Rain Therapeutics Announces First Patient Dosed in Phase 2 Trial of Tarloxotinib for the Treatment of Non-Small-Cell Lung Cancer with EGFR Exon 20 Insertion or HER2-Activating Mutations


First patient dosing comes within ten months of the Series A financing

NEWARK, Calif., March 19, 2019 — Rain Therapeutics Inc., a privately-held, clinical stage biotechnology company focused on biomarker-driven, small molecule therapeutics for patients with cancer, today announced that it has dosed the first patient in its Phase 2 clinical trial of tarloxotinib (Tarlox).  The start of the Phase 2 trial comes within 10 months of the Company announcing its Series A financing.

The open-label RAIN-701 study will evaluate the objective response to Tarlox in lung cancer patients with EGFR Exon 20 insertion or HER2-activating mutations. Tarlox is a hypoxia-activated prodrug of a pan-HER inhibitor.

“The dosing of the first patient in our Phase 2 trial is an important milestone for Rain as we advance Tarlox through clinical development,” said Avanish Vellanki, chief executive officer of Rain Therapeutics. “We continue to be very excited about the opportunity for Tarlox in all HER-addicted tumors, especially in patients with limited treatment options.”

The RAIN-701 study is a Phase 2 open-label trial designed to evaluate the objective response rate of Tarlox administered once weekly by intravenous administration. The trial will enroll approximately 40 patients at sites across the U.S., Canada and Hong Kong who have been diagnosed with NSCLC confirmed to possess EGFR exon 20 insertion mutations or HER2-activating mutations.

“Lung cancer patients with HER-family exon 20 mutations are in great need of effective and tolerable treatment options,” said lead investigator, Stephen V. Liu, MD, associate professor of medicine at Georgetown Lombardi Comprehensive Cancer Center. “As part of our mission, we are committed to engaging in essential clinical research to develop additional therapies for these patients.”

More information can be found at www.rainthera.com/patients/ and at www.clinicaltrials.gov (NCT03805841). 

About Rain Therapeutics Inc.

Rain Therapeutics Inc. is a privately-held biotechnology company developing biomarker-driven small molecule therapeutics for patients with cancer. Rain’s lead program, tarloxotinib, is a hypoxia-activated prodrug of a potent pan-HER tyrosine kinase inhibitor in development as a treatment for non-small cell lung cancer patients. Rain Therapeutics Inc. has worldwide development and commercialization rights for tarloxotinib. For more information, visit www.rainthera.com.

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