Sutro doses first patient in Phase I trial of STRO-002

18th March 2019 (Last Updated March 18th, 2019 00:00)

Sutro Biopharma has dosed the first patient in a Phase I clinical trial of anti-folate receptor alpha (FoIRα) antibody-drug conjugate (ADC) STRO-002 to treat patients with ovarian and endometrial cancers.

Sutro Biopharma has dosed the first patient in a Phase I clinical trial of anti-folate receptor alpha (FoIRα) antibody-drug conjugate (ADC) STRO-002 to treat patients with ovarian and endometrial cancers.

This is the second product candidate to be evaluated resulting from Sutro’s XpressCF+ technology platform, which initially led to the discovery of STRO-001.

In April last year, Sutro started dosing patients in a Phase I clinical trial of STRO-001 to treat lymphoma and multiple myeloma.

The multi-centre, open-label, dose-escalation with dose expansion Phase I trial will evaluate the safety, tolerability and preliminary anti-tumour activity of STRO-002.

"Our goal is to ultimately help fill the unmet need for more targeted therapies for patients with ovarian and endometrial cancer."

As part of the study, up to 160 women with advanced relapsed and / or progressive ovarian, fallopian, primary peritoneal or endometrial cancer will be enrolled.

Sutro Biopharma CEO Bill Newell said: “Moving our second product candidate into human clinical trials is another momentous milestone in Sutro’s evolution from a technology platform company to a clinical stage company.

“Our goal is to ultimately help fill the unmet need for more targeted therapies for patients with ovarian and endometrial cancer and advancing STRO-002 into the clinic brings us one step closer to achieving this.”

In preclinical studies, STRO-002 demonstrated potent in vitro cytotoxicity in ovarian cancer cell lines and inhibited tumour growth in multiple ovarian cancer xenograft models.

Safety studies conducted in non-human primates showed that STRO-002 was well tolerated at clinically relevant doses.

The Phase I study will comprise dose-escalation followed by dose-expansion, as part of which STRO-002 will be dosed as an intravenous infusion on day one of 21-day cycles.

Sutro developed STRO-002 using proprietary cell-free protein synthesis and site-specific conjugation platforms.