Benzinga | Nov 23, 2020 08:38AM EST

Ligand Pharmaceuticals Says Two Large Multinational Pharmaceutical Partners With License To Omniab Have Reached Clinical Development Milestones With Programs; Says Progress By Partners Resulted In Total Of $4.5M In Milestone Payments Being Earned By Co.

Two large pharma partners reach clinical-development milestones with OmniAb-derived antibody programs and Ligand earns $4.5 million in milestone payments

CStone Pharmaceuticals announces China NDA submission and data for its OmniAb-derived antibody to treat non-small cell lung cancer in a first-line setting

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announces clinical and regulatory progress by multiple partners utilizing antibodies from its OmniAb(r) discovery platform. Two large multinational pharmaceutical companies with a license to OmniAb have reached clinical-development milestones with their programs. The progress by these companies resulted in a total of $4.5 million in milestone payments being earned by Ligand.

In addition, CStone Pharmaceuticals recently announced that China's National Medical Products Administration has accepted for review CStone's New Drug Application (NDA) for sugemalimab (CS1001), an OmniAb-derived anti-PD-L1 monoclonal antibody used in combination with chemotherapy for the first-line treatment of advanced squamous and non-squamous non-small cell lung cancer (NSCLC). This marks the first regulatory submission by CStone for sugemalimab. Last month, CStone announced a major financial and commercial partnership with Pfizer to commercialize sugemalimab in greater China. Ligand is entitled to a 3% royalty on worldwide commercial sales of sugemalimab.

CStone also announced that positive clinical data based on a pre-planned interim analysis of the GEMSTONE-302 clinical study were disclosed in an oral presentation at European Society for Medical Oncology (ESMO) Asia Virtual Congress 2020 on November 21, 2020 (link to full release here). The GEMSTONE-302 trial is the first randomized, double-blind, Phase 3 study of an anti-PD-L1 monoclonal antibody plus platinum-based chemotherapy as first-line treatment for stage IV squamous or non-squamous NSCLC. The results showed sugemalimab plus chemotherapy as first-line treatment for advanced NSCLC demonstrated statistically significant and clinically meaningful benefit in progression free survival (PFS) compared to chemotherapy across PD-L1 expression levels and histologies. Specifically, sugemalimab in combination with chemotherapy reduced the risk of disease progression or death by 50% and produced an objective response rate (ORR) of 61.4%. The combination therapy was well-tolerated with no new safety signals detected. CStone reported that these Phase 3 data are amongst the best of those reported by other anti-PD-L1 monoclonal antibodies.

"We are very pleased with the progress and impressive data our partners are reporting with their Ligand OmniAb-derived antibodies," said John Higgins, Chief Executive Officer of Ligand. "There are currently more OmniAb programs than ever under development, and as programs advance Ligand is now collecting more and larger milestone payments that are contributing to our strong financial performance. Next year we anticipate the first two OmniAb-derived antibodies could receive regulatory approvals, and these events could start the first OmniAb royalty revenue to Ligand. With partnership and royalty rights on programs that extend to 2040 and beyond, we believe we are in the early days of a substantial growth trajectory from our OmniAb business."