Keywords- Ground-Breaking Bispecific Antibody, Low Dropout Rate, Platinum-Based Doublet Chemotherapy, Regulatory And Commercial Milestone Fees, Out-Licensing Deal.
Ivonescimab (PD-1/VEGF, AK112), a ground-breaking bispecific antibody, will be out-licensed by Biopharma Akeso Inc. to Summit Therapeutics Inc. for use in research and development and commercialization in the US, Canada, Europe, and Japan. This agreement might be worth up to $5 billion.
Akeso Inc. would get a $500 million up-front payment as per the deal. The regulatory and commercial milestone fees are included in the potential deal value overall.
Ivonescimab is a brand-new, potentially ground-breaking bispecific antibody that combines immunotherapy with the anti-angiogenesis benefits of an anti-VEGF in a single particle. It works by blocking PD-1. According to Akeso Inc., the therapy may lessen adverse effects and safety concerns.
Clinical Study Results Showing The Potential of Ivonescimab
Ivonescimab versus pembrolizumab is being tested in a Phase III clinical trial by Akeso as the first-line therapy for non-small cell lung cancer (NSCLC) with positive PD-L1 activity. Additionally, a Phase III trial comparing Ivonescimab with chemotherapy against chemotherapy is being conducted in advanced non-squamous NSCLC with mutant EGFR that was unresponsive to prior EGFR tyrosine kinase inhibitor (TKI) therapy.
The National Medical Products Administration (NMPA) in China has granted Ivonescimab breakthrough therapy designation status for three indications: the two previously mentioned indications, as well as when combined with docetaxel for the treatment of patients with locally advanced or metastatic NSCLC who failed to respond to previous PD-L1 inhibitors coupled with platinum-based doublet chemotherapy.
Ivonescimab demonstrated an overall response rate (ORR) of 68.4% for patients with NSCLC who failed EGFR-TKIs and a median progression-free survival (mPFS) of 8.2 months when merged with combination therapy (pemetrexed and carboplatin), versus a historical mPFS of 4.3 months in patients medicated with the current standard of care: combination chemotherapy. These findings were presented at the American Society of Clinical Oncology (ASCO) 2022.
In a different cohort, patients who failed PD-L1 and chemotherapy treatments showed a mPFS of 6.6 months after receiving Ivonescimab in addition to docetaxel, as compared to a previous mPFS of 4.5 months when receiving docetaxel alone, which is the current standard of care for these patients.
The research was thought to have shown a reasonable safety profile and a low dropout rate for adverse events in patients who received Ivonescimab plus chemotherapy as their first line therapy for metastatic illness.
$5 Billion In Joint Venture
Co-chief executive officer, president, and a member of Summit’s board of directors, Dr. Maky Zanganeh stated that they have identified the appropriate alliance with the ability to shift the narrative for treating patients facing tremendous odds and catastrophic diagnoses. Their objective is to lengthen the life of a patient confronting insurmountable odds while enhancing their quality of life.
Ivonescimab has shown the ability to provide patients with improved clinical benefit, says the study’s co-founder, chairperson, CEO, and president of Akeso, Dr. Michelle Xia. Over the course of the last eight years, the Akeso team has been committed to advancing Ivonescimab to the clinical Phase III stage. They are so happy to work with Summit, which has a history of effectively bringing more than a dozen different indications for the first-in-class blockbuster medicine IMBRUVICA® (ibrutinib) to market. They anticipate the quick implementation of Ivonescimab’s clinical research and marketing strategy globally.
Ivonescimab’s net product sales will also yield low double-digit percentage royalties for Akeso. Ivonescimab will be developed and commercialised exclusively in the US, Canada, Europe, and Japan by Summit. For the rest of the globe, including China, Akeso will continue to own the development and commercialization rights.
The transaction is subject to usual closing procedures, including any applicable Hart-Scott-Rodino (HSR) Act waiting periods.