Genzada Pharmaceuticals announces FDA clearance of IND application and launch of phase I human clinical trial for middle eastern-derived advanced cancer drug.
First-in-Human Trial Launched for Super-Enhancer Inhibitor GZ17-6.02
Genzada Pharmaceuticals USA Inc., a subsidiary of Ionics Life Sciences Limited (Genzada), announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a Phase 1 human clinical trial of the company’s flagship molecule GZ17-6.02 (6.02) for patients with advanced solid organ tumors or lymphoma.
“We are excited to bring 6.02 to the oncology community and we look forward to demonstrating its safety and efficacy as we move through the clinical trials process,” said Cameron E. West, MD, FAAD, chief operating officer of Genzada. “Based on numerous preclinical studies, we believe this therapeutic will be very well-tolerated and will achieve meaningful outcomes for cancer patients.”
6.02 has shown preclinical success in several therapeutic contexts, notably for pancreatic cancer and head and neck squamous cell carcinoma.
“It is great news that the IND clearance has been granted for 6.02,” said Daniel D. Von Hoff, MD, chief development officer at TD2 and adviser to Genzada. TD2 supported the research sponsor with its regulatory submissions, including the completion and filing of the drug’s IND application. The clinical research organization (CRO) will continue to manage the clinical trial for 6.02. “I know how hard the team has worked to get to this milestone for this very interesting combination with a unique mechanism of action.”
Functionally, the compound acts as an inhibitor to super-enhancers, the areas of the genome bound by transcription factors that are uniquely susceptible to repair signal disruption. 6.02 can inhibit several super-enhancer targets based on the cancer of origin.
GZ17-6.02 is derived in part from Arum palaestinum(black calla lily), a native plant found in several regions of the Middle East. Similar to the vinca alkaloids and taxanes, 6.02 is now a fully synthesized therapeutic, originally derived from naturally occurring compounds.
Enrollment of the first patient for the 6.02 trial will take place through the HonorHealth Research Institute, and will be announced in the coming months as the study initiates.