Contact Us
HavaH Therapeutics, INC
- Matt Brewer
- 2112 Andrew Alden St, Longmont, CO 80504
- +1 303 717-9446
- mb@havahtx.com
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.
Treatment of early-stage hormone receptor positive breast cancer, clinically referred to as Ductal Carcinoma In-Situ (DCIS), is met with few options beyond drugs developed in the 1960s to disrupt estrogen’s promotion of cancerous breast tumors or through more invasive surgical routes, including lumpectomy, bi-lateral mastectomies and radiation therapy. Of the 300,000 women in the United States diagnosed every year with breast cancer, up to 25% are diagnosed with DCIS; globally >250,000 patients are diagnosed with DCIS. 2+ million women live with this condition. This represents an enormous opportunity to bring forward a new treatment option that reduces long term risk for disease progression and eliminates unnecessary surgeries that expose women to infections, prolonged physical pain and emotional pain due to feelings of reduced femininity and sexuality after surgery.
Havah boasts an advanced clinical stage product with >3,500 woman-years of clinical exposure. The company’s work has recently been published in Nature Medicine (Hickey et al 2021) and has garnered significant global attention.
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.
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
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.
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.
The T+Ai™ pellet is a 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.
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
Executive Management
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 four years.
John Adair, CFo
John has over 25 years of financial and operational experience in the pharmaceutical and medical device arenas. Prior to joining Havah Therapeutics, John was CFO of Bolder Surgical and led the M&A team during the successful sale of Bolder Surgical to Hologic, Inc. in December 2021. John also co-founded Micro-Imaging Solutions whereby he led the finance and business development efforts for over 15 years. Prior to that role, John spent most of his career as a finance executive with large, multi-national corporations including Akzo-Nobel NV, Amgen and Thermo Fisher Scientific. John is a graduate of both Colorado State University where he earned a BS in Accounting and the University of Colorado-Denver where he earned an MS in Finance. John is also a CPA.
Founder and Advisor
Stephen N Birrell, Founder and ADVISOR
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.
Scientific Advisory Board
Shelley Hwang, MD, MPH
Shelley is the Mary and Deryl Hart Distinguished Professor of Surgical Oncology and Radiology, Vice Chair of Research and Disease Group Leader for the Breast Cancer Program at Duke University Comprehensive Cancer Center. Her research focus includes breast cancer prevention, identifying less invasive treatments for early-stage breast cancers including DCIS and addressing and mitigating health care disparities in breast cancer.
Seema A. Khan, MD
Seema is Professor of Surgery in the Feinberg School of Medicine at Northwestern University, and the Bluhm Family Professor of Cancer Research. She is the Co-Leader of the Cancer Prevention Research Program at the Robert H. Lurie Comprehensive Cancer Center. Her research focuses on applying biomarker knowledge to improve breast cancer risk stratification and develop preventive interventions for high-risk women. Her research is funded by the National Institutes of Health, The Breast Cancer Research Foundation, the Avon Foundation, and the Susan G. Komen Foundation.
Professor Wayne Tilley, PhD
Professer Wayne Tilley is the Inaugural Director of the Dame Roma Mitchell Cancer Research Laboratories, University of Adelaide. He completed a Fellowship at UT Southwestern in Dallas Texas in the late 1980s where he was one of the first to clone the human androgen receptor (AR) with Professor Jean Wilson, MD. A current major research focus of Professor Tilley’s lab is the development of new treatments for breast cancer that stimulate the tumor suppressive activity of the AR in the breast (Nature Medicine 2021; Lancet Oncology 2024) to counter the proliferative effects of estrogen.
Stephen N Birrell, Founder and ADVISOR
Stephen is the 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.
Board Members
Ron Martell, Director
Ron is currently CEO of Jasper Therapeutics (Nasdaq: JSPR) with 35 years’ experience building companies from clinical stage through commercial launch.
Prior to joining Jasper, Ron served as the President and CEO of MorphImmune, Inc., a private platform company advancing a highly specific targeting technology that uses a ligand-linked payload to reprogram the immune system. Previously, he was President and CEO of Nuvelution Pharma. He was also Co-Founder and Executive Chairman of Indapta, Orca Bio and Co-Founder and CEO of Achieve Life Sciences, where he led the merger of the company with Oncogenex. Ron has served as the CEO of three public biopharmaceutical companies, including Sevion and NeurogesX, and has overseen billions of dollars in industry transactions.
Earlier in his career, Ron served as Senior Vice President of Commercial Operations at ImClone Systems, where he was instrumental in deals with Bristol-Myers Squibb and Merck KGaA and built ImClone Systems’ worldwide operations to market and commercialize Erbitux®. He also served in various leadership positions with Genentech where, as Group Manager, Oncology, he was responsible for building the company’s oncology franchise, including the launch of Herceptin® and Rituxan®.
Kathy Harrison, Director
With over 30 years life science experience, including 9 years in patent attorney practice, Kathy is a serial entrepreneur and leader specialising in transitioning early stage companies through Phase 2 and beyond. Kathy led the Australian founded Havah Therapeutics as CEO from 2019 until its transition to the USA in 2024, positioning the company for global growth. Other leadership roles in biotech companies have included CEO of ASX listed Dimerix Ltd and current Managing Director of Estrenue Pty Ltd. Kathy has extensive experience in commercial drug development strategy and including leveraging intellectual property strategy to acheive value growth.
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.
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
- 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