Strategia starts phase I of Fujifilm cancer candidate

By Michael Fitzhugh, Staff Writer

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Strategia Therapeutics Inc., of Boston, has started a U.S.-based phase I trial of the antimetabolite agent FF-10502 in patients with advanced solid tumor cancers and lymphoma. The drug, which inhibits DNA synthesis, was first developed by Fujifilm Pharmaceuticals U.S.A. Inc. and has demonstrated preclinical activity against tumors resistant to gemcitabine therapy.
The company is working closely on the project with a researcher at the University of Texas M.D. Anderson Cancer Center, Strategia’s partner on a second project, and a researcher at the Sarah Cannon Research Institute in Denver.
Strategia, formerly called Boston Strategic Corp., is serving in the role of a contract research organization for FF-10502, testing of which will be sponsored by Fujifilm. But the company is also in-licensing programs, as it has with E6201, a dual-inhibitor of FMS-like tyrosine kinase 3 (FLT-3) and mitogen-activated protein (enzyme) kinase (MEK), first developed by Eisai Co. Ltd. for melanoma and later deprioritized by that company, opening the way for Strategia to negotiate worldwide rights to develop and commercialize it for all oncology indications.
“For me, it’s not really important which model we’re talking about,” Strategia’s founder, president and CEO, Keizo Koya, told BioWorld Today. “To me, paradigm shift is more important,” he said.
Koya, a pharma R&D veteran, established Strategia in 2012 to advance an efficient and cost-effective approach to R&D with the goal of tackling the problems of declining R&D productivity and inefficient allocations of infrastructure.
He likened the problems facing big pharma to those of the movie industry, where infrastructure and talent were long concentrated in just a handful of big studios. A much better approach, he posited, would be to source the best talents as needed, project by project.
Today, Strategia pursues a collaborative development model, bringing together small, global expert teams, each of which has expertise specific to a single drug. The goal, Koya said, is to rapidly and successfully move each project to completion while keeping internal infrastructure small and streamlined.
To make it easier to hew to his ideals, Koya hasn’t raised any outside funds for Strategia.
“Money has power,” he said. “I really want to create a new R&D platform for patients and the future of society.” That’s also why he sought to work with companies such as Fujifilm, one of his former employers, which he said has good drug candidates but, because it is a relatively new player in the pharmaceutical industry, has yet to build big infrastructure that would encumber it.
So far, Strategia has established seven teams for seven drug candidates in three years by collaborating with experts, organizations and companies such as Fujifilm, Eisai and MD Anderson. And the company is keeping plenty busy.
On Jan. 15, it initiated a phase I trial of the radioimmunotherapeutic FF-21101 for Fujifilm in patients with advanced cancers. It is also working on FF-10501, currently in phase I testing for patients with relapsed or refractory myelodysplastic syndromes and acute myeloid leukemia.
The company also has some phase II programs in the wings that it has yet to disclose and, where it finds success, may carry programs ahead to phase IIb studies.
By working with a staff of just 10 people, Koya said, Strategia can remain flexible. “If 10 people can handle 10 projects, then people of younger generations can think, ‘Keizo can do this kind of thing, so I can do much better in the future! We don’t need a big pharmaceutical company, just a small team to make a better drug.’”