CytoMed Therapeutics signs Business & Research Collaboration Agreement with India’s SunAct Cancer Institute Private Limited to advance use of allogeneic off-the-shelf Gamma Delta T Cells for treatment of solid cancers in a proposed Phase 2 clinical trial in India
CytoMed Therapeutics (NASDAQ: GDTC) has signed a Business & Research Collaboration Agreement with India's SunAct Cancer Institute to conduct a Phase 2 clinical trial investigating allogeneic gamma delta T cells for cancer treatment. The collaboration aims to explore the safety, tolerability, and efficacy of CytoMed's proprietary cell therapy for various solid tumors.
The accelerated trial, combining Phase 1 and Phase 2, will be jointly sponsored by both companies and led by Prof Dr Vijay Patil at SunAct Cancer Institute. CytoMed will provide scientific support and manufacture the investigational product, while SunAct contributes local expertise and access to India's healthcare infrastructure.
The five-year agreement leverages India's supportive regulatory environment through CDSCO and aims to provide affordable cancer treatment options. The collaboration aligns with CytoMed's strategy to develop cost-effective, donor-derived cell-based immunotherapies for cancer treatment.
CytoMed Therapeutics (NASDAQ: GDTC) ha firmato un Accordo di Collaborazione Commerciale e di Ricerca con il SunAct Cancer Institute in India per condurre uno studio clinico di Fase 2 che indaga le cellule T gamma delta allogeniche per il trattamento del cancro. La collaborazione mira a esplorare la sicurezza, la tollerabilità e l’efficacia della terapia cellulare proprietaria di CytoMed per vari tumori solidi.
Lo studio accelerato, che combina la Fase 1 e la Fase 2, sarà sponsorizzato congiuntamente da entrambe le aziende e diretto dal Prof. Dr. Vijay Patil presso il SunAct Cancer Institute. CytoMed fornirà supporto scientifico e produrrà il prodotto sperimentale, mentre SunAct contribuirà con la propria esperienza locale e accesso all'infrastruttura sanitaria dell'India.
L'accordo quinquennale sfrutta l'ambiente normativo favorevole dell'India attraverso il CDSCO e mira a fornire opzioni di trattamento del cancro accessibili. La collaborazione è in linea con la strategia di CytoMed di sviluppare immunoterapie cellulari derivate da donatori a costi contenuti per il trattamento del cancro.
CytoMed Therapeutics (NASDAQ: GDTC) ha firmado un Acuerdo de Colaboración Comercial y de Investigación con el SunAct Cancer Institute de la India para realizar un ensayo clínico de Fase 2 que investiga células T gamma delta alogénicas para el tratamiento del cáncer. La colaboración tiene como objetivo explorar la seguridad, la tolerabilidad y la eficacia de la terapia celular propietaria de CytoMed para varios tumores sólidos.
El ensayo acelerado, que combina la Fase 1 y la Fase 2, será patrocinado conjuntamente por ambas compañías y liderado por el Prof. Dr. Vijay Patil en el SunAct Cancer Institute. CytoMed proporcionará apoyo científico y fabricará el producto investigacional, mientras que SunAct aportará experiencia local y acceso a la infraestructura de salud de la India.
El acuerdo de cinco años aprovecha el entorno regulatorio favorable de la India a través de CDSCO y tiene como objetivo proporcionar opciones de tratamiento del cáncer asequibles. La colaboración se alinea con la estrategia de CytoMed para desarrollar inmunoterapias celulares basadas en donantes a costos reducidos para el tratamiento del cáncer.
CytoMed Therapeutics (NASDAQ: GDTC)는 인도의 SunAct Cancer Institute와 협력하여 암 치료를 위한 알로제닉 감마 델타 T 세포를 조사하는 2상 임상 시험을 실시하기 위한 사업 및 연구 협력 계약을 체결했습니다. 이 협력의 목표는 CytoMed의 독점 세포 치료의 안전성, 내약성 및 효능을 다양한 고형 종양에 대해 탐구하는 것입니다.
1상과 2상을 통합한 가속 시험은 두 회사가 공동으로 후원하며 SunAct Cancer Institute의 Vijay Patil 교수님이 이끌게 됩니다. CytoMed는 과학적 지원을 제공하고 연구 제품을 제조하며, SunAct는 현지 전문 지식과 인도 보건 의료 인프라에 대한 접근을 제공합니다.
5년 계약은 CDSCO를 통한 인도의 우호적인 규제 환경을 활용하며, 접근 가능한 암 치료 옵션을 제공하는 것을 목표로 합니다. 이 협력은 비용 효율적인 기증자 유래 세포 기반 면역 요법을 개발하려는 CytoMed의 전략과 일치합니다.
CytoMed Therapeutics (NASDAQ: GDTC) a signé un Accord de Collaboration Commerciale et de Recherche avec le SunAct Cancer Institute d'Inde pour réaliser un essai clinique de Phase 2 portant sur des cellules T gamma delta allogéniques pour le traitement du cancer. La collaboration vise à explorer la sécurité, la tolérabilité et l’efficacité de la thérapie cellulaire propriétaire de CytoMed pour divers tumeurs solides.
L’essai accéléré, combinant la Phase 1 et la Phase 2, sera co-sponsé par les deux entreprises et dirigé par le Prof. Dr. Vijay Patil au SunAct Cancer Institute. CytoMed fournira un soutien scientifique et fabriquera le produit investigational, tandis que SunAct apportera son expertise locale et son accès à l'infrastructure de santé en Inde.
L'accord de cinq ans tire parti de l'environnement réglementaire favorable de l'Inde via le CDSCO et vise à fournir des options de traitement du cancer abordables. La collaboration s'inscrit dans la stratégie de CytoMed de développer des immunothérapies cellulaires dérivées de donneurs à coût réduit pour le traitement du cancer.
CytoMed Therapeutics (NASDAQ: GDTC) hat eine Vereinbarung über Geschäft und Forschung mit dem SunAct Cancer Institute in Indien unterzeichnet, um eine klinische Studie der Phase 2 zur Untersuchung von allogenen gamma delta T-Zellen zur Krebsbehandlung durchzuführen. Die Zusammenarbeit zielt darauf ab, die Sicherheit, Verträglichkeit und Wirksamkeit der proprietären Zelltherapie von CytoMed für verschiedene solide Tumoren zu erkunden.
Die beschleunigte Studie, die Phase 1 und Phase 2 kombiniert, wird von beiden Unternehmen gemeinsam gesponsert und von Prof. Dr. Vijay Patil am SunAct Cancer Institute geleitet. CytoMed wird wissenschaftliche Unterstützung bieten und das Prüfpräparat herstellen, während SunAct lokale Expertise und Zugang zur Gesundheitsinfrastruktur Indiens beisteuert.
Die fünfjährige Vereinbarung nutzt das unterstützende regulatorische Umfeld Indiens durch das CDSCO und zielt darauf ab, erschwingliche Behandlungsoptionen für Krebs bereitzustellen. Die Zusammenarbeit entspricht der Strategie von CytoMed, kostengünstige, donorbasierte zelluläre Immuntherapien zur Krebsbehandlung zu entwickeln.
- Strategic partnership to accelerate clinical development through combined Phase 1/2 trial
- Access to India's large patient population and supportive regulatory environment
- Cost-effective clinical trial execution potential
- Five-year collaboration agreement securing long-term partnership
- Company holds multiple patents for the technology (US, MY, ZL)
- Early-stage clinical development with unproven efficacy
- Shared sponsorship may dilute control over trial execution
- Results dependent on successful manufacturing and delivery of cell therapy
Insights
The collaboration between CytoMed and SunAct represents a strategic advancement in gamma delta T cell immunotherapy development. The combined Phase 1/2 trial design is particularly efficient, potentially accelerating the development timeline while simultaneously gathering safety and efficacy data. The trial's focus on solid tumors is noteworthy, as these cancers traditionally present significant challenges for cellular immunotherapies.
India's regulatory environment and large patient population provide an ideal setting for rapid clinical development. The CDSCO's support and research incentives could significantly reduce development costs and accelerate patient recruitment. CytoMed's patented allogeneic platform (Patents: MY-200528-A; ZL 2018 8 0023646.8; US 11,629,333 B2) offers a key advantage in the 'off-the-shelf' approach, potentially enabling broader accessibility and reduced manufacturing complexity compared to autologous alternatives.
This strategic partnership could significantly enhance CytoMed's market position in the rapidly growing immunotherapy sector. India's pharmaceutical market presents substantial opportunities, with lower clinical trial costs potentially extending CytoMed's cash runway. The five-year agreement term provides adequate timeline for comprehensive clinical development while maintaining flexibility.
For a company with a market cap of
The Indian oncology market presents a strategic opportunity, with cancer rates rising and increasing demand for innovative treatments. The collaboration's focus on affordability aligns with market demands in emerging economies. The partnership with Dr. Vijay Patil, a recognized oncologist, adds credibility and local market expertise.
The allogeneic 'off-the-shelf' approach could provide a competitive advantage in terms of scalability and cost-effectiveness, particularly important in price-sensitive markets like India. Success in this trial could position CytoMed favorably for expansion in other emerging markets with similar healthcare dynamics and regulatory frameworks.
SINGAPORE, Jan. 06, 2025 (GLOBE NEWSWIRE) -- CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based clinical stage biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor-derived cell-based allogeneic off-the-shelf immunotherapies for the treatment of various cancers, today announced that it has entered into a Business & Research Collaboration Agreement (“BRCA”) with Mumbai-based SunAct Cancer Institute Private Limited (“SunAct”), a company incorporated in the Republic of India (“India”).
The BRCA forms a collaborative effort between CytoMed and SunAct 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 clinical research, including a Phase 2 investigator-initiated trial (“Clinical Trial”) in India. CytoMed and SunAct will be the joint sponsors of the Clinical Trial, working with the medical team in the SunAct Cancer Institute, led by Prof Dr Vijay Patil, a renowned medical oncologist and immunotherapy specialist in India and the founder of SunAct.
“Initiating this research and undertaking the accelerated Clinical Trial in the form of a combined Phase 1 and Phase 2 Clinical Trial targets not just the safety and efficacy of the therapeutic application and intervention of allogeneic gamma delta T Cells in the treatment of solid cancers but also expedites the gathering of information and data on the initial safety, preliminary efficacy and optimal dosing. We expect to identify the types of cancers the therapy will work for, including the side effects of the same if any and how we might manage them,” said Dr Vijay Patil. “We are excited and eager to commence and accelerate the study. This collaboration with CytoMed will provide alternative treatment for a wide range of solid cancers at a reduced cost to an increasing host of the population of India suffering from the effects of cancer. We aim to provide much needed access to and treatment for cancer at an affordable cost and to contribute to an increasing and much needed global data pool in our quest for a solution to fight cancer.”
India’s commitment in the advancement of cancer immunotherapy, harnessing the ability of the immune system and application of immunotherapies is supported by the development and approval of international collaborations and clinical trials regulated by the Central Drugs Standard Control Organization (CDSCO) of India, and incentives such as grants for research in the relevant field, which can potentially help to reduce the cost of clinical research in India.
CytoMed’s Chairman Peter Choo added, “CytoMed’s collaboration with SunAct is timely and complements our core focus of harnessing CytoMed’s proprietary off-the-shelf technologies to develop novel donor-derived cell-based allogeneic immunotherapies for the treatment of various cancers at affordable cost. We are aligned with the foresight of our partner SunAct to provide affordable no-option cancer therapeutics that could improve patients’ quality of life. We are excited to work with Dr Vijay Patil in our goal to accelerate the therapeutic application of CytoMed’s patented allogeneic gamma delta T-Cells (Patent Number: MY-200528-A; ZL 2018 8 0023646.8; US 11,629,333 B2) in an increasing population of cancer patients in India and around the world.”
Pursuant to the BRCA, CytoMed will provide scientific and technical assistance in the planning and conduct of the Clinical Trial. CytoMed will also be responsible for the manufacturing of the allogeneic gamma delta T cells as the investigational product. This collaboration leverages the in-country relationships of both SunAct and Dr Vijay Patil and their familiarity with the laws and regulations and the CDSCO, the current in-country developments in the field of immunotherapy, access to relevant healthcare personnel, institutions, and facilities, and the patient population in India.
The BRCA has a term of five years.
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
About SunAct Cancer Institute Private Limited (“SunAct”)
SunAct Cancer Institute, Thane, is at the forefront of innovative cancer treatment and research in India. As one of the first centers to introduce CAR T-cell therapy, SunAct is revolutionizing the landscape of personalized cancer care. Equipped with state-of-the-art technology and a multidisciplinary team of experts, the institute offers cutting-edge treatments, compassionate care, and access to clinical trials for various cancers.
From groundbreaking therapies to community outreach, SunAct Cancer Institute is dedicated to transforming lives through hope and healing.
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 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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