Havah Therapeutics Files Patent for HAV-088 in Breast Cancer Treatment
Havah Therapeutics, a clinical-stage biopharmaceutical company focused on developing innovative therapies for the prevention and treatment of breast cancer, has announced the filing of a new provisional patent application for HAV-088. This application specifically covers the use of HAV-088 for treating Ductal Carcinoma In Situ (DCIS), a non-invasive form of breast cancer.
A Novel Approach to Treating Hormone Receptor-Positive Disease
The patent filing is backed by promising human in vivo data demonstrating HAV-088’s on-target effect. HAV-088 is a novel androgen receptor (AR) agonist designed to target hormone receptor-positive (HR+) disease by leveraging the AR pathway to counteract estrogen-driven tumor progression.
“The filing of this provisional patent application marks an important step in our broader strategy to strengthen our intellectual property portfolio with additional disease-specific claims,” said Matthew Brewer, CEO of Havah Therapeutics. “This week’s release of 20-year survival data from a Mayo Clinic trial showed that just one year of adjuvant therapy with an AR agonist in early breast cancer led to a statistically significant reduction in recurrence or death.”
For over 40 years, endocrine therapy has been the foundation of treatment for hormone receptor-positive breast cancers. However, advancements in the androgen receptor pathway have been relatively limited. HAV-088’s unique mechanism of action sets it apart from existing therapies, offering a potentially transformative treatment for patients with HR+ breast cancer, including those resistant to standard endocrine therapies.
Mechanism of Action: AR Agonism for Tumor Suppression
HAV-088 works through AR agonism to reduce estrogen-driven gene transcription, which in turn lowers estrogen receptor (ER) expression. By limiting the tumor’s ability to respond to estrogen, HAV-088 may effectively slow or halt tumor growth. Over time, this mechanism could provide substantial benefits to patients, particularly those whose disease has developed resistance to conventional endocrine treatments such as selective estrogen receptor modulators (SERMs) or aromatase inhibitors.
Dr. Stephen Birrell, MD, PhD, Founder and Chair of Havah’s Clinical Advisory Board, emphasized the importance of this research:
“The data supporting this provisional patent may represent a significant advancement in the treatment of HR-positive DCIS and builds upon the foundational research conducted by Dr. Wayne Tilley and myself. Our research suggests that targeting the androgen receptor pathway can provide a new therapeutic avenue for patients with DCIS, a disease that currently lacks optimized endocrine treatment options.”
The Need for Improved Therapies in DCIS
DCIS is a non-invasive breast cancer where abnormal cells are found in the lining of the breast duct but have not spread beyond it. While current treatment options include surgery, radiation, and hormone therapy, there remains a need for more targeted and less invasive approaches.
Many patients diagnosed with DCIS undergo aggressive treatments, including mastectomy or lumpectomy with radiation, which can have significant long-term physical and emotional consequences. A therapy like HAV-088, which aims to reduce tumor size while preserving breast tissue, has the potential to revolutionize treatment paradigms by offering an alternative to invasive procedures.
Clinical Evidence and Future Development
The recent Mayo Clinic study provided compelling evidence for AR agonists in early-stage breast cancer, demonstrating a statistically significant reduction in recurrence and mortality with just one year of adjuvant therapy. This data reinforces the potential role of androgen receptor-targeted therapies in improving patient outcomes.
Havah Therapeutics is actively planning further clinical studies to evaluate HAV-088’s efficacy in HR+ DCIS and potentially broader applications in HR+ breast cancer. The company’s goal is to establish HAV-088 as a viable alternative or adjunct to existing endocrine therapies, particularly for patients with tumors that exhibit endocrine resistance.
Strengthening Intellectual Property and Advancing Innovation
This provisional patent filing is part of Havah Therapeutics’ broader strategy to fortify its intellectual property portfolio, ensuring long-term protection for its novel therapeutic approach. The company remains committed to advancing AR-targeted treatments and addressing the unmet needs of breast cancer patients worldwide.
