On September 23, 2021 TransCode Therapeutics, Inc. (Nasdaq: RNAZ), an emerging RNA oncology company created on the belief that cancer can be defeated through the intelligent design and effective delivery of RNA therapeutics, reported that preclinical research supporting its lead candidate, TTX-MC138, was published in Cancer Nanotechnology (Press release, TransCode Therapeutics, SEP 23, 2021, View Source [SID1234590226]). The article, entitled "Radiolabeling and PET-MRI microdosing of the experimental cancer therapeutic, MN-anti-miR10b, demonstrates delivery to metastic lesions in a murine model of metastatic breast cancer," resulted from research conducted at the Athinoula A. Martinos Center for Biomedical Imaging in the Department of Radiology at Massachusetts General Hospital and Harvard Medical School.
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This preclinical study developed a radio-labeled derivative of TTX-MC138 (referenced as MN-anti-miR10b) tagged with Cu-64, enabling highly sensitive and specific quantitative determination of its pharmacokinetics and biodistribution, as well as observation of delivery to metastases via noninvasive positron emission tomography-magnetic resonance imaging (PET-MRI). The key results of the study demonstrated that TTX-MC138, when injected intravenously, accumulated in metastatic lesions. These results suggest that TransCode’s TTX platform delivers its therapeutic candidate as intended and the company believes supports clinical evaluation of TTX-MC138. In addition, the investigation describes the development of a microdosing PET-MRI approach that could potentially be used for measurement of TTX-MC138 biodistribution in cancer patients and its delivery to clinical metastases. The capacity to carry out microdosing PET studies in patients under an exploratory investigational new drug application protocol would represent an important step on the path to clinical translation because it could facilitate and expedite approval from the U.S. Food and Drug Administration (FDA) for initial human studies.
"Our TTX technology builds upon prior experience with similar iron oxide nanoparticles that have long been used in humans for imaging, potentially enabling clinical studies that may de-risk future clinical trials by demonstrating successful drug delivery and assist in patient selection for future treatment," said Michael Dudley, CEO of TransCode Therapeutics. "For TransCode, we believe this study further confirms the pharmacokinetic profile of TTX-MC138, supporting the viability of our platform for delivery of RNA-based therapy to metastatic solid tumors. Our preclinical data further suggest the therapeutic potential of TTX-MC138, and we look forward to our Phase 0 study which has the potential to establish clinical proof-of-concept for this therapy."
TransCode expects to file an exploratory investigational new drug (eIND) application for TTX-MC138 in the first quarter of 2022 to support a Phase 0 study in patients with metastatic cancer. Under an eIND, FDA approval may be obtained more quickly and at lower cost than with a traditional IND for therapeutic agents.