Genticel receives FDA clearance of IND application for US Phase 1 clinical trial of GTL001 (ProCervix), the company's first-in-class HPV therapeutic vaccine candidate
Paris and Toulouse, June 16, 2015 - Genticel (Euronext Paris & Brussels: FR00011790542 – GTCL), a French biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus (HPV), today announces that the US Food and Drug Administration (FDA) has cleared Genticel's Investigational New Drug (IND) application to conduct in the US a phase 1 clinical study of GTL001 (known in Europe as ProCervix) in patients infected with HPV 16 and/or 18, the two HPV types responsible for 70% of cervical cancer cases.
Today, no treatment options are available for the 93 million women worldwide infected with HPV 16 and/or 18 who have not yet developed high-grade lesions or cervical cancer.
Diane M. Harper, MD, MPH, MS, will lead the US phase 1 study of GTL001 as principal investigator. Dr. Harper is the Gradie and Mary Rowntree Endowed Chair and professor of the Department of Family and Geriatric Medicine and Obstetrics and Gynecology at the University of Louisville, KY. She is an internationally recognized researcher, teacher and clinician in the prevention, diagnosis and treatment of HPV-associated diseases.
The US phase 1 study is designed to evaluate the tolerability and safety of GTL001 as a therapeutic vaccine in 20 women aged 25 to 65 infected with HPV 16 and/or 18. Three investigational sites will be recruiting these patients during the second half of 2015.
"This trial will provide important insights into the tolerability of GTL001 by enrolling patients over a broader age range than in our European studies," said Sophie Olivier, chief medical officer at Genticel. "Results from the US phase 1 study, together with those from the fully-recruited phase 2 study in Europe, will serve to design the subsequent clinical development studies for GTL001 in Europe and in the US."
Genticel previously obtained encouraging safety, tolerability and immunogenicity results from the European phase 1 study of GTL001 in 47 patients. Based on these results, in 2014 the company initiated a European phase 2 trial to evaluate the efficacy and safety of GTL001 in clearing HPV infection in 239 women aged 25 to 50. All patients were recruited by November 2014. The initial efficacy data from this phase 2 trial will be available in the first half of 2016.
"This IND clearance represents a significant advance for Genticel, as the upcoming phase 1 clinical trial for GTL001 will be our first study conducted in the US" added Benedikt Timmerman, chief executive officer of Genticel. "It reinforces our confidence in the strength of our clinical strategy and further demonstrates Genticel's ability to deliver on key aspects of its pipeline development plan."
Genticel's follow-on multivalent HPV candidate, GTL002, recently generated positive in vivo proof of concept results for all six oncogenic HPV types targeted and could be tested in a phase 1 trial as early as 2017. With GTL001 and GTL002, Genticel is the first company to establish a staged pipeline of HPV therapeutic vaccines for the millions of women burdened by this unmet medical need.
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.
Respectively, the peak sales potentials of GTL001 and GTL002 are estimated at over €1 billion and €2 billion per year. In addition 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, 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 April 1, 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.