Connect with us

Technology

Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment

Published

1 year ago

on

Companies Advance Collaborative Clinical Development of iTOL-102: A Potential Cure for Diabetes Without the Need for Chronic Life-long Immune Suppression

ZURICH and NESS ZIONA, Israel, Feb. 25, 2025 /PRNewswire/ — NLS Pharmaceutics Ltd. (Nasdaq: NLSP) (“NLS”) and Kadimastem Ltd. (TASE: KDST) (“Kadimastem”), a clinical-stage company specializing in “off-the-shelf” allogeneic cell therapy products for neurodegenerative diseases and diabetes, in collaboration with iTolerance Inc. (“iTolerance”), a U.S. based regenerative medicine company, announced today the result from the  Type B pre-IND meeting held by Kadimastem and iTolerance with a committee of the U.S Food and Drug Administration (“FDA”) on February 24, 2025, regarding the development of iTOL-102, a potential cure for diabetes that would not require life-long chronic immune system suppression. iTOL-102 is an investigational biologic for the treatment and potential cure of Type 1 Diabetes consisting of Kadimastem’s allogenic human stem cell-derived pancreatic islets (IsletRx cells) combined with iTolerance’s immunomodulator (iTOL-100).

Kadimastem and iTolerance believe that the completion of the pre-IND meeting is a significant milestone toward the clinical development of iTOL-102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by grants received from the Israel-U.S. Binational Industrial Research and Development Foundation.

iTOL-102 was evaluated at the fast-track center for testing at the Diabetes Research Institute (“DRI”) at the University of Miami School of Medicine, where it was designated as a potential breakthrough transplantation approach for the treatment of Type 1 Diabetes, as the novel combination of tolerance-inducing agent and human stem cell-derived islets. iTOL-102 demonstrated functional insulin release and disease reversal in an animal model, with full compatibility between IsletRx cells and iTOL-100.

Prior to the meeting with the FDA, Kadimastem and iTolerance received a preliminary response document from the FDA, providing critical feedback on their current preclinical and clinical development plans. This guidance is instrumental in moving forward with the next stages of development. Based on the feedback provided at the pre-IND meeting, Kadimastem and iTolerance are now updating their plans for a safety toxicology study and the preparation of a First-in-Human clinical trial.

Kadimastem believes its collaboration with iTolerance signifies a potentially transformative step in diabetes treatment, paving the way towards the potential development of iTOL-100 and requesting regulatory approvals for commercialization of a potential cure for type 1 diabetes.

iTOL-100 is an immunomodulatory microgel technology being developed by iTolerance designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem’s IsletRx human stem cell-derived islets.

Kadimastem’s IsletRx is a clinical-grade product candidate comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the necessary amounts of insulin and glucagon.

Dr. Anthony Japour, Chief Executive Officer of iTolerance, commented, “I believe that the feedback from the FDA is a critical milestone in the development of iTOL-102, and we are encouraged by their support for our innovative approach to treating Type 1 diabetes. We believe that the successful outcome of this meeting validates our commitment to bring a game-changing therapy to patients, one that could ultimately eliminate the need for chronic life-long immunosuppression. We look forward to continuing our collaboration with Kadimastem and working closely with the FDA.”

Alex Zwyer, CEO of NLS, commented, “I believe that the news demonstrates the strength of the proposed merger of NLS and Kadimastem and its technology platform to build a healthy, strong merged company that will benefit shareholders.”

Kadimastem Executive Chairman and CEO Ronen Twito said, “The promising results from the fast-track center for testing at the DRI, combined with the comprehensive studies conducted by iTolerance and Kadimastem, enabled us to complete this important milestone. We are working closely with the FDA on the necessary steps needed to implement this potential innovative technology for patients with Type 1 diabetes and demonstrate a novel islet cell transplantation approach with no need for immunosuppression.”

About Kadimastem
Kadimastem is a clinical stage cell therapy company, developing “off-the-shelf”, allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company’s lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications.

IsletRx is the company’s treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, Chief Scientific Officer of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).

Social Media: LinkedIn, X, Facebook, Instagram

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 islet 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 Statement
This press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS and Kadimastem are using forward-looking statements when they discuss the belief that the results of the pre-IND meeting with the FDA demonstrates the strength of the proposed merger; that the meeting with the FDA is a significant milestone in the development of iTOL-102, and the expected benefits of iTOL-102 in the treatment of diabetes. These forward-looking statements and their implications are based on the current expectations of the management of NLS and Kadimastem and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: risks related to the companies’ ability to complete the merger on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of the closing conditions related to the merger agreement and risks and uncertainties related to the failure to timely, or at all, obtain shareholder approvals for the transaction; unexpected costs, charges or expenses resulting from the transaction and potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger; changes in technology and market requirements; either or both companies may encounter delays or obstacles in launching and/or successfully completing their clinical trials; the companies’ products may not be approved by regulatory agencies; their technologies may not be validated as they progress and their methods may not be accepted by the scientific community; either of both of the companies may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with the products being advanced by the companies; their products may wind up being more expensive than anticipated; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; the companies’ patents may not be sufficient; their products may harm recipients; changes in legislation may adversely impact either or both of the companies; inability to timely develop and introduce new technologies, products and applications; and loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of candidate products to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, neither Kadimastem nor NLS undertakes any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading “Risk Factors” in NLS’s annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”), which is available on the SEC’s website, www.sec.gov, and in subsequent filings made by NLS with the SEC, including under the heading “Risk Factors” in NLS’s registration statement on Form F-4, filed with the SEC on December 27, 2024.

This press release may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under Kadimastem’s control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the company’s activity, as well as developments in the general environment and external factors affecting the company’s activity. The company’s results and achievements in the future may differ materially from any presented herein and the company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This press release does not constitute a proposal to purchase the company’s securities or an invitation to receive such offers. Investment in securities in general and in the company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future.

No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Additional Information about the Transaction and Where to Find It
In connection with the proposed transaction, NLS has filed a Registration Statement on Form F-4, including a proxy statement/prospectus, with the SEC. NLS may also file other relevant documents with the SEC regarding the proposed transaction. This document is not a substitute for the proxy statement/prospectus or any other document that NLS may file with the SEC. The proxy statement (if and when available) will be mailed or delivered to shareholders of NLS and Kadimastem. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the proxy statement/prospectus (if and when available) and other documents containing important information about NLS and Kadimastem and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by the Company will be available free of charge on NLS’s website at www.nlspharma.com.

Participants in the Solicitation
NLS, Kadimastem, and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from NLS and Kadimastem shareholders in respect of the proposed transaction. Information about the directors and executive officers of NLS, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in NLS’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, which was filed with the SEC on May 15, 2024. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed merger when such materials become available. Investors should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from NLS Pharmaceutics using the sources indicated above.

NLS Contacts:
InvestorRelations@nls-pharma.com
www.nlspharma.com

Kadimastem Contacts:
Sarah Bazak, Investors relations
s.bazak@kadimastem.com
www.kadimastem.com 

iTolerance Contacts: 
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

Photo: https://mma.prnewswire.com/media/2627327/Kadimastem_s_preIND.jpg

View original content to download multimedia:https://www.prnewswire.com/news-releases/kadimastem-and-itolerance-successfully-complete-pre-ind-meeting-with-the-fda-for-its-type-1-diabetes-treatment-302384761.html

SOURCE NLS Pharmaceutics Ltd.; Kadimastem Ltd.

Related Topics:
Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Technology

Intesa Communications Group Named ‘Customers First’ Winner in San Diego Regional Chamber of Commerce 2026 Small Business Awards

Published

60 minutes ago

on

July 21, 2026

By

The award-winning, women-owned San Diego public relations and government affairs firm was recognized for exceptional client service that has fueled 14 years of growth

SAN DIEGO, July 21, 2026 /PRNewswire/ — Intesa Communications Group, a leading San Diego public relations and government affairs firm, has been named the “Customers First” winner in the San Diego Regional Chamber of Commerce’s 2026 Small Business Awards. Announced July 9 at the Chamber’s annual Small Business Awards event, the recognition honors the small business whose commitment to customer service most clearly sets it apart from the competition.

Founded in 2012, the certified women-owned San Diego firm has grown from a boutique agency into one of the region’s leading public relations and government affairs firms. Intesa has doubled its team over the past two years, sustained three consecutive years of double-digit revenue growth and expanded its client portfolio by 26% last year. Intesa provides public relations, strategic communications, and government affairs services for a wide range of organizations, including San Diego State University, SeaWorld San Diego, Expedia Group, H.G. Fenton Company, San Diego Foundation, San Diego Workforce Partnership, and SBCS.

“This award belongs to every member of our team and to the clients who trust us with their most valuable asset: their reputation,” said Margie Newman Tsay, founding partner of Intesa Communications Group. “Our clients stay with us for years because we show up prepared, fully invested and ready for the moments that matter most. Being recognized for putting customers first is the highest compliment our business community can pay us.”

Intesa’s client-first approach has produced measurable results across public relations and government affairs efforts throughout the region. For example, in its first month working with the Jacobs & Cushman San Diego Food Bank, the firm helped reimagine the organization’s summer food drive messaging, generating more than 15 million impressions and helping deliver 489,026 pounds of food and $344,505 in donations — the equivalent of more than one million meals and a 175% increase from the previous year. Similarly, Logan Heights Community Development Corporation credits the firm with an 81:1 return on investment after Intesa parachuted in to help the nonprofit promote the California Mortgage Relief Program.

“Small businesses are the heart of our economy: fueling innovation, creating jobs and defining the character of communities across the San Diego region,” said Chris Cate, president and CEO of the Chamber. “We celebrate the resilience, ingenuity and community impact of our small business leaders. They are the very spirit behind our purpose to champion business and empower leaders.”

The Chamber award is as much a reflection of Intesa’s clients as it is the firm itself. The opportunity to partner with organizations doing meaningful work across the region is what makes recognition like this possible. True to form, the Intesa team plans to mark the win by thanking the clients behind the work.

“We call ourselves dot connectors, and this award is what that looks like in practice,” said Maddy Kilkenny, partner at Intesa Communications Group, who leads the firm’s government affairs practice. “Whether our team of 10 people is helping a client navigate a policy decision at City Hall or a story on the front page of the newspaper, we aim to leave them stronger and more confident than before. Hearing our clients say we deliver on that is the best win of all.”

According to the Chamber’s award requirements, businesses with 100 or fewer employees were eligible for nomination. They were voted on by a panel of chamber members, who reviewed the nominations and selected the winners of all four categories.

The recognition adds to more than 60 awards Intesa has earned for excellence in public relations, strategic communications, and public affairs, including honors from PR News, the Public Relations Society of America, PR Daily, the International Association of Business Communicators, the San Diego Business Journal (SDBJ), MARCOM, and the American Marketing Association, among others. It also comes on the heels of two Intesa team members, Emily Alvarenga and Margaret Lutz Chantung, recently receiving SDBJ’s “40 Under 40” and “Indispensable” awards, respectively.

For more information about Intesa Communications Group, visit www.intesacom.com.

About Intesa Communications Group
Intesa Communications Group is a certified women-owned San Diego public relations and government affairs firm that helps leaders communicate and advocate with confidence. Since 2012, Intesa has partnered with the region’s trusted leaders and organizations, providing strategic communications and public affairs counsel on high-stakes issues at the intersection of reputation, policy and public perception. The firm’s work has earned more than 60 industry awards across 53 recognized client campaigns, including the San Diego Regional Chamber of Commerce “Customers First” 2026 award. Learn more at www.intesacom.com.

View original content to download multimedia:https://www.prnewswire.com/news-releases/intesa-communications-group-named-customers-first-winner-in-san-diego-regional-chamber-of-commerce-2026-small-business-awards-302831350.html

SOURCE Intesa Communications Group

Continue Reading

Technology

The Inner Circle acknowledges Shankari Thiagarajan as Pinnacle Professional of The Year

Published

60 minutes ago

on

July 21, 2026

By

HOUSTON, July 21, 2026 /PRNewswire/ — Prominently featured in The Inner Circle, Shankari Thiagarajan is acknowledged as a Pinnacle Professional of The Year for her contributions to Information Technology and Agile Delivery.     

Shankari Thiagarajan has established a distinguished career in information technology project and program management, recognized for her expertise in agile delivery, digital transformation, and cross functional leadership across multiple industries. Currently serving as project manager and scrum master at Astellas Pharma Inc., she oversees agile delivery initiatives supporting global life science programs.

With more than 15 years of experience spanning technology and pharmaceutical sectors, Ms. Thiagarajan has developed a reputation for leading complex implementations and driving operational efficiency. Her expertise includes agile methodologies, project and delivery management, product ownership, healthcare IT, telecom and network optimization, financial services modernization, retail technology upgrades, and GIS and digital mapping solutions.

Ms. Thiagarajan earned a Master of Business Administration in Organizational Leadership from Campbellsville University, a Master of Science in Information Systems from Virginia Tech, and a Bachelor of Engineering in Information Technology from Jawaharlal Nehru Technological University College of Engineering Hyderabad.

Throughout her career, she has contributed to major organizations across a wide range of industries. Her accomplishments include leading agile transformations at Cigna, overseeing retail technology upgrades at Walmart, managing large scale telecom transformation initiatives at T Mobile and Verizon, and modernizing financial platforms at Security Finance. She also contributed to the early development of Google Maps during her tenure at Google India, advancing to team lead within a year.

In addition to her corporate achievements, Ms. Thiagarajan is the creator of the YouTube channel My Experiments with Life – #Positivity #Learning, launched in 2023. Through this platform, she shares motivational content and insights focused on personal growth, technology, spirituality, and lifelong learning.

Her professional accomplishments have been recognized through honors including Marquis Who’s Who 2026, a featured podcast interview with Jim Masters on Close Up TV hosted across Apple Radio, Spotify, and iHeart., recognition in The National Law Review & EIN Presswire, and a certificate of appreciation from Virginia Tech for academic excellence and community involvement.

Outside of her professional work, Ms. Thiagarajan enjoys creating motivational YouTube content, exploring technology and spirituality, listening to contemporary music, and pursuing philanthropic and educational interests. She credits her strong work ethic and determination to the example set by her parents.

Looking ahead, she plans to continue advancing her leadership capabilities and pursue executive level opportunities that allow her to make significant contributions within the information technology sector.

Guided by a philosophy rooted in courage, persistence, and continuous learning, Ms. Thiagarajan remains committed to professional growth while inspiring others to pursue excellence and self-improvement.

Contact: Katherine Green, 516-825-5634, editorialteam@continentalwhoswho.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/the-inner-circle-acknowledges-shankari-thiagarajan-as-pinnacle-professional-of-the-year-302831357.html

SOURCE The Inner Circle

Continue Reading

Technology

University of Phoenix Leaders Present at Building Blackboard Together 2026

Published

60 minutes ago

on

July 21, 2026

By

Presentations explored learning technology, accessibility and online pedagogy as higher education adapts to an AI-enabled future

PHOENIX, July 21, 2026 /PRNewswire/ — University of Phoenix leaders shared insights on artificial intelligence, accessibility, online learning and student support at Building Blackboard Together 2026, Blackboard’s flagship user conference, held July 13-15 in Dallas, Texas. The conference brought together educators, institutional leaders and industry experts to explore innovations, technologies and emerging practices shaping the future of teaching and learning.

Representing University of Phoenix were Marc Booker, Ph.D., vice provost of strategy; Kelly Hermann, vice president of Accessibility and Student Affairs; and Erin Amsden, group product manager. Through presentations and panel discussions, the leaders shared perspectives on responsible AI adoption, accessibility leadership, student engagement and the evolving role of learning technologies in supporting institutional goals and student success.

“Building Blackboard Together provides an opportunity to engage with peers across higher education who are navigating many of the same opportunities and challenges around technology, accessibility and learning mobility,” said Dr. Booker. “These conversations help advance practical approaches for supporting learners while thoughtfully integrating innovation into the educational experience.”

During the conference, University of Phoenix was also recognized with the 2026 Blackboard Catalyst Award for Ethical AI Leadership, which honors institutions advancing responsible, transparent and inclusive approaches to artificial intelligence that promote trust and equitable outcomes for learners and educators. The recognition follows the University’s ongoing efforts to support AI literacy, responsible use and AI-enabled learning experiences.

Exploring the Expanding Role of the Learning Management System

As part of the Strategic Leadership Summit, Booker served as a panelist for “The LMS as Mission-Critical: Connecting Learning, Experience & Evidence.” The session examined how learning management systems are evolving beyond course management to support learning, engagement and institutional insight across the student lifecycle.

Panelists discussed how institutions are leveraging learning technologies alongside student information systems to support teaching and learning, advising, co-curricular engagement and data-informed decision-making while addressing increasing expectations surrounding artificial intelligence, student success and accountability.

Sharing Lessons from AI-Powered Student Support

Booker also presented “Scaling AI-Powered Support Across the Student Experience at University of Phoenix,” a session focused on the University’s process for expanding its AI support assistant across the online classroom environment, moving from proof of concept to full-scale deployment over a six-month period.

In addition, Booker participated in “Online Pedagogy to Drive Institutional Growth: Best Practices and Success Stories,” a panel discussion exploring how institutions are designing engaging online learning experiences and leveraging Blackboard technologies to support quality course delivery and student engagement.

Advancing Accessibility Leadership

Hermann joined the session “Communicating Up: Turning Accessibility Work into Leadership-Ready Stories.” The presentation focused on strategies for translating accessibility initiatives into narratives, evidence and visualizations that resonate with institutional leaders.

The discussion explored ways to connect accessibility efforts to broader institutional priorities, demonstrate impact through data and support informed decision-making that advances accessibility and learner success.

Examining Emerging Challenges in Artificial Intelligence

Amsden served as a panelist for “Agentic AI in Pedagogy: Threats and Opportunities.” The session addressed the growing influence of agentic AI and its implications for academic integrity, assessment design and learner engagement.

Panelists explored how technology, pedagogy and security practices can work together to promote authentic student work while helping institutions balance innovation with responsible AI implementation.

Contributing to the Future of Teaching and Learning

Amsden, Booker and Hermann are key members of University of Phoenix’s dynamic leadership team, frequently invited to share their expertise at prestigious national conferences and events. In 2026, University leaders will participate in the ASU + GSV Summit, 1EdTech Learning Impact Conference, SXSW EDU Conference, and PESC Data Summit. These engagements underscore the University’s commitment to innovation and thought leadership in higher education, providing valuable insights and fostering collaborations that drive the future of learning.

About University of Phoenix

University of Phoenix is Built for Real Life. 50 Years Strong. The University innovates to help working adults enhance their careers and develop skills in a rapidly changing world through flexible online learning, relevant courses, academic AI pillars, and skills-mapped curriculum for associate, bachelor’s and master’s degree programs. Active students and alumni have access to Career Services for Life® resources including career guidance and tools. For more information, visit phoenix.edu.

View original content to download multimedia:https://www.prnewswire.com/news-releases/university-of-phoenix-leaders-present-at-building-blackboard-together-2026-302831360.html

SOURCE University of Phoenix

Continue Reading

Trending