Rise Therapeutics Completes Dose Escalation in R-5780 Phase 1 Cancer Trial, Advances to Dose Expansion

ROCKVILLE, Md., Sept. 22, 2026 /PRNewswire/ -- Rise Therapeutics, a clinical-stage biotechnology company developing novel oral immunotherapeutic medicines, today announced that it has completed the dose escalation portion of its ongoing Phase 1 clinical trial evaluating R-5780, the Company's lead immuno-oncology candidate. Having established a recommended dose, the study will now move into its planned dose expansion stage to enroll additional cancer patients at the highest fixed dose.

"Completing dose escalation for R-5780 is a meaningful step in translating our novel immunotherapy approach into a potential option for people fighting cancer," stated Gary Fanger, President and CEO of Rise Therapeutics. "Following its review of the available safety data, the independent Data Monitoring Committee supported advancing the study into dose expansion, where we will further evaluate R-5780's safety and tolerability and explore its potential to enhance the effectiveness of immune checkpoint inhibitor therapy."

R-5780 is being evaluated in a multi-dose Phase 1 clinical trial (NCT06398418) designed to assess the safety, drug exposure, and clinical activity of R-5780 in patients with cancer, enrolling up to 33 participants in total. This clinical study assesses the ability of R-5780 to reawaken an anti-tumor immune response in patients who are refractory to PD-1 immune checkpoint inhibitor therapy. With the dose escalation stage complete, the trial will enroll additional patients at the highest selected dose in the planned dose expansion stage to further characterize R-5780's safety and its ability to enhance responses to immune checkpoint inhibitors, in tumors that are refractory to these therapies. R-5780 is one of three Rise Therapeutics programs, all based upon its proprietary oral biologics drug delivery platform, that are now in clinical testing, alongside ongoing studies in ulcerative colitis, rheumatoid arthritis, and Sjögren's disease. This drug delivery platform was developed to enable medicine to tap into novel intestinal mechanisms that control systemic immune biology, opening a new era of treatments that correct the fundamental underlying immunological basis of cancer and autoimmune disease.

The clinical opportunity for R-5780 sits within a large and rapidly growing, yet still underserved, segment of oncology. The global immune checkpoint inhibitor market was valued at approximately $49.8 billion in 2026 and is projected to reach $154.3 billion by 2030, as immune checkpoint inhibitors remain a cornerstone of cancer treatment. However, only about one in five patients with advanced cancer responds to checkpoint inhibitor therapy, leaving roughly 80% of treated patients without benefit. R-5780 is designed to help close this gap by re-sensitizing checkpoint-refractory tumors to immune checkpoint inhibitor therapy, positioning it to address a substantial unmet need within an expanding market.

About R-5780
Immune checkpoint inhibitors have transformed the treatment of many types of cancers, yet most patients either do not respond or eventually become refractory to these therapies. R-5780 is an orally delivered, precision-directed synthetic biology medicine designed to control the patient's immune system to drive a more robust anti-tumor T cell response. By resetting immunological repertoires, R-5780 can make immune checkpoint inhibitors like PD-1 therapy more effective. R-5780 is being developed to expand the population of cancer patients who can benefit from immune oncology treatment, including those who have become refractory to, or were never responsive to, existing checkpoint inhibitor therapies.

About Rise Therapeutics
Rise Therapeutics is a privately held, clinical-stage biotechnology company located in Rockville, Maryland, that leverages its expertise in synthetic biology and immunological drug development to create novel oral immune therapies. With a strong emphasis on product development and its internal clinical GMP manufacturing infrastructure, Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. For more information, go to www.risetherapeutics.com.

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SOURCE Rise Therapeutics