Here’s why TransCode Therapeutics stock is up about 65% on Thursday
- TransCode says preclinical research supporting its TTX-MC138 was published in Cancer Nanotechnology.
- The oncology company will file an eIND application with the U.S. FDA to support a Phase 0 study.
- Shares of the Massachusetts' based firm jumped about 65% on Thursday morning.
Shares of TransCode Therapeutics Inc (NASDAQ: RNAZ) climbed by 65% on Thursday morning as the oncology company said in its press release that the preclinical research supporting its lead candidate, TTX-MC138, was published in Cancer Nanotechnology.
CEO Michael Dudley’s remarks
The preclinical study confirmed that intravenous injection of TTX-MC138 accumulates it in metastatic lesions, thereby establishing the TTX platform as suitable for an RNA based therapy against metastatic solid tumors. In the press release, CEO Michael Dudley said:
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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 to file an eIND application
Before a Phase 0 study in patients with metastatic cancer, the $55 million company will file an eIND application for TTX-MC138 with the U.S. FDA in Q1 of 2022.
An exploratory investigational new drug may secure approval from the regulator at a lower cost and more quickly, compared to the traditional IND for therapeutic agents. As per the CEO:
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.