Genticel (Euronext Paris & Brussels: FR00011790542 – GTCL), a clinical-stage biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus (HPV), today announced that a new patent No. 9,095,537, entitled “Therapy of cancer based on targeting adaptive, innate and/or regulatory component of the immune response,” has been granted in the United States. This patent, exclusively licensed by Institut Pasteur to Genticel, protects the use of the Company's CyaA-based antigen delivery vectors in combination therapy to treat cancer.
“This new patent strengthens our intellectual property portfolio and expands our potential to progress in therapeutic areas beyond early-stage disease by enabling the use of our CyaA vectors in combination with other drugs for advanced cancer,” said Martin Koch, CEO of Genticel. “Genticel now holds multiple key patents protecting our technology for use in many indications - from viral infection to cancer - in all major markets.”
The CyaA (adenylate cyclase) vector is a breakthrough in antigen delivery technology used by Genticel to develop its lead product candidate, GTL001 (ProCervix), currently in a fully recruited phase 2 clinical trial. GTL001 is a therapeutic vaccine that aims to treat the 93 million women infected worldwide with HPV 16 and/or 18 before high-grade or cancerous cervical lesions develop.
This patent completes Genticel's portfolio on the use of CyaA vectors for the treatment of advanced HPV-induced diseases including cancer. It complements the Company's proprietary European patent No. 2061505 granted in 2012, which notably claims a pharmaceutical composition comprising a chemotherapeutic agent, a recombinant CyaA comprising a tumor-associated antigen and an adjuvant for the prevention or treatment of cancer.
This new patent covers antitumor therapies that include a recombinant CyaA protein comprising a tumor-associated antigen and a TLR (toll-like receptor) agonist in patients. TLR agonists have demonstrated immunological properties as adjuvants. Furthermore, it also covers the use of a CyaA vector in combination with chemotherapeutic agents, including cyclophosphamide which is used in combination with immunotherapy protocols to treat cancer.
Aiming to solve a public health issue.
Among the 300 million women around the world currently infected with HPV, 500,000 new cases of cervical cancer are identified each year and 275,000 women succumb to the disease. 70% of cervical cancer cases are caused by two HPV types and Genticel aims to eliminate them at an early stage with GTL001 (known in Europe as ProCervix), its first-in-class immunotherapeutic vaccine candidate. The company has already completed patient recruitment for the phase 2 clinical trial of GTL001 in Europe.
Offering a promising technological platform.
Genticel's versatile platform, Vaxiclase, is ideally suited for the development of immunotherapies against multiple infectious or cancerous diseases. Genticel's second candidate, GTL002, is a multivalent HPV therapeutic vaccine designed with Vaxiclase. It targets the six most relevant HPV types in terms of global epidemiology and is currently in preclinical development.
Focusing on value creation.
The peak sales potentials of GTL001 and GTL002 are estimated at over €1 billion and €2 billion per year respectively. In addtion to this attractive HPV product pipeline, Genticel's versatile technological platform, Vaxiclase, has already generated significant interest in the pharmaceutical industry, as illustrated by the partnership agreement signed in 2015 with the Serum Institute of India Ltd. (SIIL), the world's largest producer of vaccine doses. This partnership is expected to generate $57 million in revenues for Genticel, before royalties on sales. It will enable SIIL to develop acellular multivalent combination vaccines against a variety of infectious diseases, including whooping cough.
For more information, please visit www.genticel.com
This press release and the information it contains does not constitute an offer or solicitation to buy, sell or hold Genticel shares in any country. This press release may contain forward-looking statements by the company with respect to its objectives. These statements are based on the current estimates and forecasts of the company's management and are subject to risks and uncertainties such as the company's ability to implement its chosen strategy, customer market trends, changes in technologies and in the company's competitive environment, changes in regulations, clinical or industrial risks and all risks linked to the company's growth. These factors as well as other risks and uncertainties may prevent the company from achieving the objectives outlined in the press release. No guarantee is given on forward-looking statements which are subject to a number of risks, notably those described in the registration document filed with the French Markets Authority (the AMF) on 1 April 2015 under number R.15-015 and those linked to changes in economic conditions, the financial markets, or the markets on which Genticel is present. Genticel products are currently used for clinical trials only and are not otherwise available for distribution or sale.
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