Summit Therapeutics and Pfizer Collaborate on Ivonescimab Trial with ADCs

Summit Therapeutics Inc. and Pfizer Inc. have entered into a strategic alliance aimed at advancing the development of innovative cancer therapies. The collaboration focuses on evaluating ivonescimab, a pioneering PD-1/VEGF bispecific antibody, alongside several of Pfizer's advanced antibody drug conjugates (ADCs) across various solid tumor environments. The trials, which are slated to commence mid-year, represent a significant step forward in cancer treatment research.

Bob Duggan and Dr. Maky Zanganeh, Co-CEOs of Summit, expressed optimism about the partnership's potential to rapidly develop groundbreaking treatments. They emphasized the collaborative effort's aim to extend therapeutic options beyond existing solutions, particularly for patients battling complex cancer types. By combining ivonescimab with Pfizer’s cutting-edge ADCs, the partnership seeks to push its promising late-stage development plans forward, potentially reshaping treatment norms for solid tumors.

The primary objective of this collaboration is to investigate the safety and anti-tumor efficacy of ivonescimab when used in conjunction with Pfizer's vedotin ADCs across distinct solid tumor types. Each study will focus on a particular tumor setting, aiming to identify therapeutic synergies and improve patient outcomes where current treatments fall short.

Megan O’Meara, M.D., who leads Oncology Early Stage Development at Pfizer, underscored the collaboration’s potential to transform oncology treatment landscapes. The partnership aims to explore novel combinations that address the intricate biological challenges posed by tumors, potentially paving the way for new treatment paradigms for cancer patients.

Under the terms of the agreement, Summit will provide ivonescimab for the upcoming trials, while Pfizer will manage the operational aspects of the studies. Both companies will jointly oversee the trials, retaining their individual rights to their respective therapies. The studies will commence mid-year, with additional trial specifics to be disclosed subsequently.

Ivonescimab, also known in certain regions as SMT112 or AK112, is a novel bispecific antibody designed to combine immunotherapy and anti-angiogenesis actions into one molecule. This innovative approach aims to target both PD-1 and VEGF pathways, known for their high expression in tumor environments, to enhance tumor-specific targeting and efficacy. The antibody, developed by Akeso Inc., has demonstrated the potential to improve safety and efficacy profiles over existing therapies thanks to its unique tetravalent structure and cooperative binding capabilities. Ivonescimab is undergoing multiple Phase III trials, with over 2,300 patients having participated globally.

Summit is actively pursuing clinical development of ivonescimab for non-small cell lung cancer (NSCLC), with significant progress in its Phase III trials, HARMONi, HARMONi-3, and HARMONi-7. These trials explore various combinations of ivonescimab with chemotherapy and compare it to other treatments like pembrolizumab, aiming to offer new hope for NSCLC patients. Results from these trials are anticipated in the near future.

Despite not being approved in Summit's licensed territories, ivonescimab has already received marketing authorization in China and holds a Fast Track designation from the U.S. FDA for the HARMONi trial setting. This designation highlights its potential significance in addressing urgent medical needs in cancer treatment.

Summit Therapeutics Inc. remains committed to discovering and developing therapies that address significant unmet medical needs in oncology, with a focus on improving quality and duration of life for cancer patients. Established in 2003, Summit continues to drive innovative solutions from its headquarters in Miami, Florida, and its additional offices in Menlo Park, California, and Oxford, UK.