NEW YORK – Ideaya Biosciences and Pfizer this week expanded their partnership to further evaluate Ideaya's PKC inhibitor darovasertib combined with Pfizer's Xalkori (crizotinib) in a Phase II trial of metastatic uveal melanoma patients and a Phase I trial of cMET-driven solid tumors, including hepatocellular carcinoma and non-small cell lung cancer. As of now, Ideaya is evaluating the combination in a Phase I/II trial of metastatic uveal melanoma patients and patients with GNAQ or GNA11-mutant skin melanoma. According to the firms, the uveal melanoma trial may be registrational, contingent on US Food and Drug Administration guidance this year.
Allarity Therapeutics said this week that it has requested a Type C meeting with the US Food and Drug Administration to discuss paths forward for approving its investigational tyrosine kinase inhibitor, dovitinib, for advanced kidney cancer patients. The meeting request follows a Refusal to File letter that the FDA sent Allarity last month. The Refusal to File came in response to a new drug application and accompanying premarket approval application Allarity filed for dovitinib and its companion diagnostic, DRP-dovitinib. The firm hopes to provide additional information about the regulatory future of its dovitinib program following the meeting, ideally by the end of Q3 of this year.
Qualigen Therapeutics said this week that it has extended a research agreement with the University of Louisville Research Foundation to further advance its RAS-F program in solid tumors through Q1 2023. Through the expanded partnership, Carlsbad, California-based Qualigen is hoping to identify a lead therapy and start investigational new drug-enabling studies by the end of this year. The firm's RAS-F program includes several small molecules licensed from the University of Louisville, which block a range of RAS mutations and have shown activity in preclinical tumor models. Qualigen is hoping to study these drugs in RAS-driven advanced pancreatic, colorectal, lung, and other cancers. "The expanded agreement gives our team the opportunity to generate and select additional compounds, fully explore mechanisms within the RAS pathway, and drive the program towards a lead clinical candidate," Geoffrey Clark, professor of pharmacology and toxicology at the University of Louisville, said in a statement.
Strata Oncology this week enrolled the first patient in the Strata Sentinel trial evaluating its StrataMRD circulating tumor DNA test to detect tumor recurrence and monitor treatment effectiveness. The observational study aims to enroll 100,000 patients with early-stage solid tumors who have undergone surgery or other therapy with curative intent to validate the ability of the StrataMRD test to detect cancer recurrence and monitor the clinical benefit of adjuvant or other treatments. The first patient was enrolled at Ochsner Cancer Institute in Louisiana, and Strata plans to enroll patients across 25 sites in the US.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.