On December 9, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported the selection of Kirsten rat sarcoma viral oncogene homologue (KRAS) G12V, in the context of HLA*A11, as the initial target for the co-development of T cell receptor-guided T cell engagers (TCR-TCEs) with WuXi Biologics (Press release, MediGene, DEC 9, 2024, View Source [SID1234648926]).
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The selection of this first target is a key step for the partnership between Medigene and WuXi Biologics, which aims to advance multiple TCR-TCEs over the next three years. The collaboration seeks to harness Medigene’s expertise in the generation and characterization of highly sensitive, specific and safe (3S) TCRs with WuXi Biologics’ unique anti-CD3 monoclonal antibody (mAb), its TCE platform and proprietary bispecific antibody platform WuXiBody.
"Rapid selection of KRAS G12V as the target for this first program, also known as MDG3010 in Medigene’s pipeline, marks the initial step for the development of a TCR-TCE library for the treatment of difficult-to-treat tumors. This fast program progression reflects the highly effective collaboration between the teams," said Selwyn Ho, CEO of Medigene. "We believe that the combination of Medigene’s 3S TCR and WuXi Biologics’ CD3 mAb and bispecific platform offers the potential of a best-in-class therapeutic that precisely targets broad numbers of patients expressing this validated common KRAS mutation, in an off-the-shelf administration."
KRAS mutations are widely recognized as the most common oncogene mutations and play a significant role in indications that affect a large number of patients, such as pancreatic, small bowel, colorectal, and lung cancers.1 In pancreatic cancer, KRAS mutations are among the earliest and most critical genetic alterations, present in over 95% of cases; here, G12D and G12V are the most frequent (~65%).2,3 In 2020, pancreatic cancer was the seventh leading cause of cancer-related deaths globally for both men and women, with nearly as many newly diagnosed patients (496,000) as deaths (466,000) from this single indication.4
The bispecific therapies market offers a significant opportunity in the fight against cancer, addressing the unmet need in both solid and hematologic tumors. Over 5 million cancer patients worldwide face low five-year survival rates, highlighting the urgent demand for innovative treatments. Bispecific TCR-TCEs, which harness the immune system to target cancer cells more precisely, are projected to grow at a compound annual rate of 40.9% from 2023 to 2030. By 2030, the market is expected to surpass USD 80 billion5, reflecting its potential to transform cancer treatment and improve patient outcomes.