Full Press Release Details
Kitov Enters Immuno-Oncology Field Through
Acquisition of TyrNovo
TEL AVIV, Israel, January 12,
2017 /PRNewswire/ - Kitov Pharmaceuticals Holdings Ltd. (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company,
announced today 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 U.S. 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 U.S. FDA and initiate clinical trials for its newly acquired
The market for immuno-oncology treatments
is believed to become worth $14 billion by 2019 and to grow to $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% equity stake in TyrNovo from its majority shareholder, for consideration of $2 million in cash and $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."
NT219 is a small molecule that presents
a new concept in cancer therapy by promoting the degradation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS)
1 and 2 as well as the inhibition of signal transducer and activator of transcription 3 (STAT3). While targeted anti-cancer drugs
inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways.
In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased
survival in various cancers by preventing the tumors from developing multi-drug resistance and ameliorating multi-drug resistance
after resistance is acquired. NT219, in combination with various approved oncology drugs, demonstrated potent anti-tumor effects
and increased survival in various cancer models including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate
and colon cancers, through the prevention of acquired resistance and regression of resistant tumors.
TyrNovo is developing NT219, a small
molecule originally developed by Dr. Hadas Reuveni and Prof. Alexander Levitzki at the Hebrew University, and exclusively licensed
from Yissum, the Hebrew University Research Development Company. TyrNovo demonstrated the potential of NT219 to overcome resistance
to multiple anti-cancer drugs, by using the Patient-Derived Xenograft (PDX) models, in collaboration with Prof. Izhak Haviv from
the Bar-Ilan University and Prof. M. Stemmer from Clalit HMO.
About Kitov Pharmaceuticals
Kitov Pharmaceuticals (NASDAQ/TASE:
KTOV) is an innovative biopharmaceutical drug development company. Leveraging deep regulatory and clinical-trial expertise, Kitov's
veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval.
Kitov's flagship combination drug, KIT-302, intended to treat osteoarthritis pain and hypertension simultaneously, achieved the
primary efficacy endpoint for its Phase III clinical trial and its New Drug Application with the U.S. Food and Drug Administration
is currently being prepared for submission. It's newest drug, NT219 is a small molecule that presents a new concept in cancer
therapy, and in combination with various approved oncology drugs, demonstrated potent anti-tumor effects and increased survival
in various cancer models. By lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics,
Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people's lives. For
more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.
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Chief Financial Officer
+972-3-9333121 ext. #105
LifeSci Advisors, LLC
SOURCE Kitov Pharmaceuticals Holdings