On February 23, 2021 Graviton Bioscience Corporation ("Graviton"), a privately held early-stage drug development company founded by Dr. Samuel Waksal, and Beijing Tide Pharmaceutical Co., Ltd. (Beijing Tide) a subsidiary of Sino Biopharmaceutical Limited (HKG:1177), reported the signing of an exclusive license agreement for TDI01 (Press release, Graviton Bioscience, FEB 23, 2021, View Source [SID1234576629]). The agreement grants development and commercialization rights for TDI01 to Graviton in all territories, excluding China. Under the terms of the agreement, Graviton will make an upfront payment and additional amounts for development, regulatory and sales milestone payments for all programs, as well as royalties on net sales and an option for a revenue-sharing arrangement for certain developed products. The aggregate amount of upfront, development, regulatory and sales milestone payments is up to USD 517.5 million.
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TDI01 is a targeted inhibitor of Rho/Rho containing protein kinase 2 (ROCK2). In 2020, an Investigational New Drug application for evaluation of TDI01 in fibrosis was cleared by the FDA, and a clinical trial application for the treatment of fibrosis was filed and accepted by the Center for Drug Evaluation of the People’s Republic of China. A Phase I clinical trial of the drug candidate in idiopathic pulmonary fibrosis is currently ongoing in the United States. Graviton expects to develop this novel therapeutic for the treatment of various serious diseases, including exploration of TDI01’s ability to penetrate the central nervous system, and the translation of efficacy demonstrated in certain preclinical cancer models as well as models of certain viral diseases.
"There remains a tremendous unmet need for novel, safe and effective therapies against a broad spectrum of diseases globally," said Dr. Waksal, Founder of Graviton. "Having pioneered the field in targeting ROCK2 mediated disease, I believe that the extraordinarily high selectivity and potency engineered by Beijing Tide in developing TDI01 offers great potential in advancing the next-generation of ROCK2 therapeutics. We look forward to moving TDI01 into different clinical studies in the U.S. as quickly as possible, and to begin elucidating this potential in the coming quarters."
"TDI01 is the first innovative small molecule in the clinical phase developed by Beijing Tide, and it shows great potential in treating a variety of diseases," said Sino Biopharmaceutical Limited’s Chairlady Theresa Tse. "We believe that collaborating with the experienced scientific team at Graviton would not only maximize the value of TDI01, but also accelerate the clinical development in both China and US. We look forward to initiating multiple clinical studies for different indications very soon."