TiumBio is dedicated to the discovery and development of new treatments for rare and incurable diseases. Credit: emiridikut/Shutterstock.

TiumBio has dosed the first subject in its Phase II clinical trial of an oral immuno-oncology drug, TU2218, targeting advanced solid tumours.

The first patient suffering from head and neck squamous cell carcinoma (HNSCC) was dosed in the trial.

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This trial is designed to evaluate the safety and efficacy of TU2218 in combination with Keytruda for patients with HNSCC, biliary tract cancer and colorectal cancer.

The company has initiated the study at Seoul National University Hospital and Asan Medical Centre in South Korea, with plans to extend to hospitals in the US.

A dual inhibitor, TU2218 targets both TGFR1 and VEGFR2 pathways known to diminish the effectiveness of immune checkpoint inhibitors (ICIs).

By inhibiting these pathways, TU2218 is poised to enhance the efficacy of ICIs.

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The drug has previously undergone Phase Ia and Ib trials to establish its safety, pharmacokinetics and pharmacodynamics, both as a monotherapy and in combination with Keytruda (pembrolizumab).

During the Phase Ib trial, the combination of a 195mg daily dose of TU2218 with Keytruda resulted in a partial response in three out of ten patients and stable disease in five patients, translating to an 80% disease control rate.

TiumBio is dedicated to the discovery and development of new treatments for rare and incurable diseases.

Alongside TU2218, its pipeline includes merigolix for endometriosis and uterine fibroids, currently in Phase II trials, and TU7710, a novel rFVIIa for haemophilia patients with inhibitors, also in clinical development stages.

TiumBio CEO Hun-taek Kim said: “HNSCC is a disease with a high unmet medical need, as the average survival rate for first-line treatments is known to be only about one year.

“We have selected cancer types for the Phase II clinical trial based on other trials that demonstrated strong anti-cancer effects from targeting TGF- ß or VEGF pathways. Our goal is to develop TU2218 as a first-line treatment for HNSCC.”

In March this year, the company submitted an investigational new drug application to the Korean Ministry of Food and Drug Safety for a Phase IIa clinical trial of TU2218, an oral immuno-oncology drug intended to treat cancer.