LA JOLLA, Calif., June 25, 2019 — EpicentRx Inc., a clinical-stage immuno-oncology company with two platforms developed to prime and activate both innate and adaptive anticancer responses, today announced the publication of positive results from its Phase 2 clinical trial of RRx-001, a tumor associated macrophage (TAM) repolarizing agent, in small cell lung cancer (SCLC). The successful trial results, which were published today in the British Journal of Cancer (BJC), serve as the basis for a recently initiated randomized Phase 3 trial in 3rd line or beyond SCLC clinical trial called REPLATINUM (NCT03699956).
The BJC publication by Daniel Morgensztern et al. details the results of an open-label Phase 2 trial conducted in 26 previously platinum-treated 3rd line SCLC patients in which the overall survival (OS) and progression free survival (PFS) for patients treated with RRx-001 and a reintroduced platinum doublet were 8.6 months and 7.5 months, respectively. By comparison, the OS, PFS and ORR for 3rd line SCLC are reported in the literature as 4.7 months and less than two months, respectively. Similar to other trials with RRx-001, no RRx-001-related serious adverse events or laboratory abnormalities were observed. “I’m a thoracic oncologist and in my experience as well as the experience of my colleagues, SCLC is the worst cancer, right up there with GBM and pancreatic cancer. Patients progress quickly through every therapy after first line and sometimes do not even benefit in first line. The cancer spreads and proliferates at such a rapid rate that cancer treatments just can’t keep up and that includes platinum chemotherapy. Therapeutic resistance and death are inevitable. Checkpoint inhibitors may benefit some patients but overall, their impact is minimal. RRx-001 exhibits minimal toxicity and appears to resensitize tumors to first-line chemotherapy. RRx-001 has the potential to fundamentally change how we approach and treat this terrible disease. To say that I’m excited is an understatement,” said Dr. Corey A. Carter, CEO of EpicentRx and ex-Chief of Thoracic Oncology at Walter Reed National Military Medical Center.
Since the majority of patients in this Phase 2 trial were platinum resistant, which means that they never benefited from platinum therapy in the first place, the likelihood that they would have benefited in a later line from reintroduced platinum therapy was remote.
RRx-001 is an investigational small molecule and the first representative of a novel dinitroazetidine class of structurally distinct, minimally toxic immunotherapeutics. RRx-001 is currently in development for the treatment of SCLC, GBM, hepatocellular carcinoma and colorectal cancer. It has demonstrated broad spectrum anticancer activity, in vitro and in vivo, against multiple treatment-resistant tumor types. The FDA has granted Orphan Drug Designation for SCLC, neuroendocrine tumors and GBM and the EMA has granted Orphan Drug Designation for SCLC.
EpicentRx is a privately owned biotechnology company with two minimally toxic immunotherapeutic platforms, aerospace-derived small molecules, and oncolytic viruses, that are intended to improve both the quantity and quality of life for cancer patients. The EpicentRx team has extensive experience in the life sciences industry, having discovered and developed multiple innovative anticancer therapies. EpicentRx’s lead product candidates are RRx-001, a novel IV immunotherapeutic in Phase 2 and Phase 3 clinical trials for the treatment of multiple serious and life-threatening tumor types and a TGF-beta trap, an oncolytic adenovirus that expresses a protein, which binds to and neutralizes the immunosuppressive cytokine, TGF-beta. For more information, visit www.epicentrx.com.