HLB Innovation announced on March 4 that its U.S. subsidiary, Verismo Therapeutics, has officially appointed Dr. Denis Williams as Executive Vice President of Regulatory Strategy.
Dennis Williams, Executive Vice President of Regulatory Strategy at Verismo Therapeutics. HLB Innovation
Executive Vice President Denis Williams is an expert who has led regulatory strategies in the global oncology and cell therapy fields for over 25 years. He has overseen and established global and country-specific regulatory strategies throughout the entire drug development process, from early and late-stage clinical trials to regulatory submissions and approvals.
At Adaptimmune, a UK-based global cell therapy company, he led the late-stage clinical development and regulatory strategy for TCR-engineered cell therapy “TCR-T” (Tisera), which secured approval from the U.S. Food and Drug Administration (FDA) for solid tumor indications, and drove its commercialization process.
Tisera is recognized as the first gene-modified cell therapy for solid tumor indications to obtain FDA approval, and is evaluated as a case that demonstrated both clinical efficacy and commercial potential.
Executive Vice President Williams earned his Bachelor of Pharmacy from Temple University and a Doctorate in Pharmacy from the University of Florida. He has also served as a senior regulatory officer at Teva and GlaxoSmithKline.
Through the addition of Executive Vice President Williams, Verismo plans to strengthen its global regulatory strategy and accelerate the clinical development of its CAR-T cell therapy pipeline based on its proprietary KIR-CAR platform.
Currently, the company is developing its differentiated CAR-T platform “KIR-CAR,” with the solid tumor CAR-T candidate “SynKIR-110” and the hematologic cancer CAR-T candidate “SynKIR-310” both in Phase 1 clinical trials. Notably, the company plans to present the first interim Phase 1 data for “SynKIR-110” at a global conference in the first half of this year.
Brian Kim, CEO of Verismo, stated, “Executive Vice President Denis Williams is a proven expert with experience in both late-stage development and global regulatory strategy. His direct leadership in achieving the first FDA approval for a solid tumor TCR-T cell therapy will be a valuable asset in advancing Verismo’s CAR-T pipeline.” He added, “As development of SynKIR-110 and SynKIR-310 based on the KIR-CAR platform gains momentum, we will systematically enhance our global development strategy and maximize the probability of success from clinical development through to commercialization readiness.”
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