Ne­oleuk­in's IL-2 Agonist Candidate Cleared To Start Phase 1 Trial In Solid Tumors

  • The FDA has removed the clinical hold related to Neoleukin Therapeutics Inc NLTX investigational new drug application, to begin a Phase 1 program of its cancer immunotherapeutic candidate, NL-201.
  • Back in January this year, the FDA asked the company for more information on its de novo IL-5/IL-2 agonist for solid tumors before jumping into human trials.
  • The agency asked Neoleukin to develop a new assay for the therapy that would more accurately measure the amount of protein being administered to patients and ensure the correct dosing and administration of the drug.
  • The Phase 1 study will evaluate monotherapy, intravenous treatment with NL-201 in up to 120 patients with advanced, relapsed, or refractory solid tumors.
  • The trial will assess safety, pharmacokinetics, immunogenicity, pharmacodynamics, and antitumor activity.
  • In August 2019, the company went public after a reverse merger with Aquinox Pharmaceuticals, which took a 61.42% stake in the new company in exchange for $65 million in capital for Neoleukin.
  • Price Action: NLTX shares are down 2.9% at $11.99 in the market trading session on the last check Monday.
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Posted In: BiotechNewsHealth CareSmall CapFDAGeneralBriefsPhase 1 TrialSolid Tumor
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