Algenomics Applies for WHO International Nonproprietary Name Registration for Anticancer Gene Therapy

Securing an INN in Line with International Standards

Algenomics, a company specializing in the development of RNA-based gene therapies, announced on December 23 that it has applied to the World Health Organization (WHO) for the registration of an International Nonproprietary Name (INN) for its anticancer drug candidate, RZ-001.

Algenomics

The INN requested for RZ-001 is reported to represent both the mechanism of action and the composition of this first-in-class pharmaceutical product.

The INN is a system in which the WHO assigns a standardized name to the active ingredient of a pharmaceutical. This system ensures that a single ingredient is given a unified name worldwide. The purpose of the system is to guarantee the accurate identification and safe use of medicines, even when drugs with the same ingredient are distributed by various companies and in different countries, by using a consistent name. Once an INN is secured, the substance can be officially recognized by its ingredient name in global academic, regulatory, and medical communities. It also allows for rapid search and classification of the substance information during business meetings or licensing negotiations, and provides a clear structure for understanding its specifications.

Algenomics plans to accelerate the global development and commercialization of RZ-001, starting with this INN application.

RZ-001, developed using Algenomics’ RNA editing platform technology known as ‘RNA Substitution Enzyme,’ has received Investigational New Drug (IND) approval from both the Ministry of Food and Drug Safety in Korea and the U.S. FDA, and is currently undergoing clinical trials for glioblastoma, a malignant brain tumor, and hepatocellular carcinoma. For glioblastoma, interim results from the Phase 1/2a clinical trial were presented at the ESMO ASIA conference on December 5, demonstrating an excellent safety profile. For hepatocellular carcinoma, interim results from the Phase 1b/2a clinical trial are expected to be announced in the first half of next year.

Lee Sungwook, CEO of Algenomics, stated, "We will use this INN application as an opportunity to accelerate the development and commercialization of RZ-001."