iTolerance, Inc. Announces Formation of Strategic Advisory Board and Appointment of Inaugural Members

Establishment of Strategic Advisory Board provides renowned business development, clinical and regulatory leadership and expertise as iTolerance advances its proprietary technologies enabling tissue, organoid or cell therapy without the need for life-long immunosuppression

MIAMI, FL / ACCESSWIRE / January 23, 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 the formation of its Strategic Advisory Board and appointments of Wayne Pines, Sigurd Kirk, and Dr. Khemraj Hirani as its inaugural members.

"The establishment of our Strategic Advisory Board is an exciting milestone for the Company. As we continue to advance our iTOL-100 technology platform and lead development programs, iTOL-101 and iTOL-102, towards the clinic, it is important that we have strategic guidance from individuals with a diverse background of expertise to support our initiatives. Mr. Pines, Mr. Kirk and Dr. Hirani all bring significant experience and expertise in their respective fields that we believe will be critical as we work to advance these programs into the clinic and establish iTolerance as a pioneering regenerative medicine company," commented Dr. Anthony Japour, Chief Executive Officer of iTolerance.

Wayne Pines

Mr. Pines serves as Senior Director and a member of the International Advisory Council at APCO Worldwide in Washington, D.C. Mr. Pines is an international consultant on issues related to the Food and Drug Administration (FDA), including media, legislative, regulatory and marketing challenges, and other government agencies such as the Centers for Medicare and Medicaid. He advises clients on government policies, navigating products through the FDA approval process, and promotional issues.

Mr. Pines served for ten years in senior positions at the FDA, including as Chief of Consumer Education and Information, Chief of Press Relations and Associate Commissioner for Public Affairs. In 2020, he served as a Senior Advisor on COVID-19 to the FDA commissioner. He has authored or edited more than a dozen books about the FDA, including books about the product approval process, FDA's regulation of medical communications, crisis management, and the history of the FDA. His latest book, published in 2022, is "How FDA Really Works: Insights from the Experts." He is widely published and quoted in the media about the FDA and health care issues and policies.

Mr. Pines was a Director and former Chairman of the Board of the MedStar Health Research Institute, which oversees research at ten hospitals in the Washington-Baltimore area. He is a Founder, Director and former President of the Alliance for a Stronger FDA, a coalition seeking more appropriated funding for FDA. He was a Co-Founder of the FDA Alumni Association; a member of the Public Health Service's first Task Force on AIDS Education; Executive Vice President of an international public relations agency; and Chairman of a health care market research firm. He also serves as a member of the Executive Committee of the Regional Board of the Anti-Defamation League.

Sigurd ("Sig") Kirk

Mr. Kirk is a senior business development executive with over 15 years of pharmaceutical experience gained in global multi-billion dollar publicly traded companies. His strategic leadership, experience in high value merger and acquisition transactions, and deep financial skills, have driven exceptional growth in the businesses he has supported.

From 2009 until its acquisition by AbbVie Inc. in May 2020, Mr. Kirk held various positions at Allergan plc. (formerly Actavis). From May 2012 until May 2020, Mr. Kirk was Executive Vice President, Corporate Business Development at Allergan plc., where he was a member of the 12-person Executive Leadership Team. He was an integral member assessing development and commercial opportunities, leading due diligence, as well as negotiating and transacting key legal and financial terms. Mr. Kirk also served as Senior Vice President, Global Controller and Chief Accounting Officer for Barr Pharmaceuticals, Inc. from 2003 through the acquisition of Barr by Teva Pharmaceuticals in late 2008. Mr. Kirk has continued to serve as a member of the Board of Directors for Arravive, Inc. (NASDAQ:ARAV) since May 2021. He began his career at Deloitte & Touche as an Audit Manager, earning his CPA certification. Mr. Kirk received his Bachelor of Business Administration degree from Pace University.

Khemraj (Raj) Hirani, M. Pharm., Ph.D., RPH, CIP, CCRP, RAC, MBA

Dr. Hirani is a board-certified executive with over 21 years of experience in investigational drugs/biologics from bench to clinic with a strong scientific background. The highlights of his career include building an operational and regulatory infrastructure for clinical trials that enables optimal product development in several therapeutic areas. His expertise includes oversight of operational units in industry and academia; regulatory and quality management leadership in drugs, biologics, and combination products; increasing efficiencies, improving quality control, and optimal outcomes.

As a principal strategic and regulatory consultant for small and medium-sized companies, Dr. Hirani has supported Signos Inc, Rancho Santa Fe Bio Inc, Ambulero Inc., Eyepharma Inc., Betalin Therapeutics Inc., and others. In addition, he is a scientific co-founder of the University of Miami spin-off clinical stage (Phase 3) biotech company, PriZm Therapeutics.

Throughout his career, he has played vital roles as a drug safety investigator in over 25 clinical trials. These include sponsors such as Johnson & Johnson, Genentech, Millennium, Merck, Tibotec, Pfizer, Bayer, BMS, Gilead, and the National Institutes of Health.

Dr. Hirani has served as member of the data safety monitoring boards, human ethics boards, feasibility expert, and review editor for over 20 peer-reviewed journals. He has taught Fundamentals and Advanced Regulatory Affairs, Quality Assurance, and Ethics in product development to MVSIO (MD/MS Vision Science and Investigative Ophthalmology) course at the Bascom Palmer Eye Institute. Dr. Hirani obtained his Bachelor's degree in Pharmaceutical Sciences from the College of Pharmaceutical Sciences, Manipal, India, his MBA/PGDBA from the Indian Institute of Modern Management, and his M. Pharm-Ph.D. in Pharmacology from the Department of Pharmaceutical Sciences, Nagpur, India. He completed his postdoctoral fellowship at the College of Medicine, University of South Florida, and a summer research internship at RIKEN Brain Science Institute, Wako-shi, Japan. Currently he serves as the Deputy Director of the Diabetes Research Institute and Associate Vice Chair of Regulatory and Research Compliance for the Department of Medicine, University of Miami Miller School of Medicine.

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-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.

Investor Contact
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
[email protected]

Media Contact

Susan Roberts
T: 202.779.0929
[email protected]

SOURCE: iTolerance, Inc

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