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Company selected for oral presentation on mucopolysaccharidosis-1 (MPS-1), demonstrating potential of SIG-005 to provide sustained production of active human alpha-L-iduronidase in a preclinical model

CAMBRIDGE, Mass., July 23, 2021 (GLOBE NEWSWIRE) -- Sigilon Therapeutics, Inc. (NASDAQ:SGTX), a biotechnology company that seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform, today reported results from several ongoing preclinical studies in the rare lysosomal diseases MPS-1, MPS-2, and MPS-6. Three scientific abstracts were selected for presentation—including an oral presentation on MPS-1—during the 16th International Symposium on MPS and Related Diseases (MPS 2021), which is being held virtually from July 23-25.

MPS-1 is a rare genetic disorder resulting from defects in the gene that encodes alpha-L-iduronidase (IDUA), an enzyme that breaks down glycosaminoglycans (GAGs). Eventually the progressive accumulation of GAGs results in multi-organ involvement.

“Despite approved therapies for MPS-1, including hematopoietic stem cell transplantation and enzyme replacement therapy, patients experience high treatment burden and long-term disease progression,” said Rogerio Vivaldi M.D., M.B.A., President and Chief Executive Officer of Sigilon. “While still early in its development, we are highly encouraged by these results with SIG-005, which demonstrated active IDUA production for up to 6 months in vitro and in vivo, and a dose-response relationship with tissue GAG clearance in the MPS-1H mouse model.”

Sigilon recently filed a Clinical Trial Application (CTA) in the United Kingdom for SIG-005 in MPS-1 and anticipates submitting an Investigational New Drug (IND) application and a CTA in the United States and Brazil, respectively. If approved, Sigilon expects to initiate a Phase 1/2 clinical trial of SIG-005 in patients with MPS-1 in the second half of 2021.

PRESENTATION DETAILS

Oral Presentation

Title: “SIG-005: Novel Encapsulated Non-Viral Cell-Based Therapy for MPS-1”
Date/Time: Friday, July 23^rd at 12:25 PM EDT
QA Session: 12:35 PM EDT

E-Poster Presentations

Title: “SIG-018: novel encapsulated non-viral cell-based therapy for MPS-2”
Date: Friday, July 23^rd
QA Session: 1:30-2:30 PM EDT

Title: “Development of a novel encapsulated non-viral cell-based therapy for MPS-6”
Date: Friday, July 23^rd
QA Session: 1:30-2:30 PM EDT

For more information and to access the presentations and Q&A sessions, please visit the MPS 2021 meeting virtual platform. The presentations will also be made available on the “Presentations” page of the “Science” section of the Sigilon corporate website at www.sigilon.com following the presentations.

Additionally, please visit Sigilon’s booth in the virtual exhibit hall to learn more about the Company’s technology and commitment to patients and caregivers.

About Sigilon Therapeutics
Sigilon Therapeutics seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics™ platform. Sigilon’s product candidates are non-viral engineered cell-based therapies designed to produce the crucial proteins, enzymes or factors needed by patients living with chronic diseases such as hemophilia, lysosomal diseases and diabetes. The engineered cells are protected by Sigilon’s Afibromer™ biomaterials matrix, which shields them from immune rejection and fibrosis. Sigilon was founded by Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology.

Forward-Looking Statements
This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning. These forward-looking statements address various matters, including the results and potential benefits of our preclinical studies, the timing for our regulatory submissions for SIG-005 and the timing for initiation of a Phase 1/2 clinical trial of SIG-005. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, that we have incurred significant losses since inception and our need for additional funding; the SLTx platform consists of novel technologies that are not yet clinically validated for human therapeutic use; that we have only any results from the testing of any of our product candidates in clinical trials and any favorable preclinical results are not predictive of results that may be observed in clinical trials; we may be unable to obtain and maintain patent protection and other intellectual property rights for SIG-001 or any other product candidates and for our SLTx platform, or the scope of the patent and other intellectual property protection obtained may not be sufficiently broad; and the risks identified under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended March 31, 2021 and in any subsequent filings with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of these statements.  Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investor Contact
Rob Windsor
Sigilon Therapeutics, Head of Investor Relations
robert.windsor@sigilon.com
617-586-3837

Media Contact
Amy Bonanno
Solebury Trout
abonanno@soleburytrout.com
914-450-0349