DGAP-News: Biocure Technology Inc. / Key word(s): Miscellaneous
2018 In Brief
Positive Pre-Clinical Trial Results on Leukemia CAR-T Cell Therapy Development
Successful Toxicity Tests on Multiple Sclerosis Treatment
Acquired 6,060 Square Meters Land for Biosimilar Manufacturing Facilities
Completed OTC Listing
Signed Strategic Agreements with Research Partners
Expanded the Board of Directors
Established the BioCure Advisory Board
Vancouver, British Columbia--(Newsfile Corp. - November 19, 2018) - Biocure Technology Inc. (CSE: CURE) (OTCQB: BICTF) (the 'Company' or 'Biocure') is pleased to provide a shareholders' update on its operations.
Purchased land for manufacturing facilities
In order to expand our R&D and manufacturing center Biocure entered into a land purchase agreement with Korea Land & Housing Corp. (KLHC), a state-run land and housing development company in Korea, for the acquisition of a 6,060-square-metre industrial usage parcel. The purpose of the land purchase is to provide space for manufacturing facilities of the Company's biosimilar products as well as CAR T-Cell products under the announced joint venture with Pharos Vaccine Inc. KLHC plans to complete land formation work by the end of 2019 with architecture design and construction for the manufacturing facilities following.
New Advisory Board
To strengthen our overall profile an advisory committee was formed. The committee will support the management in advancing the Company. The Company welcomed Jae Soo Shin, Heon Ju Lee and Hyun Soo Lee to the Biocure team. Their combined expertise and experience will be a great asset in advancing the Company and helping bridge the business in Korea to North America. Bringing such an experienced advisory committee to Biocure will allow management to benefit from an extensive depth of medical knowledge and industry-focused strategic thinking.
Entered into an agreement with Osong HI-Tech Medical Industry Promotion Foundation
During the year the Company entered into a contract with Osong Hi-Tech Medical Industry Promotion Foundation for non-clinical biodistribution tests of anti-CD19 CAR-T cell therapy. This is a prerequisite to making an investigational new drug (IND) application to the Korean Food & Drug Administration (KFDA), and non-clinical toxicity tests in nudemice will be performed by the contractor. In addition, BiocurePharm has commissioned CdmoGen Co. Ltd. to produce master cell bank (MCB) for the production of lentiviral vectors for clinical trials of anti-CD19 CAR-T cell therapy.
In order to expand our investor base, a secondary listing on the OTC Markets was undertaken and trading began on OTCQB under the symbol BICTF. The OTCQB listing will enable Biocure Technology to efficiently provide US investors with current information, greater visibility and allow the Company to expand its U.S. investor base.
Completed interferon beta 1b toxicity testing
The Company successfully implemented the preclinical trial of interferon beta 1b and were pleased to update our shareholders on its progress. We completed most of the toxicity testing and have developed MCB (master cell bank) and WCB (working cell bank). Currently, BP Korea is in the middle of an in vivo potency test. We have already produced 35,000 vials of interferon beta 1b for its preclinical trial and stability test at the GMP manufacturing facility in Korea. We do expect the preclinical trial to be completed by the end of Q1 2019 and will advance to clinical trial in Q3 2019.
Strengthen the board of directors
In order to diversify and strengthen our board of directors we welcomed Dr. Hans Frykman as our new director of Biocure Technology Inc. Dr. Frykman is the current medical director of Neurocode Labs in Vancouver and UBC Diagnostic Services lab. Dr. Frykman has a medical degree from Karolinska Institute in Stockholm, a PhD in biocatalysis at Royal Institute of Technology, and postgraduate 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 biochemistry.
CAR-T Pre Clinical Trial results
This is the first breakthrough milestone achieved in Korea and serves as a pre-requisite by Korea FDA (KFDA) for proceeding to an IND (Investigation of a New Drug) application. The trial results demonstrated and confirmed no toxicity was found on 7th and 28th days from the injection of reengineered CAR-T cells into a immuno deficient mouse. The study further showed encouraging results as no toxicity symptoms have risen from the high-volume injection. We believe these to be strong indicators for the next phase clinical trials.
The trial, first of its kind in the history of Korea, is a result of a wide Korean scientific collaboration. BioCure has performed the trial via its wholly owned subsidiary BiocurePharm in collaboration with Pharos Vaccine with the assistance of Osong Medical Innovation Foundations as the trial CRO (Contract Research Organization) and Croen Corp. who led the toxicity tests under GLP (Good Laboratory Practice) standards.
We have successfully completed the safety test of a Biodistribution analysis study and toxicity study for single dose intravenous injection as per the Korea FDA guidelines. This milestone allows us to advance into the actual production of anti-CD19 CAR-T Cell for a clinical trial and we have already contracted CdmoGen Co. Ltd. and Master Cell Bank to produce a Lentiviral Vector under GMP standards necessary for advancing to the next stage of CAR-T Cell based clinical trials.
Biocure is a South Korean based Bio Pharmaceutical company specializing in the development and potential commercialization of biosimilar pharmaceutical products. Biocure is in the process of pre- clinical trials of five major biosimilar products in South Korea, including Interferon Beta 1b, PEG- Filgrastim and Ranibizumab as well as CAR-T Cell Therapy. Interferon Beta 1b is used for treating relapsing forms of multiple sclerosis ('MS') Filgrastim is used to treat neutropenia, a lack of certain white blood cells caused by bone marrow transplants, chemotherapy, and other conditions. Ranibizumab is used for treating macular degeneration. It is also used to treat a type of eye problem known as macular edema, as well as certain eye problems caused by diabetes. Biocure is also developing a foot and mouth disease vaccine, a hair growth production product and a breast cancer detection kit.
ON BEHALF OF THE BOARD OF DIRECTORS
/S/ 'SANG MOK LEE'
For further information, please contact:
Biocure Technology Inc. Telephone: 604-609-7149, or
Certain statements in this news release, which are not historical in nature, constitute 'forward looking statements' within the meaning of that phrase under applicable Canadian securities law. These statements include, but are not limited to, statements or information concerning the Company's proposed activities under the Agreement and the expectations of the Company regarding funding payments due pursuant to the Agreement. These statements reflect management's current assumptions and expectations and by their nature are subject to certain underlying assumptions, known and unknown risks and uncertainties and other factors which may cause actual results, performance or events to be materially different from those expressed or implied by such forward looking statements. Except as required pursuant to applicable securities laws, the Company will not update these forward-looking statements to reflect events or circumstances after the date hereof. More detailed information about potential factors that could affect financial results is included in the documents filed from time to time with the Canadian securities regulatory authorities by the Company. Readers are cautioned not to place undue reliance on forward looking statements. Neither the Canadian Securities Exchange (the 'CSE') nor the Investment Industry Regulatory Organization of Canada) accepts responsibility for the adequacy or accuracy of this release.
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|Company:||Biocure Technology Inc.|
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