The 184-patient milestone moves KORTUC's lead program toward readout, alongside a cervical cancer study with UC San Diego and newly authorized K-BOOST rectal cancer trial in France
PALO ALTO, Calif., Sept. 15, 2026 (GLOBE NEWSWIRE) -- KORTUC INC., a clinical-stage oncology biotechnology company developing an investigational intratumoral radiosensitizer, today announced that it has achieved its target enrollment of 184 patients in its registrational, randomized Phase II breast cancer trial. The study is now moving toward patient follow-up, data analysis, and an efficacy readout targeted for 2027. The news comes following a Series B round and broader company update: KORTUC now has three clinical studies advancing in breast, cervical and rectal cancer.
Together, they reflect a growing international development program - including a U.S. academic collaboration with the University of California San Diego, a United Kingdom-led breast cancer trial and a newly authorized France-based rectal cancer study, with additional trial sites in India and Thailand.
KRC-01, a proprietary intratumoral formulation based on hydrogen peroxide and sodium hyaluronate, addresses hypoxia - or lack of oxygen - a problem for over 50% of solid tumors. It is designed to raise oxygen levels within tumors and inactivate antioxidative enzymes that contribute to radioresistance. Sodium hyaluronate slows the decomposition of hydrogen peroxide, helping the formulation remain within the tumor as radiation treatment is delivered.
Three clinical programs advancing globally
Breast cancer trial reaches 184-patient enrollment target: The breast cancer trial is led by The Institute of Cancer Research in the United Kingdom. The study’s primary endpoint is complete response - no detectable tumor on MRI after treatment, a particularly meaningful outcome for patients with locally advanced or recurrent disease. It compares radiotherapy alone with radiotherapy plus KRC-01 in patients with primary or recurrent locally advanced breast cancer. The study is being conducted through six centers in the United Kingdom and four centers in India (NCT03946202).
“Reaching our 184-patient enrollment target is a defining milestone for KORTUC,” said Kazu Matsuda, CEO of KORTUC. “It moves our lead program beyond target recruitment and toward data readout, while our cervical and rectal studies expand the evaluation of KRC-01 into two additional cancers. Through clinical collaborations in the United States, United Kingdom and France, we are building the global evidence needed to assess KRC-01 across tumors where hypoxia can limit radiation response.”
Cervical cancer - global study with U.S. academic collaboration: KORTUC's ongoing global Phase 1/2 study, conducted in partnership with the University of California San Diego, is evaluating KRC-01 with standard chemoradiotherapy in 70 patients with untreated, locally advanced cervical cancer. Following first enrollment in March 2026, the study is progressing through a 10-patient safety and dose-schedule phase before a 60-patient randomized phase comparing standard treatment with or without KRC-01. The randomized phase will primarily evaluate progression-free survival (PFS), while also assessing overall survival (OS) and quality of life, examining whether adding KRC-01 can translate into meaningful longer-term benefits for patients. Registry sites are listed in Thailand, India and the United Kingdom (NCT05570422).
Rectal cancer - France: The Phase II K-BOOST clinical trial has received authorization to proceed in France and is expected to begin enrollment following site activation. Sponsored by Gustave Roussy, the study will enroll 24 adults with non-metastatic, high-risk stage III rectal cancer at Gustave Roussy and Institut Bergonié. Participants will receive eight intratumoral KRC-01 injections alongside standard long-course chemoradiotherapy, followed by consolidation chemotherapy. The primary endpoint is the clinical complete response rate at week 24. The study will explore whether adding KRC-01 can support an organ-preservation pathway for patients while retaining surgery as an established treatment option. K-BOOST is registered under EU Clinical Trial number 2025-524378-40-00 and ClinicalTrials.gov identifier NCT07622017.
KRC-01 is an investigational product and has not been approved for commercial use. For more information about KORTUC and its clinical development program, visit KORTUC.com.
About KORTUC
KORTUC INC. is a U.S.-based oncology biotechnology company headquartered in Palo Alto, California. Originally founded in Japan, KORTUC is focused on overcoming tumor hypoxia to improve the effectiveness of radiotherapy for solid tumors. With a proprietary radiosensitizer and global clinical collaborations, the company aims to make effective, affordable, and accessible cancer therapies available to patients worldwide. For more information, please visit https://kortuc.com/
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