Arvinas Appoints Laurie Smaldone Alsup, M.D., to Board of Directors Dr. Smaldone Alsup Brings Additional Product Commercialization and Global Regulatory Experience
NEW HAVEN, Conn., Nov. 21, 2019 (GLOBE NEWSWIRE) -- Arvinas Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, announced today that Laurie Smaldone Alsup, M.D., has joined its board of directors. Dr. Smaldone Alsup, who is currently the Chief Scientific Officer and Chief Medical Officer for NDA Group, brings experience leading commercially successful product approvals and global regulatory strategies that have advanced programs through all stages of clinical development.
“Laurie has a track record of leading the regulatory approval efforts for dozens of marketed products, increasing patient access to new medicines around the globe,“ said John Houston, Ph.D., President and CEO of Arvinas. “At Arvinas, our mission is to bring innovative new medicines to patients with limited treatment options. Laurie’s guidance will be important as we advance our lead programs through development and begin preparing for commercialization.”
Dr. Smaldone Alsup has nearly 30 years of experience in the pharmaceutical industry, helping companies develop accelerated commercialization and market access strategies in the U.S. and global markets. Her expertise is broadly focused across therapeutic areas including cancer, HIV/AIDS, infectious diseases, rare diseases, and metabolic, neurologic, and immunologic disorders. She spent over 20 years at Bristol Myers Squibb in roles of increasing responsibility in clinical development, regulatory strategy, and corporate risk management. Dr. Smaldone Alsup received her M.D. from the Yale School of Medicine and completed her residency in Internal Medicine at Yale New Haven Hospital and a fellowship in Medical Oncology at Yale. She currently serves on the boards of Blackberry Ltd. and Theravance Biopharma.
“Arvinas is advancing the first targeted protein degraders through clinical development, recently presenting their first clinical data on lead programs ARV-110 and ARV-471,” said Dr. Smaldone Alsup. “Throughout my career, I have had the great pleasure of helping companies build effective global development strategies to bring valuable new medicines to patients. I look forward to joining the Arvinas team as they prepare to advance their novel programs through the regulatory approval process.”
ARV-110 is an orally-bioavailable PROTAC® protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). Arvinas’ Phase 1 trial of ARV-110 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.
ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.
ARV-471 is a PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of women with metastatic breast cancer. Arvinas’ Phase 1 trial of ARV-471 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.
In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor.
Arvinas is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of patients with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with ER+/HER2- locally advanced or metastatic breast cancer. For more information, visit www.arvinas.com.
This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates and the potential advantages and therapeutic potential of our product candidates. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of various risks and uncertainties, including but not limited to: whether we will be able to successfully conduct Phase 1 clinical trials for ARV-110 and ARV-471, complete our other clinical trials for our product candidates, and receive results from our clinical trials on our expected timelines, or at all, whether our cash resources will be sufficient to fund our foreseeable and unforeseeable operating expenses and capital expenditure requirements, our expected timeline and other important factors discussed in the “Risk Factors” sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.
Contacts for Arvinas
Will O’Connor, Stern Investor Relations
Cory Tromblee, ScientPR