Company will need to provide a new assay to satisfy FDA before commencing Phase I trials.
After submitting an IND less than a month ago, biopharma company Neoleukin was benched by the FDA with a clinical hold for their lead cancer immunotherapy candidate.
Before approving the application, the FDA wants to see a new assay for the therapy to more accurately measure the amount of protein patients in the Phase I trial would be receiving to prove correct dosing and administration for NL-201. There were also some additional requests not related to the clinical hold to be addressed by adjustments to the company’s IND.
Launched in early 2019 with hopes to improve on nature’s approach to battling cancer, Seattle-based Neoleukin has been laser-focused on its lead candidate.
NL-201 is the world’s first computationally-designed de novo protein therapeutic. As an IL-2/IL-15 agonist, it activates IL-2’s powerful immune-stimulating cytokine signaling without any binding to CD25. The drug spurs IL-2 to expand anti-tumor effector T-Cells and stimulates IL-15 to simultaneously create more anti-tumor NK cells.
Despite the clinical hold, Neoleukin is confident in its candidate to move forward.
“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.”
The landscape of immuno-oncology drug discovery has been evolving rapidly the past few years, with more biotechs than ever researching and developing new candidates. According to Cancer Network, in the past three years the number of active drugs in development has grown by more than 90%, from 2,030 in 2017 to 3,876 as of last fall. The majority target T-cell immunomodulators.
The very first immunotherapy cancer treatment IL-2 was approved by the FDA in the 1980s for kidney cancer and melanoma. However, its toxicity has greatly limited clinical application due to the interference with CD25. Neoleukin hopes to change that with its unique platform which positions it with potential for best-in-class IL-2/IL-15 cancer immunotherapy.
Like many other biopharma companies, Neoleukin is also working on novel molecules designed to treat or prevent infection by the SARS-Cov-2 virus. Lead molecule, NL-CVX1 was shown to prevent infection of multiple human cell lines in vitro and protected hamsters from infection after intranasal exposure to the virus. After publishing the findings in the journal Science, Neoleukin is tossing around the idea of advancing this molecule into clinical trials in humans.
