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Akeso, Summit Therapeutics Ink $5B Licensing Deal for PD-1/VEGF Bispecific Antibody

NEW YORK – Akeso said on Tuesday that it signed a licensing and collaboration agreement with Summit Therapeutics for commercialization of its bispecific antibody ivonescimab.

Zhongshan, China-based Akeso will receive a $500 million upfront payment. With regulatory and commercial milestones, the deal could be worth up to $5 billion. The company is also eligible for low double-digit royalties on net product sales of ivonescimab. In return, Menlo Park, California-based Summit gains exclusive rights to develop and commercialize ivonescimab in the US, Canada, Europe, and Japan, while Akeso will keep development and commercialization rights for the rest of the world, including China.

Akeso is conducting two Phase III trials of the drug. One of the trials will evaluate ivonescimab in patients with non-small cell lung cancer whose tumors are positive for PD-L1 expression compared to Merck's Keytruda (pembrolizumab). A second Phase III trial is underway comparing ivonescimab plus chemotherapy to chemotherapy alone in patients with EGFR-mutated advanced non-squamous NSCLC that have failed prior EGFR-tyrosine kinase inhibitor therapy.

In a Phase II study, patients with NSCLC who had failed EGFR-TKIs had an overall response rate of 68.4 percent and median progression free survival of 8.2 months compared to a median progression-free survival of 4.3 months in a historical comparison group treated with current standard-of-care chemotherapy. In another cohort of that study, patients who had failed PD-L1 and chemotherapy had a median progression-free survival of 6.6 months compared to 4.5 months for a historical cohort treated with docetaxel alone.