On January 8, 2018 TG Therapeutics, Inc. (NASDAQ:TGTX) (or "TG") and Jiangsu Hengrui Medicine Co., Ltd. (SSE:600276) (or "Hengrui") reported that the companies have entered into an exclusive global license agreement pursuant to which TG Therapeutics will obtain worldwide rights, excluding Asia but including Japan, for the development of Hengrui’s Bruton’s Tyrosine Kinase (BTK) inhibitor program, including lead candidate TG-1701 (known in China as SHR-1459), as monotherapy and in combination with ublituximab (TG-1101), TG’s glycoengineered anti-CD20 monoclonal antibody, and umbralisib (TGR-1202), TG’s next generation PI3K-delta inhibitor (Press release, TG Therapeutics, JAN 8, 2018, View Source [SID1234523028]). In addition to TG-1701, the global license agreement covers TG-1702 (SHR-1266), another BTK inhibitor in pre-clinical development.
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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 China in December 2017 while TG-1702 (SHR-1266) is in pre-clinical development.
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).
Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are pleased to be partnering with one of the leading Chinese biopharmaceutical companies. We have been evaluating potential BTK inhibitors for quite some time and we were really impressed with Hengrui’s research that led to the development of these two highly selective BTK inhibitors. We believe TG-1701 could be comparable to the best-in-class BTK inhibitors and in combination with ublituximab and umbralisib, could represent a truly unique triple combination treatment option across CLL and NHL." Mr. Weiss continued, "With our UNITY program, we have pivotal and registration directed trials either already fully enrolled or enrolling across CLL and NHL for our U2 combination of umbralisib + ublituximab, and for umbralisib as a single agent. With this license, we have taken a major step toward the development of a next generation, wholly-owned, proprietary, triplet therapy. Our goal is to advance TG-1701 into the clinic as quickly as possible in the first half of this year."
"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 TG Therapeutics and their vision in re-defining the treatment landscape for lymphoma patients."
"Our steadfast commitment towards providing better and safer medicines for patients has propelled Hengrui to be a leading biopharmaceutical company in China," said Piaoyang Sun, Ph.D., Chairman of Hengrui. "In recent years we have worked hard to generate and develop novel, potentially high impact oncology assets across modalities including immuno-oncology, targeted therapies, hormonal therapies, antibody-drug conjugates, oncolytic viruses, and epigenetics, among others. Hengrui is absolutely delighted to be a partner of TG Therapeutics to jointly make a difference for patients who suffer hematology malignancies around the world."
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.