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Arvinas Receives Fast Track Designation for its Targeted Protein Degrader ARV-110 as a Treatment for Men with Metastatic Castration-Resistant Prostate Cancer
“While great strides have been made in the treatment of men with metastatic castration-resistant prostate cancer, current AR-targeted standard of care treatments are less effective in patients whose disease includes increased levels of androgen production or mutations in the androgen receptor,” said
About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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. Between 15-25% of patients do not respond to second-generation hormone therapies like abiraterone and enzalutamide, and the majority of responsive patients will ultimately become resistant, resulting in poor prognoses for men diagnosed with this devastating condition.
About PROTAC® Protein Degraders
Arvinas’ PROTAC® protein degraders harness the body’s own natural protein disposal system to degrade disease-causing proteins. PROTAC® protein degraders recruit an E3 ligase to tag the target protein with ubiquitin, which directs its degradation through the proteasome, a large protein complex that breaks down the ubiquitinated target protein into small peptides and amino acids. As the target protein is degraded, the PROTAC® protein degrader is released and acts iteratively to destroy additional target protein.
PROTAC® protein degraders offer numerous potential therapeutic advantages, including broad tissue distribution, routes of administration that include oral delivery, and simpler manufacturing than other new modalities, such as cell-based therapies.
ARV-110 is an orally bioavailable PROTAC® protein degrader designed to selectively target and degrade androgen receptor (AR) protein. ARV-110 is being developed as a potential treatment for men with mCRPC. ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.
The Phase 1 clinical trial of ARV-110, for men with mCRPC whose disease has progressed after treatment with standard of care therapies, began in 1Q2019. Preliminary clinical data for the trial will be shared in 2H2019, including safety, tolerability, and PK data. Full disclosure of trial information is expected in 1H2020, including prostate-specific antigen (
Arvinas is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies to degrade disease-causing proteins. Arvinas uses its proprietary technology platform to engineer 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. For more information, see 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, including the timing of preliminary and full data from our clinical trial for ARV-110 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 a Phase 1 clinical trial for ARV-110, 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
Source: Arvinas Inc.