On December 13, 2021 BeiGene (NASDAQ: BGNE; HKEX: 06160), a global science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, and Nanjing Leads Biolabs, Inc. (Leads Biolabs), a privately-owned clinical stage biotechnology company in China and the U.S., reported entry into a license and collaboration agreement granting BeiGene worldwide research, development and manufacturing rights and exclusive commercialization rights outside of China to LBL-007, a novel investigational antibody targeting the LAG-3 pathway (Press release, BeiGene, DEC 13, 2021, View Source [SID1234596971]). Data from a Phase 1 clinical trial of LBL-007 in patients with advanced solid tumors were presented at the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

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"We are excited about the strategic opportunity of adding an anti-LAG-3 agent to our portfolio and the potential to expedite the clinical development and scientific understanding of both LBL-007 and the anti-LAG-3 pathway as monotherapy and in combination with other immuno-oncology assets in BeiGene’s portfolio, including our anti-PD-1 inhibitor tislelizumab, where we see exciting combination potential for improved anti-tumor activity," said Lai Wang, Ph.D., Global Head of R&D at BeiGene. "Nanjing Leads Biolabs has developed a promising clinical candidate, which complements our I/O program and supports our strategic imperatives of global clinical excellence and opportunities to address unmet medical needs around the world."

Under the terms of the agreement, Leads Biolabs will receive $30 million upfront and is eligible to receive up to $742 million in clinical development, regulatory approval, and sales milestones, plus tiered double-digit royalties on sales in the licensed territory.

"Securing a collaboration to further develop LBL-007 has been a key strategic priority, and we are excited to begin working with BeiGene, a global leader in oncology," said Xiaoqiang Kang, M.D., Ph.D., CEO and Chairman of Leads Biolabs. "BeiGene is the ideal partner for Leads Biolabs given its extensive experience in the development of oncology medicines worldwide and the compelling immuno-oncology combination opportunity in its pipeline. By collaborating with BeiGene, Leads Biolabs expects to significantly accelerate the development and commercialization of LBL-007."

About LBL-007
LAG-3 is an immune checkpoint receptor expressed on activated T cells to negatively regulate these cells, resulting in tumor immune escape. LBL-007, a novel investigational anti-LAG-3 antibody, was developed by screening of a human antibody phage display library and demonstrated specific binding to human LAG-3, stimulation of IL-2 release and blockage of LAG-3 binding to MHC II and other known LAG-3 ligands. LBL-007 monotherapy was shown in pre-clinical studies to significantly inhibit tumor growth, with more pronounced tumor inhibition when combined with an anti-PD-1 antibody. LBL-007 has obtained IND clearance in both the U.S. and China, as well as completed a Phase 1a clinical trial, and is currently in Phase 1b/2 clinical trials in China.

BeiGene Oncology
BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,750 colleagues dedicated to advancing more than 90 ongoing or planned clinical trials (over 70 clinical trials are ongoing) involving more than 14,000 patients and healthy volunteers. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.