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Method of producing human IFN-a using sendai virus-infected haematopoietic stem cells

Organization:BIOHemaCell, QC, CA
I.P. Brief:The invention relates to a novel method for the large scale production of human natural interferon-alpha (IFNa) using ex vivo expanded cord blood (CB) haematopoietic cells. Claims comprise the methods for expansion, priming with IFNa and infection with Sendai virus of haematopoietic CB cells for the production of natural IFNa
Summary of I.P.:IFNa are widely used in the treatment of more than 20 malignancies and virologic diseases including hepatitis C infection. The reference therapy for hepatitis C patients is IFNa produced by recombinant DNA technology. Up to 50% of these patients fail to respond or become refractory to the reference treatment. The natural INFa protein is markedly different from the single-subtype recombinant protein: is composed of a mix of different subtypes with distinct activities, induces fewer adverse effects and low or no resistance, and is efficient in hepatitis C patients that have become refractory to the reference therapy. Natural INFa currently available on the market are produced by overnight culture of Sendai virus-infected human leukocytes isolated from the buffy coats prepared from several hundred blood donations. The use of CB cell cultures for the production of natural IFNa has several advantages over the current methods: higher overall IFNa productivity (1000-fold higher per cord blood), simplified logistics of the natural IFNa production since CB cells can be pooled and frozen prior to culture allowing sufficient time to perform adequate microbiological testing and increased safety due to a lower risk of transmission of pathogenic agents by the use of CB
Patent:US Patent No: US 6,472,208 B1. International application published under the Patent Cooperation Treaty (PCT) No: PCT/CA00/01479
Keywords:Human natural interferon-alpha, cord blood haematopoietic stem cells, cell expansion, pools of cord blood, increased overall IFNa productivity, simplified logistic, increased safety
Primary Industry:Pharma & Biotech
Specific Market:Treatment of hepatitis C patients refractory to recombinant IFNa
Market Size:In 2002, IFNa corresponded to ~13% of the therapeutic proteins market value representing more than 4B US$. The hepatitis C market represents ~70% of the IFNa targeted market. Up to 50% of hepatitis C patients fail to respond or become refractory to recom
State of the Art:The reference therapy for hepatitis C patients is IFNa produced by recombinant DNA technology (recombinant IFNa). Natural IFNa on the market prepared from adult blood donations are not approved for the treatment of hepatitis C patients in the US but are used as second-line treatment in some European countries
Figures of Merit:Expected medical advantages over the recombinant products by a natural protein constituted of a mix of different subtypes with distinct activities, inducing fewer adverse effects and low or no resistance, and expected development advantages by simplified logistics of manufacturing and increased safety of the product compared to other natural INFa
Tech.  Obstacles:The main challenge is the scaleup of the culture system. Although small bioreactor systems were shown efficient, industrial production of IFNa would require larger systems. Additional work will permit to better define the bioreactor type for this purpose but the objective can be met with cell culture technologies currently available
Market Obstacles:A first phase development plan is proposed that will allow the completion of the R&D activities for the validation of the proof of concept within 12 months following the receipt of its first capital. Essentially, this first phase is intended to produce the INFa according to the method described in the patent and to purify them in order to obtain a standard product as determined by the subtype analysis and the biological activities (measured in in vitro assays and an animal model). In a second phase, as for any commercial therapeutic protein, pre-clinical studies will be needed (GMP production, safety and toxicity studies, dose escalation and dose-related responses) leading to the IND submission and preparation of clinical studies with the hepatitis C infection as the targeted therapeutic indication
Patent Landscape:References cited in the patent: US patent No 5,436,151 A (7/1995 McGlave et al.) and 6,288,030 B1(9/2001 Hershendon et al.)
Publications:Banatvala JE et al. Interferon response to Sendai and Rubella viruses in human foetal cultures, leucocytes and placental cultures J Virol. 1971 13 :193-201; Splichal I. et al. Ontology of interferon alpha secreting cells in the porcine fetal hematopoietic organs. Immunol. Lett. 1994 43:203-208; Cantell K, Hirvonen S, Kauppinen HL, Myllyla G. Production of interferon in human leukocytes from normal donors with the use of Sendai virus. Methods Enzymol. 1981;78(Pt A):29-38; Collins PC, Miller WM, Papoutsakis ET. Stirred culture of peripheral and cord blood hematopoietic cells offers advantages over traditional static systems for clinically relevant applications. Biotechnol Bioeng. 1998 Sep 5;59(5):534-43; Nyman TA, Tolo H, Parkkinen J, Kalkkinen N. Identification of nine interferon-alpha subtypes produced by Sendai virus-induced human peripheral blood leucocytes. Biochem J. 1998 Jan 15;329 ( Pt 2):295-302
Research Team:Currently one member in the research team: Chantal Proulx (applicant) has more than 10 years of research experience; PhD in Microbiology and Immunology; R&D scientist at HÉMA-QUÉBEC from 1996 to 2004; expertise in stem cell culture and haematopoiesis; co-inventor of present technology


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