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
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SOURCE NLS Pharmaceutics Ltd.; Kadimastem Ltd.
