TransCode Therapeutics has received written approval from the Dana Farber Cancer Institute Institutional Review Board (IRB) to proceed with its first-in-human (FIH) Phase 0 clinical trial of TTX-MC138 for the treatment of patients with advanced solid tumours.
Designed to inhibit the pro-metastatic RNA, microRNA-10b, TTX-MC138 is said to be the master regulator of metastasis in several advanced solid tumour types, including glioblastomas, breast, pancreatic, ovarian and colon cancer.
The planned study will enrol around 12 individuals who will be administered a single microdose of radiolabeled TTX-MC138 followed by noninvasive positron emission tomography-magnetic resonance imaging (PET-MRI).
The dosage amount of TTX-MC138 delivered to metastatic lesions will be quantified along with the pharmacokinetics at a subtherapeutic dose in patients with cancer.
TransCode CEO and co-founder Michael Dudley said: “The delivery of RNA therapeutics to sites other than the liver has remained a significant challenge for decades.
“Overcoming this challenge would represent an unprecedented step in unlocking therapeutic access to a variety of well-documented genetic targets involved in a range of cancers and beyond.”
The trial will also provide data regarding future therapeutic dose levels, dose schedules, and potential safety that could inform later-stage studies. It is not planned to demonstrate a therapeutic effect.
TransCode Operations senior vice-president Susan Duggan said: “The FDA authorisation and IRB approval to initiate this trial mark the development of TransCode Therapeutics into a clinical-stage oncology company.”
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