Ovarian cancer drug to enter Phase II clinical trial

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Our Cancer Drug Discovery Center building – now the home of our drug discovery scientists. Credit: Institute for Cancer Research

An innovative cancer drug discovered by scientists at the Institute of Cancer Research in London is set to enter a new clinical trial.

The drug, called Idetrexed and formerly known by experimental drug names such as BTG945, ONX-0901 and CT900, was developed by scientific teams at what is now the ICR’s Center for Cancer Drug Discovery.

It has already shown particular promise in ovarian cancer in a first human phase I study led by researchers from the ICR and our partner hospital, the Royal Marsden NHS Foundation Trust.

The Phase II study will further test the efficacy and safety of Idetrexed in a larger group of patients, specifically those with ovarian cancer.

Idetrexed is undergoing a larger trial thanks to a new agreement between US-based pharmaceutical company Algok Bio and BTG International, which previously worked with the ICR on the drug’s development. Cancer Research UK also helped fund earlier research.

Algok Bio’s exclusive license agreement with BTG grants the former the right to develop and commercialize idetrexed worldwide. Under the terms of the agreement, Algok Bio will make an upfront payment to BTG and additional payments contingent upon the achievement of certain regulatory and commercial milestones, as well as tiered royalty payments.

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Algok Bio will shortly initiate pivotal studies to register Idetrexed for the treatment of ovarian cancer. Additional clinical programs exploring other indications and combination therapies with standard of care are also underway.

About idetrexed

Idetrexed is a potent thymidylate synthase inhibitor that induces cell death while selectively targeting the alpha-folate receptor (FRα), which is highly expressed in cancer cells compared to normal tissue in a variety of solid tumors.

In a phase I study conducted by the ICR and The Royal Marsden, the results of which were published in Clinical Cancer Research last year, Idetrexed treated 109 cancer patients, including patients with ovarian cancer who were resistant to platinum-based chemotherapy.

Among 25 platinum-resistant ovarian cancer patients with high or moderate FRα expression who received the recommended phase II dose, tumor shrinkage was observed in nine patients (overall response rate, 36%; 95% CI, 18-57.5).

According to the World Health Organization, ovarian cancer is the seventh most common cancer in women worldwide, with over 300,000 new cases each year. More than 90% of ovarian cancers express FRα, with high levels of overexpression also observed in endometrial cancer, triple-negative breast cancer and mesothelioma.

Kidney, lung, colon and gastric cancers also show different levels of expression.

Algok Bio’s development of Idetrexed shows promise for the treatment of these cancers, and the exclusive licensing agreement with BTG represents an important milestone in the development of this innovative therapy.

Professor Udai Banerji, Principal Investigator of the Idetrexed Phase I trial and Co-Director of Drug Development at ICR and The Royal Marsden, said: “Idetrexed is a small molecule targeting FRα-overexpressing cancers and has significant single-agent activity in Phase I At a similar stage of development, Idetrexed has demonstrated comparable efficacy to late-stage drugs such as antibody-drug conjugates that have been successfully developed.

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“This drug has significant potential as a potential future treatment for ovarian cancer and I am excited that it is now advancing to the next phase of clinical development. I wish Algok Bio the very best in developing this drug for patients with ovarian cancer and other FRα-overexpressing cancers.”

dr Sung Chul Kim, President and Founder of Algok Bio said, “As the only small molecule drug with a unique mechanism of action currently targeting FRα, the efficacy and safety profiles in early clinical trials have been very promising and competitive with other antibodies. We are excited to be part of this development program and believe it has significant potential as an effective treatment for patients with ovarian cancer.”

For more information: Susana Banerjee et al., A Phase I Trial of CT900, a Novel α-Folate Receptor-Mediated Thymidylate Synthase Inhibitor, in Patients with Solid Tumors with Expansion Cohorts in Patients with High-Grade Serous Ovarian Cancer, Clinical Cancer Research ( 2022 ). DOI: 10.1158/1078-0432.CCR-22-1268

Journal Information: Clinical Cancer Research