Arvinas Authorized to Proceed with ARV-471

Arvinas (NASDAQ:ARVN) has announced that the US Food and Drug Administration (FDA) has authorized the company’s investigational new drug application (IND) for ARV-471 to treat locally advanced or metastatic ER positive/HER negative breast cancer.

As quoted in the press release:

Arvinas expects to initiate a Phase 1 clinical trial for ARV-471 in the third quarter of 2019.

“ARV-471 is our second program in six months to receive IND clearance, and we are pleased to be advancing it into the clinic and progressing Arvinas’ portfolio of PROTAC^® protein degraders for the treatment of patients with cancer and other life-threatening diseases,” said John Houston, Ph.D., President and CEO of Arvinas. “We hope the activity ARV-471 demonstrated preclinically will translate into a new, beneficial treatment for patients with locally advanced or metastatic ER positive/HER2 negative breast cancer.”

In the United States, breast cancer is the second most common cancer and the second leading cause of cancer death in women. The American Cancer Society estimates that in 2019, there will be approximately 268,000 women diagnosed with invasive breast cancer in the United States. Metastatic breast cancer accounts for approximately 6% of newly diagnosed cases. Approximately 80% of newly diagnosed breast cancers are ER positive, with many patients developing resistance to current treatment options over time.

Click here to read the full press release.