Bellevue, WA – Algok Bio Inc. (Algok Bio), a US-based biopharmaceutical company dedicated to researching and developing innovative therapeutics for unmet medical needs, has initiated a Phase 1b clinical trial for its lead drug candidate, Idetrexed, in collaboration with the UK’s Institute of Cancer Research (ICR). Launched on February 28, 2025, the trial evaluates Idetrexed in combination with AstraZeneca’s PARP inhibitor Lynparza (olaparib) for platinum-resistant ovarian cancer patients with medium to high FRα expression.

Since acquiring the global development and commercialization rights for Idetrexed from BTG International, a subsidiary of Boston Scientific, in 2023, Algok Bio has been advancing both a monotherapy trial (Phase 2) and a combination study with a PARP inhibitor. This latest trial aims to establish the optimal dosage (Phase 1b) and assess safety and efficacy (Phase 2a), with objective response rate (ORR) and progression-free survival (PFS) as key endpoints.

The Phase 1b study follows a dose-optimization strategy, starting with Lynparza at its approved monotherapy dosage of 300 mg twice daily, with potential stepwise reductions to 200 mg and 150 mg twice daily. Idetrexed will be administered at doses up to one level below the optimal monotherapy dosage to determine the maximum tolerated dose (MTD) of the combination therapy.

Idetrexed’s FRα-targeting mechanism offers a distinct advantage over existing treatments, maximizing therapeutic effects while maintaining a strong safety profile. In a prior Phase 1 monotherapy study, Idetrexed demonstrated fewer side effects, higher patient compliance, and superior efficacy across a broader range of FRα expression levels compared to existing FRα-targeting antibody-drug conjugates (ADCs).

“Many combination therapies with PARP inhibitors have faced challenges, but Idetrexed’s unique synergy and non-overlapping side effects with PARP inhibitors set it apart,” said Dr. Sung Chul Kim, President of Algok Bio. “This trial represents a significant step in offering a new treatment option for ovarian and gynecological cancers.”

Additionally, Idetrexed has potential applications beyond ovarian cancer, as FRα is overexpressed in more than 90% of ovarian cancer cases and is also present in other epithelial-derived malignancies, including endometrial, pancreatic, breast, lung, gastric, and colorectal cancers.

With the global ovarian cancer market projected to reach $6.7 billion by 2028, Algok Bio remains committed to advancing targeted therapies that address critical unmet medical needs, both as monotherapy and combination treatments.

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