SINGAPORE, Dec. 5, 2023
/PRNewswire/ -- CytoMed Therapeutics Limited (NASDAQ: GDTC)
("CytoMed" or "Company"), a Singapore-based biopharmaceutical company
focused on harnessing its proprietary technologies to develop novel
donor-derived cell-based allogeneic immunotherapies for the
treatment of various cancers, today announced that it has entered
into a Heads of Agreement (HOA) with CytoMed Therapeutics China
Limited (CytoMed China), a company incorporated in Hong Kong and a Memorandum of Understanding
(MOU) with BioNex Solutions Inc., 千尋生命科學.
The HOA forms a collaborative effort between CytoMed and
CytoMed China to explore and investigate the safety, tolerability,
potency, and efficacy of CytoMed's proprietary allogeneic gamma
delta T cells for the treatment of various cancers (including solid
tumors) in human subjects through an investigator-initiated trial
(IIT) in the People's Republic of
China (China). The IIT is
to be initiated through an entity to be incorporated in
Chongqing, a municipality directly
under the Central Government.
"Initiating this IIT in collaboration with CytoMed in
China offers a cost-effective and
expedited means of meeting the call for alternative therapy and
acquiring patient data," said Daniel
Liao, Chairman of CytoMed China.
Pursuant to the HOA, CytoMed will provide technical
assistance in the planning and conduct of the clinical trial and
will grant CytoMed China, a loan of up to an aggregate of
S$1 Million over three years. Subject
to approval being granted for and the progress of, the clinical
trial, CytoMed is granted a first right of refusal to acquire a
majority interest in CytoMed China, a new set-up by independent
third parties. CytoMed will use this HOA to leverage the in-country
relationships of CytoMed China, its familiarity with the laws and
regulations, its access to relevant healthcare personnel,
institutions, and facilities, and the patient population in
China.
The HOA is a legally binding document and shall expire if
approval for the IIT is not obtained by September 30, 2024, unless extended by mutual
consent.
In August 2023, China issued a directive to guide the healthy
development of, among other things, somatic cell research and
development. In November 2023, the
State Council in Beijing
introduced a work plan, Beijing Work Plan 2.0, aimed at exploring
and bolstering the rules and regulations in the health and medical
industry as well as offering incentives for participation by
foreign (Hong Kong, Macau, and Taiwan) and international entities in the
field of stem cells and gene therapy.
"The recent approval of the Beijing Work Plan 2.0 demonstrates
China's increasing interest in
cell therapy," said Dr. Tan Wee
Kiat, Chief Operating Officer of CytoMed. "This is a
timely opportunity for CytoMed to extend our patented allogeneic
gamma delta T cells platform for the treatment of both blood and
solid tumors to China.
Additionally, fostering collaborations supports CytoMed's overall
goal - delivering this potential treatment to patients."
In addition to this HOA, CytoMed has recently entered a MOU with
BioNex Solutions Inc., a company incorporated/headquartered in
Taiwan, Republic of China, to explore the potential
application of CytoMed's unmodified allogeneic gamma delta T cells
in patients who have no authorized therapy options for their
relevant medical conditions.
BioNex is a private company with patient-centric care
facilities, targeting unmet medical needs in cancer treatment.
BioNex specializes in the realm of cell therapy and is committed to
pioneering advancements in the field.
Both the HOA and MOU were entered into just months after CytoMed
announced that the chimeric antigen receptor gamma delta T
cell (CAR-γδ T cell) technology, licensed exclusively to CytoMed
from the Agency for Science, Technology and Research (A*STAR) of
Singapore has been granted a
patent by the China National Intellectual Property Administration
(CNIPA).
About CytoMed Therapeutics Limited (CytoMed)
Incorporated in 2018, CytoMed was spun off from the Agency for
Science, Technology and Research (A*STAR), Singapore's leading research and development
agency in the public sector. It is a biopharmaceutical company
focused on harnessing its licensed proprietary technologies, namely
gamma delta T cell and gamma delta Natural Killer T cell, to create
novel cell-based immunotherapies for the treatment of human
cancers. The development of novel technologies has been inspired by
the clinical success of existing CAR-T therapies in treating
hematological malignancies, as well as the current clinical
limitations and commercial challenges in extrapolating the CAR-T
principle into the treatment of solid tumors. For more information,
please visit www.cytomed.sg and follow us on Twitter @CytomedSG,on
LinkedIn, and Facebook
Forward Look Statements
This press release contains forward-looking statements as
defined by the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include statements concerning plans,
objectives, goals, strategies, future events or performance, and
underlying assumptions and other statements that are other than
statements of historical facts. When the Company uses words such as
"may, "will, "intend," "should," "believe," "expect," "anticipate,"
"project," "estimate" or similar expressions that do not relate
solely to historical matters, it is making forward-looking
statements. Forward-looking statements are not guarantees of future
performance and involve risks and uncertainties that may cause the
actual results to differ materially from the Company's expectations
discussed in the forward-looking statements. These statements are
subject to uncertainties and risks including, but not limited to,
the following: the Company's plans to develop and
commercialize its product candidates; the initiation, timing,
progress and results of the Company's current and future
pre-clinical studies and clinical trials and the Company's R&D
programs; the Company's expectations regarding the impact of the
ongoing COVID-19 pandemic on its business, the Company's industry
and the economy; the Company's estimates regarding expenses, future
revenue, capital requirements and needs for additional financing;
the Company's ability to successfully acquire or obtain licenses
for additional product candidates on reasonable terms; the
Company's ability to establish and maintain collaborations and/or
obtain additional funding and assumptions underlying or related to
any of the foregoing and other risks contained in reports filed by
the Company with the SEC. For these reasons, among others,
investors are cautioned not to place undue reliance upon any
forward-looking statements in this press release. Additional
factors are discussed in the Company's filings with the SEC, which
are available for review at www.sec.gov. The Company undertakes no
obligation to publicly revise these forward–looking statements to
reflect events or circumstances that arise after the date
hereof.
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SOURCE CytoMed Therapeutics Limited
