On August 30, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that its partner Gloria Biosciences (GloriaBio) has received approval from China’s National Medical Products Administration (NMPA) for zimberelimab (GLS-010), an OmniAb-derived anti-PD-1 monoclonal antibody for the treatment of recurrent or refractory classical Hodgkin’s lymphoma (cHL) (Press release, Ligand, AUG 30, 2021, View Source [SID1234587002]). GloriaBio has development and commercialization rights in China with respect to zimberelimab through a sublicense agreement with Ligand’s licensee Wuxi Biologics Ireland Limited.
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Zimberelimab is a fully human monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in the downregulation of the immune system by preventing the activation of T cells. Other anti-PD-1 antibodies have been approved by the U.S. FDA in multiple cancer types. In addition to cHL, GloriaBio is investigating zimberelimab in advanced solid tumors and in March 2021 was granted Breakthrough Therapy Designation for the treatment of patients with recurrent or metastatic cervical cancer in China. Zimberelimab is being developed by Arcus Bioscience in North America, Europe, Japan and certain other territories through a 2017 license agreement.
"We are delighted to see GloriaBio’s progress with zimberelimab including receipt of NMPA approval. When we acquired the OmniAb technology in 2016, there were no OmniAb-derived antibodies in the clinic. GloriaBio’s approval just five years after our acquisition and just four years after they entered the clinic is truly impressive," said John Higgins, CEO Ligand Pharmaceuticals. "Approval of this OmniAb-derived antibody represents the first of many regulatory events we expect over the coming years from what we believe is the industry’s best-in-class antibody discovery engine. Indeed, this is our biggest year ever for regulatory approvals for our partnered products."
About Zimberelimab
Zimberelimab is a fully human monoclonal antibody that binds to PD-1, restoring the antitumor activity of T cells. GloriaBio contracted with Ligand’s partner WuXi Biologics to discover and develop GLS-010 using Ligand’s transgenic rat platform, OmniRat. WuXi and GloriaBio subsequently out-licensed zimberelimab rights to Arcus, excluding China and certain other territories. Arcus, in collaboration with Gilead Sciences, is conducting multiple Phase 1 and Phase 2 trials to evaluate the safety and tolerability of zimberelimab in subjects with prostate, colorectal, non-small cell lung (NSCLC), pancreatic, triple-negative breast and renal cell cancers. A Phase 3 trial was initiated in 2021 to evaluate zimberelimab monotherapy or in combination with Arcus’ anti-TIGIT antibody (AB154) in patients with PD-L1-positive locally advanced or metastatic NSCLC.
In a Phase 2 study in Chinese patients with relapsed and refractory cHL zimberelimab showed impressive preliminary efficacy and a manageable safety profile, with an overall response rate of 90.6%, a 6-month progression-free survival rate of 88.2% and treatment-related adverse events (TRAEs) of mostly grade 1-2; most immune-related adverse events were grade 1-2 and did not limit treatment.1 In a Phase 2 study in Chinese patients with recurrent or metastatic cervical cancer zimberelimab also showed TRAEs of mostly grade 1-2.2 Zimberelimab also demonstrated encouraging therapeutic activity and manageable safety profile in Chinese patients with relapsed or refractory cHL and recurrent or metastatic cervical cancer, and could be a new safe and effective treatment option. GloriaBio has received approval in China for zimberelimab for the treatment of recurrent or refractory cHL. Under the terms of Ligand’s agreement with WuXi, Ligand is entitled to royalties on future product sales.
About OmniAb
The OmniAb antibody discovery platform provides Ligand’s biopharmaceutical partners access to the world’s most advanced antibody repertoires and screening technologies to enable unparalleled discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse, each capable of generating high-quality, fully human antibodies that have been naturally optimized through in vivo affinity maturation. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. OmniAb animals comprise the most diverse host systems available in the industry and are optimally leveraged through AI-enhanced antigen design and immunization methods, paired with high-throughput microfluidic-based single B cell screening and deep computational analysis of next-generation sequencing datasets to identify fully human antibodies with superior performance and developability characteristics. The OmniAb suite of technologies and differentiating AI and BI features are combined to offer a highly efficient and customizable end-to-end solution for the growing antibody discovery needs of the global biopharmaceutical industry.