Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment
NLS Pharmaceutics (NLSP) and Kadimastem announced successful completion of a pre-IND meeting with the FDA for iTOL-102, a potential diabetes treatment. iTOL-102 combines Kadimastem's IsletRx cells (stem cell-derived pancreatic islets) with iTolerance's immunomodulator iTOL-100, aiming to cure Type 1 Diabetes without requiring life-long immune suppression.
The treatment was evaluated at the Diabetes Research Institute at the University of Miami School of Medicine, where it demonstrated functional insulin release and disease reversal in animal models. Based on FDA feedback, the companies are updating plans for safety toxicology studies and First-in-Human clinical trials.
IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin, offering a scalable source of insulin-producing cells to address donor islet shortages. The technology can detect glucose levels and produce required amounts of insulin and glucagon.
NLS Pharmaceutics (NLSP) e Kadimastem hanno annunciato il completamento con successo di un incontro pre-IND con la FDA per iTOL-102, un potenziale trattamento per il diabete. iTOL-102 combina le cellule IsletRx di Kadimastem (isole pancreatiche derivate da cellule staminali) con l'immunomodulatore iTOL-100 di iTolerance, con l'obiettivo di curare il Diabete di Tipo 1 senza la necessità di una soppressione immunitaria a vita.
Il trattamento è stato valutato presso il Diabetes Research Institute della University of Miami School of Medicine, dove ha dimostrato un rilascio funzionale di insulina e una reversibilità della malattia in modelli animali. Sulla base del feedback della FDA, le aziende stanno aggiornando i piani per studi di tossicologia sulla sicurezza e per trial clinici di Fase I.
IsletRx è un prodotto di grado clinico composto da cellule simili a isole pancreatiche umane capaci di secernere insulina, offrendo una fonte scalabile di cellule produttrici di insulina per affrontare la carenza di isole da donatore. La tecnologia è in grado di rilevare i livelli di glucosio e produrre le quantità necessarie di insulina e glucagone.
NLS Pharmaceutics (NLSP) y Kadimastem anunciaron la finalización exitosa de una reunión pre-IND con la FDA para iTOL-102, un posible tratamiento para la diabetes. iTOL-102 combina las células IsletRx de Kadimastem (islotes pancreáticos derivados de células madre) con el inmunomodulador iTOL-100 de iTolerance, con el objetivo de curar la Diabetes Tipo 1 sin necesidad de una supresión inmune de por vida.
El tratamiento fue evaluado en el Diabetes Research Institute de la Universidad de Miami School of Medicine, donde demostró liberación funcional de insulina y reversión de la enfermedad en modelos animales. Basándose en los comentarios de la FDA, las empresas están actualizando sus planes para estudios de toxicología de seguridad y ensayos clínicos de Primera en Humanos.
IsletRx es un producto de grado clínico compuesto por células similares a islotes pancreáticos humanos capaces de secretar insulina, ofreciendo una fuente escalable de células productoras de insulina para abordar la escasez de islotes de donantes. La tecnología puede detectar los niveles de glucosa y producir las cantidades necesarias de insulina y glucagón.
NLS Pharmaceutics (NLSP)와 Kadimastem은 잠재적인 당뇨병 치료제 iTOL-102에 대해 FDA와의 사전 IND 회의가 성공적으로 완료되었음을 발표했습니다. iTOL-102는 Kadimastem의 IsletRx 세포(줄기세포 유래 췌장 섬)와 iTolerance의 면역 조절제 iTOL-100을 결합하여 평생 면역 억제가 필요 없는 제1형 당뇨병을 치료하는 것을 목표로 합니다.
이 치료는 마이애미 대학교 의과대학의 당뇨병 연구소에서 평가되었으며, 동물 모델에서 기능적인 인슐린 방출과 질병 역전이 나타났습니다. FDA의 피드백을 바탕으로, 두 회사는 안전성 독성 연구 및 인체 첫 번째 임상 시험 계획을 업데이트하고 있습니다.
IsletRx는 인슐린을 분비할 수 있는 인간 췌장 섬유 유사 세포로 구성된 임상 등급 제품으로, 기증자 섬의 부족 문제를 해결하기 위해 인슐린 생성 세포의 확장 가능한 공급원을 제공합니다. 이 기술은 포도당 수치를 감지하고 필요한 양의 인슐린과 글루카곤을 생산할 수 있습니다.
NLS Pharmaceutics (NLSP) et Kadimastem ont annoncé l'achèvement réussi d'une réunion pré-IND avec la FDA pour iTOL-102, un traitement potentiel du diabète. iTOL-102 combine les cellules IsletRx de Kadimastem (îlots pancréatiques dérivés de cellules souches) avec l'immunomodulateur iTOL-100 d'iTolerance, visant à guérir le diabète de type 1 sans nécessiter de suppression immunitaire à vie.
Le traitement a été évalué au Diabetes Research Institute de l'Université de Miami School of Medicine, où il a montré une libération fonctionnelle d'insuline et une réversibilité de la maladie dans des modèles animaux. Sur la base des retours de la FDA, les entreprises mettent à jour leurs plans pour des études de toxicologie de sécurité et des essais cliniques de première ligne.
IsletRx est un produit de qualité clinique composé de cellules similaires à des îlots pancréatiques humains capables de sécréter de l'insuline, offrant une source évolutive de cellules productrices d'insuline pour faire face aux pénuries d'îlots de donneurs. La technologie peut détecter les niveaux de glucose et produire les quantités nécessaires d'insuline et de glucagon.
NLS Pharmaceutics (NLSP) und Kadimastem haben den erfolgreichen Abschluss eines Pre-IND-Meetings mit der FDA für iTOL-102, eine potenzielle Diabetesbehandlung, bekannt gegeben. iTOL-102 kombiniert Kadimastems IsletRx-Zellen (stammzellabgeleitete Bauchspeicheldrüseninseln) mit iTolerance's Immunmodulator iTOL-100, mit dem Ziel, Typ-1-Diabetes zu heilen, ohne lebenslange Immunsuppression zu erfordern.
Die Behandlung wurde am Diabetes Research Institute der University of Miami School of Medicine evaluiert, wo sie eine funktionale Insulinfreisetzung und eine Rückbildung der Krankheit in Tiermodellen zeigte. Basierend auf dem Feedback der FDA aktualisieren die Unternehmen ihre Pläne für Sicherheits- und Toxikologiestudien sowie für klinische Studien mit Menschen.
IsletRx ist ein klinisch zugelassenes Produkt, das aus menschlichen, insulinproduzierenden Inselzellen besteht, die in der Lage sind, Insulin zu sekretiert, und bietet eine skalierbare Quelle für insulinproduzierende Zellen, um Engpässe bei Spenderinseln zu beheben. Die Technologie kann Glukosespiegel erkennen und die erforderlichen Mengen an Insulin und Glukagon produzieren.
- Successful completion of FDA pre-IND meeting for iTOL-102
- Demonstrated disease reversal in animal models
- Technology offers scalable, unlimited source of insulin-producing cells
- Potential to eliminate need for chronic immunosuppression
- Still in early development stages
- Additional safety toxicology studies required
- Clinical trials yet to begin
- No human efficacy data available yet
Insights
The successful FDA pre-IND meeting for iTOL-102 represents a significant regulatory milestone for both Kadimastem and iTolerance, with direct implications for NLS Pharmaceutics (NLSP) given its pending merger with Kadimastem. This development advances a potentially groundbreaking Type 1 diabetes treatment toward clinical trials.
The technology combines two innovative components: Kadimastem's IsletRx (stem cell-derived insulin-producing cells) and iTolerance's iTOL-100 (immunomodulatory microgel). This dual approach addresses the two fundamental challenges that have historically islet transplantation therapies: sourcing sufficient insulin-producing cells and preventing immune rejection without systemic immunosuppression.
For NLSP investors, this news carries strategic importance beyond typical early-stage clinical developments. The pending merger with Kadimastem would transform NLSP from its current CNS-focused pipeline into a diversified regenerative medicine company with multiple clinical-stage assets. The FDA's constructive feedback validates a key component of this acquisition target's technology platform.
Market context is important here - the global Type 1 diabetes treatment market exceeds
Investors should note several key considerations:
- This remains an early-stage program - completion of toxicology studies and IND filing likely places first human trials at least 12-18 months away
- The designation as a "potential breakthrough" by the Diabetes Research Institute adds scientific credibility but doesn't confer regulatory advantages like an FDA Breakthrough Designation
- The merger between NLSP and Kadimastem remains pending - this news strengthens the strategic rationale but doesn't guarantee completion
- Animal model success, while promising, historically translates to human efficacy in diabetes cell therapies at rates below
20%
For a micro-cap company like NLSP (
Companies Advance Collaborative Clinical Development of iTOL-102: A Potential Cure for Diabetes Without the Need for Chronic Life-long Immune Suppression
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
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).
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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
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
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SOURCE NLS Pharmaceutics Ltd.; Kadimastem Ltd.
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