Patent Application filed with the United States Patent and Trademark Office (USPTO)

Havah Therapeutics, a clinical stage biopharmaceutical company developing innovative therapies for prevention and treatment of breast cancers, announces the filing of a new provisional patent application directed to the use of HAV-088 for treating Ductal Carcinoma In-Situ.

Backed by human in vivo data demonstrating on-target effect, the patent application covers the potential application of HAV-088, a novel androgen receptor (AR) agonist, in treating hormone receptor positive (HR+) disease.

“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.

“Endocrine therapy has been the foundation of treatment for hormone receptor-positive cancers for over 40 years, yet few advances have focused on the androgen receptor pathway. HAV-088, through AR agonism, is designed to reduce estrogen-driven gene transcription, thereby lowering estrogen receptor expression and limiting the tumor’s ability to respond to estrogen. Over time, we believe this could offer meaningful benefits to patients whose disease is resistant to standard endocrine therapies.”

"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," said Stephen Birrell, MD, PhD, Founder and Chair of Havah’s Clinical Advisory Board.

About Havah Therapeutics

Havah Therapeutics is developing a novel therapeutic implant intended to treat hormonally sensitive cancers and other breast conditions. This groundbreaking method relies on stimulating (agonizing) the androgen receptor in breast tissue, utilizing natural hormonal mechanisms to potentially treat women safely and with greatly reduced side effects. The product candidate, HAV-088, is a combination of two registered agents (testosterone and anastrozole, a low dose aromatase inhibitor) that is designed to provide three months of continuous medication, which the Company believes may enable a superior product profile for compliance, safety and efficacy. Havah Therapeutics is currently participating in the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. For more information, visit www.havahtx.com.

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