Biocure Technology Inc enters into Joint R&D Agreement for development of CAR T-cell Therapy
Vancouver, British Columbia – December 4, 2017 – Biocure Technology Inc. (formerly Gravis Energy Corp.) (CSE: CURE) (the “Company” or “Biocure”) is pleased to announce that its wholly owned subsidiary BiocurePharm Corporation (“Biocure Korea”) has entered into a joint R&D agreement (the “Agreement”) with Pharos Vaccine Inc. (“Pharos”) dated November 30, 2017 for the purpose of carrying out research and development activities relating to the commercialization of anti-CD19 CAR-T (Chimeric Antigen Receptor T Cell) and for the pursuit of pre-clinical and clinical trials.
In August 2017, Novartis Pharmaceuticals Corp. was the first company to obtain FDA approval for gene immune-therapy in the United States with its product “Kymriah”, which is for usage in treatment of pediatric and young adult patients with a form of acute lymphoblastic leukemia. Kymriah is a CAR T-cell therapy product. In October 2017, Gilead Sciences Inc. received FDA approval for its lymphoma product “Yescarta” another CAR T-cell therapy product used to treat adult patients with certain types of non-Hodgkin lymphoma.
The market for CAR-T Cell therapies is expected to grow steadily till 2028 by 53.9% of annual growth rate and reach U$8.3 Billion in value. (Source : Coherent Market Insight, CAR-T Cell Therapy Market, 2017. 2)
Many Korean biopharmaceutical companies also have been working to develop CAR-T Cell therapy, but none of them is yet to proceed to pre-clinical trial stage.
Pharos, a professional R&D company for cell therapy products in Korea, has developed optimized technologies for CAR T gene, virus vector, gene transfer, cell multiplication and cell treatment
Biocure Korea and Pharos held preliminary discussion with the Korean FDA for the commencement of pre-clinical trials and clinical trials, where clinical trials would be implemented not only in Korea but in other countries such as Germany and potentially Canada.
The purpose of the Agreement is to set forth joint development works to produce CAR T-Cell for pre-clinical trials and clinical trials, establish manufacturing technology and SOP (Standard Operation Procedure), establish Quality Control method a, prepare materials for safety and efficacy, apply for Biologics License in Korea and ultimately, Product Registration and Conditional Commercial Sales License.
Pursuant to the Agreement, Biocure Korea will fund all fees and expenditures throughout all stages until product registration and commercial sales license are obtained and is setting up a GMP (Good Manufacturing Practice) Facility to manufacture products and will perform worldwide marketing except in China. Pursuant to the Agreement, Pharos will provide a license for the use of its technology, prepare products for pre-clinical & clinical trial and address all technology-related activities until product registration and conditional commercial sales license are obtained.
Additionally, Biocure Korea shall pay to Pharos Technology License Fees in the aggregate amount of 3.8 billion Korean won, of which 500 million Korean won shall be paid in five equal installments over the first year of the Agreement, 300 million Korean won will be paid once the application for phase 1 clinical trials are approved, 1 billion Korean won will be paid once the phase 1 clinical trials are completed and the final 2 billion Korean won will be paid once the phase 2 clinical trials are completed. Biocure Korea will also pay certain sales linked technical fees from sales of the product developed.
Any technical achievements or outcomes completed under the Agreement shall belong to both parties as joint intellectual property and cannot be sold or transferred to the third party without consent of the other party. If there is any profit generated from such intellectual property, it shall be equally shared by both parties, subject to the sales linked technical fees.
Pursuant to the Agreement, Biocure Korea is obligated to set up GMP Facilities in the second half of 2018 to manufacture Pharos’ Lentivirus which is a lentivirus vector for manufacturing anti-CD19 CAR-T-cell. It is a non-replicative viral vector of high-efficiency gene that has been independently researched and developed by Pharos. The facility is to be transferred to Pharos at its requires subject to negotiations regarding the value of such facility.
The Agreement has a 15 year term. Each of Biocure Korea and Pharos have been selected by the Ministry of Health and Welfare in Korea as a Project for CIDD (Consulting for Innovative Drug Development) Program by which the companies could receive financial aids and government policy supports from Korean Government in developing innovative drugs such as CAR T Cell.
Dr. Sang Mok Lee, CEO & President of the Company says, “We are very excited about this first step to work with Pharos on the development of CAR T Cell and to be the first runner in this life-saving treatment for many desperate patients in Korea. We are confident in our ability to complete pre-clinical trials within 6 months and move forward to clinical trials. Our target timeline to obtain Product Registration and Conditional Commercial Sales License in Korea is by the end of 2019. We are also in discussion with a few hospitals in Korea and other countries for the clinical trial. We are striving hard for commercialization of our CAR T Cell as soon as possible.”
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 clinical trials of five major biosimilar products in South Korea, including Interferon Beta 1b, Filgrastim and Ranibizumab. 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”
CEO and Director