Neoleukin Therapeutics, Inc., “Neoleukin” (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, today announced dosing the first patient in a Phase 1 trial of NL-201 for advanced solid tumors. NL-201 is a de novo protein designed to mimic the therapeutic activity of natural cytokines IL-2 and IL-15. The Phase 1 study will be conducted at multiple sites in Australia and North America. The first patient was dosed in Australia.
The Phase 1 study is planned to enroll up to 120 patients with advanced, relapsed, or refractory solid tumors. Patients will receive monotherapy, intravenous NL-201 and may continue treatment until disease progression. The trial will assess safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity. When the recommended dose and schedule are determined, Neoleukin expects to enroll indication-specific expansion cohorts of patients with renal cell carcinoma and melanoma.
“NL-201 is a novel immunotherapy that was computationally designed to overcome the limitations of native IL-2 by eliminating the alpha receptor binding interface. We believe it is the first fully de novo protein to enter clinical development,” said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. “Our preclinical studies have demonstrated activation of immune cells at low doses, potentially reducing the toxicities associated with high-dose IL-2. We are excited to begin this trial to determine the optimal dose and schedule for NL-201 and evaluate its potential as a monotherapy to help cancer patients.”
