The Albany Gazette - iTolerance, Inc. Appoints Former Chief of the Laboratory of Biochemistry in the FDA's Center for Drug Evaluation and Research (CDER), Emily Shacter, Ph.D., to its Scientific Advisory Board

MIAMI, FL / ACCESS Newswire / August 21, 2025 / iTolerance, Inc. ("iTolerance" or the "Company"), an early-stage privately-held biotechnology company focused on the development of innovative regenerative medicines, today announced the appointment of Emily Shacter, Ph.D. to the Company's Scientific Advisory Board. Dr. Shacter has been supporting CMC development for iTolerance since February 2024.

"We are honored to welcome Dr. Shacter to our Scientific Advisory Board. With decades of experience as a leader in the regulation and development of biopharmaceuticals, we believe the insight Dr. Shacter will be instrumental as we continue to transition to a clinical-stage company and advance our therapies as a potential cure for Type 1 Diabetes. This appointment further strengthens our ability to navigate complex regulatory pathways, potentially accelerate clinical translation and unlock the full potential of our pipeline. Additionally, Dr. Shacter's addition to our Scientific Advisory Board reflects our steadfast commitment to investing in the talent and guidance for iTolerance that we believe is needed to become a leader in the rapidly evolving regenerative medicine market," commented Anthony Japour, Chief Executive Officer of iTolerance.

Dr. Shacter added, "Throughout my career at the FDA and in industry, I have seen firsthand both the challenges and opportunities involved in developing complex biological products. iTolerance's platform technology, with its potential to enable tissue, organoid, and cell therapies without the need for life-long immunosuppression, provides an opportunity to address a profound unmet need in the field. I look forward to applying my experience to help guide the Company's scientific and regulatory strategy as it moves toward clinical translation."

Dr. Shacter is an esteemed expert in the regulation and development of biopharmaceuticals who served for nearly two decades at in the Division of Therapeutic Proteins of the Office of Biotechnology Products in the FDA's Center for Drug Evaluation and Research (CDER). Her FDA career focused on oversight of biochemical characterization, manufacturing and control of complex protein therapeutics, including biosimilars and breakthrough biologics. As former Chief of the Laboratory of Biochemistry in the FDA's CDER, she oversaw the review of numerous INDs and BLAs, played a role in shaping regulatory policy and advancing the science of biologics review, ran a laboratory research program, and oversaw the research of the principal investigators in her group. The research carried out in her laboratory provided the expertise required to understand and regulate complex biological products. Since 2012, she has served as an independent consultant, advising biotechnology companies on scientific and regulatory strategy for biologic drug development.

Additional career highlights include:

• Served as an FDA scientific advisor to the World Health Organization (WHO) for the development of international biosimilar guidelines;

• Engaged in FDA advisory and leadership roles, including the CDER Biosimilars Review Committee, Follow-on Biologics Working Group, and various CMC policy development efforts;

• Served as an editor and board member for major scientific journals including Free Radical Biology and Medicine and Journal of Biological Chemistry;

• Was an invited speaker and organizer at over 50 national and international conferences focused on biologics regulation, biosimilars, and analytical science;

• Authored or co-authored over 75 peer-reviewed publications in fields including protein oxidation, cell regulation, immunology, and cancer biology; and

• Received multiple FDA awards including the CDER Excellence in Mentoring Award and Center for Biologics Evaluation and Research Scientific Achievement Award for Excellence in Laboratory Science.

In addition to her decorated career in government and industry, Dr. Shacter's research made significant contributions to understanding the molecular mechanisms of apoptosis, particularly in the context of cancer and inflammation. Her work focused on how reactive oxygen species produced during inflammation-such as hydrogen peroxide and taurine chloramine-affect the ability of chemotherapy drugs to induce apoptosis in cancer cells. She discovered that oxidative stress can inhibit both tumor cell death and the immune clearance of dying cells, and that antioxidants can restore chemotherapy efficacy. Dr. Shacter also identified the actin-regulating protein cofilin as a key intracellular redox sensor whose oxidation triggers mitochondria-dependent apoptosis. Additionally, she uncovered a novel role for the anticoagulant protein S in promoting macrophage phagocytosis of apoptotic cells. These findings provided critical insights into the interplay between inflammation, oxidative stress, and cell death, with implications for improving cancer therapies.

Dr. Shacter holds a Ph.D. in Biochemistry from Johns Hopkins University, completed in partnership with the National Institutes of Health, and a B.Sc. in Zoology from the University of Maryland.

About iTolerance, Inc.

iTolerance is a 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 cadaveric and stem cell-derived pancreatic islets to potentially cure Type 1 diabetes. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential 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: 908.824.0775
[email protected]

Media Contact
Susan Roberts
T:202.779.0929
[email protected]

SOURCE: iTolerance, Inc.

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(W.Williams--TAG)