AIM-001

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.