Kipsbiopharma (hereafter Kipspharma) announced on May 20 that its U.S. subsidiary, Algok Bio, will begin recruiting clinical trial patients for Idetrexed, a new drug candidate for ovarian cancer, starting in June under the leadership of the Institute of Cancer Research (ICR) in the United Kingdom.
According to Kipspharma, the UK Medicines and Healthcare products Regulatory Agency (MHRA) recently approved the clinical trial application (CTA) for a Phase 1(b) study of combination therapy involving Idetrexed and AstraZeneca's PARP (Poly ADP-Ribose Polymerase Inhibitor) inhibitor Lynparza (active ingredient: Olaparib), a treatment for BRCA-mutated ovarian, breast, prostate, and pancreatic cancers.
As a result, from early June, patient recruitment and dosing for the Phase 1b clinical trial targeting approximately 15 patients in the UK will commence. The company expects initial clinical results to be available in the second half of 2026.
Algok Bio signed an investigator-initiated clinical trial agreement with the Institute of Cancer Research in March. Since acquiring the global exclusive 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.
This study will determine the optimal dose (Phase 1b) of combination therapy with Idetrexed and Olaparib in patients with platinum-resistant ovarian cancer. Furthermore, the company plans to selectively recruit patients with medium to high expression of FRα (Folate Receptor Alpha) among those with platinum-resistant ovarian cancer, and to proceed to Part 2 (Phase 2a) to evaluate the safety and efficacy of the optimal combination dose.
In the Phase 1(b) trial, dosing of Olaparib will start at 300 mg twice daily, the approved dose for monotherapy, and then be gradually reduced to 200 mg and 150 mg twice daily. For Idetrexed, the strategy is to administer doses one level lower than the optimal monotherapy dose to evaluate the maximum tolerated dose (MTD) for the combination therapy. The primary endpoints of the Phase 2(a) trial are patient safety and objective response rate (ORR), while the secondary endpoint is progression-free survival (PFS).
Idetrexed is a small molecule compound that targets FRα. Compared to existing small molecule compounds, it offers superior selectivity for FRα, making it a biomarker-based new drug candidate that can maximize therapeutic effects in patients expressing FRα.
Kim Sungcheol, CEO of Algok Bio, stated, "In the Phase 1 monotherapy study, Idetrexed showed significantly fewer side effects and higher patient compliance compared to antibody-drug conjugate (ADC)-based therapies targeting FRα, and demonstrated high efficacy in patients with a broader range of FRα expression. In addition, it shows a very high synergy with the mechanism of action of PARP inhibitors, and since the clinical side effects do not overlap, the combination therapy has great potential for success."
FRα is one of the intracellular folate receptors and is known to be overexpressed in more than 90% of ovarian cancer patients. It is also expressed in various epithelial malignancies, including endometrial, pancreatic, breast, lung, gastric, and colorectal cancers.
Meanwhile, according to market research firm GlobalData, more than 240,000 new cases of ovarian cancer occur annually, and the global ovarian cancer market is projected to reach $6.7 billion (approximately 9.6 trillion KRW) by 2028, with a compound annual growth rate (CAGR) of 14.4%.
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