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Tempus, Kartos Therapeutics to Develop CDx for Skin Cancer Therapy

NEW YORK – Tempus announced on Thursday that it will collaborate with Kartos Therapeutics to develop a companion diagnostic test for Kartos' drug navtemadlin for Merkel cell carcinoma. 

The test will be developed on Tempus' xT platform and will be used to identify patients with TP53 wild-type Merkel cell carcinoma (MCC) who could be eligible for treatment with navtemadlin. MCC is an aggressive skin cancer associated with high risk of recurrence and metastasis, Tempus said in a statement. 

Chicago-based Tempus' xT assay is a 648-gene panel that will be used to find 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. 

Navtemadlin is an orally available MDM2 inhibitor that overcomes MDM2 dysregulation by restoring p53 activity and inducing apoptosis of TP53 wild-type tumor cells. The therapy "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 TP53 wild-type MCC and other tumor types," Kartos CEO and Chief Medical Officer Jesse McGreivy said in a statement. 

The test will be used to support Kartos' Phase II study of the treatment, Tempus said. "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," Michael Yasiejko, executive VP at Tempus, said. 

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