Contact Us
HavaH Therapeutics, Pty Ltd
- Nyroca House
- 10-20 New Street
- North Adelaide, South Australia 5006 Australia
- +61 8 7200 5606
- hi@havahtx.com
ANDROGEN THERAPY IN BREAST DISEASE- 30 YEARS OF BENCH TO CLINICAL DEVELOPMENT
Who We Are
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
Background Science
ANDROGENS ARE AN ESSENTIAL HORMONE IN BOTH MEN AND WOMEN-THE BALANCE BETWEEN ESTROGENS AND ANDROGENS IS CRITICAL IN THE MAINTENANCE OF HORMONAL HOMEOSTASIS, CONTROL OF PROLIFERATION/DIFFERENTIATION AND THE INTERFACE BETWEEN HORMONAL FUNCTION AND THE IMMUNE SYSTEM.
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
The Basis of the HavaH Therapy
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.
HavaH T+Ai™ Therapy
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+AiT™ 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.
Why subcutaneous T+Ai™
T+Ai was developed with the aim to provide a long term safe and well tolerated therapy to prevent breast cancer. Due to its unique properties in hormonal modulation – potential applications include use In ductal carcinoma In situ (DCIS) to prevent progression to Invasive breast cancer, and early treatment of ER+ cancers to prevent development of hormonal resistant disease.
Rare breast disease where autoimmunity is the underlying mechanism of the pathogenesis and are suitable for T+Ai™ include granulomatous and peri-ductal mastitis
Key Properties:
- Precise delivery of testosterone designed for women
- Unique PK profile and extended release delivery
- Utilization of specific intramammary enzymatic concentrations in the breast
- Close to 100% compliance
- Suitable for mono- or combination therapies
The Founders Perspective
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+AiTM 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.
Stephen N Birrell
MD PhD
Founder and Chairman
Executive Team
Stephen N Birrell, Founder and Chairman
Founder and inventor, 30-year breast cancer specialist/surgeon and renowned medical innovator, clinical oncologist, widely published molecular oncologist in leading journals incl. Nature, founder/ pioneer of three leading (Australian) multi-disciplinary breast centres in both the public and private sectors. Dr Birrell, with his scientific research partner, Prof Wayne Tilley, are internationally recognized for pioneering the use of androgens in breast disease.
MD PhD FRACS
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.
MSc, FIPTA, GAICD
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.
Tim Luscombe, CFO and Company Secretary
Tim is a Director of Bio101 who provide outsourced CFO, company secretarial and corporate advisory services to the healthcare sector. A Qualified Chartered Accountant, Tim has extensive experience in providing financial advice, company secretarial and CFO services to Healthcare businesses ranging from ASX listed entities to Not-for-Profit organisations. Tim is CFO and Company Secretary for a number of ASX listed, public unlisted and private companies in the medical technologies, medical devices, biotechnologies and pharmaceuticals sectors. Tim holds a Bachelor of Commerce from the University of Melbourne and a Certificate in Governance Practice from the Governance Institute of Australia.
Joe Schacter, Business Development
Previous experience with Business Development and Operations at two technology startups. Prior to that, Joe was an Analyst on the licensing team at Torreya Partners, a boutique advisory firm in New York. He helped Torreya source Iota Biosciences, which Torreya founded and then was acquired by Astellas
Presentations
Dr Stephen Birrell talk about testosterone in gynaecology at a National Meeting June 4th 2022
Advisory Network
- Prof. Jack Cuzick, CBE FRS
- John Snow Professor of Epidemiology Queen Mary University UK
- Prof Charles Loprinzi
- Susan Komen Regis Professor of Oncology Mayo Clinic MN USA
- Prof Laura Esserman
- Prof Surgery and Radiology UCSF USA
- Prof Neal Rosen
- Director of Cancer Research MSKCC USA
- Prof Ed Gelmann
- Director Prostate Cancer Research University of Arizona
- Prof Jason Carroll
- Director Breast Cancer Research, Cambridge Institute Cambridge Uni UK
- Prof Wayne Tilley
- Dame Roma Mitchell Chair of Cancer Biology University of Adelaide Australia
- Mr John Ramsey
- ex-Director Global Drug Development AstraZenca UK