NeoImmuneTech said Friday that its board of directors has decided to establish a Polish subsidiary to prepare for full-scale clinical trials in the European market.

NeoImmuneTech expects that the Polish subsidiary's possible designation as a European small and medium enterprise (SME) will enable it to benefit from the European Medicines Agency (EMA) throughout its development program.

The benefits provided by the EMA include regulatory guidance for drug approval, administrative and procedural support, assistance with protocol development for orphan medicines, and direct financial support in the form of fee reductions and waivers.

NeoImmuneTech believes that the SME designation will give it an advantage in obtaining the EMA's Priority Medicines (PRIME) status. PRIME is granted to medicines that are expected to be superior to existing treatments or in areas of unmet medical need.

"In addition to our various ongoing U.S. clinical trials, we planned to establish a Polish subsidiary to more efficiently and effectively scale up (clinical trials) in the European market and accelerate the timeline for marketing authorization," NeoImmuneTech said.

It went on to say, "We plan to actively and continuously pursue the most efficient and fastest way to bring NT-I7 to market by utilizing the experience of our new CEO Oh Yun-seok, who joined the company earlier this year."