NEW YORK and BEIJING, Feb. 23, 2021 /PRNewswire/ -- 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), announced today the signing of an exclusive license agreement for TDI01. 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.
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."
Graviton is a New York-based company founded in 2020 with the goal of developing novel therapeutics for the treatment of autoimmune, cancer, certain genetic, fibrotic and other serious diseases. TDI01, a highly selective, potent inhibitor of Rho/Rho associated coiled-coil containing protein kinase 2 (ROCK2) is currently being studied in the United States for the treatment of idiopathic pulmonary fibrosis (IPF). Graviton anticipates entering human clinical studies in the U.S. in 2021.
Leading the company is Dr. Waksal, the Founder and former Chairman and CEO of Kadmon Pharmaceuticals (NASDAQ: KDMN), where he led the licensing and early development of what is now the most advanced ROCK2 inhibitor in development, belumosudil. Dr. Waksal is also the Founder and former CEO and President of ImClone Systems (acquired by Eli Lilly), a Founder of MeiraGTx (NASDAQ: MGTX) and is the Founder of Equilibre Biopharmaceuticals Corp.
About Beijing Tide Pharmaceutical Co., Ltd.
Beijing Tide Pharmaceutical Co., Ltd is an innovative pharmaceutical company with integrated R&D, manufacturing, marketing, sales, and distribution capabilities. Beijing Tide is a major subsidiary company in Sino Biopharmaceutical Limited and is developing both innovative and special formulation drugs in cardiovascular, pain management, respiratory, and oncology. Sino Biopharmaceutical Limited, and its subsidiaries, are China's leading innovative research and development-driven pharmaceuticals group, with businesses covering multiple pharmaceutical R&D platforms, production and sales. Its products include a variety of leading biologic and chemical therapeutics in a number of fields, such as liver disease, cancer, cardiovascular and cerebrovascular disease, orthopedics, digestive system, anti-infection and respiratory diseases. It was listed in the "Top 50 Global Pharmaceutical Companies" published by the authoritative American magazine "PharmExec" for two consecutive years in 2019 and 2020.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Graviton, its strategy, future operations, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: our ability to successfully develop our product candidates and complete our planned clinical programs, expectations regarding the safety and efficacy of our drugs, expectations regarding possible milestone and royalty payments under the license agreement with Beijing Tide Pharmaceutical, expectations regarding our ability to manufacture, develop and commercialize drugs around the world, and other factors. In addition, the forward-looking statements included in this press release represent Graviton's views as of the date hereof. Graviton anticipates that subsequent events and developments will cause Graviton's views to change. However, while Graviton may elect to update these forward-looking statements at some point in the future, Graviton specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Graviton's views as of any date subsequent to the date hereof.
For Graviton Bioscience Corporation:
For Beijing Tide Pharmaceutical Co., Ltd.
Dr. Berry HE
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SOURCE Graviton Bioscience Corporation