper Type 1 (Th1) tumor infiltrating lymphocytes (TIL) that can be amplified by co-administered anti-PD-1/PD-L1 antibodies.

About Avelumab

Avelumab is a human antibody specific for a protein called PD-L1, or programmed death ligand-1. Avelumab is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T-cells, exposing them to anti-tumor responses. Avelumab has been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. Common adverse reactions in patients treated with avelumab include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite, and rash. Immune-mediated adverse reactions have also been reported and can include pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

The US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) metastatic Merkel cell carcinoma (mMCC) in adults and pediatric patients 12 years and older and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab is not approved for any indication in any market outside the US.

About EP-101 STEMVAC

EP-101 STEMVAC is a T-helper Type 1 (Th1)-selective, multi-antigen DNA vaccine designed to induce a robust and targeted anti-tumor immune response. Preclinical results have demonstrated the ability of EP-101 to induce a cytotoxic immune response to vaccine antigens and have demonstrated efficacy and stem cell targeting in breast cancer models. EP-101 STEMVAC is currently being evaluated in a Phase 1 dose-ranging study in HER2- advanced stage breast cancer patients, and has the potential to treat other tumors of epithelial origin by virtue of its proprietary complement of vaccine antigens.

Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US

Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US, enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer's PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.

About EpiThany

EpiThany, Inc. is dedicated to the advancement of innovative therapies to improve the lives of cancer patients. EpiThany's groundbreaking technologies enable the targeting of a multitude of tumor antigens across a spectrum of cancers, driving Th1-selective (tumor-eradicating) immune responses. EpiThany was launched in 2014 capitalizing on the R&D platform developed at the Tumor Vaccine Group at the University of Washington by pioneering cancer vaccine researcher Nora Disis, scientific co-founder of the company. In addition to EpiThany's EP-101 STEMVAC product candidate and its EP-201 single antigen product candidate for ovarian cancer, which will be entering Phase 2 clinical testing in 2017, the company leverages its proprietary platform technology and veteran clinical team to drive its clinical-stage pipeline of multiple antigen, Th1-selective vaccines through development for treatment of breast, ovarian, and colorectal tumors, with early vaccine candidates in other solid tumor indications. For more information, visit www.epithany.com.

References

1—7 Available upon request

EpiThany Media Contact:
Julie Rathbun
Rathbun Communications
206-769-9219
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