Havah’s mission is to develop therapies with reduced side effects and early prevention and treatment of breast cancers including hormonal refractory ER+ breast cancer and metastatic cancer. Havah uses targeted modulation of the hormonal balance in the breast to achieve a more nuanced hormonal regulation than traditional hormonal therapies.
FOUNDER AND CSO, DR STEPHEN BIRRELL DEVELOPED THE HAVAH TECHNOLOGY WHICH HAS BEEN USED IN AN OPEN LABEL COHORT STUDY OF OVER 1,000 WOMEN DEMONSTRATING A SUPERIOR SAFETY PROFILE AND REDUCTION IN BREAST CANCER RISK
Recent literature has shown the criticality of maintaining intra mammary concentrations of dihydroxy testosterone (DHT- the active metabolite of testosterone) levels sufficiently to maintain a homodimer form of the androgen receptor to support cellular processes which are antiproliferative
Utilising careful dosing in the form of a subcutaneous extended-release therapy, the Havah T+Ai™ technology maintains breast tissue DHT levels which support prevention and reduction of tumor growth, and well as anti-inflammatory cell function.
T+Ai™ is a subcutaneous pellet combination treatment containing testosterone and anastrozole, demonstrating a unique PK profile which drives the hormonal milieu of the breast.
The open label cohort study of Havah T+Ai™ technology has demonstrated statistically significant reductions in mammographic breast density (MBD) and Background Parenchymal Enhancement (BPE), both known indicators of breast cancer risk and both of which reduce the likelihood of detection of malignant and non-malignant breast disease.
Clinical trials have demonstrated reduction in aromatase inhibitor reduced arthralgia and characterised the unique PK profile of the subcutaneous pellet.
Rare breast disease where autoimmunity is the underlying mechanism of the pathogenesis and are suitable for T+Ai™ include granulomatous and peri-ductal mastitis
OVER THE LAST 20 YEARS MANY ATTEMPTS HAVE BEEN MADE TO INTRODUCE AN ANDROGENIC PRODUCT FOR WOMEN, THERE IS STILL A LACK OF REGISTERED PRODUCTS AVAILABLE FOR CLINICIANS DESPITE OVER 4 MILLION OFF LABEL PRESCRIPTIONS PER ANNUM BEING WRITTEN FOR A TESTOSTERONE PRODUCT FOR WOMEN IN THE USA ALONE.
A recent consensus opinion from the representative clinical colleges outlined the importance of a registered product being made available for women diagnosed with hypoandrogenism. Registration of T+Ai™ would open the door for multiple other uses for androgenic products as a therapeutic intervention in conditions which are being targeted by Havah Therapeutics.
Havah Therapeutics is dedicated to developing androgenic products for women and draws on an extensive international network of experts.
After 30 years of preclinical and clinical research into androgen function in women, the evidence is increasingly supportive of agonism of the androgen receptor as a means to breast health and freedom from both malignant and non malignant breast diseases.
Kathy Harrison, CEO AND MANAGING DIRECTOR
Biotech company leader with 30 years industry experience including 9 years in patent attorney practice. Leadership roles in biotech companies have included CEO of ASX listed Dimerix Ltd and current Director of Estrenue Pty Ltd. Kathy has extensive experience in intellectual property strategy, commercial drug development strategy and achieving drug development milestones. Kathy’s qualifications in science, intellectual property law and governance provide the depth of skill to lead Havah through its next stage of growth.
Jim Weiss – Business Advisor
Over the past 22 years, Jim Weiss evolved his one-person consultancy into Real Chemistry, a global health innovation company that uses real-world data, proprietary technologies and analytical insights to solve the health care industry’s most significant challenges. He is a pioneer in the application of analytics, data and precision targeting to the biopharma and health care industry.
Jim is a board member and investor in Indapta Therapeutics, a natural killer cell company focused on cancer, and a business advisor to IMIDomics, a discovery company for immune-mediated diseases; Corvus Pharmaceuticals, a clinical-stage biotech company focused on novel medicines for autoimmune diseases and cancer; and Dstillery, a custom audience solutions company.
He is also a Board member and contributor to several nonprofits, including the Foundation for the Institutes of Health, the Cancer Research Institute, American Cancer Society’s BrightEdge, LAGRANT Foundation, and the Healthcare Businesswomen’s Association.
Matt Brewer, MBA, Business Advisor
Joe Schacter, Business Development
New Trial Aims to Change Treatment Approach for DCIS Patients
Quantum Leap Healthcare Collaborative (QLHC) has launched a groundbreaking clinical trial called Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS) that aims to revolutionize the treatment of ductal carcinoma in situ (DCIS) and reduce unnecessary surgeries. The trial will enroll over 300 patients across 40 sites in the United States and evaluate three investigational endocrine therapy arms.
By Laura Esserman and Scott Eggener
Dr. Esserman is a surgeon and breast cancer oncologist at the University of California, San Francisco. Dr. Eggener is a surgeon and urologic oncologist at the University of Chicago.