Summit Bets $5 Billion On Akeso’s Bispecific Antibody

Summit is going all in on Akeso’s ivonescimab, inlicensing the rights to develop and distribute the bispecific antibody in the US, Canada, Europe, and Japan. The deal, estimated to be worth $5 billion, could be the break Akeso needs to introduce its antibody products into the global market beyond China. 

Akeso will receive an upfront payment of $500 million and could unlock up to $4.5 billion in milestones. If the drug begins commercialization, Akeso could reap low double-digit royalties on net sales. The Chinese company retains the rights for all other regions, including China. Following the closing of the deal, Akeso CEO Dr. Michelle Xia will join the board of directors of Summit. 

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Bispecific Antibody For Cancer

For the last eight years, Akeso has focused on advancing ivonescimab through the clinic. The company is now saying that the PD-1/ VEGF bispecific is the most advanced of its class in the clinic; neither the US FDA nor EMA has approved a PD-1-based bispecific. 

China, however, approved the drug earlier this year to treat advanced cervical cancer patients whose disease had progressed despite chemotherapy. To date, ivonescimab (brand name “Kaitanni”) is the only PD-1-based bispecific to be approved in the country. 

Ivonescimab has also received Breakthrough Therapy Designations in China for three indications: combination therapy with chemotherapy for non-small cell lung cancer (NSCLC) who have failed EGFR-TKI or PD-(L)1 therapy, and monotherapy for first-line advanced NSCLC patients who test positive for PD-L1. 

At ASCO 2022, Akeso revealed in a presentation that ivonescimab treatment, in combination with pemetrexed and carboplatin, had an overall response rate (ORR) of 68.4% in a Phase 2 study in NSCLC patients who have failed EGFR-TKI. The combination therapy resulted in a median progression-free survival (mPFS) of 8.2 months compared to 4.3 months in patients treated with the chemotherapies alone, the current standard of care. 

In a separate cohort, ivonescimab combined with docetaxel in patients who have failed PD-(L)1 and chemotherapies showed an mPFS of 6.6 months versus a historical mPFS of 4.5 months with docetaxel alone. The trial demonstrated a tolerable safety profile and had a low discontinuation rate for adverse events, said Akeso. 

NSCLC indications will be the first targets of Summit’s development activities for ivonescimab, which has been relabeled SMT112. Summit has stated that it plans to start treating patients in clinical studies by the second quarter of 2023. 

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Joy Lin

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