The trial is structured as a non-randomised, open-label study in patients with relapsed, resistant or metastatic HPV-related cancers. Credit: Kmpzzz / Shutterstock.

US-based biotechnology company Toragen has reported positive safety outcomes from a Phase I trial of TGN-S11, its small molecule drug candidate for the treatment of human papillomavirus (HPV) related cancers.

The ongoing trial is assessing the drug’s performance both as a standalone therapy and in combination with the programmed cell death protein 1 (PD-1) checkpoint inhibitor Keytruda.

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It is structured as a non-randomised, open-label study in patients suffering from relapsed, resistant or metastatic HPV-related cancers.

The first part of the trial involves escalating doses of TGN-S11 monotherapy, while the second part is assessing the Keytruda combination therapy.

Nine subjects have so far received the drug candidate as a single agent across the first three dose cohorts in Part I, without any safety concerns reported.

One-third of these subjects have experienced reductions in tumour size and circulating tumour HPV deoxyribonucleic acid (DNA) [ctHPV DNA] levels.

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Three patients in Part II have been treated with the combination therapy at Level I, showing signs of drug activity while not reporting any safety issues.

One patient receiving the combination therapy has seen a significant 93% decrease in ctHPV DNA.

Toragen CEO Dr Sandra Coufal said: “We have been very pleased with the positive safety profile for TGN-S11 in patients who completed the first three monotherapy dose cohorts of Part I and the first level of Part II in combination with Keytruda in this ongoing Phase I trial.

“The drug activity observed in five of these 12 subjects is also very encouraging. Based on the current progress, we believe both parts of the study will be completed by the end of 2024.”

TGN-S11 is an approved antimicrobial agent whose mechanism of action involves inhibiting the E5 oncogene protein.

Last year, Toragen received a proceed letter from the US Food and Drug Administration (FDA) for its investigational new drug application for TGN-S11.