On January 13, 2025 Rise Therapeutics, a biotechnology company engaged in developing novel oral Immunotherapeutics, reported that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a cancer Phase 1 clinical trial for its program candidate, R-5780 (Press release, Rise Therapeutics, JAN 13, 2025, View Source [SID1234649681]). This is Rise Therapeutics’ fourth clinical program to enter patient clinical testing. For separate products, other clinical studies are ongoing for the treatment of ulcerative colitis, rheumatoid arthritis, and type 1 diabetes.
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R-5780 is an orally delivered immune oncology drug candidate being developed for the treatment of cancer. R-5780 has demonstrated a pronounced ability to engage immune pathways that enhance the effectiveness immune checkpoint inhibitor therapy. This drug candidate builds upon the growing understanding of how certain gut-regulated immune pathways can help promote efficacy of immune oncology drugs. R-5780 is a precision-directed synthetic biology medicine that engages selective immune pathways that can support a robust anti-tumor T cell response. This revolutionary immune oncology drug candidate is one of the first of its kind in the context of mechanism of action and potential for success in the context of cancer treatment.
"The FDA’s clearance for R-5780 is a testament to the innovation and dedication of our team at Rise Therapeutics driving novel immunotherapies forward into human proof-of-concept" states Christian Furlan Freguia, Senior Vice President of Research at Rise Therapeutics. "R-5780 represents a pioneering approach that leverages the power of gut-regulated immune pathways to enhance the effectiveness of immune checkpoint inhibitors… We believe R-5780 has the potential to expand responses in patients that become refractory to immune checkpoint inhibitors and increase responsiveness in tumors initially unresponsive to these medications".
The Phase I clinical trial (NCT06398418) will be a multi-dose clinical trial assessing the safety, drug exposure, and clinical activity of R-5780 in patients with cancer. The study will enroll up to 33 participants.