Malaysia's Cancer Care Leap: Off-the-Shelf Cell Therapy Begins Trials

KUALA LUMPUR, Malaysia – December 08, 2025 – A landmark collaboration between Singapore’s CytoMed Therapeutics and the prestigious Universiti Malaya Medical Centre (UMMC) is set to bring a potentially transformative cancer treatment to Malaysia. The partners have announced a first-in-human Phase I clinical trial for an "off-the-shelf" immunotherapy, a move that could fundamentally alter the landscape of accessibility and affordability for advanced cancer care in Southeast Asia.

The trial will investigate CTM-GDT, an allogeneic cell therapy developed by CytoMed that uses a special type of immune cell—unmodified Gamma Delta (γδ) T cells—derived from healthy donors. This approach stands in stark contrast to existing personalized cell therapies that are prohibitively expensive and logistically complex, placing them out of reach for most patients in the region. For cancer patients in Malaysia who have exhausted conventional treatment options, this trial represents a new frontier of hope.

A Strategic Answer to a Regional Healthcare Crisis

The high cost of cancer care is a pressing issue across Southeast Asia. In Malaysia, the financial burden can be staggering, with advanced treatments like targeted therapy or immunotherapy costing upwards of RM 50,000 per month and total treatment costs for some cancers approaching RM 400,000. This reality creates a deep chasm between what is medically possible and what is economically feasible for the average patient.

CytoMed's collaboration with UMMC directly confronts this challenge. The core innovation lies in its allogeneic, or "off-the-shelf," platform. Unlike autologous therapies such as CAR-T, which require harvesting, engineering, and re-infusing a patient's own cells—a bespoke process that can take weeks and cost hundreds of thousands of dollars—CytoMed's CTM-GDT is manufactured in batches from a single healthy donor. These cells can then be stored and used to treat multiple patients on demand.

"This collaboration... will pave the way for an affordable cancer immunotherapy option to patients with limited treatment alternatives," stated CytoMed's Chairman, Peter Choo, in the announcement. He highlighted that the allogeneic model is "significantly more cost-effective to manufacture, offers lower, speedier and simpler logistics, making it more accessible to patients."

The choice of UMMC as a partner reinforces the trial's significance. As one of Malaysia's premier teaching hospitals and a tertiary referral center for oncology, UMMC possesses the sophisticated infrastructure and deep clinical expertise necessary to conduct such a pioneering study. Professor Dr. Lim Soo Kun, Head of UMMC's Clinical Investigation Centre, affirmed this shared vision, stating, "This partnership reflects our shared commitment to advancing clinical innovation for the benefit of our community."

The Science of Innate Defense: Unmodified Gamma Delta T Cells

At the heart of this trial is a unique and powerful component of the human immune system: the Gamma Delta (γδ) T cell. These cells form a crucial bridge between the body's innate and adaptive immune responses. A key advantage that has captured the attention of the scientific community is their ability to recognize and kill cancer cells without relying on the Major Histocompatibility Complex (MHC) proteins that conventional T cells require. This MHC-independence is what makes them ideal candidates for an allogeneic therapy, as they are less likely to attack the recipient's healthy tissues, a dangerous complication known as Graft-versus-Host Disease (GvHD).

CytoMed’s CTM-GDT product uses these cells in their natural, unmodified state, harnessing their inherent cancer-fighting abilities. This approach is distinct from genetically engineered CAR-T therapies, which insert a synthetic receptor to target a specific marker on cancer cells. While CAR-T has shown remarkable success in blood cancers, its application to solid tumors has been challenging, and the engineering process adds significant cost and complexity.

The scientific rationale for bringing CTM-GDT into human trials is robust, bolstered by a research collaboration between CytoMed and the world-renowned MD Anderson Cancer Center in the United States. A recent co-authored publication from this partnership demonstrated that donor-derived γδ T cells were highly effective at killing acute myeloid leukemia (AML) cells in preclinical models, even those resistant to standard therapies. These findings provide a strong foundation for the new trial in Malaysia, suggesting the therapy's potential across a broad range of cancers.

A Calculated Expansion for a Singaporean Biotech Pioneer

For CytoMed Therapeutics (NASDAQ: GDTC), a 2018 spin-off from Singapore's Agency for Science, Technology and Research (A*STAR), the Malaysian trial is a pivotal piece of a larger regional strategy. The clinical-stage company is positioning itself as a leader in next-generation cell therapies tailored for the Southeast Asian market and beyond.

This new trial for unmodified γδ T cells (CTM-GDT) in Malaysia strategically complements CytoMed's ongoing ANGELICA trial in Singapore, which is testing a genetically engineered CAR-γδ T cell product (CTM-N2D). This dual-pronged approach allows the company to explore the potential of its γδ T cell platform in both its natural and engineered forms, diversifying its clinical pipeline and mitigating risk. By establishing clinical operations in both Singapore and Malaysia, CytoMed is building a formidable operational footprint in the region’s two most advanced life sciences hubs.

This expansion is supported by astute strategic moves, including the recent acquisition of technology from TC BioPharm. As a publicly traded entity on the NASDAQ, CytoMed is under the watchful eye of investors, and this steady, milestone-driven progression demonstrates a clear path toward value creation. By focusing on the unmet needs of a vast patient population with a technology designed for accessibility, CytoMed is not just developing a drug; it is building a business model that could redefine the biopharmaceutical landscape in this part of the world.

While the journey from a Phase I trial to a commercially available treatment is long and fraught with challenges, this initiative represents more than just a scientific experiment. It is a tangible step toward a future where a patient’s access to life-saving innovation is not dictated by their geographic location or financial status. As the trial at UMMC gets underway, the global oncology community will be watching closely to see if this "off-the-shelf" approach can deliver on its immense promise.