April 27, 2024

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[THE INVESTOR] Korean biopharmaceutical company GemVax & Kael said on Jan. 15 that it plans to file an Investigational New Drug application for its Alzheimer’s disease therapy candidate with the US Food and Drug Administration before July. 

The company has been working on telomerase peptide GV1001, which was initially developed as an anti-cancer drug.

“We hope to clear the regulatory hurdles to initiate clinical studies in the US this year after submitting an application in the first quarter,” said CEO Song Hyung-gon.

In Korea, GemVax & Kael is recruiting patients with mid- and late-stage Alzheimer’s to conduct phase 2 clinical programs. The company’s lead drug candidate reflects a new approach to develop the dementia drug. So far, other global drug makers have focused on targets like amyloid beta protein, tau protein, beta secretase and 5-hydroxytryptamine 6 receptor.

According to the Daejeon-based company, patients with the memory disorder have shorter telomeres, which shorten with every cell division. And the length of telomeres can be maintained by activation of telomerase, resulting in cognition enhancement of patients.

Alzheimer’s disease is the most common form of dementia worldwide, affecting millions of patients, with no therapeutic options available to date.

By Park Han-na (hnpark@heraldcorp.com)