NewgLabPharma Completes US FDA Pre-IND Process for Novel Anticancer Drug

[Asia Economy Reporter Hyunseok Yoo] Newgelab Pharma announced on the 14th that it has successfully completed the Pre-IND process by receiving a Pre-IND Letter from the U.S. Food and Drug Administration (FDA) for its metabolic anticancer drug candidate ‘KAT (Ko Anti-cancer Technology).’

Newgelab Pharma applied for a Pre-IND meeting with the FDA in March and submitted preliminary consultation materials to proceed with clinical trials of KAT as a treatment for liver cancer. Recently, the FDA notified that due to the COVID-19 situation, the Pre-IND meeting would be conducted in the form of a written review.

The Pre-IND process is the first step toward clinical trial approval. It is conducted to increase the likelihood of clinical trial approval by discussing the trial plan covering clinical trials and new drug development with the FDA before submitting an IND application.

Newgelab Pharma plans to complete the IND submission by June by reflecting the FDA’s feedback received during this Pre-IND process.

Hanshin Young, Head of Clinical Division at Newgelab Pharma, said, “Although the Pre-IND process was conducted as a written review instead of a face-to-face meeting due to the COVID-19 situation, we believe we received sufficient answers to our inquiries. We will diligently prepare the IND application based on the discussions.”

The metabolic anticancer drug KAT is a novel drug substance that, unlike existing anticancer treatments, selectively kills cancer cells by blocking their metabolic processes.