Nibrozetone

The combination AdAPT-001 + a checkpoint inhibitor achieved high durable overall response rates and an 8 month+ PFS in patients who progressed on checkpoint inhibitors and chemotherapy TORREY PINES, Calif., Oct. 28, 2024 – EpicentRx, a clinical-stage biopharmaceutical company, announced a poster presentation on the combination of AdAPT-001 plus a checkpoint inhibitor in checkpoint inhibitor-resistant tumors at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC) in Houston, Texas from November 6-10, 2024. Primary resistance to immune checkpoint blockade therapy (ICBT) is widespread, and so are cases where tumors initially respond but subsequently acquire resistance and relapse. A central mechanism of ICBT resistance is overexpression of the immunosuppressive cytokine, transforming growth factor-beta (TGFβ). AdAPT-001 expresses a TGFβ trap that selectively neutralizes TGFβ isoforms 1 and 3. “Checkpoint blockade immunotherapies are effective in a minority of patients with tumors that are infiltrated by T cells,” said EpicentRx CEO and oncologist, Dr. Tony Reid. “Results from the Phase 2 clinical trial with AdAPT-001 in multiple metastatic tumor types, including melanoma, sarcoma, triple negative breast cancer and squamous cell cancer of the head and neck strongly suggest that the TGFβ trap, which AdAPT-001 expresses, durably sensitizes previously checkpoint inhibitor-resistant tumors in many cases for six months or more to those same checkpoint inhibitors. These are potentially practice-changing results.” MD Anderson Sarcoma Specialist and Lead Investigator, Dr. Anthony Conley, concurred that, “Most of the tumors on this Phase 2 clinical trial are not only without driver mutations, but are also non-inflamed and non-immunogenic, which makes them broadly resistant to tyrosine kinase inhibitors, checkpoint inhibitors, and chemotherapy. My colleagues and I are very encouraged by the impressively durable overall response rates and long PFS with AdAPT-001 to date, which highlight its potential to redefine the standard of care for late-stage, therapy resistant patients.” Abstract Number 663: AdAPT-001, a first-in-class 2-in-1 TGF-beta inhibitor plus a checkpoint inhibitor: updated results from a Phase 2 study in solid tumors Presenter: Anthony P. Conley, MD, Lead Investigator, MD Anderson Cancer Center. Date: Friday, November 8, 2024 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 www.epicentrx.com. Business Development Contact: Scott Caroen EpicentRx scaroen@epicentrx.com Media Contact: Ashley Thomaz MCS Healthcare Public Relations ashleyt@mcspr.com

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.