Transcript Targovax
Targovax Transforming the Treatment of Operable Pancreatic Cancer Erfaringer med OFU www.targovax.com www.targovax.com Pancreatic Cancer - 4th leading cause of cancer death 112 000 new cases per year, 15-20% operable Survival for patients with operable disease – 15% after 5 years Survival for patients with non-operable disease – 10% after 12 months Patient survival unchanged over last 30 years www.targovax.com TG01 – RAS and Cancer RAS controls cell division RAS mutations are found in – 80-90% pancreatic cancer – 40-50% colorectal cancer – 25-30% non small cell lung cancer Difficult to hit with antibodies, small molecules RAS screening is becoming routine Current treatment options provide no survival benefit www.targovax.com The Creation of Targovax 10 year follow up shows long term survivors CTN 9502/9706 + CTN 98010 100 90 N=20 Operated and RAS peptide treated patients Median Survival (MS): 28 months 80 Survival (%) 70 International Journal of Cancer, 2010 60 Best standard of care, hist. control: Resected (R0+R1) pts.: 20.2 months Resected (R0+R1) + adjv. gemcitabine: 22.1 months (Oettle H et al, 2007) 50 40 30 20 10 0 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 102 108 114 120 4 long term survivors, 3 with Months from resection long term memory response Median survival improved TG01: Strong immune responses in all patients Well tolerated, low toxicity www.targovax.com Significant Progress Made 2010: Company established Etablererstipend granted, Innovasjon Norge 2011: Orphan Drug status granted in EU and US for TG01 GMP production established for TG01 Detailed clinical development programme through pivotal Phase III OFU support granted, Innovasjon Norge 2012: Experienced team established European Medicines Agency advice supporting the clinical development plan GMP production established for adjuvant GM-CSF from a reliable source Clinical Phase I/II trial initiated December 2012 www.targovax.com Our Team – Driving a Virtual Organisation Jon Amund Eriksen (COO, Dir. R&D) Berit Iversen Hanne Mette Kristensen Tone Otterhaug (VP QA and (CEO) (VP Clinical and Technical Development) Non-clinical Development) www.targovax.com Key milestones OS DFS H2 2014 H2 2015 Q3 2013 Phase I Phase II Combination with Gemcitabine 6-12 patients Immunology responses Milestones Milestones Production scale up PIII 18-24 patients Immunology Disease Free Survival (DFS) Overall Survival (OS) www.targovax.com OFU - støtten har vært utløsende for oppstart av Targovax’ kliniske studie innenfor operabel bukspyttkjertelkreft en god og viktig støtteordning www.targovax.com Søknads- og kontraktsprosess Intensjonsavtale med OUS signert april 2011 OFU-søknad innsendt april 2011 OFU panelvurdering august 2011 OFU-tilsagn oktober 2011 OUS søker HSØ innovasjonsmidler mars 2012 OFU samarbeidsavtale signert april 2012 OUS søker Kreftforeningen innovasjonsmidler juni 2012 Første utbetaling september 2012 Studieavtale signert desember 2012 Kontaktpersoner hos Innovasjon Norge: 1 Kontaktpersoner på sykehuset: 10+ www.targovax.com Erfaringer God dialog med Innovasjon Norge Lang prosess frem til første utbetaling - mye dokumentasjon Gode utbetalingsprosedyrer deretter - rapporterer direkte fra regnskap med revisorbekreftelse så ofte det passer bedriften Noen forbedringspunkter: Ønsker bedre samordning av støtte til begge forskningspartnerne (jfr f. eks. Eurostars) IN/HSØ Ønsker mer klarhet ifm ansvar på OUS: hvem er ansvarlig på hvilket trinn i søknadsprosessen. Standardprosedyre A-Å? Kan Inven2 bistå med dette? www.targovax.com