Company leveraging iTOL-100 to advance a pipeline of programs that have the potential to cure diseases, such as Type 1 Diabetes, without the need for life-long immunosuppression

MIAMI, FL / ACCESSWIRE / September 18, 2023 / iTolerance, Inc. ('iTolerance' or the 'Company'), an early-stage regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, today announced that the European Patent Office (EPO) has issued patent no. EP3592392 entitled 'FasL-Engineered Biomaterials with Immunomodulatory Function' covering its regenerative SA-FasL microgel immunomodulatory technology, iTOL-100.

iTolerance's iTOL-100 immunomodulatory technology is a biotechnology-derived bio-synthetic form of the naturally occurring protein FasL, mixed with a biotin-PEG microgel that would allow convenient and effective co-administration with implanted cells or organoids to induce local immune tolerance without the need for life-long immunosuppression. This proprietary technology has broad applicability and can be applied to both allogenic and stem cell-derived organoids across a number of diseases.

Dr. Anthony Japour, Chief Executive Officer of iTolerance, commented, 'We are pleased to expand our global IP portfolio in this key territory for our potentially transformative technology, iTOL-100. The issuance of this European patent further highlights our growing belief in iTOL-100's potential and our dedication to advancing its development. Our focus and priorities remain on progressing towards our first in human clinical study for lead program, iTOL-102, which combines our iTOL-100 platform technology with an inexhaustible supply of insulin producing allogeneic stem cell-derived pancreatic islets, adding to its commercial viability over cadaveric islets.'

The European patent claims FasL-hydrogels themselves, and covers the methods of making the hydrogels, and methods of using the hydrogels to induce immune tolerance and to treat Type 1 Diabetes. The patent term extends through March 9, 2038.

About iTOL-100

iTolerance's iTOL-100 immunomodulatory technology is a biotechnology-derived Streptavidin-FasL fusion protein, a synthetic form of the naturally occurring protein FasL, mixed with a biotin-PEG microgel (SA-FasL microgel) that potentially allows convenient and effective co-administration with implanted cells or organoids to induce local immune tolerance without the need for life-long immunosuppression. This proprietary technology has broad applicability and can be applied to allogenic and stem cell-derived organoids across several diseases.

About iTolerance, Inc.

iTolerance is an early-stage privately-held regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. The Company's lead program, iTOL-102, leverages significant advancements in stem cells to derive pancreatic islets, which allows an inexhaustible supply of insulin-producing cells. Utilizing iTOL-100 to induce local immune tolerance, iTOL-102 has the potential to be a cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression.For more information, please visit itolerance.com.

Forward-Looking Statements

This press release contains 'forward-looking statements' within the meaning of the 'safe-harbor' provisions of the Private Securities Litigation Reform Act of 1995. When used herein, words such as 'anticipate', 'being', 'will', 'plan', 'may', 'continue', and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, anticipated levels of revenues, future national or regional economic and competitive conditions, and difficulties in developing the Company's platform technology. Consequently, forward-looking statements should be regarded solely as the Company's current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. The Company cannot guarantee future results, events, levels of activity, performance or achievements. The Company does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Contact
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
iTolerance@jtcir.com

Media Contact
Susan Roberts
T: 202.779.0929
sr@roberts-communications.com

SOURCE: iTolerance, Inc.