New Haven biotech Arvinas Inc. released early data on Wednesday suggesting its experimental drug ARV-110 was effective on a hard-to-treat type of prostate cancer that’s been resistant to other medicines.
Although the drug is still in the earliest stage of clinical trials and the patient sample is small, Arvinas CEO John Houston said the results are significant because they mark the first time a so-called protein degrader, an entirely new type of drug, has shown signs of working in humans.
“Seeing the first signs of efficacy at such an early stage is very exciting,” Houston told New Haven BIZ in a phone interview Wednesday. “This is not just a validation for the platform, but also potentially a breakthrough for patients that don’t have many other options.”
Arvinas, which will present the results virtually during the annual meeting of the American Society of Clinical Oncology, said two prostate cancer patients experienced 50% lower levels of prostate-specific antigen (PSA) after they were treated with ARV-110. One patient also experienced an unconfirmed tumor reduction.
Doctors use PSA tests to screen for prostate cancer and measure whether treatments are working. Elevated levels of the protein can be a warning sign of cancer.
The 15 patients studied were all diagnosed with metastatic castration-resistant prostate cancer, a stubborn form of the disease. Most had been treated unsuccessfully with two widely used anti-androgen drugs as well as chemotherapy, according to Arvinas Chief Medical Officer Ron Peck, MD.
“Our trial of ARV-110 has enrolled a particularly heavily pre-treated population of patients who have exhausted most available treatment options,” said Peck in a statement. “Despite this, ARV-110 demonstrated the first evidence of anti-tumor activity in this difficult-to-treat population.”
Arvinas said the drug continued to show an acceptable safety profile, although the study uncovered a dangerous interaction with the cholesterol-lowering drug Crestor. Use of that drug is now prohibited with ARV-110.
The patients who responded to the treatment were among eight given the highest doses in the study, 140 mgs. or more. Patients are still being enrolled to test the drug’s safety at even higher doses, Arvinas said.
Unlike other drugs that inhibit proteins that cause disease, Arvinas’ removes them by harnessing the body’s own cellular trash-disposal system. ARV-110 targets the androgen receptor, which plays a role in prostate tumors. The drug is based on PROTACs technology (short for proteolysis-targeting chimeras) developed by renowned Yale scientist Craig Crews.
Crews was a pioneer of targeted protein degradation, now a hot field in pharmaceutical research, and founded Arvinas in 2013 to commercialize his research.
Since then, the biotech startup has landed partnerships worth hundreds of millions with big pharma players like Pfizer and Bayer. It was believed to be the first to test a protein degrader in humans when it launched the prostate cancer trial last May.
Arvinas also has a second protein degrader drug in clinical trials targeting an advanced form of breast cancer. It expects to report data for that trial later this year.
Contact Natalie Missakian at news@newhavenbiz.com.
