A Japanese drugmaker is teaming up with subsidiaries of one of the largest pharmaceutical companies in the U.S. and another Japan-based company to develop small-molecule oncology drugs, including those targeting a hard-to-reach gene expressed in cancer cells that has been the subject of growing interest in biopharma.
Taiho Pharmaceutical, based in Tokyo, said Monday that it had entered a research and licensing deal with a subsidiary of Kenilworth, New Jersey-based Merck, as well as Otsuka Pharmaceutical’s Astex Pharmaceuticals division, to develop drugs against various targets. These include the gene KRAS, widely expressed in cancer cells but long considered “undruggable” because of its structure.
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Financial terms of the deal include a $50 million upfront payment for Taiho and Astex, as well as up to $2.5 billion in milestones. Merck operates under the name MSD outside the U.S. and Canada to avoid confusion with Germany-based Merck KGaA.
“Taiho has used its unique and proprietary drug discovery platform to generate a number of small-molecule inhibitors,” Taiho Managing Director Teruhiro Utsugi said in a statement. “This alliance builds on our KRAS research up to now, and together with [Merck], it allows us to combine expertise to significantly accelerate the global research, development and commercialization of a number of our mutant KRAS programs by accessing external talent and resources.”
Merck also has a partnership with Cambridge, Massachusetts-based Moderna Therapeutics to develop mRNA cancer vaccines, including Moderna’s KRAS-targeting cancer vaccine, mRNA-5671.
A number of companies, ranging from large drugmakers to startups, have been exploring drugs targeting KRAS. Interest in the field has accelerated since Amgen first presented data on the drug AMG 510, which targets a form of the mutation called KRAS G12C.
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Amgen most recently presented data at the European Society for Medical Oncology’s annual meeting in September, on 55 patients who were evaluable for efficacy and had colorectal, appendiceal or non-small cell lung cancer. Twelve patients with colorectal cancer and 13 with non-small cell lung cancer received the drug at the targeted treatment dose of 960mg; among CRC patients, one achieved a partial response and 10 achieved stable disease, while in the NSCLC cohort there were seven partial responses and six patients who achieved stable disease. One patient with appendiceal cancer achieved a partial response, while another achieved stable disease.
Another company, San Diego-based Mirati Therapeutics, presented the first data from its Phase I/II trial of the KRAS G12C inhibitor MRTX849 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October. Across all dose levels, three of six patients with NSCLC and one of four with CRC achieved a partial response.
Additional companies developing KRAS inhibitors include Germany-based Boehringer Ingelheim, BridgeBio and others.
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