TD2 Supports the Successful IND Filing for Genzada Pharmaceuticals
First-in-Human Trial Launched for Super-Enhancer Inhibitor GZ17-6.02
Genzada Pharmaceuticals Announces FDA Clearance of IND Application and Launch of Phase I Human Clinical Trial for Middle Eastern-Derived Advanced Cancer Drug
Sterling, Kan. (November 16, 2018) 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.
About Genzada Pharmaceuticals USA Inc.
Genzada is a drug discovery and development company focused on generating clinically useful molecules for today’s most challenging diseases, with an initial focus on pancreatic adenocarcinoma, head and neck squamous cell carcinoma, and glioblastoma multiforme. Genzada also has a robust pipeline of compounds in various stages of development which have shown promise in a host of unmet areas of cancer research. As newcomers in the field of pharmaceutical research, we are eager to demonstrate our capabilities on behalf of the physicians and patients we aim to serve. For more information, visit www.genzada.com.
About Translational Drug Development (TD2)
TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.
About HonorHealth Research Institute
HonorHealth Research Institute in Scottsdale, Ariz., offers comprehensive cancer care and research through clinical trials, diagnosis, treatment, prevention and support services in collaboration with leading scientific researchers and community oncologists. HonorHealth is a nonprofit health system serving an area of 1.6 million people in the greater Phoenix area. The network encompasses five acute care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation and community services with approximately 11,500 employees, 3,700 affiliated physicians and 3,100 volunteers. HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network. HonorHealth's mission is to improve the health and well-being of those we serve. Learn more at www.HonorHealth.com.
Genzada Pharmaceuticals USA Inc. HonorHealth Media Relations
Jason West, 620-204-7150 Marketing Department
Translational Drug Development (TD2)
Amanda Rider, 972-770-5083