Synthorx Initiates Patient Dosing in Australia and Announces Clearance of IND in the U.S. for Lead Immuno-oncology Product Candidate, THOR-707
“Our preclinical studies of THOR-707 have shown expansion of NK and CD8+ T cells, and durable anti-tumor effects without vascular leak syndrome (VLS), the toxicity that has limited the use of high-dose IL-2”, said
More information about the trial is available at https://clinicaltrials.gov/ct2/show/NCT04009681.
THOR-707 is the first product candidate designed using Synthorx’ Expanded Genetic Alphabet platform technology. THOR-707 is a recombinant interleukin-2 (IL-2) cytokine that is pegylated at one specific site, intended to block engagement of the high affinity IL-2 receptor alpha chain while retaining potency on the beta chain, thereby maintaining potent effector T-cell anti-tumor activity while exhibiting an improved safety profile. In preventing engagement of the alpha chain of the receptor, the IL-2 product can be dosed for expansion of CD8+ T cells, without expansion of immune-suppressive regulatory CD4+ T cells, and without activation of non-lymphoid cells that trigger the sometimes-fatal complication of vascular leak syndrome, observed with approved recombinant IL-2 (aldesleukin). This site-specific pegylation also increases the pharmacokinetic properties of THOR-707, including a longer half-life.
This press release contains forward-looking statements about Synthorx as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, preclinical data or plans underlying THOR-707 and the development of Synthorx’ product candidates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as a development stage company; Synthorx’ ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Synthorx’ plans to develop and commercialize its product candidates; the potential for any future clinical trials of THOR-707 or other product candidates to differ from preliminary or expected results; Synthorx’ ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; Synthorx’ reliance on key third parties, including contract manufacturers and contract research organizations; Synthorx’ ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which Synthorx operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Synthorx assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the documents the company files with the SEC available at www.sec.gov.
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Source: Synthorx, Inc.