TransCode Therapeutics, a leading RNA oncology company, revealed today promising initial results from its Phase 0 clinical trial featuring TTX-MC138, the company’s flagship therapeutic candidate. The trial aims to showcase the effective delivery of TTX-MC138 to metastatic cancer, including lesions beyond the liver. Following this announcement, TransCode Therapeutics witnessed a significant surge in its stock value.
At the time of this publication, Transcode Therapeutics Inc stock (RNAZ) has witnessed a surge.
Transcode Therapeutics Inc
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Initial data demonstrated the presence of radioactivity consistent with TTX-MC138 accumulation, detected via noninvasive imaging in previously identified metastatic lesions using fluorodeoxyglucose (FDG)/positron emission tomography (PET). Furthermore, radiolabeled TTX-MC138 exhibited pharmacokinetic behavior aligning with expectations from preclinical IND-enabling studies. The patient exhibited excellent tolerance with no reported adverse reactions. Metabolite analysis indicated sustained circulation of intact radiolabeled TTX-MC138 for over 20 hours, mirroring predictions from Drug Metabolism and Pharmacokinetics (DMPK) modeling. Additionally, the drug candidate analyzed in the bloodstream corresponded precisely to the manufactured drug candidate, confirming in vivo stability. Comprehensive data analysis for this initial patient is currently underway and will be incorporated into the final report encompassing all study participants.
Dr. Zdravka Medarova, Ph.D., Chief Technology Officer at TransCode, remarked, “These preliminary clinical results strongly endorse our belief that TTX-MC138 can be effectively delivered to metastatic lesions, holding promise for metastatic cancer treatment. Preclinical evidence highlighting the crucial role of miRNA-10b in metastatic progression across various major cancer types suggests that inhibiting miRNA-10b in patients with advanced disease could yield a significant impact on their condition.”
The Phase 0 trial, an open-label, single-center microdose study, aims to demonstrate the delivery of radiolabeled TTX-MC138 to radiographically confirmed metastases in subjects with advanced solid tumors. The study may enroll up to 12 subjects, each slated to receive a single microdose of radiolabeled TTX-MC138, followed by positron emission tomography/magnetic resonance imaging (PET-MRI) and blood analyses. The objective is to quantify the amount of TTX-MC138 delivered to metastatic lesions, particularly beyond the liver, and evaluate the therapeutic candidate’s pharmacokinetics in these patients. This trial is anticipated to provide critical insights into TTX-MC138 delivery to clinical metastases, informing future dose selection and frequency for further clinical development. It is important to note that the trial is not designed to demonstrate a therapeutic effect.
Prior IND-enabling studies in non-human primates (NHP) illustrated TTX-MC138’s extended circulation and tissue distribution, consistent with hepatic clearance. Data from the NHP study were integrated into a DMPK model, aiming to simulate the pharmacokinetics and tissue distribution of TTX-MC138 in humans. The model predicted circulation and tissue distribution in humans aligning with results from TransCode’s nonclinical studies, which observed numerous complete regressions of metastatic disease.
TTX-MC138, comprising an iron oxide nanocarrier linked to a nucleic acid tailored to inhibit the oncogenic RNA, microRNA-10b, shows potential as a treatment for several advanced solid tumors. TransCode’s research suggests that TTX-MC138 could be a game-changer for these cancers. Administration of TTX-MC138 resulted in complete regression of metastatic disease in multiple mouse models of pancreatic and breast cancer. Furthermore, the therapeutic agent demonstrated successful delivery and bioactivity in a spontaneous feline mammary carcinoma case study.
CEO Michael Dudley of TransCode Therapeutics emphasized, “Our Phase 0 trial entails a single microdose of radiolabeled TTX-MC138 followed by noninvasive PET-MRI imaging and metabolite analysis. Given the striking parallels between humans and non-human primates in terms of anatomy, physiology, and molecular biology, we anticipated patient results in line with those observed in our NHP studies, as evidenced by today’s preliminary data.”
This study was conducted in collaboration with Dr. Andreas Varkaris, MD, Ph.D., an attending physician and investigator for the Termeer Center for Targeted Therapies at Massachusetts General Hospital and the principal investigator of TransCode’s study.
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