Neoleukin Therapeutics Announces Initiation of Phase 1 NL-201 Trial

– Trial Evaluating NL-201 in Patients with Advanced Solid Tumors Underway –

SEATTLE, WA, USA I May 05, 2021 I 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.”

About NL-201

NL-201 is a de novo receptor agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models.

About Neoleukin Therapeutics, Inc.

Neoleukin is a biopharmaceutical company creating next generation immunotherapies for cancer, inflammation and autoimmunity using de novo protein design technology. Neoleukin uses sophisticated computational methods to design proteins that demonstrate specific pharmaceutical properties that provide potentially superior therapeutic benefit over native proteins.  Neoleukin’s lead product candidate, NL-201, is a combined IL-2 and IL-15 agonist designed to improve tolerability and activity by eliminating the alpha receptor binding interface. For more information, please visit the Neoleukin website: www.neoleukin.com.

SOURCE: Neoleukin Therapeutics

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