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Rain Therapeutics, Tempus Partner to Identify Patients with MDM2-Amplified Tumors for Basket Trial

NEW YORK – Rain Therapeutics said on Thursday it has inked an agreement with Tempus, under which the Chicago-based firm will provide testing and patient matching services for Rain's Phase II tumor-agnostic basket trial for its investigational drug RAIN-32.

Tempus will provide centralized tumor testing and patient matching services through its Connect & TIME Trial Network platform. Specifically, it will evaluate patients with solid tumors for pre-specified MDM2 amplification levels and normal p53 status using its DNA- and RNA-based tumor sequencing tests, Tempus xT and Tempus xE, as well as conduct comprehensive tumor profiling to determine if they are eligible to receive Rain's MDM2 inhibitor RAIN-32 within the Phase II basket trial.

Earlier this week, Rain announced a similar partnership with Caris Life Sciences for this same study. Caris is providing whole-exome and -transcriptome sequencing services to help Rain identify patients eligible for the trial slated to begin in the second half of 2021.

The Newark, California-based company licensed RAIN-32, previously called milademetan, from Daiichi Sankyo in September. The firm is also planning two other trials of the drug, a Phase III study in MDM2-amplified liposarcoma and a Phase II trial in intimal sarcoma.

RAIN-32 showed activity in both MDM2-amplified liposarcoma and solid tumors in a Phase I trial presented last year. In patients with liposarcoma the disease control rate was 58.5 percent, and among patients with non-liposarcoma solid tumors the disease control rate was 32.4 percent.