How Toragen Is Fast-Tracking TGN-S15 to IND

In an interview with PharmTech, Sandra Coufal, MD, CEO of Toragen, discusses the strategic approach to drug development, intellectual property, and regulatory advancement for the company’s lead compound, TGNS15.

Dr. Coufal explains why Toragen chose to advance TGNS15 over TGNS11. Since TGNS11 is a racemic compound tied to a generic, it offers limited IP protection. TGNS15, however, was an undifferentiated enantiomer before Toragen began its work, giving the company a stronger patent position. As Dr. Coufal notes, "Since it was an undifferentiated or a non-differentiated enantiomer prior to Toragen working on it, we actually have patents that are composition of matter patents, not just method of use patents." With those patents filed and method of use patents already granted, TGNS15 is the clear path forward.

Dr. Coufal also highlights a key formulation decision that the drug is available in liquid form, specifically designed to serve patients who cannot swallow pills. This method was developed for patients with head and neck cancers who have undergone disfiguring resections. "We wanted to be certain to have a liquid form available," she explains, adding that patients in this population "may have special tubes that they eat from."

On the chemistry, manufacturing, and controls front, Dr. Coufal shares that Toragen has successfully identified and crystallized its preferred salt form. The company is now focused on scaling up production to good manufacturing practice standards for human use.

Perhaps most significantly, Dr. Coufal explains that because TGNS15 derives from a compound with decades of human safety data, Toragen anticipates the FDA will require only a fraction of the standard investigational new drug-enabling studies that are typically required, which could save the company millions of dollars and considerable time on its path toward Phase II trials across multiple HPV-positive cancer indications.