Clinical trial for MDM2 amplified cancers expected to commence in second half of 2021
NEWARK, Calif., June 03, 2021 (GLOBE NEWSWIRE) — Rain Therapeutics Inc., a clinical-stage company developing precision oncology therapeutics, today announced a master program and a genomic analysis platform agreement for comprehensive genomic profiling tests utilizing artificial intelligence and precision medicine company Tempus’ genomic analysis platform. Under the terms of the agreement, Tempus will provide both centralized tumor testing and patient matching services using their Connect & TIME Trial® Network for the planned Phase 2 MDM2-amplified tumor-agnostic basket trial for RAIN-32, an oral MDM2 inhibitor in patients with certain solid tumors with pre-specified MDM2 amplification levels and wild type p53. The study is expected to commence in the second half of 2021.
“We are excited to enhance our tumor agnostic, MDM2-amplified basket trial strategy through this collaboration with Tempus, a company that shares our patient-centric mission,” said Robert Doebele, M.D., Ph.D., cofounder and chief scientific officer at Rain Therapeutics. “Tempus’ suite of DNA- and RNA-based tumor sequencing capabilities, including Tempus|xT and Tempus|xE, and comprehensive tumor profiling tests for solid tumors, will be invaluable as we seek to genetically identify and enroll patients with MDM2-dependent tumors in our novel Phase 2 basket trial evaluating RAIN-32.”
“Roughly two-thirds of the U.S. population is located within 100 miles of an active TIME Trial site, giving patients access to genomically matched clinical trials with cutting-edge investigative therapies closer to home,” said Dr. Kimberly Blackwell, Chief Medical Officer at Tempus. “We look forward to collaborating with Rain Therapeutics on their exciting Phase 2 asset, RAIN-32, and making this trial option available to patients facing MDM2-amplified cancer.”
RAIN-32 (milademetan, formerly known as DS-3032), is a small molecule, oral inhibitor of mouse double minute 2 (MDM2), which is oncogenic in numerous cancers. Rain in-licensed RAIN-32 in September 2020 based on the results of a Phase 1 clinical trial, which demonstrated meaningful antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors. This trial also validated a rationally-designed dosing schedule that has been shown to mitigate safety concerns and widen the therapeutic window of MDM2 inhibition, unlocking the potential for RAIN-32 in a broad range of MDM2-dependent cancers. Based on these data, we anticipate commencing a pivotal Phase 3 trial in LPS in the second half of 2021, a Phase 2 tumor-agnostic basket trial in certain solid tumors in the second half of 2021 and a Phase 2 trial in intimal sarcoma by early 2022. RAIN-32 has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for patients with liposarcoma.
About Rain Therapeutics Inc.
Rain Therapeutics Inc. is a clinical-stage precision oncology company developing therapies that target oncogenic drivers for which it is able to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors’ underlying genetics rather than histology. Rain’s lead product candidate, RAIN-32 (milademetan, formerly known as DS-3032), is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. In addition to RAIN-32, Rain is also developing a preclinical program that is focused on inducing synthetic lethality in cancer cells by inhibiting RAD52.For more information, visit www.rainthera.com.
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