On September 11, 2015 TMRC Co., Ltd. ("TMRC" Hisao Ekimoto, President & CEO, Tokyo, Japan) reported that it has entered into an exclusive license agreement with Syros Pharmaceuticals Inc. ("Syros" Nancy Simonian, CEO, Massachusetts, USA) for the U.S. biopharmaceutical company to develop and commercialize TM-411 (tamibarotene) in North America and Europe for cancer (Press release, TMRC, SEP 11, 2015, View Source [SID:1234512621]).
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Syros plans to initiate a Phase 2 clinical trial of TM-411 (which Syros refers to as SY-1425) in 2016 in a genomically defined subset of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Syros’ proprietary gene control platform is designed to systematically analyze patient tissue to identify crucial genes that become dysregulated in diseased cells in order to create medicines that return cells to a non-diseased state.
Using its platform, Syros discovered a biomarker associated with RARα dependency in subsets of AML and breast cancer patients based on analysis of their tumors. Syros observed the elevated biomarker in approximately 25% of AML patient samples analyzed. Syros then demonstrated in patient-derived xenograft models of AML that tumors with the biomarker for RARα dependency responded to TM-411 while tumors without the biomarker did not respond to the therapy.
Treatment with TM-411 extended survival in animals carrying patient-derived tumors with the biomarker.
Syros plans to research the potential role of this biomarker in other cancers, including breast cancer.
›Tamibarotene
The retinoic acid derivative invented by Dr. Koichi Shudo at Faculty of Pharmacy at University of Tokyo exhibits stronger differentiation activity with improved stability and safety than the retinoid agents currently available. Tamibarotene was developed by Toko Pharmaceuticals and approved (Amnolake Tablet 2 mg) for relapsed/refractory acute promyelocytic leukemia (APL) in Japan on April 11, 2005.