iTolerance, Inc. Awarded Industry Discovery and Development Partnership with JDRF for Advanced Pre-Clinical Development of iTOL-100 and iTOL-101 for the Treatment of Type 1 Diabetes

Company advancing development of lead program, iTOL-101, as a potential breakthrough in curing Type 1 Diabetes with the potential to eliminate the need for chronic life-long immunosuppression

The up to $850,000 award issued to iTolerance was given in furtherance of JDRF’s charitable mission to cure and mitigate the effects of Type 1 Diabetes

MIAMI, FL / ACCESSWIRE / June 28, 2022 / iTolerance, Inc. (“iTolerance” or the “Company”), an early-stage regenerative medicine company developing technology to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, today announced it has been awarded an Industry Discovery and Development Partnership (“IDDP”) of up to $850,000 from JDRF, a nonprofit organization that funds Type 1 Diabetes (T1D) research, provides a broad array of community and activist services to the T1D population and actively advocates for regulation favorable to medical research and approval of new and improved treatment modalities.

Anthony Japour, MD, Chief Executive Officer of iTolerance, commented, “We are incredibly pleased to expand and deepen our partnership with the JDRF. We are grateful for their continued support and dedication to the Type 1 Diabetes community. This funding provides us with the additional capital to support the translation of iTOL-100 production, iTolerance’s proprietary biotechnology-derived fusion protein immunomodulator platform, from the academic research laboratories to commercial manufacturing. In addition, the partnership will support Good Laboratory Practice efficacy, safety, toxicology, and pharmacokinetic studies. This will put us a step closer toward a first in human Phase 1/2a clinical trial.”

Dr. Japour continued, “The support that the JDRF has provided to our team thus far has been significantly valuable in enabling us to complete our pre-clinical non-human primate study which demonstrated long-term success of allogeneic islet implantation without chronic immunosuppression for the treatment of diabetes. The results from that landmark study were recently published[1] in the peer-reviewed journal, Science Advances. We believe the extension of their support with this IDDP is truly a natural next step as we collectively advance towards a potential breakthrough cure for T1D without the need for chronic immunosuppression.”

The JDRF award to iTolerance is in support of advancing the Company’s platform technology, iTOL-100, which leverages the naturally occurring protein, Fas Ligand (FasL) which is present in all mammals and functions as a natural way for the body to establish local immune tolerance. In pre-clinical studies conducted to date, iTOL-100 has been shown to establish durable, localized immune tolerance, allowing the implanted tissue, organoid or cell therapy to function as a replacement for damaged native cells. Additionally, the award supports the advancement of pre-clinical studies evaluating iTolerance’s lead program, iTOL-101, to support a first-in-human clinical study in Type 1 Diabetes.

“We enthusiastically support the iTolerance team’s effort toward translating to the clinic the work of our JDRF-funded researchers. The recently published study demonstrates long-term glycemic control in a non-human primate model of diabetes by combining allogenic islets with the SA-FasL microgel. This work has the promise to provide a cell replacement therapy that cures T1D without the need for chronic immunosuppression. The advancement of pre-clinical development builds on the ongoing support from JDRF and we look forward to this next stage of development,” added Esther Latres, Ph.D., JDRF Vice President of Research.

About JDRF

JDRF’s mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter (@JDRF), Facebook (@myjdrf), and Instagram (@jdrfhq).

About iTOL-100

The Company’s iTOL-100 platform 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. In pre-clinical studies, iTOL-100 has been shown to establish durable, localized immune tolerance, allowing the implanted tissue, organoid or cell therapy to function as a replacement for damaged native cells. iTOL-100 has broad applicability and can be applied to both allogenic and stem cell-derived organoids across a number of diseases.

About iTolerance, Inc.

iTolerance is an early-stage privately held regenerative medicine company developing technology 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-101 is being developed for Type 1 Diabetes and in a pre-clinical non-human primate study, pancreatic islet cells co-implanted with iTOL-101 exhibited long-term function with control of blood glucose levels and restoration of insulin secretion without the use of chronic immune suppression. The Company’s second lead candidate, iTOL-102, is leveraging 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 liver failure and iTOL-301 as a potential regenerative protein and cell therapy that leverages stem cell sources to produce proteins or hormones in the body in conditions of high unmet need 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.

[1] https://www.science.org/doi/abs/10.1126/sciadv.abm9881

Investor Contact:

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

SOURCE: iTolerance, Inc.

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