Investors + Media: Press Release

Arvinas Announces Updated Phase 1 Data Demonstrating Clinical Activity of PROTAC® Protein Degrader ARV-110 in Patients with Refractory Prostate Cancer

May 13, 2020 at 5:49 PM EDT

- Describes the first evidence of clinical benefit for PROTAC® protein degraders, a novel therapeutic modality -

- Data to be presented during the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting -

NEW HAVEN, Conn., May 13, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced updated safety and initial efficacy data contained in an abstract scheduled as an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 29–31, 2020. The presentation will share updated data from the dose escalation portion of Arvinas’ Phase 1/2 clinical trial of ARV-110 in men with metastatic castration-resistant prostate cancer. The abstract describes two patients with ongoing confirmed prostate-specific antigen (PSA) responses, including one with an unconfirmed partial tumor response.

“We are thrilled to present the first evidence that our PROTAC® protein degrader, ARV-110, can provide clinical efficacy,” said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. “This is a significant milestone for our technology platform and for the field of targeted protein degradation.”

“While still early, we are pleased to see a safety profile to date for ARV-110 that continues to support dose escalation,” added Ron Peck, M.D., Chief Medical Officer at Arvinas. “Our trial of ARV-110 has enrolled a particularly heavily pre-treated population of patients who have exhausted most available treatment options. Most patients received both enzalutamide and abiraterone as well as prior chemotherapy. Despite this, ARV-110 demonstrated the first evidence of antitumor activity in this difficult-to-treat patient population.”

The presentation will include data collected since the abstract submission date. Dose escalation continues, with enrollment initiated above the previously disclosed daily dose of 280 milligrams.

Abstract details are as follows:
Presentation Title: First-in-human phase I study of ARV-110, an androgen receptor PROTAC degrader in patients with metastatic castrate-resistant prostate cancer following enzalutamide and/or abiraterone
Abstract Number: 3500
Session Type: Oral Abstract Session
Session Track: Development Therapeutics – Molecularly Targeted Agents and Tumor Biology

For a copy of the abstract, please visit ASCO’s official website.

About ARV-110
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.

ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
In the United States, prostate cancer is both the second most prevalent cancer in men and the second leading cause of cancer death in men. The American Cancer Society predicts that one in nine men will be diagnosed with prostate cancer in his lifetime. Metastatic castration-resistant prostate cancer (mCRPC) is defined by disease progression despite androgen deprivation therapy and is often correlated with rising levels of prostate-specific antigen (PSA).

Current AR-targeted standard of care treatments for mCRPC are less effective in patients whose disease has increased levels of androgen production, AR gene or gene enhancer amplification, or AR point mutations. Up to 25 percent of patients do not respond to second-generation hormone therapies like abiraterone and enzalutamide, and the vast majority of responsive patients will ultimately become resistant, resulting in poor prognoses for men diagnosed with this devastating condition.

About Arvinas
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 men with metastatic castrate-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

Forward-Looking Statements
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, the conduct of and plans for our ongoing Phase 1/2 clinical trials for ARV-110 and ARV-471, the plans for presentation of data from our clinical trials for ARV-110 and ARV-471, the potential advantages and therapeutic potential of our product candidates and the sufficiency of cash resources. 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 1/2 clinical trials for ARV-110 and ARV-471, complete our 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.

Media Contacts

Investors
Will O’Connor, Stern Investor Relations
ir@arvinas.com

Media
Kirsten Owens, Arvinas Communications
kirsten.owens@arvinas.com