$5 billion bispecific antibody pharma collaboration

Biopharma Akeso Inc. has announced it will enter into a collaboration potentially worth up to $5 billion with Summit Therapeutics Inc., by out-licensing its breakthrough bispecific antibody, ivonescimab (PD-1/VEGF, AK112) for development and commercialisation in the US, Canada, Europe, and Japan.

Under the agreement, Akeso Inc. will receive a $500 million upfront payment. The total potential deal value includes regulatory and commercial milestone payments.

Ivonescimab is a novel, potential first-in-class bispecific antibody which combines immunotherapy via a blockade of PD-1 with the anti-angiogenesis benefits of an anti-VEGF into a single molecule. Akeso Inc. state the therapy could help reduce side effects and safety concerns.

Evidence of ivonescimab’s potential in clinical trials

Akeso is conducting a Phase III clinical trial of ivonescimab versus pembrolizumab as the first-line treatment for non-small cell lung cancer (NSCLC) with positive PD-L1 expression. In addition, A Phase III trial of Ivonescimab plus chemotherapy versus chemotherapy in epidermal growth factor receptor (EGFR) mutated advanced non-squamous NSCLC that failed in prior epidermal growth factor receptor EGFR tyrosine kinase inhibitors (TKIs) therapy is ongoing.

Ivonescimab has received breakthrough therapy designation status in China from the National Medical Products Administration (NMPA) for three indications: the two aforementioned indications, as well as combined with docetaxel for the treatment of locally advanced or metastatic NSCLC patients who failed to prior PD-(L)1 inhibitor combined with platinum-based doublet chemotherapy.

At the American Society of Clinical Oncology (ASCO) 2022, Phase II study results showed ivonescimab demonstrated an overall response rate (ORR) for patients with NSCLC who failed EGFR-TKI’s of 68.4 percent and a median progression-free survival (mPFS) of 8.2 months when combined with combination chemotherapy (pemetrexed and carboplatin) compared to historical mPFS of 4.3 months in patients treated with the current standard of care: combination chemotherapy (pemetrexed and platinum-based chemotherapy).

In a separate cohort, ivonescimab combined with docetaxel in patients who failed PD-(L)1 and chemo therapies demonstrated a mPFS of 6.6 months as compared to a historical mPFS of 4.5 months with docetaxel alone, a current standard of care regimen for these patients.

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 (AEs).

A $5 billion collaboration

“… we have found the ideal partnership with the potential to change the paradigm for treating patients facing difficult odds with devastating diagnoses,” commented Dr Maky Zanganeh, Co-Chief Executive Officer, President, and a member of Summit’s Board of Directors. “… Our goal is to improve the quality of life of a patient facing immeasurable odds while extending the duration of that patient’s life.”

“Ivonescimab has demonstrated the potential to deliver superior clinical benefit for patients.” stated Dr Michelle Xia, co-founder, Chairwoman, CEO, and President of Akeso. “The Akeso team has been dedicated to the development of ivonescimab in the past eight years and advanced the molecule to the clinical Phase III stage…. We are so pleased to partner with Summit, who has the track record of successfully bringing over a dozen indications to market for the first-in-class blockbuster drug IMBRUVICA^® (ibrutinib)… we look forward to the swift execution of clinical development and commercial plan in a global setting for ivonescimab.”

Akeso will also receive low double-digit percentage of royalties on net product sales of ivonescimab. Summit will receive the exclusive rights to develop and commercialise ivonescimab (SMT112) in the US, Canada, Europe, and Japan. Akeso will retain development and commercialisation rights for the rest of the world including China.

The deal is subject to customary closing practices, including applicable waiting periods under the Hart-Scott-Rodino (HSR) Act.