TG Therapeutics and Jiangsu Hengrui Medicine Announce Global License Agreement for Development and Commercialization of Novel BTK Inhibitor Program for the Treatment of Hematologic Malignancies
US IND Filing Expected in the First Half of 2018
Hengrui is Eligible to Receive Collaboration and Licensing Payments of Approximately $350MM, in Addition to Royalties on Future Sales
Under the terms of the agreement, Hengrui will receive an up-front licensing fee and near-term milestones, payable in TG common stock, and will be eligible to receive additional payments contingent on certain clinical, regulatory, and commercial milestones, totaling approximately $350MM, as well as tiered royalties on net sales.
TG-1701 (SHR-1459) and TG-1702 (SHR-1266)
are orally available, covalently-bound BTK inhibitors that exhibit superior selectivity to BTK compared to ibrutinib in in vitro kinase screening. Hengrui commenced a Phase 1 clinical trial for TG-1701 (SHR-1459) in
Previously, TG reported that the triple combination of ublituximab, umbralisib, and the BTK inhibitor ibrutinib, resulted in a 100% Overall Response Rate (ORR) among 19 treated patients with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), an 86% ORR among 7 treated patients with iNHL (Follicular Lymphoma and Marginal Zone Lymphoma) and 100% ORR in the 4 treated patients with Mantle Cell Lymphoma (MCL).
"TG Therapeutics has a distinctive strategy towards addressing B-cell lymphomas, employing unique combination strategies to harness key drivers of oncogenesis based on a portfolio of differentiated assets," said Lianshan Zhang, Ph.D., President of Global R&D of Hengrui. "We have been very impressed by the leadership at
"Our steadfast commitment towards providing better and safer medicines for patients has propelled Hengrui to be a leading biopharmaceutical company in China," said
ABOUT BTK INHIBITORS
Bruton's tyrosine kinase (BTK) is an essential component of the B-cell receptor signaling pathways that regulate the survival, activation, proliferation, and differentiation of B lymphocytes. Targeting BTK with small molecule inhibitors has been demonstrated to be an effective
treatment option for B-cell lymphomas and autoimmune diseases.
About Jiangsu Hengrui Medicine Co., Ltd.
Jiangsu Hengrui Medicine Co., Ltd., established in 1970, is a leading biopharmaceutical company based in
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both ublituximab and umbralisib, or the combination of which is referred to as "U2",
are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future. TG Therapeutics is headquartered in New York City.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially are the following: our ability to successfully and cost effectively complete preclinical and clinical trials; the risk that early clinical trial results, that may have influenced our decision to proceed with additional clinical trials, will not be reproduced in future studies; the risk that the combination of ublituximab (TG-1101) and umbralisib (TGR-1202), referred to as ‘U2' or TG-1303 and being studied in the UNITY clinical trials, will not prove to be a safe and efficacious combination or backbone for future triple or quad combination therapies; the risk that the company will not move forward with the development of TG-1701 or any inhibitor in the BTK inhibitor program licensed from Hengrui Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
Vice President, Investor Relations
For Hengrui Medicine:
Global Business Development
Senior Vice President/ICR
Senior Vice President/ICR
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