EpicentRx Initiates Dosing in Phase 3 Trial of Immunotherapy RRx-001 for Third-line Small Cell Lung Cancer

— RRx-001 is a small molecule immunotherapy targeting CD47 – SIRPα that repolarizes tumor associated macrophages —

LA JOLLA, Calif.–(BUSINESS WIRE)–EpicentRx, Inc., a clinical cancer immunotherapy company targeting both sides of the immune system to deliver cancer treatments with minimal toxicity, announced today that it has dosed the first patient in the Phase 3 REPLATINUM trial evaluating RRx-001 for the treatment of third-line and beyond small cell lung cancer (SCLC). REPLATINUM is EpicentRx’s first Phase 3 study of RRx-001, a small molecule immunotherapy targeting CD47 – SIRPα.

Lung cancer is one of the most common cancers in the world, and the most common cause of cancer-related death. SCLC accounts for about 15% of all lung cancers, with a prevalence of over 300,000 patients globally. Almost 70% of SCLC patients present with extensive-stage disease at time of diagnosis and do not respond well to first- and second-line therapies due to the development of treatment resistance.

“The need for progress in third-line or beyond SCLC is clear, as the outcomes for these patients are uniformly fatal,” said Corey A. Carter, M.D., President & CEO of EpicentRx and former head of thoracic oncology at Walter Reed Military Medical Center. “SCLC, especially SCLC in third-line or beyond, is dramatically underserved with ineffective options for patients.”

REPLATINUM, an open-label, multicenter, crossover trial designed in collaboration with FDA, will evaluate the efficacy and safety of RRx-001 plus platinum doublet chemotherapy versus platinum doublet chemotherapy alone in 126 patients. REPLATINUM’s primary endpoint is progression-free survival, with overall survival and overall response rate as secondary endpoints.

The REPLATINUM trial follows positive results from EpicentRx’s ongoing Phase 2 QUADRUPLE THREAT trial, which is testing RRx-001 plus platinum chemotherapy in multiple cancer types, including SCLC. In patients with previously treated SCLC, RRx-001 plus platinum chemotherapy dramatically increased response rates, overall survival and progression-free survival compared to historical controls while suggesting a decrease in toxicities from chemotherapy. The QUADRUPLE THREAT data were recently published in the British Journal of Cancer.

“The strength of the Phase 2 trial allows us to keep REPLATINUM at a manageable size and should reduce the time and costs associated with a Phase 3 clinical trial. We are excited to have enrolled the first patient and look forward to working closely with our excellent clinical sites,” said Dr. Carter.

RRx-001 has Orphan Drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma, and from EMA for SCLC.

About RRx-001

RRx-001 is a next generation small molecule immunotherapy being developed by EpicentRx. The therapy targets the CD47 – SIRPα axis and repolarizes tumor associated macrophages (TAMs) and other immunosuppressive cells in the tumor microenvironment to an immunostimulatory phenotype. RRx-001 stimulates the immune system and can be used as monotherapy or in combination with chemotherapy, immunotherapy, radiation and targeted agents, giving the therapy the potential to convert “treatment-resistant” tumors into “treatment-sensitive” tumors. RRx-001 is currently in the Phase 3 REPLATINUM trial for the treatment of third-line and beyond small cell lung cancer (SCLC). RRx-001 is also in the Phase 2 QUADRUPLE THREAT trial for the treatment of SCLC, non-small cell lung cancer, neuroendocrine tumors, ovarian and prostate cancer, and the Phase 2 PREVLAR trial for the prevention of oral mucositis. Clinical studies for the drug have also been conducted for the treatment of colorectal cancer, brain metastases and glioblastoma.

About EpicentRx, Inc.

EpicentRx is a patient-driven oncology company developing new mechanisms of immunotherapy that work across diverse patient populations and tumor types with minimal toxicity, enabling the best-possible quality of life during treatment. Through two distinct technology platforms, each targeting a different half of the immune system, the company is developing drug candidates designed to act alone or in combination with other medicines to outsmart cancer. EpicentRx’s lead program is among a portfolio of novel drugs derived from dinitroazetidine that downregulates CD47 – SIRPα to alter the tumor microenvironment and optimize immune response, and has been tested in several clinical trials including an ongoing Phase 3 study in small cell lung cancer. The company is also advancing multiple programs through its smart virus platform, including personalized cancer vaccines that have shown to be effective in both chemotherapy and immune resistant tumors.

Contacts

Michelle Linn, Bioscribe, Inc.

774-696-3803

[email protected]