Algok Bio Inc. (Algok Bio), a US-based biopharmaceutical company dedicated to researching and developing innovative therapeutics for unmet medical needs, has announced that it has secured an exclusive worldwide license agreement with global healthcare company BTG International Ltd. (BTG) for the development and commercialization of idetrexed, a clinical-stage targeted oncology drug for ovarian cancer that is heading into Phase II development.
Idetrexed is a potent thymidylate synthase inhibitor that triggers cell death while selectively targeting the folate receptor α (FRα), which is highly expressed in cancer cells compared to normal tissues across a variety of solid tumors. The small molecule compound was discovered by The Institute of Cancer Research (ICR) in London, which led its early development with support from Cancer Research UK and BTG.
A Phase I study (NCT02360345) conducted by ICR and The Royal Marsden NHS Foundation Trust, published in Clinical Cancer Research in 2022, treated 109 cancer patients, including ovarian cancer patients resistant to platinum-based chemotherapy, with idetrexed. Among 25 platinum-resistant ovarian cancer patients with high or medium expression of FRα who received the recommended Phase II dose, tumor shrinkage was observed in 9 patients (overall response rate 36%; 95% CI, 18-57.5).
Dr. Sung Chul Kim, President and Founder of Algok Bio, commented, "As the only small molecule drug with a unique mechanism of action currently targeting FRα, the efficacy and safety profiles in early clinical studies were highly promising and competitive with other antibody-drug conjugate drugs. We are thrilled to be a part of this development program and believe it holds significant potential as an effective treatment for ovarian cancer patients."
Algok Bio's exclusive license agreement with BTG grants the former the rights to develop and commercialize idetrexed worldwide. Under the agreement, Algok Bio will make an upfront payment to BTG and additional payments contingent on achieving specific regulatory and sales milestones, as well as tiered royalty payments. Algok Bio will soon initiate pivotal studies for registering idetrexed for ovarian cancer treatment. Additional clinical programs exploring other indications and combination regimens with standard care will also be pursued.
According to the World Health Organization, ovarian cancer is the seventh most commonly diagnosed cancer in women worldwide, with over 300,000 new cases diagnosed each year. Over 90% of ovarian cancer cases express FRα, with high levels of overexpression also observed in endometrial, triple-negative breast cancer, and mesothelioma. Furthermore, kidney, lung, colorectal, and gastric cancers exhibit varying degrees of expression. The development of idetrexed by Algok Bio holds significant promise for the treatment of these cancers, and the exclusive license agreement with BTG represents a major milestone in the development of this innovative therapy.
Algok Bio is a biopharmaceutical start-up based in Greater Seattle Area, Washington, committed to the research and development of next-generation therapeutics for unmet medical needs. Inspired by the Korean word for "grain," Algok Bio diligently separates the wheat from the chaff, identifying the most promising drug development projects to bring to market. Established in 2020, the company is primarily funded and backed by Korean public company KPS Corp (KOSDAQ: 256940). Algok Bio is currently developing AGK-102, a first-in-class monoclonal antibody therapeutic targeting cancer stem cell biomarker TM4SF4, with preclinical development set to complete and early clinical development in lung cancer expected to begin in 2024. The company will continue building its portfolio through partnerships targeting unique and promising biological mechanisms in human diseases.
For more information, please visit http://www.algokbio.com/