Currently TransCode is continuing research on a variety of both diagnostic and therapeutic approaches targeting biomarkers broadly prevalent across numerous tumor types.
Establishing Proof of Concept
As a next step, the company intends to advance TTX-MC138 to the clinic to be evaluated in human subjects suffering from late stage cancer. TransCode has received written guidance from the FDA in response to our pre-IND submission for our proposed first-in-human study and we are proceeding ahead under that guidance.
Based on FDA guidance, we expect to initiate an exploratory clinical trial under an eIND that will demonstrate proof of mechanism of delivery and target engagement. Based on the results of this study, the exploratory IND will be withdrawn, and a full IND will be submitted to support a Phase I/II clinical trial intended to evaluate safety and dose/response in patients with metastatic cancer.
The FDA has not evaluated or approved TTX-MC138 and it is currently not available for patient use.