Targeted HSV-1 derived oncolytic virus Myb34.5 granted orphan designation in the US and in the European Union for the treatment of pancreatic cancer.
Paris, January 22nd, 2015 - Karcinolys SAS, a privately-held biotechnology company, today announced that orphan designations have been granted by the U.S. Food and Drug Administration (FDA) and by the European Commission for its oncolytic virus Myb34.5 for the treatment of pancreatic cancer.
The U.S. Orphan Drug Act (ODA) provides for granting a special status to a drug or biological product intended to treat a rare disease or condition. An orphan designation qualifies the sponsor of the drug for various development incentives and seven years of U.S. market exclusivity after marketing approval.
European orphan medicinal product status confers up to ten years of marketing exclusivity in all European Union (EU) member countries following marketing approval, and a range of other benefits including EU-funded research, protocol assistance, and fee reductions.
“We are committed to developing a therapy for one of the most insidious and lethal cancers, particularly as only standard treatments relying on a few approved palliative chemotherapies and targeted therapies are currently available,” said Jean-Luc Béjot, MD, MBA, Chief Executive Officer of Karcinolys. “We are pleased that the FDA and the European Commission have granted Orphan Designation to Myb34.5 as a potential new therapy for Pancreatic Cancer, a disease with great unmet medical need.”
About Myb34.5
Myb34.5 is a replication-conditional oncolytic virus derived from herpes simplex virus type 1 (HSV-1) through targeted genetic engineering. The key mutation is the insertion of cellular transcription factor b-myb gene as a promoter gene sequence controlling and retargeting the expression of HSV-1 virulence gene gamma34.5 (34.5). Replication of Myb34.5 in infected cells is conditioned by the expression of b-myb, which has been found to be over-expressed in pancreatic ductal adenocarcinoma cells. Myb34.5 selectively replicates in cancer cells, resulting in infected cancer cell death, while sparing normal surrounding tissue cells. Karcinolys in-licensed Myb34.5 from Massachusetts General Hospital (MGH, Harvard University, Boston, Ma., USA) in 2007.
Myb34.5 was granted orphan drug designation by the FDA on December 23, 2014, and by the European Commission on January, 15th 2015. Myb34.5 is not approved for sale for any indication.
About Pancreatic Cancer
Pancreatic cancer develops in the exocrine glandular system of the pancreas. Since more than 90% of pancreatic cancers originate from the ductal epithelium, the term pancreatic cancer is commonly used in the literature as a synonym to pancreatic ductal adenocarcinoma.
The aetiology of pancreatic cancer remains largely unknown. Evidence of a causative role has been identified only for smoking tobacco, with a risk 2.5 to 3.6 times higher than in nonsmokers.
The 2012 estimated incidences of pancreatic cancer were approximately 80,000 in the Europe Community and 43,000 in the United States of America. The incidence is slowly increasing.
In only 10-20% of patients with pancreatic cancer, the tumour is surgically resectable at the time of diagnosis. Eighty to 90% of pancreatic cancers are diagnosed at a stage at which the tumour is unresectable. At this stage, the standard treatments mostly rely on only a few approved palliative chemotherapies and targeted therapies.
About Karcinolys
Karcinolys is a biotechnology company focused on developing oncolytic virus Myb34.5 in oncology indications. Myb34.5 is currently in preclinical studies for pancreatic cancer and hepatocellular carcinoma. The company expects that first-in-man trials could start in S2 2016. For more information, please visit the Company’s website at https://karcinolys.wordpress.com
Contact
Jean-Luc Béjot, MD, MBA, Chief Executive Officer
Karcinolys SAS
Cell: +33 (0)6 45 62 30 43
Email: jean-luc.bejot@karcinolys.com
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