Ascendis Pharma presents dose-escalation data from transcendIT-101

Ascendis Pharma disclosed new data from the dose-escalation portion of transcendIT-101, the company’s Phase 1/2 open-label, multi-center trial of TransCon TLR7/8 Agonist in patients with advanced solid tumors. TransCon TLR7/8 Agonist is an investigational long-acting prodrug designed to provide sustained, localized release over weeks of resiquimod with low systemic exposure. The dose escalation data from transcendIT-101, presented by Diwakar Davar, M.D. of the University of Pittsburgh Medical Center during the annual meeting of the Society for Immunotherapy of Cancer, suggests that intratumoral TransCon TLR7/8 Agonist was safe and well-tolerated alone or in combination with pembrolizumab; that it demonstrated target immune system engagement in injected and non-injected tumors along with a systemic immune response; and that it showed early signs of clinical activity alone or in combination with pembrolizumab. All 23 of the patients enrolled in the dose escalation portion of the trial had advanced or metastatic solid tumors that had progressed on prior treatments, 9 in the monotherapy cohort and 14 in the combination therapy cohort. Two dose levels were evaluated: 0.3 mg/lesion and 0.5 mg/lesion. The recommended Phase 2 dose was declared at 0.5 mg/lesion for up to two lesions. The Phase 1/2 transcendIT-101 trial is continuing to enroll patients, with dose expansion focused on investigating TransCon TLR7/8 Agonist in combination with pembrolizumab in 4 cancer types where increased Toll-like receptor activity has potential to improve adaptive immune activation and host defense against cancers: head and neck squamous cell carcinomas; other HPV-associated cancers; melanoma; and cutaneous squamous cell carcinomas.