FDA Authorizes TransCode's First-In-Human Clinical Trial With Solid Tumor Patients

TransCode Therapeutics Inc RNAZ has received written authorization from the FDA to proceed with its First-in-Human (FIH) Phase 0 clinical trial.
The planned clinical trial is to evaluate TransCode's lead therapeutic candidate, TTX-MC138, in up to 12 cancer patients with advanced solid tumors.
TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, described as the master regulator of metastasis in several advanced solid tumors.
Related: TransCode Therapeutics Shares Shoot Higher After Encouraging Preclinical Data From Lead Cancer Candidate.
A Phase 0 clinical trial is an exploratory study conducted under an Investigational New Drug application.
In TransCode's planned clinical trial, up to 12 patients will be given a single dose of a radiolabeled TTX-MC138 followed by noninvasive positron emission tomography-magnetic resonance imaging.
The trial is intended to quantify the amount of radiolabeled TTX-MC138 delivered to metastatic lesions and the pharmacokinetics of the therapeutic candidate in cancer patients.
The trial could yield critical therapeutic dose, timing, and potential safety data. This trial is not intended to demonstrate any therapeutic effect.
Price Action: RNAZ shares are up 27.8% at $0.78 on the last check Thursday.