Tempus, a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare, has announced a new collaboration to develop a companion diagnostic (CDx) test with Kartos Therapeutics, a clinical-stage biopharmaceutical company, in support of its ongoing Phase II study of navtemadlin (KRT-232).

The CDx test will be developed on Tempus’s xT platform. It will be used to identify patients with TP53 wild-type (TP53WT) MCC who may be eligible for treatment with navtemadlin, a potent, selective, orally available MDM2 inhibitor that overcomes MDM2 dysregulation by restoring p53 activity and inducing apoptosis of TP53WT tumor cells.

Kartos is collaborating with Tempus to use the xT assay, a 648-gene panel, to identify patients with advanced or metastatic MCC who have retained functional TP53WT and who have failed or are intolerant to anti-PD-1/L-1 immunotherapy. While anti-PD-1/L-1 antibodies have become standard-of-care for advanced or metastatic MCC, there remains an urgent need for effective therapies for patients who fail to respond, relapse, or are intolerant to immunotherapy, the company reported.

“We are pleased to be collaborating with the Tempus team to progress our goal of developing innovative therapies that meaningfully improve the lives of patients,” said Jesse McGreivy, MD, CEO and CMO at Kartos Therapeutics, in a company statement. “This partnership will allow us to develop a test to identify cancer patients who may benefit from treatment with navtemadlin; a therapy which offers a unique mechanism to restore the function of p53, one of the most critical tumor suppressor proteins, resulting in apoptosis of malignant cells in TP53WT MCC and other tumor types.”

“Our proprietary platform provides a comprehensive suite of solutions for novel drug development programs while also giving physicians the data needed to make informed treatment decisions for their patients,” said Michael Yasiejko, Executive Vice President at Tempus, in prepared remarks. “We look forward to supporting Kartos’ diagnostic efforts in identifying cancer patients who could benefit from a more personalized approach to their treatment using a widely-available assay and clinician-friendly tools.”