Building Biopharmaceutical Solutions And Developing Biosimilar Products
This profile is part of a paid investor education campaign.*
Biocure Technology Inc. (CSE:CURE, OTC:BICTF) is a Korean biopharmaceutical technology company currently using their proprietary technology platform to develop biosimilar products. In parallel, the company is also making use of this same technology to test a CAR-T cell targeted immune-therapy designed to treat terminal leukemia patients.
Using its proprietary genetic engineering technology platform, Biocure has designed a suite of exclusive processes aimed at developing biosimilars, defined as biological products highly similar to FDA-approved reference products originally developed by another organization. Once patents for a given product are expired, companies, like Biocure, are able to use their own processes to design and deploy almost identical products, that meet strict FDA specifications. A relatively underpopulated market, Biocure has found an opportunity in creating biosimilars like its Interferon beta-1b, used to treat multiple sclerosis (MS) symptoms.
Alongside its biosimilar products, Biocure has also been working towards being the third worldwide developer of a CAR-T cell therapy, an innovative approach to treating relapse and refractory cancers. Biocure’s therapy is designed to address latter-stage acute lymphoblastic leukemia. Preclinical trial results displayed a complete remission of cancerous cells within seven to 28 days from the injection, with no toxicity symptoms. The results meet Korean FDA guidelines and allow Biocure to advance towards clinical trials.
Biocure has also partnered with Y Biologics to develop a combined anticancer therapy that utilizes its CAR-T cell therapy. The two companies also intend to develop a next generation anticancer treatment for solid tumors pending preclinical trial results.
Beyond its two key product lines, the company is also developing other biopharmaceutical products that include a vaccine for foot-and-mouth disease as well as a hair growth and skin regeneration product.
Biocure is led by a management team with over 95 years of collective experience in biopharmaceutical development. Supported by a team of biopharmaceutical specialists and working together with universities and researchers, the company is working towards developing its proprietary products, addressing the needs of multi-billion-dollar markets.
Biocure has a tightly-held share structure with approximately 35 percent held by insiders, friends and family. Most of the company’s shares are held by Korean investors, but the company is working towards educating investors abroad, starting with Canadian investors through their listing on the CSE.
- Playing key role in underpopulated biosimilar market
- Two key products to entered clinical trials in 2018
- Interferon beta-1b to be one of a few biosimilar products for MS in multi-billion-dollar market
- CAR-T therapy designed to treat acute lymphoblastic leukemia
- Preclinical results displayed complete remission of cancerous cells within seven to 28 days with no toxicity
- Collaborative partnership in place with Y Biologics to develop combined anticancer therapy
- Strong relationships with universities and researchers, as well as Korea’s FDA body
- Joint venture partnership in place with MHU and Gold Dream
- Management team with over 95 years of collective experience
One of the primary focus points of Biocure’s product development work is the design, testing and production of biosimilar products, including their Interferon Beta 1b, PEG-Filgrastim and Ranibizumab.
What is a biosimilar?
A biosimilar is a biological medical product which is almost identical to an FDA-approved product originally developed by another organization (reference product), whose patent has expired. As biological products, biosimilars and their reference products are produced from living organisms and are specifically monitored to ensure consistent quality.
Unlike generic drugs, which are replicas of the reference medical product that do not need to undergo additional testing prior to development, biosimilars have to be approved by the FDA following a rigorous evaluation and testing program, as they are developed through different processes than the original patented process.
As part of the approval process, the biosimilar has to be compared to the reference product with regards to purity, molecular structure and bioactivity, and be proven to show no clinically meaningful differences. Once approved, biosimilars are produced in FDA-licensed facilities and tracked in a post-market surveillance program that aims to ensure the safety of the product.
The most advanced of Biocure’s biosimilar products is the Interferon beta-1b, which is delivered via injection and is designed to alleviate some of the symptoms associated with MS. MS is a disease of the central nervous system where the immune system attacks healthy cells.
Looking to enter a market currently worth multi billion dollars that has only a few other market competitors, Biocure’s Interferon beta-1b biosimilar is currently undergoing its pre-clinical trial process, due to be completed this year. Biocure has so far completed toxicity testing and has developed a master cell bank (MCB) and working cell bank (WCB). As part of the trial, the company has already produced 35,000 vials of Interferon beta-1b at their GMP-certified manufacturing facility.
The company then expects to complete the clinical trials in the near term, using the company’s capability for commercial mass production to launch the product in 2020. Upon commercialization, the company plans to enter multiple markets, starting in the Middle East, North Africa, Europe and Brazil.
Additional biosimilar products
As Biocure works towards developing its Interferon Beta 1b product, it also has two additional biosimilar offerings in the pre-clinical trial stage. This includes the PEG-Filgrastim—an anti-cancer treatment—and Ranibizumab—a macular degeneration treatment.
CAR-T Cell Therapy
CAR-T cell therapy is a targeted immune-therapy designed to treat relapsed and refractory cancer patients. CAR-T cells are a novel form of potential treatment for cancer by “enlisting” and strengthening the power of a patient’s own immune system to attack cancerous tumors. T-Cells are the fundamental protection agent of the human immune system and play a critical role in orchestrating the immune response and killing cells infected by pathogens. An innovative approach to cancer treatment, which is showing significant progress in bringing patients back from terminal-stage cancer, there are only two FDA-approved CAR-T cell therapies currently. Biocure is working towards becoming one of leading producers in the world.
Biocure’s CAR-T cell therapy is designed to treat terminal patients with acute lymphoblastic leukemia (ALL), who have relapsed more than once. Currently in the pre-clinical study stage, second generation CAR-T cell is expected to combine with other therapeutic options and to have a better control of complications.
Pre-clinical trials have shown positive results with regards to safety and toxicity of Biocure’s CAR-T cell treatment. The results also showed the complete remission of cancerous cells within seven and 28 days from the injection of reengineered CAR-T cells into a mouse, with no toxicity symptoms. These results follow Korea FDA guidelines and allow Biocure to advance into the production of anti-CD19 CAR-T cells for a clinical trial.
While its CAR-T cell therapy is not a biosimilar product, Biocure has been able to use its same technology platform to develop the treatment.
In January 2019, Biocure signed a collaboration agreement with Y Biologics (YB), a private Korea-based R&D company that specializes in antibody therapeutics for cancer, autoimmune disease and metabolic disease. Biocure and YB will research the effectiveness of a combined treatment that maximizes anticancer effects utilizing YB’s Immune Checkpoint Inhibitor PD-1 and Biocure’s anti-CD19 CAR-T cell therapy. The two companies also intend to develop a next generation anticancer treatment for solid tumors down the line. Moving forward, Biocure and YB will be planning and implementing a preclinical trial for the combined therapy.
Sang Mok Lee—President, CEO and Director
Dr. Sang Mok Lee has been the President and CEO of the company since its inception in 2005. He holds a PhD in microbiology from Busan National University in Korea and is currently an adjunct professor in microbiology at Chungnam National University. He is a committee member for the hi-tech medical complex city in Daejoen, Korea and a committee member of KOFST (the Korean Federation of Science and Technology Societies).
Konstantin Lichtenwald, CPA, CGA—CFO and Director
Mr. Lichtenwald has over ten years of finance and accounting experience, including corporate compliance, accounting and financial management and IPO, RTO services. Mr. Lichtenwald offers extensive knowledge and know-how for companies in two key financial jurisdictions, North America and German. His accounting and financial skills offer some multi-faceted hands-on approach to strategic management and problem solving. Mr. Lichtenwald earned his bachelor of business administration degree from Pforzheim University, Germany, and holds the professional designation of Chartered Professional Accountant (CPA, CGA) and Chartered Certified Accountant (ACCA), where he is a member of Chartered Professional Accountants of B.C. and Canada as well as a member of the Association of Chartered Certified Accountants of United Kingdom.
Dr. Hans Frykman—Director
Dr. Hans Frykman is the current medical director of Neurocode Labs in Vancouver and UBC Diagnostic Services Lab. Neurocode is world leading in the field of neurogenetis accepting difficult adult and paediatric neurology cases from Asia, North America and Europe. It is Canada’s first and only clinical whole exome sequencing laboratory. Also, Neurocode has a best in class software product linking genotype to phenotype in the area of neurogenetics. UBC Diagnostic Services Lab is Canada’s leading clinical Neuroimmunology laboratory servicing all provinces with this highly complex testing. Under Dr. Frykman’s guidance, the UBC Diagnostic Services lab has expanded fourfold. Dr. Frykman has a medical degree from Karolinska Institute in Stockholm, a PhD in Biocatalysis at Royal Institute of Technology, and post graduate medical training from Karolinska University Hospital Solna Campus, Mayo Clinic, University of Minnesota, Memorial Sloan Kettering and University of British Columbia in the areas of internal medicine, oncology, clinical pathology, molecular genetics and medical biochemisty. Dr. Frykman held research positions with the US Government, Astra Zeneca, Akzo Nobel and Novo Nordisk. Early in his career he was part of the discovery teams around Victoza and Losec (Prilosec). He is licensed to practice medicine in Sweden and British Columbia.
Sang Goo (Collin) Kim—Director
Sang Goo (Collin) Kim holds a bachelor degree of business administration from Korea University, Seoul, Korea. He came to Vancouver, Canada in 2006 after working for Hanwha Corp., one of Korean business conglomerates for 16 years, where he was dedicated to International trading business for various industrial products. He has been working as a Vice President for Columbia Capital since 2008 and a director of ArcPacific Resources Corp., a public Canadian junior exploration company, since 2015. He is actively working on several projects and business opportunities with Canadian firms and major Korean state-owned firms to utilize his vast knowledge and work experience.
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