Keeps Biopharma Wins Phase 2 Approval for Ovarian Cancer Drug, Challenges ELAHERE

[Financial News] Keeps Biopharma is entering a domestic Phase 2 clinical trial for Idetrexed, a next-generation ovarian cancer treatment. Unlike existing folate receptor alpha (FRα)-targeted therapies, which primarily focus on patients with high expression levels, Idetrexed is also designed to target patients with moderate expression, drawing attention to the drug.
According to Keeps Biopharma on the 14th, the Ministry of Food and Drug Safety approved Idetrexed’s domestic Phase 2 investigational new drug (IND) application on the 11th. The trial will enroll 50 patients with platinum-resistant, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer whose tumors express moderate or higher levels of FRα.
The key question is how effectively Idetrexed can address the limitations of existing FRα therapies. While AbbVie’s ELAHERE, the current market leader, is an antibody-drug conjugate (ADC), Idetrexed is based on a small-molecule compound. Keeps Biopharma is pursuing a strategy to expand the eligible patient population while relatively reducing the toxicity burden.
In particular, while ELAHERE was developed primarily for patients with high FRα expression, Idetrexed is being tested in patients with moderate or higher expression.
In the earlier Phase 1 trial, which included patients with moderate expression, Idetrexed recorded an objective response rate (ORR) of 36%. However, a direct numerical comparison with ELAHERE is difficult because the trial designs and patient populations differed.
In the United Kingdom, a combination trial of Idetrexed and the PARP inhibitor Olaparib is also underway under the leadership of the Institute of Cancer Research (ICR). If meaningful data are secured from the domestic monotherapy Phase 2 trial and the combination trial, the drug’s prospects for follow-up trials and global licensing deals are expected to improve.
An industry source said, "With the FRα therapy market already established, it is important for late entrants to demonstrate clear differentiation from existing drugs in terms of patient coverage or safety. If the Phase 2 data are confirmed, they will mark an important turning point in assessing the value of partnering with global pharmaceutical companies."
Kim Ha-yong, chief executive overseeing Keeps Biopharma, emphasized, "We will demonstrate Idetrexed’s competitiveness through clinical data generated in South Korea and the United Kingdom and develop it into a best-in-class drug within its class."


[email protected] Kim Kyung-ah Reporter