In brief
Auxi Therapeutics Sdn Bhd has opened a GMP laboratory for cell and gene therapy at Universiti Malaya Medical Centre in Kuala Lumpur. The 6,000-square-foot facility, built with an investment of about RM6 million, is intended to produce therapies including CAR-T treatment. UMMC and Auxi are conducting clinical trials of CAR-T therapy for aggressive B-cell lymphoma; a trial for multiple myeloma is planned, according to the release. The laboratory also includes a production area for lentiviral vectors used in CAR-T cell modification. UMMC says the facility will support treatment services, research, internships and technology sharing. The announcement describes the project as a collaboration between UMMC and Auxi, with support from MIDA and Bioeconomy Corporation.
Key takeaways
- Auxi Therapeutics opened a cell and gene therapy laboratory at Universiti Malaya Medical Centre in Kuala Lumpur.
- The facility spans 6,000 square feet and was built with an investment of about RM6 million.
- UMMC and Auxi are conducting CAR-T clinical trials for aggressive B-cell lymphoma; a multiple myeloma trial is planned.
- The laboratory is designed to produce CAR-T cells and lentiviral vectors, and to support research and training.
KUALA LUMPUR, April 17, 2024 -- Auxi Therapeutics Sdn Bhd unveils its state-of-the-art GMP CAR-T & CGT Laboratory at Universiti Malaya Medical Centre (UMMC), a facility with transformative potential to revolutionise cancer treatment and promote precision medicine.
The 6,000 sq ft laboratory, built with an investment of about RM6 million, is dedicated to the production of cellular and gene therapies (CGT) with a focus on chimeric antigen receptor-T cell (CAR-T) therapy. Addressing unmet medical needs in the treatment of cancer and other challenging diseases, these therapies have shown promise in targeting and eliminating cancer cells with high precision.
In her speech at the opening ceremony on April 17 (Wednesday), UMMC Director Prof Dr Nazirah Hasnan hails the launch as a significant milestone towards advancing healthcare and pioneering innovative treatments. “As we inaugurate this Auxi Therapeutics GMP CAR-T & CGT Laboratory, we embark on a journey filled with endless possibilities and opportunities for groundbreaking discoveries, therapeutic innovations, and ultimately, improved patient outcomes,” she says.
The commitment of Auxi Therapeutics to advance research and development in cell and gene therapy aligns seamlessly with the UMMC mission to provide world-class healthcare services to the patients, Prof Dr Nazirah adds. “The impact of this facility extends far beyond its physical walls, as it symbolises hope, progress, and the relentless pursuit of excellence in healthcare.”
The establishment of the laboratory is anchored on the founding mission of Auxi Therapeutics to provide affordable cancer treatment options and contribute to society by improving access to innovative therapies. The team strives to make T cell-based immunotherapies accessible to hospitals and patients seeking better genomic answers for cancer.
Elaborating on the company’s vision of a cancer-free world, Auxi Therapeutics and Auxilto Group Managing Director Mr Choo Yan Ho says CAR-T and CGT therapies represent a paradigm shift towards precision medicine, in which treatments are tailored to individual patients’ genetic profiles and disease characteristics.
“The Auxi Therapeutics GMP CAR-T & CGT Laboratory has the potential for significant regional and global impact. By offering affordable and accessible CAR-T and CGT therapies, the laboratory contributes to improving healthcare outcomes and reducing the burden of cancer on individuals, families and societies,” he says.
CLINICAL TRIALS FOR AGGRESSIVE B-CELL LYMPHOMA ARE UNDERWAY
The collaboration between UMMC and Auxi Therapeutics stemmed from a shared interest on the research and development for CAR-T and CGT. Both came to the idea of building a laboratory within the UMMC compound to house cell collection, cell manufacturing and clinical trial under one roof, and the journey from the conception of the idea to its realisation took about a year.
With the laboratory, UMMC will be able to offer CAR-T therapy and other CGT, including dendritic cell-cytokine-induced killer cell (DC-CIK) therapy, to government and private cancer patients. The facilitywill benefit students and researchers from the Faculty of Medicine through internship and technology sharing.
Cancer patients can approach UMMC for enquiries on Auxi Therapeutics GMP CAR-T & CGT Laboratory. Blood cancer patients may contact Consultant Clinical Haematologist Prof Dr Bee Ping Chong, and patients with solid tumour may refer to Consultant Clinical Oncologist Prof Dr Ho Gwo Fuang.
UMMC is currently working with Auxi Therapeutic on clinical trials of CAR-T for aggressive B-cell lymphoma, and trial for multiple myeloma is coming soon, says Prof Dr Bee. “CAR-T therapy involves extracting the patient’s very own T lymphocyte cells, which are then engineered and modified by using specific viruses, enabling them to recognise the target cancer cells. Finally, the modified T cells are then re-infused into the patient and off they go to do their job of killing the offensive cancer cells,” he explains in his speech at the gala dinner held after the launch.
The Auxi Therapeutics GMP CAR-T & CGT Laboratory houses a dedicated area for the production of lentiviral vectors, which are crucial for the genetic modification of cells in CAR-T therapy. It is the first fully integrated GMP CAR-T and CGT laboratory with lentiviral manufacturing facility in Malaysia. The laboratory is equipped with specialised infrastructure for the production of CAR-T cells, allowing for the customisation and development of personalised therapies.
This facility has been meticulously designed to meet stringent national and international standards, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Tissue Practice (GTP) standards. In order to ensure optimal conditions and safety, the laboratory is electronically controlled and monitored round-the-clock. It is also a fully integrated smart facility, encompassing various production lines and quality control protocols.
AUXI THERAPEUTICS’ COMMITMENT ALIGNS WITH NATIONAL BIOTECHNOLOGY POLICY 2.0
Malaysian Investment Development Authority (MIDA) and Bioeconomy Corporation, a lead development agency for the biotechnology industry under the purview of Ministry of Science, Technology and Innovation (MOSTI), facilitated the establishment of the Auxi Therapeutics GMP CAR-T & CGT Laboratory.
MIDA Executive Director, Manufacturing Development (Resource), Ms Umarani Muniandy says at the gala dinner: “I am very proud to convey my sincere congratulations to Auxi Therapeutics Sdn Bhd for the launch of its laboratory at UMMC, which undertakes the production of cell and gene therapy products and focuses on T cell-based immunotherapies for cancer treatment.”
Bioeconomy Corporation recognises the immense potential of cell and gene therapies in revolutionising healthcare and improving patient outcomes, says its Senior Vice President Ts Soeraya Satem Ahmad. “We are proud to support organisations such as Auxi Therapeutics in their relentless pursuit of innovation and excellence, which significantly contributes to our efforts in facilitating groundbreaking bio-based technology advancements in Malaysia,” she says. “This commitment aligns with the objectives outlined in the National Biotechnology Policy 2.0 led by MOSTI, particularly in enhancing public health and wellbeing through precision medicine.”
Ts Soeraya also reveals that Auxi Therapeutics intends to participate in Bio-based Accelerator (BBA), a flagship programme by Bioeconomy Corporation that serves as a catalyst for economic growth, innovation, and industry leadership in Malaysia’s bio-based sector.
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Questions around this news
How does CAR-T therapy work?
CAR-T therapy uses a patient’s T cells, a type of immune cell. The cells are collected and genetically modified so they can recognize a target on cancer cells, then returned to the patient. The release describes the laboratory as supporting this process, including production of lentiviral vectors used in genetic modification.
What does Good Manufacturing Practice mean for a cell therapy laboratory?
Good Manufacturing Practice (GMP) is a system of requirements for consistently producing and controlling medicines. It covers areas such as facilities, equipment, staff training, documentation and quality checks. For cell therapies, GMP processes help ensure that products are made under controlled conditions and meet defined quality standards before they are used.
Which cancer clinical trials are underway at UMMC?
UMMC is working with Auxi Therapeutics on CAR-T clinical trials for aggressive B-cell lymphoma, according to the release. It also says a trial for multiple myeloma is planned for the near future. The release does not provide trial phase, enrollment details, results or a start date for the multiple myeloma trial.
What work will the new UMMC laboratory support?
The laboratory is intended to bring cell collection, cell manufacturing and clinical trials together at UMMC. It has infrastructure for producing CAR-T cells and lentiviral vectors, and the release says UMMC plans to offer CAR-T and other cell and gene therapies. It also describes opportunities for medical students and researchers to gain experience through internships and technology sharing.
