Cancer immunotherapy targeting the CD47 protein is gaining traction as a promising approach to improve patient outcomes, with multiple clinical trials underway and regulatory support increasing. These therapies aim to disrupt the "don't eat me" signal that cancer cells use to evade the immune system, thereby enhancing the body’s natural defenses against tumors.
Overcoming Limitations of Traditional Cancer Treatments
Traditional cancer treatments like surgery, radiation, and chemotherapy, while effective in eradicating primary tumors, often come with systemic toxicities and high relapse rates. The increasing prevalence of cancer and the limitations of conventional therapies have spurred the demand for novel, targeted approaches. Targeting the CD47 surface checkpoint is one such innovative strategy, aiming to inhibit cancer proliferation by blocking the CD47/SIRPα interaction, which normally prevents macrophage phagocytosis.
Clinical Development of CD47 Inhibitors
Several CD47-targeted therapies are currently in clinical development. HX009, a recombinant humanized anti-CD47/PD-1 bifunctional antibody developed by Waterstone Hanxbio, is being assessed in a Phase 1/2 clinical trial for patients with advanced solid tumors. Evorpacept (ALX148), a novel CD47 inhibitor, is being evaluated in combination with Cetuximab and Pembrolizumab for colorectal cancer, with Venetoclax and Azacitidine for acute myeloid leukemia, and with Rituximab and Lenalidomide for B-cell non-Hodgkin lymphoma.
Magrolimab, developed by Forty Seven (now part of Gilead), is another advanced CD47 inhibitor showing encouraging results in early-stage clinical trials for hematological tumors, especially when combined with other cancer treatments. Late-stage trials are evaluating magrolimab in solid cancers alongside docetaxel, Nivolumab, Pembrolizumab, Azacitidine, and Venetoclax.
Regulatory Support and Market Expansion
Regulatory bodies have shown support for CD47-targeting therapies through IND clearances and drug designations. The FDA granted fast track designation to PT217, a bispecific antibody targeting CD47 and DLL3, in April 2024. China’s NMPA accepted Immuneonco’s clinical trial application for pivotal phase 3 studies of its CD47 inhibitor IMM-01 in combination with the PD-1 inhibitor tislelizumab. These developments indicate a rapidly expanding CD47 market, driven by the rising incidence of cancer.
Global Participation and Future Outlook
The CD47 immunotherapy field involves numerous pharmaceutical companies, hospitals, and research centers, including The First Affiliated Hospital of Soochow University, Cancer Hospital Chinese Academy of Medical Sciences, and Zhejiang Cancer Hospital. While the United States currently leads the CD47 immunotherapy sector, developing countries like China are increasingly engaged in preclinical and clinical studies, fueled by technological advancements and a rising cancer patient population.
Although no CD47-targeted therapies have yet been approved for commercial use, several are expected to enter the market soon, driven by the surge in clinical trials and research. The potential of CD47 inhibitors has led to significant partnerships and acquisitions, such as Gilead Science's acquisition of Forty Seven for US$4.9 billion in 2020 and Pfizer's acquisition of Trillium Therapeutics for US$2.26 billion in 2021.
