We have created a platform of drug candidates with the objective of improving patient outcomes. Our lead therapeutic candidate, TTX-MC138, is focused on treating metastatic cancer, which has been shown to be responsible for approximately 90% of all cancer deaths representing over 9 million deaths per year worldwide. We believe that TTX-MC138 has the potential to produce regression without recurrence in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas and others. Additionally, the Company’s other drug candidates, TTX-siPDL1, TTX-siLIN28b, TTX-RIGA, TTX-CRISPR and TTX-mRNA, focus on treating tumors using RNA technology made possible through its proprietary delivery platform.
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 Based on the results of this study, the exploratory IND will be withdrawn, and a full IND will be submitted to support a Phase I/II clinical trial intended to evaluate safety and dose/response in patients with metastatic cancer.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.