KPS Enters Phase 1b Clinical Trial Combining PARP Inhibitors Led by UK Cancer Research Institute

KPS, transforming into a biopharmaceutical company, has launched its global anticancer drug project.

KPS's U.S. subsidiary Algok Bio Inc. officially announced on the 28th of last month that it has initiated Phase 1b clinical trials for the new drug candidates Idetrexed and the PARP (Poly ADP-Ribose Polymerase Inhibitor) inhibitor Lynparza (active ingredient Olaparib, a treatment for BRCA-mutated ovarian, breast, prostate, and pancreatic cancers), led by the UK’s Institute of Cancer Research (ICR).

Algok Bio had previously acquired the worldwide exclusive development and sales rights for Idetrexed from BTG International, a subsidiary of Boston Scientific, in 2023, and has been planning Phase 2 monotherapy clinical trials and combination clinical studies with PARP inhibitors.

This study selectively recruits patients with platinum-resistant ovarian cancer who exhibit medium to high expression levels of FRα (folate receptor alpha) to determine the optimal dosage of the combination therapy of Idetrexed and Olaparib (Phase 1b). It will then proceed to Part 2 (Phase 2a) to evaluate the safety and efficacy of the combination therapy at the optimal dose.

In Phase 1b, the plan is to start with the approved Olaparib monotherapy dose of 300 mg twice daily and gradually reduce it to 200 mg and 150 mg twice daily. For Idetrexed, doses will be administered down to one level below the monotherapy optimal dose to assess the maximum tolerated dose (MTD) of the combination therapy. The primary endpoint of Phase 2a is patient safety and objective response rate (ORR), while the secondary endpoint is progression-free survival (PFS).

Idetrexed is a low-molecular-weight compound targeting FRα, with superior selectivity compared to existing low-molecular-weight compounds targeting FRα, making it the only biomarker-based candidate that can maximize therapeutic effects in patients expressing FRα.

Notably, in Phase 1 monotherapy studies, Idetrexed showed significantly fewer side effects and higher patient compliance compared to existing FRα-targeting antibody-drug conjugate (ADC) therapies, demonstrating high efficacy in patients with a broader range of FRα expression, making it a promising treatment option.

Seongcheol Kim, CEO of Algok Bio, stated, “Various drugs have been tested for combination therapy with PARP inhibitors but have repeatedly failed. Idetrexed shows very high synergy with the mechanism of action of PARP inhibitors and does not share overlapping clinical side effects, giving it great potential for success as a combination therapy.”

He added, “The initiation of this combination clinical trial is encouraging as it presents new treatment options in the field of female cancers, including ovarian cancer. We are also exploring clinical development strategies to provide patients with the fastest and most efficient treatment approaches for monotherapy and will soon announce detailed plans.”

Meanwhile, FRα is one of the folate receptors within cells and is known to be overexpressed in more than 90% of ovarian cancer patients. It is also expressed in various epithelial-derived malignancies such as endometrial cancer, pancreatic cancer, breast cancer, lung cancer, stomach cancer, and colorectal cancer.

According to the market research firm GlobalData, over 240,000 ovarian cancer patients are diagnosed 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%.

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