Summit Therapeutics and MD Anderson Partner to Speed Up Ivonescimab Development

Summit Therapeutics Inc. (NASDAQ: SMMT) and The University of Texas MD Anderson Cancer Center have announced a strategic five-year partnership to fast-track the development of ivonescimab. This collaboration aims to leverage MD Anderson’s clinical and research capabilities alongside Summit’s novel PD-1 / VEGF bispecific antibody to explore new therapeutic applications, including various tumors not currently part of the development plan.

The partnership will see MD Anderson leading multiple clinical trials to assess the safety and potential clinical benefits of ivonescimab. It will also involve additional research activities to identify potential biomarkers. Early research may cover different cancer types such as renal cell carcinoma, colorectal cancer, skin cancer, breast cancer, and glioblastoma, rapidly expanding the scope of ivonescimab’s development program.

Allen S. Yang, MD, PhD, Chief Medical Officer of Summit, expressed enthusiasm for the collaboration, stating it will accelerate the clinical development of ivonescimab and potentially benefit a broad range of patients. Recent results from the Phase III HARMONi-A and HARMONi-2 non-small cell lung cancer (NSCLC) clinical trials, conducted by Summit’s partner Akeso, have shown promise, in addition to positive Phase II data in other solid tumors.

Christopher Flowers, M.D., Division Head of Cancer Medicine at MD Anderson, highlighted the institution's commitment to bringing new, impactful medicines to patients swiftly. He noted that collaborating with Summit could enhance the clinical development of ivonescimab and its unique mechanism of action, aiming to improve treatment options for cancer patients.

The collaboration involves a joint steering committee to oversee the design and conduct of preclinical and clinical studies, expected to commence later this year.

Ivonescimab, known as SMT112 in Summit’s licensed territories, is an investigational bispecific antibody that combines immunotherapy by blocking PD-1 with anti-angiogenesis effects by blocking VEGF. This combination is intended to target tumor tissue more effectively than normal tissue, displaying higher affinity in the presence of both PD-1 and VEGF. Ivonescimab's tetravalent structure enhances its binding in the tumor microenvironment, potentially improving efficacy and safety profiles.

Engineered by Akeso Inc., ivonescimab is currently undergoing multiple Phase III clinical trials. Over 1,800 patients have participated in global clinical studies involving ivonescimab. Summit has initiated its clinical development in NSCLC, with two multi-regional Phase III trials, HARMONi and HARMONi-3, enrolling patients in 2023. HARMONi aims to evaluate ivonescimab combined with chemotherapy in patients with EGFR-mutated, non-squamous NSCLC who have progressed after EGFR TKI treatment. HARMONi-3 will compare ivonescimab combined with chemotherapy to pembrolizumab combined with chemotherapy in first-line metastatic squamous NSCLC patients.

Additionally, Akeso has reported positive outcomes from two single-region Phase III trials in China for ivonescimab in NSCLC. HARMONi-A evaluated ivonescimab with chemotherapy in patients with EGFR-mutated, non-squamous NSCLC following EGFR TKI treatment. HARMONi-2 compared ivonescimab monotherapy to pembrolizumab monotherapy in patients with PD-L1 positive tumors.

As an investigational therapy, ivonescimab is not yet approved by regulatory authorities in Summit’s licensed territories, including the United States and Europe, though it received marketing authorization in China in May 2024.

Summit Therapeutics, established in 2003 and listed on the NASDAQ Global Market under the symbol "SMMT," focuses on biopharmaceutical oncology, aiming to develop and commercialize therapies that improve patients' quality of life and address unmet medical needs. The company is headquartered in Miami, Florida, with additional offices in Menlo Park, California, and Oxford, UK.

The University of Texas MD Anderson Cancer Center in Houston is renowned for its cancer care, research, education, and prevention, aiming to eliminate cancer globally. It is one of the first National Cancer Institute-designated comprehensive cancer centers and consistently ranks as a top hospital for cancer treatment.