DOWNLOAD PRESS RELEASE

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+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.

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+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.

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

Matt Brewer, ceo and president

Matt has over 20 years of life science business development, operations, and finance experience. Previously, he served as Chief Business Officer of Ashvattha Therapeutics, raising over $65 million in capital to drive the company’s development efforts of novel therapeutics for intractable diseases of the brain including GBM and neurodegeneration. Matt was the Founder and CEO of BaroFold where he led the turnaround and management buyout of the predecessor company, successfully raising venture capital, closing numerous non-dilutive licensing arrangements with industry partners, and out-licensing BaroFold’s protein therapeutic clinical asset for treating multiple sclerosis. As Founder and Managing Partner of Crest Asset Management, Matt managed a private equity healthcare portfolio consistently outperforming industry benchmarks and generating a 2.5x return on paid in capital over for years.

Kathy Harrison

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, Director

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.

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

Media Articles & Presentations

Get Real With The Chairman – Episode Five: Dr. Laura Esserman And Dr. Steve Birrell

Dr. Laura Esserman and Dr. Steve Birrell are changing the breast cancer treatment paradigm through their collaboration on an I-SPY trial, which is reevaluating the treatment of DCIS.

Since 1993, Dr. Esserman has worked at UCSF as a surgeon and oncology specialist and co-lead of their Breast Oncology Program. She’s published over 400 peer-reviewed articles, including the New York Times, where she published an editorial on whether Ductal Carcinoma in SITU should still be called cancer. In 2016, she was named one of TIME magazine’s 100 Most Influential People. She was also a member of President Obama’s Council of Advisors on Science and Technology.

Dr. Steve Birrell is the Founder of HAVAH Therapeutics based in Adelaide, Australia. His three-decade career in cancer spans many roles. He’s a specialist, surgeon, medical innovator, and one of the most published molecular oncologists. Havah is developing a potentially revolutionary testosterone-based approach to the treatment of breast cancer.

DCIS Press Conf/Webinar

Not Everything We Call Cancer Should Be Called Cancer

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.

Not Everything We Call Cancer Should Be Called Cancer

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.

Dr Stephen Birrell Talk About Testosterone In Gynaecology At A National Meeting June 4Th 2022

Advisory Network

Contact Us

HavaH Therapeutics, INC