An important milestone for MegaPro Biomedical: The first patient enrollment of New Anticancer Drug MPB-1734
MegaPro Biomedical Co., Ltd. (hereinafter referred to as "MegaPro", Taiwan OTC Stock Code: 6827) announced today that the company's in-house-development nano-micelle anticancer drug MPB-1734 has conducted its first patient enrollment case in Taiwan, which is a significant milestone in the development of MPB1734 with its core technology: nanomicelle. MegaPro is currently on schedule for the Phase 1/2a clinical trial of MPB-1734 (NCT04643418). It is estimated that the Phase 1 clinical trial will be completed in the second half of 2023 as relevant trial data would be obtained, and the Phase 2a clinical trial will continue to carry on.
MegaPro states that MPB-1734, a new formulation new drug of anticancer medicine developed by the company, has been approved by the US FDA and Taiwan FDA in November 2020 and April 2021, respectively, for Phase 1/2a clinical trials. The safety, PK and efficacy effect of MPB1734 will be explored among advanced solid tumors patients (such as ovarian cancer, head and neck cancer, esophageal cancer, etc.), and the first patient was enrolled at Taipei Veterans General Hospital today. As the clinical trial of the new anti-cancer drug MPB-1734 is progressing smoothly, the company is expected to start the Phase 2a clinical trial in Taiwan and the United States in the next two years.
MegaPro states that the development of the new anti-cancer drug MPB-1734 as a new formulation new drug is based on the company's proprietary nanomicelle technology platform. After encapsulating specific anticancer drugs, the efficacy of the drug is enhanced by more drug/micelle accumulation at the tumor site through unique passive targeting, while reducing the side effects of the cancer drugs. In-vitro and in-vivo animal studies have both shown that the MPB-1734 has an outstanding antitumor effect on the drug-resistant malignant animal models. Therefore, this novel candidate of MPB-1734 anti-cancer drug is expected to provide a better treatment response for cancer patients.
According to market report from Biomedtracker, a professional market intelligence organization, the number of ovarian cancer patients worldwide has exceeded 200,000 annually. The market size for ovarian cancer drugs in the United States, the European Union, and Japan in 2019 was US$2.1 billion, and it is expected to grow to US$3.1 billion in 2029. Ovarian cancer was identified as the rare diseases in Europe and the United States. Because the diagonosis of ovarian cancer is not easy, most of the patients are already in the third or fourth stage of cancer when diagnosed. Even after surgery treatment or chemotherapy, more than half of the patients would find the cancer relapsed within 18 months.
From the current clinical data in various countries, only half of the patients with ovarian cancer recurrence responded to platinum related drugs. For those another 50% of the patients who were resistant to platinum medicines, there are not many other choices for them. From MegaPro’s previous results, MPB-1734 has a very good tumor inhibition rate for platinum-resistant ovarian cancer xenograft animal model. Hopefully, MPB-1734 could solve the dilemma of being in lack of curable drugs, benefitting a vast number of ovarian cancer patients.
According to the 2019 announcement by the Statistics Department of the Ministry of Health and Welfare, the incidence rate of male head and neck cancer ranks third in Taiwan, while also being the sixth leading cause of cancer deaths in Taiwan, which include oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, etc. In 2020, the number of head and neck cancer patients has exceeded 750,000. According to market analysis, the H&N cancer drug market size in the United States, the European Union, and Japan in 2019 was 1.2 billion US dollars; by 2029, it is estimated that the market will increase to 3.4 billion US dollars. Currently, advanced head and neck cancers often require combination therapy such as surgery, radiation, chemical drugs or targeted drugs. However, after recurrence, it would usually become resistant to chemotherapy or target therapy, which makes the treatment more difficult. MegaPro’s MPB-1734 has been confirmed to have a considerable better efficacy effect on H&N tumors in animal model. When MPB-1734 combined with immune checkpoint inhibitors, such as anti-PD-1/PD-L1 antibody, it was proved from the animal study that the tumor will be further suppressed thus to improve the therapeutic effect.
MegaPro furthers states that MPB-1734 is currently undergoing clinical trials for patients with advanced solid tumors. MPB1734 will be designed to go through 505(b)(2) pathway with the hope of orphan drugs designation and other fast-track review pathway, and hopefully it could strive for the fast approval and to perform combination therapy with immunotherapy and other first-line drugs.
MegaPro’s unique nanomicelle and nanoparticle technology has been proved its clinical benefits by several clinical trials. Recently, the company has moved into the Zhubei Biomedical Park. MegaPro has established many updated analytical equipment and manufacturing trial-run facilities in this new laboratory to assist effectively R&D capabilities. Working together with professional CMOs/CROs locally and worldwide, the company's overall progress and operating prospects are optimistic.
About MegaPro Biomedical Co., Ltd.:
MegaPro Biomedical Co., Ltd. (stock code: 6827) was founded in 2014 and spun-off from the Industrial Technology Research Institute. It is a new drug development company mainly engaged in the niche nano-medicines. MegaPro holds two proprietary nanotechnology platforms - "Nanoparticles" and "Nanomicelles". At present, MegaPro has developed three major product pipeline, MPB-1514 for iron deficiency anemia (phase 2a completed), MPB-1523 contrast agent for MRI diagnosis of hepatocellular carcinoma (phase 2 completed), and MPB-1734, a new formulation of anticancer drug.
For more company introduction, please refer to the official website: https://www.megaprobio.com/
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This document and accompanying related information contains predictive description. Except for the facts that have occurred, all statements about future business operations, possible events and prospects (including but not limited to forecasts, goals, estimates and business plans) of MegaPro Biomedical Co., Ltd. (hereinafter referred to as the Company) are predictive statements. The forecast statement could be affected by various factors and uncertainties, resulting in considerable differences from the actual situation. These factors include but are not limited to price fluctuations, actual demands, exchange rate changes, market share, market competition, laws, finance and regulations changes, international economic and financial market conditions, political risks, cost estimates, etc., and other risks and variables beyond the control of the company. These forward-looking statements are predictions and assessments based on current conditions, and the Company is not responsible for future updates.