CellControl and BioInvent sign Phase III Manufacturing Agreement for ACA 125 Antibody
CellControl and BioInvent sign Phase III Manufacturing Agreement for ACA 125 Antibody Martinsried, Germany, and Lund, Sweden; 5 April 2002: CellControl Biomedical Laboratories AG and BioInvent International AB today announce an agreement for the large scale cGMP (current Good Manufacturing Practise) manufacturing of CellControl's ACA-125 antibody. The ACA-125 is an imitation of the natural antigen CA 125 which is present in 80 percent of ovarian carcinomas. When injected, the substance causes a specific immune reaction to CA 125 in the patient's body. A tumour vaccine on this basis promises a breakthrough for cancer therapy, in particular the treatment of relapses. CellControl is presently preparing for the ACA 125 to undergo Phase I and II clinical trials. Under the agreement, BioInvent, through its subsidiary BioInvent Production AB, will carry out process qualification and cGMP production of the antibody including regulatory support, for phase III trials. "In BioInvent we have found a very professional partner for Phase III manufacturing, with the special qualification and know-how required to produce the larger Phase III volumes", says Dr Karl Krista, member of CellControl's board of management. Cristina Glad, President of BioInvent Production AB, comments on the agreement: "We look forward to initiating this collaboration with CellControl. We find its strategy within the oncology field very interesting in combining cancer diagnoses and therapy, and we are impressed with its aggressive development plan." - ENDS - For more information, please contact: BioInvent International AB Buchanan Communications Svein Mathisen Nicola How / Louise Bolton President and CEO Tel: +44 20 7466 5000 Tel: +46 46 286 85 67 Mobile: +46 708 97 82 13 E-mail: sm@bioinvent.com Cristina Glad President, BioInvent Production AB Tel: +46 46 286 85 51 Mobile: +46 708 16 85 70 E-mail: cg@bioinvent.com Notes to Editors: BioInvent International AB, listed on the O-list of the Swedish Exchange, is a biotechnology company devoted to providing state-of-the- art antibody technology to the pharmaceutical and biotech industry. A cornerstone is its proprietary human antibody gene library, n-CoDeR(TM). This is a collection of more than ten billion functional antibody genes that are ready to be screened against desired antigens. n-CoDeR(TM) has been used successfully for the isolation of antibody fragments with specificity for a number of antigens, including peptides, proteins and carbohydrates. BioInvent offers biotechnology and pharmaceutical companies access to n-CoDeR(TM) through collaborative research and development programs. BioInvent's capabilities in large-scale contract manufacturing of protein-based drugs through a state-of-the-art cGMP-certified facility further underpin its competitiveness in the antibody arena. BioInvent has been supplying monoclonal antibodies, fusion proteins and other recombinant proteins to the world's leading pharmaceutical and biotechnology companies for therapeutic use since 1988. These antibodies and proteins are used in all phases of clinical trials in both the US and across Europe. The cGMP-certified manufacturing facility is designed to meet FDA and EU regulations from early clinical development to commercial scale-up, with multi-kilogram annual capacity. BioInvent is headquartered in Lund, Sweden, employing a total of 115 people. CellControl specialises in cutting-edge products and services for the individual treatment of cancer patients. The company's specific expertise includes micro- and biosensor chip technology, oncological prediction "in silico", tumour vaccines, molecular-biological approaches and receptor test procedures For further information, see www.cellcontrol.de or www.bioinvent.com ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2003/09/25/20030925BIT00980/wkr0001.doc http://www.waymaker.net/bitonline/2003/09/25/20030925BIT00980/wkr0002.pdf