A new bar was set for the most valuable out-license deal struck by a China-based company, as Akeso Inc., (HKG: 9926) handed US firm Summit Therapeutics Inc., (NASDAQ: SMMT) exclusive development and commercialization rights to the bispecific antibody (BsAb) ivonescimab. The deal covers the territories of the United States, Canada, Europe, and Japan. Akeso retains development and commercialization rights to the drug in all other territories, alongside co-branding brand equity in said regions.
Deal Terms and Financials
Summit will make a USD 500 million upfront payment and is committed to USD 4.5 billion in regulatory and commercial milestone payments, alongside low double-digit royalties on net sales. This far outstrips the previous biggest out-license deal struck by a China-based firm, BeiGene’s USD 2.89 billion license of a TIGIT inhibitor to Novartis in December last year. Alongside the deal, Akeso founder and CEO Dr. Michelle Xia will be appointed to Summit’s board of directors.
Ivonescimab: Mechanism and Development
Ivonescimab (AK112 / SMT112) is a novel, potential first-in-class bispecific antibody that combines a dual mechanism of immunotherapy via blockade of programmed death-1 (PD-1) with anti-angiogenesis benefits from inhibition of anti-vascular endothelial growth factor (VEGF). The drug has reached the Phase III stage, the most advanced of and PD-1/VEGF BsAb under development globally. No PD-1-based BsAbs have so far been approved in the US or Europe.
Clinical Trials and Future Plans
Akeso has initiated a Phase III head-to-head study for ivonescimab in first-line PD-L1-positive non-small cell lung cancer (NSCLC) compared with pembrolizumab, and another Phase III for ivonescimab combined with chemotherapy vs. chemotherapy alone in advanced NSCLC with epidermal growth factor receptor (EGFR) mutations resistant to EGFR tyrosine kinase inhibitor (TKI). According to clinicaltrials.gov, 10 clinical trials for the drug are in China while 1 Phase I study was held in Australia.-Fineline Info & Tech
