On May 16, 2019 Biocure Technology Inc. (formerly Gravis Energy Corp.) (CSE: CURE OTCQB: BICTF) (the "Company" or "Biocure") reported that Biocure Pharm Corp.("BPK"), a subsidiary of the Company has entered into an agreement with Pharos Vaccine Inc. for the development of overseas market of CAR T-cell products on exclusive basis (Press release, Biocure Technology, MAY 16, 2019, View Source [SID1234628754]).
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The two Companies will work together in developing anti-CD19 CAR T-cell therapy products, conduct preclinical, clinical trials and commercialize anti-CD19 CAR T-cell therapy products overseas to treat leukemia and lymphoma patients. Some of the highlights of collaborative R&D work scopes in the Agreement include:
Manufacture of products for preclinical trial of Contract Product
Preclinical trial of Contract Product
Manufacture of 3 batch of test product for clinical trial application of Contract Product
Application for clinical trial of Contract Product
Manufacture of product for clinical trial of Contract Product
Clinical trial of the Contract Product
Establishment of manufacturing technology and SOP of Contract Product
Establishment of QC test method and SOP of Contract Product
Preparation of safety / efficacy data of Contract Product
Establishment and operation of GMP Facility of Contract Product
Biologics License Application (BLA) of Contract Product
Obtaining the product registration and (conditional) sales permit for Contract Product
Pharos and BPK (collectively "Parties") have agreed on the exclusive manufacturing and marketing rights of anti-CD19 CAR T-cell products for 15 years from the starting date of sales in the markets. The territories BPK shall have exclusive rights under this Agreement are all the countries except China.
Dr. Sang Mok Lee, a CEO and President of Biocure as well as BPK states, "I am pleased to have this agreement executed with Pharos to be clear about what both firms are supposed to do for the development of world market of CAR-T Cell products beyond Korea market. Biocure has finished successfully pre-clinical trial in Korea last September 2018 and now plans to start a clinical trial in the Q3 this year. Our next goal shall be developing overseas market by implementing clinical trials in those countries we are targeting to enter into. By this Agreement, Pharos and Biocure could have clear paths on what roles each firm should play in the development of world markets."