EpicentRx, Inc.

The highly competitive award from the CDMRP Toxic Exposures Research Program will fund the development of EpicentRx’s small molecule, RRx-001 (nibrozetone), as a neuroprotective agent and medical countermeasure against neurotoxic chemical exposures. TORREY PINES, Calif. , Sept. 17, 2024 /PRNewswire/ -- EpicentRx and A/Prof. Richard Gordon from the Queensland University of Technology’s Translational Research Institute (QUT-TRI) have been awarded funding from the US Department of Defense Congressionally Directed Medical Research Programs (CDMRP). The Translational Research Award, funded through the CDMRP Toxic Exposures Research Program (TERP), will fund research at both EpicentRx and QUT-TRI in Brisbane, Australia to enable bench-to-bedside development of the proprietary EpicentRx small molecule radio- and chemoprotector, RRx-001 (nibrozetone), as a medical countermeasure for chemical exposures linked to neurodegeneration. Growing evidence suggests that increased exposure to chemicals from industrialization, and in occupations such as military service, firefighting and farming, could be responsible for the rising global incidence of neurological disorders such as Parkinson’s disease and Amyotrophic Lateral Sclerosis. Acute and chronic exposures to specific classes of chemicals such as pesticides, organophosphates, heavy metals and some solvents, have been shown to directly and indirectly damage the central nervous system to either trigger or worsen neurological decline. In both clinical and preclinical studies, RRx-001 has been shown to protect healthy cells from toxicity induced by radiation and chemotherapy. Based on positive results in preclinical models, as well as new insights into the drug’s mode of action, the CDMRP TERP award of $1.6 million for three years will fund further development of RRx-001 and new formulations that can effectively protect the central nervous system and gut-brain axis from damage caused by chemical exposures. “The unique pharmacological properties of RRx-001 and its broad protective activity in the central nervous system make this drug an excellent candidate for neuroprotection and deployment as a medical countermeasure for acute and chronic chemical exposures,” commented co-PI Dr. Richard Gordon , an internationally recognized neuroscientist and toxicologist. “We are honored to be selected for this award from the U.S. DoD,” said Dr. Tony Reid , Chief Executive Officer. “These non-dilutive funds will advance the clinical development of RRx-001 as a potential treatment for veterans that have suffered from the effects of neurotoxicity.” The CDMRP Translational Research Award will enable the next phase development for RRx-001 and builds on ongoing work funded by the Michael J. Fox Foundation, Shake It Up Australia Foundation and FightMND to evaluate the therapeutic efficacy of RRx-001 for neurodegenerative diseases and its protective mechanisms of action in the central nervous system. About EpicentRx: EpicentRx Incorporated is a privately held biopharmaceutical company with two innovation-driven platforms of which nibrozetone (RRx-001) and AdAPT-001 are the lead compounds, respectively. The company’s mission is disease remission, which it hopes to accomplish with novel, well-tolerated therapies that target a diverse range of unmet needs in cancer and non-cancer indications. Nibrozetone (RRx-001), a multimechanistic small molecule, is designed and currently under clinical investigation to preferentially target diseased tissues like tumors even as it shields normal cells from harm. A late-stage clinical trial named KEVLARx is currently ongoing for protection against chemoradiation-induced oral mucositis in first line head and neck cancer. Learn more at . The work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $1,599,985.00), through the Toxic Exposures Research Program under Award Nos. HT9425- 24-1-0982 and HT9425-24-1-0983. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense. Media Contact: Ashley Thomaz Email: ashleyt@mcspr.com View original content to download multimedia: SOURCE EpicentRx, Inc.

Data affirm positive immune effects of AdAPT-001 plus a checkpoint inhibitor in sarcomas and triple negative breast cancer with established checkpoint-inhibitor resistance The paucity of immune related adverse events suggests that AdAPT-001 may protect against them. TORREY PINES, Calif., May 23, 2024 /PRNewswire/ -- EpicentRx, a clinical-stage biopharmaceutical company, announced that The American Society of Clinical Oncology (ASCO) has invited Dr. Anthony P. Conley, an MD Anderson Cancer Center (MDACC) Sarcoma Specialist and Lead PI, to give an oral presentation on the unprecedented clinical activity of AdAPT-001 plus an immune checkpoint inhibitor (ICI) in the ongoing Phase 2 open-label BETA PRIME clinical trial that has so far enrolled close to 70 patients. This activity includes complete responses and several durable partial responses in established checkpoint inhibitor-resistant tumor types like sarcoma and triple negative breast cancer, with some patients on treatment for nearly two years. To date, no dose-limiting toxicities or AdAPT-001 related serious adverse events have occurred and only one immune related adverse event (irAE) has been reported. This lack of irAEs suggests that AdAPT-001 may prevent or attenuate ICI-mediated immune attack on normal tissues but not cancerous ones. Lead EpicentRx therapy, AdAPT-001, is the most clinically advanced TGF-β ligand trap that antagonizes the immunosuppressive effects of TGF-β and augments responses to ICIs, even ICIs which patients previously failed. BETA PRIME is a multicenter Phase 2a clinical trial led by Dr. Anthony P. Conley from MDACC and Dr. Lucy B. Kennedy from the Cleveland Clinic. AdAPT-001 is dosed every two weeks in combination with an ICI. "This is incredibly exciting news to have been selected for an oral presentation at ASCO, where the most important trials are presented, discussed, and reviewed," said lead PI, Dr. Anthony P. Conley. "It is a great honor and an indication of the activity, safety, and tolerability of AdAPT-001 in combination with a checkpoint inhibitor. Credit to our clinical trial patients, the EpicentRx team and everyone from MDACC associated with the management of the BETA PRIME clinical trial." The abstract is available on ASCO.org/abstracts. Presentation details: Abstract Number for Publication: 2506 Abstract Title: Phase 1/2 study of the TGF-β-trap-enhanced oncolytic adenovirus, AdAPT-001, plus an immune checkpoint inhibitor for patients with immune refractory cancers. Session Type and Title: Oral Abstract Session – Developmental Therapeutics - Immunotherapy About AdAPT-001 AdAPT-001 is an investigational immunotherapy with a TGF-β receptor-immunoglobulin Fc fusion trap, designed to neutralize isoforms 1 and 3 of the profibrotic, proangiogenic, prohypoxic, and immunosuppressive cytokine, TGF-β, and to sensitize resistant tumors to checkpoint blockade. It is the most clinically advanced TGF-β ligand trap in development. In the ongoing Phase 2 BETA PRIME trial, AdAPT-001 was administered as single-agent and in combination with checkpoint inhibitors to patients with treatment-refractory tumors. Importantly, AdAPT-001 plus checkpoint inhibitors improved toxicity and AE profile over what is typically observed with checkpoint inhibitors. No dose limiting toxicities, AdAPT-001 related serious adverse-events, or dose reductions have been observed to date. About EpicentRx EpicentRx is at the epicenter of innovative drug development with therapies like AdAPT-001 and RRx-001 that target diseases and toxicities of hugely unmet medical need. For more information about the trial and EpicentRx's pipeline, please visit . Business Development Contact: Sa'ar Yaniv EpicentRx [email protected] Media Contact: Ashley Thomaz MCS Healthcare Public Relations [email protected] SOURCE EpicentRx, Inc.

Compelling clinical data demonstrate that AdAPT-001, which delivers a TGF-β trap to tumors, reverses established resistance to checkpoint inhibitors and makes checkpoint inhibitors more active SAN DIEGO, April 2, 2024 /PRNewswire/ -- EpicentRx, Inc, a clinical-stage biotechnology drug and device company with two therapeutic platforms that address cancer and inflammatory diseases of unmet clinical need, today announced that an abstract on its lead therapy, AdAPT-001, will be presented at the American Association for Cancer Research (AACR) Annual Meeting to be held in San Diego, CA from April 5-10, 2024. AdAPT-001 constitutes a novel strategy to deliver a transforming growth factor-beta (TGF-β) trap to tumors. Importantly, data from a Phase 1/2 clinical trial demonstrate that administration of AdAPT-001 successfully converted immunologically cold tumors, such as sarcomas and triple negative breast cancer, into immunologically hot tumors. Furthermore, AdAPT-001 administration also demonstrates reversion of established resistance to checkpoint inhibitors. "We're excited to share groundbreaking clinical data with our lead therapy, AdAPT-001, against several treatment- and checkpoint inhibitor resistant solid tumors," said Tony R. Reid, MD, PhD, CEO of EpicentRx. "We're also thrilled to be working with top-notch investigators like Dr. Anthony P. Conley from the MD Anderson Cancer Center and Dr. Lucy B. Kennedy from the Cleveland Clinic." "Immune checkpoint inhibitors are largely ineffective against sarcomas. TGF-β is a soluble protein that suppresses immune responses," said treating study investigator and sarcoma oncologist, Dr. Conley from the MD Anderson Cancer Center. "Based on the several unprecedented responses that I have seen with AdAPT-001, which expresses a TGF-β trap, this TGF-β blockade from AdAPT-001 synergizes with PD-1/PD-L1 inhibition in checkpoint-resistant sarcoma." Poster Presentation: Title: Improved clinical outcomes in patients that received treatment beyond tumor progression with AdAPT-001 +/- a checkpoint inhibitor Presenters: Dr. Anthony P. Conley of MD Anderson Cancer Center and Drs Tony Reid (CEO) and Chris Larson (VP) of EpicentRx. Date and Time: Tuesday, April 9, 2024, 1:30 PM - 5:00 PM PDT Location: Poster Section 48 Poster Number: 23 About AdAPT-001 AdAPT-001 is an investigational immunotherapy with a TGF-β receptor-immunoglobulin Fc fusion trap, designed to neutralize isoforms 1 and 3 of the profibrotic, proangiogenic, prohypoxic, and immunosuppressive cytokine, TGF-β, and to sensitize resistant tumors to checkpoint blockade. In the ongoing Phase 1/2 BETA PRIME trial, AdAPT-001 was administered as single-agent and in combination with checkpoint inhibitors to patients with treatment-refractory tumors. Importantly, AdAPT-001 plus checkpoint inhibitors improved toxicity and AE profile over what is typically observed with checkpoint inhibitors. No dose limiting toxicities, AdAPT-001 related serious adverse events, or dose reductions have been observed to date. About EpicentRx To learn more, visit . Media contact: Jennifer Latchford, [email protected] SOURCE EpicentRx, Inc.