Summit Therapeutics announced a definitive agreement of its partnership with Akeso to in-license its breakthrough bispecific antibody, ivonescimab. The agreement supports Summit’s mission of developing and commercializing groundbreaking oncology pipeline products aimed at improving the quality of life of patients with serious unmet medical needs. Ivonescimab, known as AK112 in China and Australia, and also as SMT112 in the United States, Canada, Europe, and Japan, is a novel, potential first-in-class bispecific antibody combining the power of immunotherapy via a blockade of PD-1 with the anti-angiogenesis benefits of an anti-VEGF into a single molecule. Akeso has already demonstrated success by commercializing the only PD-1 bispecific approved in China. Its product, a PD-1 / CTLA-4 bispecific, was approved by the Chinese National Medical Products Administratio earlier this year. Ivonescimab was engineered to bring two well established oncology targeted mechanisms together. It is our belief that the novel design has the potential to reduce side effects and safety concerns. As presented at ASCO 2022, ivonescimab treatment was associated with an overall response rate in a Phase II study in patients with non-small cell lung cancer who have failed EGFR-TKI’s of 68.4% and a median Progression-Free Survival time period of 8.2 months when combined with combination chemotherapy as compared to historical mPFS of 4.3 months in patients treated with combination chemotherapy alone, the current standard of care. The study, which similarly had patients receiving ivonescimab plus chemotherapy as their first line therapy for metastatic disease, was considered to have demonstrated a tolerable safety profile and a low discontinuation rate for adverse events. The definitive partnership calls for Summit to receive the rights to develop and commercialize ivonescimab in the United States, Canada, Europe, and Japan. Akeso will retain development and commercialization rights for the rest of the regions including China. In exchange for these rights, Summit will make an upfront payment of $500 million. The total potential deal value is $5.0 billion, as Akeso will be eligible to receive regulatory and commercial milestones of up to $4.5 billion. In addition, Akeso will be eligible to receive low double-digit royalties on net sales. In conjunction with the closing of the deal, Dr. Michelle Xia will be appointed to the board of directors of Summit. The deal is subject to customary closing practices, including applicable waiting periods under the Hart-Scott-Rodino (HSR) Act.
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