Havah Therapeutics, a clinical stage biopharmaceutical company based in Boulder, Colorado, has recently formed a Clinical Advisory Board to support the development of its innovative hormonal implant therapies for the prevention and treatment of breast cancers. This board is chaired by the founder of Havah Therapeutics, Stephen Birrell, MD, PhD, who is also the Chief Medical Officer of Wellend Health, an Australian clinic specializing in breast hormone-health and high-risk breast cancer clinical trials.
The Clinical Advisory Board is composed of several distinguished experts in the fields of breast cancer biology, endocrine signaling, and biomarker-driven risk reduction strategies. The expertise brought by this group will be critical as Havah Therapeutics advances its androgen-targeted therapy into late-stage clinical studies for Ductal Carcinoma In-Situ (DCIS) and into combination studies for more advanced breast cancers.
Matthew Brewer, CEO of Havah Therapeutics, emphasized the importance of the board's guidance in moving their androgen-targeted therapy forward. Shelley Hwang, MD, MPH, a prominent figure in breast cancer research and a member of the advisory board, expressed her enthusiasm for participating at this pivotal stage of the company's development. She highlighted the potential of Havah Therapeutics' androgen receptor targeting therapy to offer a viable alternative to invasive surgery and radiation for DCIS patients, based on insights from the ongoing Phase 2 RECAST DCIS study and her experience with the COMET Study.
The Clinical Advisory Board includes:
1. **Stephen Birrell, MD, PhD**: Founder of Havah Therapeutics and Chief Medical Officer of Wellend Health. He is also a Clinical Affiliate academic at the University of Adelaide Dame Roma Mitchell Cancer Research Laboratories.
2. **Shelley Hwang, MD, MPH**: Mary and Deryl Hart Distinguished Professor of Surgical Oncology and Radiology, Vice Chair of Research, and Disease Group Leader for the Breast Cancer Program at Duke University Comprehensive Cancer Center. Her research focuses on breast cancer prevention and less invasive treatments for early-stage breast cancers, including DCIS.
3. **Seema A. Khan, MD**: Professor of Surgery at the Feinberg School of Medicine at Northwestern University and Bluhm Family Professor of Cancer Research. Co-Leader of the Cancer Prevention Research Program at the Robert H. Lurie Comprehensive Cancer Center. Her research aims to improve breast cancer risk stratification and develop preventive interventions.
4. **Professor Wayne Tilley, PhD**: Inaugural Director of the Dame Roma Mitchell Cancer Research Laboratories, University of Adelaide. Known for his early work on cloning the human androgen receptor, his current research focuses on developing new treatments that stimulate the tumor suppressive activity of the androgen receptor in breast tissue.
Havah Therapeutics is actively involved in the RECAST DCIS study, a Phase 2 trial aimed at evaluating the suitability of active surveillance for DCIS. This study examines the company's proprietary combination of testosterone and anastrozole, known as HAVAH T+Ai™, which targets androgen and estrogen receptor pathways. This combination is being tested alongside two other endocrine therapy arms to prevent the progression of DCIS to invasive breast cancer.
Havah Therapeutics is dedicated to developing a novel therapeutic implant that addresses hormonally sensitive cancers and other breast conditions. This approach leverages the natural hormonal mechanisms of the body to treat patients safely and effectively, with fewer side effects. The implant, which combines testosterone and anastrozole, provides continuous medication over three months, aiming to enhance compliance, safety, and efficacy for patients.
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