Tempus Announces Companion Diagnostic Collaboration with Kartos Therapeutics

Tempus, a leader in artificial intelligence and precision medicine, today 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). Tempus’ CDx test, which will be developed on Tempus’ xT platform, will be used to identify patients with TP53 wild-type (TP53WT) Merkel cell carcinoma (MCC) who may be eligible for treatment with navtemadlin. Navtemadlin is a potent, selective, orally available MDM2 inhibitor that overcomes MDM2 dysregulation by restoring p53 activity and inducing apoptosis of TP53WT tumor cells.

Although rare, MCC is one of the most aggressive and lethal types of skin cancer, associated with a high risk of recurrence and metastasis, making it very difficult to treat. 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. 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 (wild-type) TP53 and who have failed or are intolerant to anti-PD-1/L-1 immunotherapy.

“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, Chief Executive Officer and Chief Medical Officer at Kartos Therapeutics. “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. “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.”