oNKord® Clears FDA Approval

Pharma Tech Outlook: Pharma Tech Magazine

oNKord® Clears FDA Approval

By Pharma Tech Outlook | Wednesday, October 14, 2020

Troels Jordansen, CEO

Glycostem’s product, oNKord®, gains Orphan Drug Designation (ODD) license from the FDA.

FREMONT, CA: Glycostem Therapeutics receives FDA approval for its new drug innovation, oNKord®. Being one of the leading clinical-stage company, Glycostem is focused on the development of therapeutic off the shelf natural killer cells. With oNKord® obtaining the Orphan Drug Designation license from the FDA for the treatment of Multiple Myeloma (MM), cancer patients would get access to a new hope of treatment.

oNKord® is a  first-generation NK drug that is produced by this company. Being a cellular immunotherapy product in the drug landscape, oNKord® would be used to treat acute myeloid leukemiaAML patients as a part of I-IIa (pivotal) phase in the clinical trial. This can also be one of the reasons why Glcostem would be one of the leaders in the realm of cellular immunotherapy. “With our platform, we can expand the original cell population by 50,000-fold without using feeder cells,” says Troels Jordansen, CEO of Glycostem.

The ODD designation that is granted by the FDA enables the company’s drug, oNKord®, to be qualified for a wide range of incentives such as seven years of market exclusivity after the regular approval, FDA guidance for the developmental stages of the drug, and exemption of FDA application fees and tax. oNKord® is produced in a state of the good manufacturing practice (GMP) licensed production facility.

Based in the Netherlands, Glycostem Therapeutics is a clinical-stage biotech company that works towards developing allogeneic cellular immunotherapy to treat various types of cancer. The company leverages the efficiency of allogeneic raw material to develop its lead product, oNKord®. Glycostem is listed as one of the Top Immunotherapy Solution Providers in Europe by Pharma Tech Outlook.

Weekly Brief

Read Also