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FDA Benches Immune-Boosting Cancer Therapy with Clinical Hold

January 8, 2021

Via: BioSpace

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.

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