On January 8, 2021 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported that on January 7, 2021, it received a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug (IND) Application to begin a Phase 1 clinical program of its immunotherapeutic candidate, NL-201 (Press release, Neoleukin Therapeutics, JAN 8, 2021, View Source [SID1234573767]).
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The FDA has informed Neoleukin that it needs to develop a new assay that more precisely measures the amount of protein being administered and demonstrate with this assay that dose and administration procedures will accurately deliver the intended dose of NL-201. The FDA also had additional requests not related to the clinical hold to be addressed by amendment of the IND.
"We will work diligently to address the FDA’s questions as quickly as possible," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "We believe that we will be able to develop the requested assay and respond within the next several months. While we do not have a definitive timeline as to when we will be able to obtain clearance to proceed, we look forward to working with the FDA to satisfy their requests."
About NL-201
NL-201 is a de novo receptor agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data have demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells.