One clinical trial of NeoImuneTech's new immuno-cancer drug

Difficulties in recruiting subjects, suspension of researcher retirement

Only one case of phase 1 clinical trial of NT-I7 COVID-19 was conducted

NeoImuneTech has suspended one clinical trial for the treatment of COVID-19 of NT-I7 (efineptakin alfa), which is being developed as a new immuno-cancer drug.

 

According to ClinicalTrials.gov operated by NIH in the U.S.

 

on the 12th, it was confirmed that NeoImuneTech withdrew one phase 1 clinical trial related to NT-I7 in the second half of last year.

 

Earlier, NeoImuneTech was approved by the U.S.

 

Food and Drug Administration (FDA) in June 2020 for two clinical trials related to COVID-19.

 

The withdrawn clinical trial corresponds to a pilot study.

 

Pilot research is a small-scale study conducted to minimize errors before entering large-scale clinical trials of new drugs.

 

Regarding the reason for the suspension of clinical trials, the company explained, "We withdrew it because the situation in the United States changed rapidly due to the emergence of vaccinations and treatments because it did not match the planned clinical design in the early stages of the COVID-19 incident." NeoImuneTech attempted to develop NT-I7 treatments as the number of patients increased rapidly due to the COVID-19 pandemic.

 

From June 2020, 30 adult patients with mild COVID-19 were recruited and NT-I7 was administered as muscle injection to conduct clinical trials for treatment effectiveness and safety evaluation by dose with the NIH.

 

A month later, an additional phase 1 clinical trial of NT-I7 was approved to obtain more detailed data than the existing clinical trial.

 

The study was conducted by Jian Campian of Washington University in St.

 

Louis.

 

This clinical trial planned to confirm the immune effect of COVID-19 due to an increase in lymphocytes in the blood after NT-I7 administration.

 

However, the additional clinical trial was withdrawn due to Professor Jian Campian's resignation without registering a single subject for more than a year since it was approved.

 

In addition, the clinical trial conducted with NIH is in the process of recruiting patients.

 

NT-I7 is a hyleukin-7 T cell amplifier developed by NeoImuneTech as a new immuno-cancer drug.

 

NT-I7 has a mechanism to remove cancer cells and infected cells by increasing the number of T cells in the body.

 

According to NeoImuneTech, NT-I7 was clinically confirmed to amplify and activate T cells in cancer patients and patients with lymphocytopenia.

 

Currently, NeoImuneTech is examining clinical effects with a combination of immuno-cancer drugs such as Merck's Keytruda, Roche's Tecentriq, and BMS' Opdivo and NT-I7.

 

There are only 10 global clinical trials aimed at securing indications for various carcinomas such as gastric cancer, breast cancer, and non-small cell lung cancer.