Kipspharma Receives IND Approval for Domestic Phase 2 Trial of Idetrexed

Kipsbiopharma (hereinafter Kipspharma) is set to officially begin domestic Phase 2 clinical trials for its next-generation targeted anticancer drug candidate, Idetrexed. Attention is focused on whether it can surpass 'Elahere,' the antibody-drug conjugate (ADC) that currently dominates the ovarian cancer treatment market, and emerge as a best-in-class new drug within its category.

Kipspharma announced on September 14 that it had received approval for the domestic Phase 2 clinical trial plan (IND) for Idetrexed from the Ministry of Food and Drug Safety on September 11. The company plans to accelerate clinical development in line with its scheduled development timeline, having secured IND approval.

This Phase 2 trial will target 50 patients with platinum-resistant high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that show moderate or higher expression of the folate receptor alpha (FRα). The company explained that since more than 90% of ovarian cancer patients display FRα overexpression, the market potential for targeted therapies remains high.

Idetrexed is expected to compete directly with Elahere, currently the only approved FRα-targeting therapy in the ovarian cancer field. Elahere, AbbVie’s ADC therapy, recorded sales of $690 million last year and has grown into a blockbuster drug, but has continuously faced criticism due to its side effects, including ocular toxicity and thrombocytopenia.

Kipspharma highlights that Idetrexed is uniquely differentiated as a small molecule-based delivery agent. Compared to ADC therapies, it is expected to reduce toxicities and side effects, making it potentially more suitable for indication expansion or use in combination therapy with other anticancer agents.

The company also reported positive results from an ongoing combination clinical trial in the UK, led by the Institute of Cancer Research (ICR), evaluating Idetrexed alongside AstraZeneca's PARP inhibitor Olaparib (brand name Lynparza).

There is also keen interest in efficacy results from the Phase 2 clinical trial. In earlier Phase 1 studies, Idetrexed achieved an objective response rate (ORR) of 36%. The company noted that this result is especially distinctive because it covers not only patients with high FRα expression but also those with moderate to high levels of expression.

Elahere achieved a 42.3% ORR in the FRα-high patient subgroup in the Phase 3 MIRASOL study. In contrast, Idetrexed showed meaningful response rates even among patients with moderate FRα expression, which demonstrates broader treatment potential across a larger patient population.

Kipspharma aims to confirm the safety and efficacy of Idetrexed and prove its commercial viability through this Phase 2 trial. Based on the clinical results, the company plans to expedite subsequent trials and seek various business opportunities, including global technology licensing deals.

A Kipspharma representative stated, "Initial data from the ongoing UK combination trial of Idetrexed and a PARP inhibitor have been positive and this is highly encouraging. We will also rapidly proceed with the monotherapy Phase 2 trial in Korea to prove our value in the global anticancer market and enter full-scale commercialization."

Kim Hayong, Chief Executive Officer of Kipspharma, commented, "The Phase 2 IND approval for Idetrexed is highly significant for our development strategy, as it marks the entry of our core pipeline into the data-generation phase. From this year, through clinical data from both the UK and Korea, we will do our utmost to demonstrate that Idetrexed, as a small molecule agent, can deliver superior efficacy compared to the ADC drug Elahere and further solidify its position as a best-in-class new therapy."

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