Neoleukin Therapeutics Announces Submission of Investigational New Drug Application for NL-201 De Novo Protein Immunotherapy Candidate for Cancer

SEATTLE, WA, USA I December 10, 2020 I Neoleukin Therapeutics, Inc., “Neoleukin” (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, today announced the submission of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration to begin a Phase 1 clinical program of its lead immunotherapeutic candidate, NL-201. NL-201 is a computationally designed de novo protein that is a mimetic of natural cytokines IL-2 and IL-15.

“This IND submission is an important milestone for our company, and I’m proud of our team’s efforts in advancing NL-201 toward first-in-human evaluation,” said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. “We look forward to initiating patient enrollment in our Phase 1 trial, which is planned to be conducted in both North America and Australia.”

The Phase 1 study is expected to enroll up to 120 patients with relapsed or refractory solid tumors. Patients will receive intravenous monotherapy with NL-201 in order to assess safety, pharmacokinetics, pharmacodynamics, and antitumor activity. When the recommended dose and schedule are determined, indication-specific expansion cohorts will be enrolled to estimate safety and antitumor activity. In addition to the IND application, Neoleukin has submitted a Clinical Trial Notification (CTN) application for NL-201 in Australia.

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 have 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.

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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