Kips Pharma: First Patient Dosed in UK Combination Trial of Ovarian Cancer Drug Candidate Idetrexed

Kips Biopharma (hereafter Kips Pharma) announced on October 15 that its U.S. subsidiary, Algok Bio, began dosing the first patient at the end of last month in a combination clinical trial of the ovarian cancer drug candidate Idetrexed, led by the Institute of Cancer Research (ICR) in the United Kingdom.

This clinical trial is a Phase 1b/2a study evaluating the optimal dosage, safety, and efficacy of a combination therapy of Idetrexed and the PARP (Poly ADP-Ribose Polymerase) inhibitor Lynparza (active ingredient: olaparib). In May, the company received Clinical Trial Authorization (CTA) approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA), after which the clinical trial was launched (website opened) and full-scale patient recruitment began.

Lynparza, a targeted anticancer drug from AstraZeneca, holds an overwhelming number one position in the global market share among PARP inhibitor drugs for various cancers, including ovarian, breast, prostate, and pancreatic cancers. In the domestic PARP inhibitor market, its market share reached 70% over the past year (from Q4 2023 to Q3 2024). The company expects that, if the combination trial is successful, Idetrexed will be able to enter the existing Lynparza market more easily. In this case, not only will it be possible to expand from ovarian cancer to other indications, but it will also allow for diversification of development strategies.

This study targets approximately 15 patients with platinum-resistant ovarian cancer. In Part 1 (Phase 1b), the optimal dosage of the combination therapy of Idetrexed and Lynparza will first be determined. Subsequently, in Part 2 (Phase 2a), patients with platinum-resistant ovarian cancer who have medium to high expression levels of FRα (Folate Receptor Alpha) will be selectively enrolled to rigorously verify the safety and efficacy (such as objective response rate and progression-free survival) of the optimal combination dosage.

The results for Part 1 of the combination clinical trial are expected to be available in the second half of next year after dosing is completed.

Algok Bio previously signed an investigator-initiated clinical trial agreement with the Institute of Cancer Research in March. Since acquiring the exclusive worldwide development and commercialization rights for Idetrexed from BTG International, a subsidiary of Boston Scientific, in 2023, Algok Bio has been planning both a Phase 2 monotherapy clinical trial and a combination study with PARP inhibitors.

Idetrexed is the only small-molecule compound targeting FRα and is a biomarker-driven drug candidate designed to maximize therapeutic effects in patients expressing FRα. FRα is one of the intracellular folate receptors and is overexpressed in more than 90% of ovarian cancer patients, as well as in various epithelial-derived malignant tumors such as endometrial, pancreatic, breast, lung, gastric, and colorectal cancers.

Kim Hayong, CEO of Kips Pharma, stated, "Among our domestic and overseas subsidiaries, Algok Bio is responsible for developing anticancer drug candidates, while Kips Biomed is focusing on advancing oral drug delivery platform technology. Our pipeline expansion strategy is progressing smoothly," adding, "We expect to sequentially release tangible results according to our existing development roadmap."

This content was produced with the assistance of AI translation services.