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Molecular Templates has begun Phase 1 dosing of MT-8421, a distinct engineered toxin body targeting CTLA-4, for advanced solid tumor treatment

10 November 2023
3 min read

The first patient has been treated in the Phase 1 clinical trial of MT-8421, a new engineered toxin body targeting CTLA-4, by Molecular Templates, Inc. The company, which is a clinical-stage biopharmaceutical organization specializing in innovative therapies with effective unique modes of action for cancer, revealed this development. The trial is designed to test the treatment for advanced solid tumors.

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MT-8421 and MT-6402 are distinctive examples of our uncommon approach to immuno-oncology - dismantling the Tumor Microenvironment (TME) through an exclusive process, directly eliminating tumor and immune cells, and not just inhibiting the ligand-ligand connections seen with current antibody therapies. The ETB technique includes effective annihilation of CTLA4+ regulatory T cells by the enzymatic destruction of ribosomes, plus the method of cell eradication is independent of TME.

Our Phase 1 study is an open-label, multiple-center, first-in-human study that focuses on dose-escalation, dose-expansion and it has been crafted to examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and the initial effectiveness of MT-8421.

We will enroll adult participants with tumors that have been shown to benefit from CTLA-4 inhibitors, as well as a select range of tumor types that are known to typically possess an immune-rich TME, such as melanoma, hepatocellular carcinoma, non-small cell lung cancer, renal cell carcinoma, mesothelioma, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, urothelial carcinoma, and cervical carcinoma.

Eric Poma, PhD, CEO and Chief Scientific Officer of Molecular Templates, states that "MT-8421 introduces a single approach to immuno-oncology, specifically with CTLA-4 targeting due to its potential to eliminate Tregs within the TME, bypassing the peripheral region," adding, "We anticipate this first-in-human study to bring benefits to patients."

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According to the data provided by the Synapse Database, As of November 9, 2023, there are 115 investigational drugs for the CTLA4 target, including 163 indications, 152 R&D institutions involved, with related clinical trials reaching 1585, and as many as 35082 patents.

MT-8421 has shown potential in treating various types of cancers and is currently in Phase 1 of clinical development. Further research and clinical trials will be necessary to determine the drug's efficacy and safety profile in larger patient populations.

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