TGN-S11 and Early Indicators of Drug Activity

In an interview with PharmTech, Sandra Coufal, MD, CEO, Toragen, discusses the methods used to measure drug activity in phase I clinical trial patients and what the encouraging early results mean for the study's next stage.

Dr. Coufal explains that the research team used two approaches to track treatment response. The first was a monthly blood test measuring circulating tumor HPV DNA numbers, a tool oncologists rely on to gauge whether a patient's therapy is working. "It actually decreases and precedes a decrease in size of tumors on CAT scan," Dr. Coufal notes, highlighting its value as an early indicator of what is happening in the body. The team observed dramatic reductions in HPV DNA levels among patients, signaling meaningful drug activity.

The second measurement approach was standard-of-care CAT scans conducted every six to eight weeks, aligned with known tumor cell doubling times. Results were similarly promising, with some tumors shrinking and others remaining stable.

Looking ahead to phase II, the team aims to enroll enough patients to reach statistically significant conclusions about partial and complete response rates. "If we had had more patients like we will have in phase II, then we get into being able to determine partial response or complete response, really more efficacy parameters," Dr. Coufal said.

Safety remains a priority as researchers work to identify the highest tolerable dose for patients. Dr. Coufal expressed confidence in the drug's profile, noting that the removal of the non-preferred enantiomer makes tolerability a lesser concern than it might otherwise be.