Update on Clinical Milestone - CytoMed Therapeutics Announces First Patient Dosed in its First-in-Human Phase I Clinical Trial of Allogeneic CAR-Gamma Delta T Cell Therapy in Patients with Advanced Solid Tumours or Haematological Malignancies
CytoMed Therapeutics (NASDAQ: GDTC) has announced the dosing of its first patient in the ANGELICA Trial, a Phase I clinical trial evaluating allogeneic NKG2DL-targeting CAR gamma delta T cells (CTM-N2D) for advanced solid tumors and hematological malignancies. This marks the company's transition to a clinical-stage biopharma. Unlike traditional CAR-T therapy that uses patient's own cells, CytoMed's approach uses donor blood-derived gamma delta T cells, which can be used without donor-patient matching. This method aims to improve cell quality, reduce production costs, and increase therapy accessibility.
CytoMed Therapeutics (NASDAQ: GDTC) ha annunciato la somministrazione del primo paziente nel Trial ANGELICA, uno studio clinico di Fase I che valuta le cellule T gamma delta CAR che mirano a NKG2DL (CTM-N2D) per tumori solidi avanzati e neoplasie ematologiche. Questo segna la transizione dell'azienda verso una biopharma in fase clinica. A differenza della tradizionale terapia CAR-T che utilizza le cellule del paziente, l'approccio di CytoMed sfrutta le cellule T gamma delta derivate dal sangue di donatori, utilizzabili senza necessità di corrispondenza tra donatore e paziente. Questo metodo mira a migliorare la qualità delle cellule, ridurre i costi di produzione e aumentare l'accessibilità alla terapia.
CytoMed Therapeutics (NASDAQ: GDTC) ha anunciado la dosificación de su primer paciente en el Ensayo ANGELICA, un estudio clínico de Fase I que evalúa células T gamma delta CAR dirigidas a NKG2DL (CTM-N2D) para tumores sólidos avanzados y malignidades hematológicas. Esto marca la transición de la compañía hacia una biopharma en etapa clínica. A diferencia de la terapia CAR-T tradicional que utiliza las células del propio paciente, el enfoque de CytoMed utiliza células T gamma delta derivadas de sangre de donantes, que se pueden usar sin necesidad de coincidencia entre donante y paciente. Este método busca mejorar la calidad celular, reducir los costos de producción y aumentar la accesibilidad a la terapia.
CytoMed Therapeutics (NASDAQ: GDTC)는 고형암 및 혈액암에 대한 알로제닉 NKG2DL 표적 CAR 감마 델타 T 세포(CTM-N2D)를 평가하는 1상 임상시험인 ANGELICA 시험에서 첫 환자의 투여를 발표했습니다. 이는 회사의 임상 단계 생명공학 회사로의 전환을 의미합니다. 환자의 세포를 사용하는 전통적인 CAR-T 치료와는 달리, CytoMed의 접근법은 기증자의 혈액에서 유래한 감마 델타 T 세포를 사용하여, 기증자와 환자 간의 일치를 요구하지 않습니다. 이 방법은 세포 품질을 개선하고 생산 비용을 줄이며, 치료 접근성을 높이는 것을 목표로 합니다.
CytoMed Therapeutics (NASDAQ: GDTC) a annoncé l'administration du premier patient dans l'Essai ANGELICA, un essai clinique de Phase I évaluant les cellules T gamma delta CAR ciblant NKG2DL (CTM-N2D) pour des tumeurs solides avancées et des maladies hématologiques. Cela marque la transition de l'entreprise vers une bio-pharma en phase clinique. Contrairement à la thérapie CAR-T traditionnelle qui utilise les propres cellules du patient, l'approche de CytoMed utilise des cellules T gamma delta dérivées du sang de donneurs, pouvant être utilisées sans correspondance entre donneur et patient. Cette méthode vise à améliorer la qualité des cellules, réduire les coûts de production et augmenter l'accès à la thérapie.
CytoMed Therapeutics (NASDAQ: GDTC) hat die Dosierung des ersten Patienten in der ANGELICA-Studie bekannt gegeben, einer Phase-I-Studie zur Evaluierung von allogenen NKG2DL-gerichteten CAR-Gamma-Delta-T-Zellen (CTM-N2D) bei fortgeschrittenen soliden Tumoren und hämatologischen Malignomen. Dies markiert den Übergang des Unternehmens zu einem klinischen Bio-Pharma-Unternehmen. Im Gegensatz zur herkömmlichen CAR-T-Therapie, die die eigenen Zellen des Patienten verwendet, nutzt CytoMed Spenderblut-abgeleitete Gamma-Delta-T-Zellen, die ohne Spender-Patienten-Abstimmung verwendet werden können. Diese Methode zielt darauf ab, die Zellqualität zu verbessern, Produktionskosten zu senken und die Zugänglichkeit der Therapie zu erhöhen.
- Achievement of clinical-stage milestone with first patient dosing in Phase I trial
- Received clinical trial authorization from Health Sciences Authority in Singapore
- Innovative approach potentially reducing production costs compared to traditional CAR-T therapy
- Technology allows treatment without donor-patient matching, increasing accessibility
- Early-stage Phase I trial with unproven safety and efficacy
- Faces competition from established CAR-T therapies
Insights
The initiation of patient dosing in CytoMed's Phase I ANGELICA trial represents a significant milestone in advancing allogeneic CAR-gamma delta T cell therapy. This novel approach using donor-derived cells rather than patient-derived cells could potentially address key limitations of traditional CAR-T therapy, including manufacturing complexity, cost and accessibility.
The trial's focus on both solid tumors and hematological malignancies is particularly noteworthy, as most approved CAR-T therapies are to blood cancers. The use of gamma delta T cells, which don't require HLA matching, could significantly expand the patient population that could benefit from cell therapy. However, investors should note that this is an early-stage trial primarily focused on safety and efficacy data will take time to mature.
This development positions GDTC strategically in the growing cell therapy market. The allogeneic approach could offer significant cost advantages over autologous CAR-T treatments, which typically cost
For a company with a market cap of
SINGAPORE, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Further to an announcement on October 7, 2024, CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the treatment of blood and solid cancers, is pleased to announce that the first patient has been dosed in its first-in-human Phase I dose-escalation clinical trial (NCT05302037) (“ANGELICA Trial”). This trial has been registered with and has received clinical trial authorisation from the Health Sciences Authority in Singapore.
The ANGELICA Trial evaluates allogeneic NKG2DL-targeting chimeric antigen receptor-grafted (CAR) gamma delta T cells (CTM-N2D) in patients with advanced solid tumours or haematological malignancies. Refer to Form 6K announcement on October 7, 2024.
“Dosing the first patient in the ANGELICA Trial, CytoMed has reached a significant milestone as a clinical stage biopharma,” says Chairman Peter Choo. “The ANGELICA Trial aims to assess the safety and potential efficacy of an allogeneic CAR-T therapy patients with advanced solid tumours or haematological malignancies.”
This is different from the current CAR-T cell therapy that typically involves taking patient’s blood cells and modifying these cells by grafting an artificial protein, known as a chimeric antigen receptor, on the surface of T cells, a type of white blood cells. The modified T cells are then re-infused into the patient to target and destroy cancer cells. Unlike chemotherapy which targets all actively dividing cells including healthy ones, CAR-T cells specifically recognize targets present on cancer cells (antigens) to kill them, thus sparing most healthy cells.
The ANGELICA Trial taps on blood drawn from eligible donors, potentially improving the quality of CAR-T cells, reducing production costs and increasing patients’ accessibility to therapy.
CytoMed’s ANGELICA Trial uses a subtype of T cells known as gamma delta T cells which can be derived from donors, expanded, modified and infused into unrelated patients without the need for donor-patient compatibility matching.
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. CytoMed is a biopharmaceutical company focused on harnessing its licensed proprietary technologies, namely gamma delta T cell and iPSC-derived gamma delta Natural Killer T cell, to create novel cell-based allogeneic immunotherapies for the treatment of various human cancers. The development of novel technologies has been inspired by the clinical success of existing CAR-T therapies in treating haematological malignancies, as well as the current clinical limitations and commercial challenges in extrapolating the CAR-T principle into the treatment of solid tumours. For more information, please visit www.cytomed.sg and follow us on Twitter (“X”) @CytomedSG, on LinkedIn, and Facebook
Forward-Looking 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 future COVID-19 outbreak 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.
Contact :
CytoMed Therapeutics Limited
enquiry@cytomed.sg
Attention : Evelyn Tan, Chief Corporate Officer
FAQ
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