MegaPro Biomedical MPB1523 Nano-MRI contrast agent makes a breakthrough and works with Stanford University in the CAR-T cell therapy experiment, which was published at the WMIC conference
The self-developed nano-MRI contrast agent MPB1523 by MegaPro Biomedical Co., Ltd. (hereinafter referred to as "MegaPro", Taiwan OTC stock code: 6827) has been adopted by Stanford University, the world's most authoritative experts in MRI contrast agents. The two parties collaborated on an animal experiment of CAR-T cell therapy for brain glioblastoma multiforme (GBM) with the iron oxide nanoparticle (IOP) technology independently developed by MegaPro Biomedical, and has completed the brain cancer MRI image labeling test. This year, at the World Molecular Imaging Congress (WMIC), it has been announced that in the future, MPB1523 will advance with the progress of phase III clinical trials and obtaining drug certificates. In addition to MRI detection of hepatocellular carcinoma, it is expected to be used as a real-time tracking contrast agent for CAR-T cell therapy to assist medical teams to provide better treatment options for patients.
The R&D and management teams of MegaPro Biomedical are all from the "National Program on Nano Technology" team of the Industrial Technology Research Institute and have been focusing on the nano-drug development platform for many years. Through two self-developed nanotechnology platforms - "Nanoparticles" and "Nano Cells", the pre-clinical development of a number of new drugs has been successfully completed. The MPB1523 nano-iron oxide MRI contrast agent developed by the company based on iron oxide nanoparticle (IOP) technology can accelerate the phagocytosis of nano-iron oxide particles by immune cells through the regulation of surface hydrophilicity and hydrophobicity. This can achieve clear markings of malignant tumors, and patients would not be under the risks of heavy metal deposition and nephropathy.
Dr. Jassy Wang, general manager of MegaPro Biomedical, states that the MPB1523 nano-iron oxide MRI contrast agent developed by the company has passed the US Food and Drug Administration (FDA) human clinical trial review (IND) in February 2018, and has been approved for clinical phase II. After the test was officially published at the Contrast Media Research Symposium in November 2019, it was highly recognized by the international authority on contrast agents - Professor Heike E. Daldrup-Link of Stanford University in the United States, who stated that the MRI identification accuracy of MPB1523 for hepatocellular carcinoma was close to 100%, and the contrast of liver cancer cells is more than 10 times higher than that of current clinical products, which is apparently superior to other current products from the industry on the market. MegaPro Biomedical completed the clinical phase II acceptance of MPB1523 at the end of April 2020, and its adverse reaction rate was only at 3.84%, which was significantly lower than the industry average of 10-15%.
Dr. Hsu Yuanhong, deputy general manager of MegaPro Biomedical Research and Development, states that MegaPro Biomedical and Stanford University collaborated in the CAR-T cell therapy experiment and used the nano-MRI contrast agent-MPB1523 developed by MegaPro Biomedical to treat brain glioblastoma multiforme (GBM). In CAR-T cell therapy animal experiments, the primary key to the success of CAR-T therapy in the treatment of solid tumors is that these cells must effectively enter the tumor. During the treatment process, it is impossible to know whether the cells have entered the tumor in real time. Usually, all courses of treatment must be completed before the treatment effect can be evaluated. If it is ineffective, it cannot be remedied and the golden window treatment period will be missed. Stanford University used the MPB1523 nano-MRI imaging agent developed by the company with nano-iron oxide particles, which can be successfully labeled on CAR-T cells and endowed with the function of real-time tracking in vivo. The results of the animal experiments clearly showed images of CAR-T having entered brain tumors. In future clinical use, doctors can more accurately predict the treatment effect or give immediate feedback, increasing the success rate of treatment. At present, the experimental results have been published at this year's WMIC conference. In the future, it is expected that the scope of application of MPB1523 detection will be extended from hepatocellular carcinoma to CAR-T cell tracking and other diseases that require higher identifiabilities.
According to the report of Global Industry Analysts, Inc, a professional research institution, the global developer market will be approximately US$4.9 billion in 2020, with a CAGR of 3.9% from 2021 to 2027. It is estimated that the global developer market will reach US$6.4 billion in 2027. In MRI examinations, the most commonly used developer is the Gadolinium (Gd) developer, but Gadolinium ion is a lanthanide heavy metal element, which is toxic and thus must be combined with an extremely stable compound to reduce heavy metal residues, resulting in difficulties to maintain product stability. In addition, concerns about nephrotoxicity and brain accumulation of gadolinium ions have also received considerable attention.
MegaPro Biomedical is the first in the industry to modify polyethylene glycol (PEG) molecules with terminal functional groups, and then combine PEG with iron oxide nanoparticles by covalent bonding to form PEG-coated iron oxide Nanoparticles, making the outer layer of iron oxide nanoparticles that are insoluble in water hydrophilic, which accelerates the absorption of immune or stem cells to achieve a developing effect. At present, the company has more than 50 complete patent layouts in terms of structure, application and formula in nanoparticles in addition to key technologies related to mass production process and quality control, which will help the stable growth of mass production quality and scale, while shortening the time to market.
MegaPro Biomedical states that the company’s MPB1523 nanometer MRI contrast agent has recently negotiated with the Chinese for authorization and collaboration, and is expected to submit an application to the US FDA for Phase III clinical trial in the next year or two. The company's nanoparticle technology platform products also include MPB-1514 iron supplement injection for iron deficiency anemia, which is expected to be authorized for collaboration with the Chinese next year; the clinical application of MRI contrast agent-lymph node metastasis diagnosis is currently undergoing planning for phase II clinical trial; the MRI contrast agent- applied to the in vivo tracking of stem cell therapy and immune cell therapy is being developed in collaboration with Stanford University in the United States, while magnetic hyperthermia therapy is also being actively developed in collaboration with domestic universities. IOP is expected to become an innovative drug with multi-purposes.
Looking forward to the future, MegaPro Biomedical will continue to use its self-developed nanoparticle and nanocell technology platform to develop new drugs. With the growth of the global biotechnology industry, pharmaceutical companies from various countries will invest in the development of various new drugs and medical applications to improve overall healthcare, cancer diagnosis and quality of treatment. MegaPro is sure to become a company with considerable development potential in the future biotechnology and new drug development industry.
The link to the presentation of MegaPro Biomedical MPB1523 at the 2021 Global Molecular Imaging Conference is as follows: https://www.xcdsystem.com/wmis/program/QSb7b5D/index.cfm?pgid=2585&sid=23778&abid=86485
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