MIAMI, FL / ACCESSWIRE / March 1, 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 it has completed a Pre-Investigational New Drug Application ("pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") to discuss the development of the Company's iTOL-100 immunomodulatory technology. A pre-IND meeting provides an opportunity for a drug development company and the FDA to discuss the drug's development plan and to obtain the agency's guidance for clinical studies of the company's new drug candidate.

iTolerance's iTOL-100 immunomodulatory technology is a biotechnology-derived Strepavidin-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. Utilizing its iTOL-100 immunomodulatory technology, the Company is developing iTOL-102 as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. iTOL-100, which acts to generate localized immune tolerance is combined with insulin producing stem cell-derived pancreatic islets to be implanted in the body. These stem cell-derived pancreatic islets are potentially capable of secreting insulin in response to sugar intake, similar to how native pancreatic islet cells behave. Additionally, the use of stem cell-derived pancreatic islets provides a potentially inexhaustible supply of insulin-producing cells.

"It's critical to have open dialogue with regulatory bodies as we continue the development of our lead program, iTOL-102. The meeting and subsequent feedback provided valuable insight and clarity for iTolerance as we advance our iTOL-100 immunomodulatory technology," commented Dr. Anthony Japour, Chief Executive Officer of iTolerance. "We are grateful for the guidance from the FDA and are pleased that it was in line with our team's expectations. Importantly, the Agency's guidance allows the company to maintain its current timeline for the iTOL-102 development program. Moving forward, our focus remains on the advancement of iTOL-102 towards an IND submission."

About iTolerance, Inc.iTolerance is an early-stage privately held regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression. Leveraging its proprietary biotechnology-derived Strepavidin-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 the treatment of 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 StatementsThis 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 ContactJenene ThomasChief Executive OfficerJTC Team, LLCT: 833.475.8247[emailprotected]

Media ContactSusan RobertsT: 202.779.0929[emailprotected]

SOURCE: iTolerance, Inc.

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