Kitov Pharmaceuticals Holdings Ltd, an innovative biopharmaceutical company, has announced the expansion of its pipeline through the acquisition of a majority stake in TyrNovo Ltd., a privately held developer of novel small molecules in the immuno-oncology therapeutic field.
The expansion into developing immuno-oncology drugs comes as Kitov plans to file its New Drug Application (NDA) with the US Food and Drug Administration (FDA) for its flagship combination drug, KIT-302, which is intended to treat osteoarthritis pain and hypertension simultaneously, in Q1 2017, with commercial launch anticipated for the first half of 2018. Kitov plans to harness its development and regulatory capabilities in proceeding towards submitting an investigational new drug (IND) application with the US FDA and initiate clinical trials for its newly acquired drug, NT219.
The market for immuno-oncology treatments is believed to become worth USD 14 billion by 2019 and to grow to USD 34 billion by 2024, driven by long-term and durable tumor responses to immuno-oncology drugs, according to Global Data.
Kitov will initially acquire an approximately 56 per cent equity stake in TyrNovo from its majority shareholder, for consideration of USD 2 million in cash and USD 1.8 million equivalent ordinary shares of Kitov based on the closing price of Kitov's shares on the TASE on January 11, 2017. Following the closing of this initial acquisition, which is expected to take place on January 13, 2017, Kitov anticipates that it may acquire additional equity stakes in TyrNovo from all or part of TyrNovo's additional minority shareholders for consideration consisting of ordinary shares of Kitov in such amounts as to be agreed with the shareholders.
"The TyrNovo acquisition represents a major milestone in Kitov's strategic vision of establishing a diverse pipeline that we believe will secure long term value creation for its shareholders. We are excited about NT219 and its prospects in the oncology field. NT219 can be developed as a platform combination drug for overcoming multi-drug resistance often observed in various tumors. It has the potential to be developed as a combination therapy with several approved oncology drugs for multiple types of tumors," stated Dr. Paul Waymack, Kitov's Chairman and Chief Medical Officer.
"The Kitov regulatory team has a proven track record in the development and approval of drugs for oncology as well as other indications required to develop NT219 towards submission of an IND and initiation of clinical trials," Waymack added.
TyrNovo is led by its CEO, Dr. Hadas Reuveni, a co-inventor of the TyrNovo technology, who received her Ph.D., Summa Cum Laude, for anti-cancer drug discovery from the Hebrew University of Jerusalem and has nearly two decades of R&D experience in Biotechnology. Dr. Reuveni commented, "I am excited to join Kitov and its team to expedite the development of NT219, which addresses a true unmet medical need for numerous oncology indications. Cancer drug resistance is the major reason for failure in anti-cancer drug treatment. Preventing resistance to the drugs is critical for improving effective cancer treatment."
