EpicentRx "BETA-PRIME" Phase 1 Study Progresses After Demonstrating Good Safety and Tolerability
Phase 1 trial with cancer-targeting adenovirus enhanced with a TGFβ Trap continues to investigate safety and anti-tumor activity in patients with advanced cancer
TORREY PINES, Calif., April 21, 2022 /PRNewswire/ -- EpicentRx Inc., a leading-edge immunotherapy company using groundbreaking science to treat cancer and multiple inflammatory-driven diseases, today announced the initiation of the next stage of its Phase 1 trial, BETA-PRIME, with AdAPT-001, a TGF-beta (TGFß) trap-enhanced cancer targeting adenovirus. This milestone marks the successful completion of the first part of the Phase 1 trial where nine patients were enrolled in a 3+3 dose escalation and evaluated for safety, tolerability, and optimal dose level of AdAPT-001. Based on favorable safety observations the study will transition to the next stage, enrolling additional patients at the highest evaluated dose of AdAPT-001 with treatment given every 2 weeks. This next stage of the trial will precede the final stage of the BETA-PRIME study where a checkpoint inhibitor will be combined with AdAPT-001.
"We are very encouraged with the early safety and tolerability results seen in the first part of this Phase 1 study, and the clinical data is consistent with the favorable safety profile observed in preclinical studies," said Tony R. Reid, M.D., Ph.D., Chief Executive Officer of EpicentRx. "The patients we are enrolling in this study have resistant cancer which requires newer agents that are well-tolerated and attack the tumor in a non-traditional way. Our hope is that AdAPT-001 may prove to be that therapeutic option for these patients."
TGFß, a protein that inhibits the activity of the immune system as a safeguard against severe inflammation and autoimmunity, is hijacked by cancer cells to escape immune elimination. Therapeutically resistant cancer is an area of high unmet medical need, which this triple combination strategy involving the AdAPT-001 cancer targeting virus armed with a TGFß trap and a checkpoint inhibitor intends to address.
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SOURCE EpicentRx, Inc.