Rise Therapeutics, a biotechnology company specializing in oral immunotherapeutics, has announced that the FDA has cleared its Investigational New Drug (IND) application for R-5780, an orally administered immunotherapy, to proceed with a Phase 1 clinical trial in cancer patients. This marks Rise Therapeutics' fourth clinical program to enter patient testing, with other ongoing studies focusing on ulcerative colitis, rheumatoid arthritis, and type 1 diabetes.
R-5780: A Novel Approach to Cancer Immunotherapy
R-5780 is designed to enhance the effectiveness of immune checkpoint inhibitor therapy by engaging specific immune pathways regulated by the gut. This precision-directed synthetic biology medicine aims to stimulate a strong anti-tumor T cell response. The drug holds promise for patients who have become refractory to immune checkpoint inhibitors or whose tumors are initially unresponsive to these medications.
"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," said 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."
Phase 1 Trial Details
The Phase 1 clinical trial (NCT06398418) is a multi-dose study designed to evaluate the safety, drug exposure, and clinical activity of R-5780 in patients with various cancers. The trial aims to enroll up to 33 participants. Eligible patients include those with unresectable stage III or IV melanoma, basal cell carcinoma, or squamous cell carcinoma, regardless of BRAF mutation status, as well as those with other solid tumors who are refractory to anti-PD-1/L1 therapy. Refractory status is defined as disease progression after at least two complete cycles of immune checkpoint inhibitor (ICI) therapy or disease progression six months from initiation of ICI therapy while still on active therapy.
Patients must also have a life expectancy of over 3 months, an ECOG performance status of 0, 1, or 2, and disease that is evaluable by CT or MRI per RECIST 1.1 criteria or clinically apparent disease that the investigator can follow for response.
The primary endpoint of the study is to determine the incidence and severity of adverse events related to R-5780 administration from baseline through week 4. Secondary endpoints include assessing quality of life scores from baseline through the end of study day 112, as well as measuring blood and fecal evaluations of inflammation and assessment of R-5780 on fecal levels.
Rise Therapeutics' Focus
Rise Therapeutics is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. The company leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies.
