HUTCHINSON, Kan. – May 12, 2022 – Genzada Pharmaceuticals USA Inc. (Genzada), a subsidiary of Ionics Pharmaceuticals SA, announced today the official opening of a Phase 1B clinical trial for the oral therapeutic GZ17-6.02 (6.02) in combination with capecitabine in patients with metastatic breast cancer.
“This is a significant and exciting achievement for our company,” said Chief Operating Officer Cameron West, MD. “Our Phase 1 study demonstrated that 6.02 has a favorable safety profile and provided clinical benefit to patients. Based on this data, in addition to the robust preclinical data, we are optimistic that 6.02 in combination with capecitabine in patients with metastatic breast cancer may provide increased benefit over single-agent capecitabine.”
The first site to open is Texas Oncology in Dallas, Texas, headed by leading breast cancer expert Dr. Joyce O’Shaughnessy. “I am delighted to be participating in the trial of G217-6.02 as I’m very excited to be able to offer metastatic breast cancer patients a highly novel super-enhancer inhibitor therapy that holds great promise in the studies conducted to date,” said Dr. O’Shaughnessy.
Dr. Joe Bailes, Genzada Chief Medical Officer, is optimistic about the study. “This is an important milestone for Genzada Pharmaceuticals and we are excited to partner with Dr. O’Shaughnessy and Texas Oncology to work toward bringing about additional treatment options for patients with advanced or metastatic hormone positive breast cancer,” said Dr. Bailes.
Genzada worked closely with TD2, a contract research organization, to optimize clinical trial design, project and data management, and other operational aspects of the study.
“We are thrilled to support the Phase 1B of 6.02 and delighted by the opportunity to partner with Genzada to develop their novel medicines,” said Dr. Stephen Gately, President and CEO of TD2. “The team took a collaborative approach to designing the trial while leveraging TD2’s extensive experience in metastatic breast cancer to help guide the clinical strategy to focus on patients most likely to get clinical benefit.”
The 6.02 investigational agent is derived in part from the black calla lily (Arum palaestinum), a native plant found in several regions of the Middle East. Traditional Middle Eastern medicine has used the lily for more than 1,000 years as an herbal remedy for multiple maladies, including inflammation, viral infections and cancer.
Via a novel mechanism of action, 6.02 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 has demonstrated pre-clinical activity in multiple tumor types, including breast cancer, colorectal cancer, pancreatic cancer, and head and neck squamous cell carcinoma. Additionally, 6.02 modulates autophagy, a cellular “recycling process,” which is dysregulated in multiple malignancies.
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. Genzada also has a robust pipeline of compounds in various stages of development that have shown promise in a host of unmet areas of cancer research. Genzada is eager to develop safe and effective therapeutics serving patients with various malignancies and dermatologic conditions. 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 Texas Oncology
Texas Oncology is an independent private practice with more than 500 physicians and 210 locations across the state. Meeting the oncology needs of Texans for more than 35 years, the practice includes Texas Center for Proton Therapy, Texas Breast Specialists, Texas Oncology Surgical Specialists, Texas Urology Specialists, and Texas Center for Interventional Surgery. As a lead participant in US Oncology Research, Texas Oncology played a role in the development of more than 100 FDA-approved therapies. For more information, visit www.TexasOncology.com.
Genzada Pharmaceuticals USA Inc.
Translational Drug Development (TD2)
Amanda Rider, 972-770-5083