Sandra Coufal, MD

Sandra Coufal, Toragen, discusses advancing TGNS15 with strong IP, liquid formulation, and an accelerated FDA pathway, potentially saving millions on IND-enabling studies.

 How Toragen Is Fast-Tracking TGN-S15 to IND

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.

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Sandra Coufal, MD, Toragen, discusses advancing TGNS15 with strong IP, liquid formulation, and an accelerated FDA pathway, potentially saving millions on IND-enabling studies.

How Toragen Is Fast-Tracking TGN-S15 to IND

Sandra Coufal, Toragen, discusses how TGN-S15's preferred enantiomer showed no neurotoxicity and reduced tumor growth, supporting development of a safer, cheaper oral cancer drug.

From Bench to Pill Enantiomer Science and Oral Delivery

, Sandra Coufal, MD, CEO, Toragen, walks through the preclinical research that validated her team's preferred enantiomer compound for TGN-S11, Toragen’s small molecule inhibitor of the E5 oncogene protein, in patients with cancers associated with HPV.

Dr. Coufal describes two key rodent studies that shaped the direction of TGN-S11’s development program. The first was a neurotoxicity assessment, in which the non-preferred enantiomer triggered seizures in half of the test animals, while the preferred enantiomer showed no such effect. The second was a tumor model study using HPV-positive cancer cells, for which animals were treated for 69 days across three drug variants. The preferred enantiomer outperformed both the racemic compound and the non-preferred enantiomer in reducing tumor growth. As Dr. Coufal explains, "We were able to confirm the efficacy and also confirm the absence of neurotoxicity in the preferred enantiomer, and that's what gave us confidence to go forward."

From there, Dr. Coufal discusses the intellectual property strategy her team has pursued, focusing on patenting GRAS-designated salt forms of the preferred enantiomer. One salt form stood out for its pharmacokinetic profile, specifically a blunted peak drug concentration after ingestion. "That high Cmax in your bloodstream after taking a small molecule is what's really most associated with toxicity," Dr. Coufal notes.

Sandra Coufal, MD, Toragen, discusses how TGN-S15's preferred enantiomer showed no neurotoxicity and reduced tumor growth, supporting development of the oral cancer drug.

Sandra Coufal, MD

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