SEATTLE, December 10, 2020 (GLOBE NEWSWIRE) — Neoleukin Therapeutics, Inc., “Neoleukin” (NASDAQ:NLTX), a biopharmaceutical company using sophisticated computational methods to develop de novo protein therapeutics, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration to advance a Phase 1 clinical program of its lead immunotherapeutic candidate, NL -201. NL-201 is a computer-aided design New Protein that is a mimetic of the natural cytokines IL-2 and IL-15.
“This IND filing is an important milestone for our company, and I am proud of our team’s efforts in advancing NL-201 toward first-in-human evaluation,” said Jonathan Drachman, MD, Neoleukin’s Chief Executive Officer. “We look forward to beginning patient enrollment for our Phase 1 study, to be conducted in both North America and Australia.”
Up to 120 patients with recurrent or refractory solid tumors are expected to be enrolled in the Phase 1 study. Patients will receive intravenous monotherapy with NL-201 to assess safety, pharmacokinetics, pharmacodynamics, and antitumor activity. Once the recommended dose and schedule are established, indication-specific expansion cohorts will be enrolled to assess safety and antitumor activity. In addition to the IND application, Neoleukin has submitted a clinical trial application (CTN) for NL-201 in Australia.
NL-201 is a de novo receptor agonist of the IL-2 and IL-15 receptors designed to proliferate cancer-fighting CD8 T cells and natural killer (NK) cells without favoring cells expressing the Express alpha receptor subunit (CD25). Previously presented preclinical data 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 developing next-generation immunotherapies for cancer, inflammation and autoimmune diseases using de novo protein design technology. Neoleukin uses sophisticated computational methods to design proteins that exhibit specific pharmaceutical properties that offer potentially superior therapeutic utility 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 site. For more information, visit the Neoleukin website: www.neoleukin.com.
Safe haven / Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, without limitation, proposed development activities and timelines, and the therapeutic properties and potential of the Company’s product candidates and the like New Protein Design Technology. Forward-looking statements are identifiable by words such as “anticipate,” “intend,” “plan,” “goal,” “aim,” “believe,” “forecast,” “estimate,” “expect,” “strategy,”,” “ future”, “likely”, “may”, “should”, “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties, including risks and uncertainties related to the Company’s cash projections, the Company’s ability to advance its product candidates, the receipt and timing of potential regulatory filings, the naming, approval and commercialization of product candidates, timing and results pre-clinical and clinical studies, the timing of announcements and updates regarding the Company’s clinical studies and related data market conditions and other impacts of COVID-19 that could cause actual results to differ materially from Neoleukin’s expectations. Additional information regarding potential risk factors that could affect Neoleukin’s business and financial results are set forth under the heading “Risk Factors” in documents the Company files with the Securities and Exchange Commission (SEC) from time to time and in other reports filed with the SEC. Neoleukin undertakes no obligation to publicly update any forward-looking statements, whether written or oral, made from time to time as a result of new information, future developments or otherwise.