On May 23, 2024 EpicentRx, a clinical-stage biopharmaceutical company, reported that The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 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 (Press release, EpicentRx, MAY 23, 2024, View Source [SID1234643591]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 (Free ASCO Whitepaper), 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 (Free ASCO Whitepaper).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.