Kipspharma Secures Exclusive License for Next-Generation Targeted Anticancer Drug "Idetrexed" from U.S. Subsidiary

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Kips Biopharma (hereafter Kipspharma) announced on February 11 that it has signed a license agreement with its U.S. subsidiary Algok Bio to introduce the exclusive rights for development and commercialization in Korea and Southeast Asia for the next-generation targeted anticancer drug candidate "Idetrexed."

Kipspharma has secured the rights to Idetrexed under terms that include payment of an upfront fee and development-stage milestone payments. The licensed territory covers major Southeast Asian countries including Korea, Taiwan, Thailand, Vietnam, Indonesia, Malaysia, the Philippines, and Singapore. The specific contract value was not disclosed in accordance with mutual agreement between the two companies.

Through this technology in-licensing, Kipspharma has laid the groundwork to leap from a company focused on generic drug production and distribution to an R&D-centered company with its own clinical development capabilities. By internalizing an innovative oncology pipeline, the company is securing a mid- to long-term growth engine, and by actively expanding investment in new drug development, it also expects to benefit from government preferential drug pricing policies and other incentives granted to R&D-focused pharmaceutical companies in the future.

Idetrexed is a biomarker-based targeted anticancer agent that precisely targets folate receptor alpha (FRα), which is overexpressed on the surface of cancer cells. The clinical value of the FRα target has already been demonstrated, as "Elahere," the first FRα-targeting antibody-drug conjugate (ADC) new drug, obtained approval from the U.S. Food and Drug Administration (FDA) and more recently from the Korean Ministry of Food and Drug Safety.

In particular, Idetrexed is a small-molecule compound and therefore shows significantly fewer adverse events, such as cytopenia and ocular toxicity, which are regarded as drawbacks of ADC drugs, and is aiming to become a "best-in-class" therapy. It is considered a promising asset with high commercial value, as it is expected to expand its indications not only to ovarian cancer, in which FRα is overexpressed in more than 90% of patients, but also to various solid tumors such as endometrial cancer, pancreatic cancer, and triple-negative breast cancer.

Idetrexed is currently in a phase 1b/2a clinical trial led by the Institute of Cancer Research (ICR) in the United Kingdom, a world-renowned cancer research institution, to evaluate the optimal combination dose, safety, and efficacy when used in combination therapy with the PARP (Poly ADP-Ribose Polymerase) inhibitor "Lynparza" (ingredient name olaparib). Having successfully completed a pre-meeting with the European Medicines Agency (EMA) that it applied for in the fourth quarter of last year, Algok Bio plans to begin in earnest within this year a phase 2 clinical trial in Europe of Idetrexed monotherapy in cancer types with high FRα expression.

In connection with these global clinical data, Kipspharma plans to obtain approval from the Ministry of Food and Drug Safety within the first half of this year for an investigational new drug (IND) application for a phase 2 clinical trial of Idetrexed in Korea. Through this, the company intends to demonstrate its own clinical execution capabilities and to proactively respond to the government’s ongoing drug pricing system reform, thereby solidifying its position as an R&D investment-driven company.

Kim Hayong, Chief Executive Officer of Kipspharma, said, "This license agreement is meaningful in that we are strengthening the company’s R&D fundamentals by introducing a promising anticancer new drug candidate and establishing ourselves as one of the pillars of global clinical development," adding, "We will focus on providing new treatment options to cancer patients with high unmet needs through successful clinical development and on the company’s long-term growth based on technological capabilities."

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