SPY003, a novel half-life extended IL-23p19 monoclonal antibody (mAb), with first-in-human dosing now expected first quarter 2025
New data on SPY003 presented at UEGW demonstrating robust preclinical activity including comparable potency and a greater than three-fold extension in half-life in NHPs relative to risankizumab1. Spyre portfolio now uniquely includes extended half-life molecules targeting α4β7, TL1A, and IL-23 with potential Q8W-Q12W maintenance dosing.
Additional preclinical data on SPY003 in combination with SPY001 or SPY002 presented at UEGW showing enhanced preclinical efficacy and pharmacodynamics
WALTHAM, Mass., Oct. 14, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: SYRE) (the "Company" or "Spyre"), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of inflammatory bowel disease ("IBD"), today announced updated pipeline progress and timelines, as well as scientific presentations at the United European Gastroenterology Week ("UEGW") Congress.
"The Spyre team has made significant progress in advancing its potentially best-in-class molecules into first-in-human studies within an expected nine-month window," said Cameron Turtle, DPhil, chief executive officer of Spyre. "With these promising molecules against the top three validated targets in IBD, we believe that Spyre is uniquely positioned to develop monotherapy and combination products with the potential to meaningfully improve both efficacy and convenience compared to today's standard of care."
The posters were presented at the UEGW Congress on Saturday, October 12, 2024, and details are as follows:
Title: A Novel Monoclonal Antibody Drug Candidate SPY001 Targeting Integrin ɑ4β7 for the Treatment of IBD: In Vitro Properties and Non-Human Primate Pharmacokinetics and Safety
Poster #PP1103
Title: Characterization of Two Novel Extended Half-life Monoclonal Antibody Drug Candidates Targeting TL1A for the Treatment of IBD
Poster #MP450
Title: Development and Characterization of SPY003, a Novel Extended Half-life Monoclonal Antibody Drug Candidate Targeting IL-23 for the Treatment of IBD
Poster #MP118
Title: Combining IL-23 Blockade with Anti-ɑ4β7 or Anti-TL1A for the Treatment of IBD is Supported by In Vitro and Mouse IBD Model Experiments
Poster #PP1111
Full session details can be accessed via the UEGW program. New data disclosures are also available in Spyre's updated corporate presentation.
1Synthesized comparator antibody
About Spyre Therapeutics
Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation of inflammatory bowel disease (IBD) products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
For more information, please visit http://spyre.com.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical fact are forward-looking statements. These forward-looking statements include statements regarding the Company's business strategy, including the Company's potential success of developing best-in-class therapeutics for IBD with the potential to meaningfully improve both efficacy and convenience compared to today's standard of care, the potential efficacy, safety and dosing profile of its product candidates, the potential therapeutic benefits of its product candidates as monotherapies or in combinations and their potential extended half-life, and the timing of clinical trials and interim data release, including first-in-human studies for SPY002 and SPY003. The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "predict," "target," "intend," "could," "would," "should," "project," "plan," "expect," the negatives of these terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Spyre's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited those uncertainties and factors described under the heading "Risk Factors" and "Note about Forward-Looking Statements" in Spyre's most recent Quarterly Report on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in other filings by Spyre from time to time. Should one or more of these risks or uncertainties materialize, or should any of Spyre's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Spyre does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. This press release does not purport to summarize all of the conditions, risks and other attributes of an investment in Spyre.
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