HLB Innovation (024850) announced Wednesday that its U.S. subsidiary Verismo Therapeutics has appointed Dr. Dennis Williams as Senior Vice President of Regulatory Strategy.
Williams brings more than 25 years of experience in global oncology and cell therapy regulatory strategy. At UK-based cell therapy company Adaptimmune, he led late-stage clinical development and approval strategy for Tecelra, the world's first T-cell receptor (TCR) gene-modified cell therapy to receive FDA approval for solid tumor indications, guiding the product through commercialization.
Williams holds a Bachelor of Science in Pharmacy from Temple University and a Doctor of Pharmacy from the University of Florida. He previously served as regulatory officer at Teva and GlaxoSmithKline (GSK), where he led key product approvals and indication expansions.
With Williams' appointment, Verismo aims to strengthen its global regulatory strategy capabilities and accelerate clinical development of novel therapies based on its chimeric antigen receptor T-cell (CAR-T) platform, KIR-CAR. The company is currently conducting Phase 1 clinical trials for solid tumor CAR-T candidate SynKIR-110 and hematologic cancer CAR-T candidate SynKIR-310. Interim Phase 1 data for SynKIR-110 is expected in the first half of this year.
"Dr. Williams' experience leading the first FDA approval of a solid tumor TCR-T cell therapy will be a tremendous asset in advancing Verismo's CAR-T pipeline to the next level," said Brian Kim, CEO of Verismo. "As development of SynKIR-110 and SynKIR-310 enters full swing, we will enhance our global development strategy and maximize the probability of success from clinical development through commercialization readiness."