Full Press Release Details
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.