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.

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