Genticel has announced positive preclinical in vivo proof of concept results of GTL002, its multivalent HPV therapeutic vaccine candidate based on the Company's versatile Vaxiclase platform.
No treatment options are available for women infected with oncogenic HPV types but who have not yet developed high-grade lesions or cervical cancer: GTL002 seeks to eradicate the 6 most oncogenic HPV types affecting 158 million women worldwide.
As a reminder, GTL001 (known in Europe as ProCervix), Genticel's first-in-class therapeutic vaccine candidate currently in phase 2 in Europe, already targets the 2 most oncogenic HPV types that affect 93 million women.
With GTL001 and GTL002, Genticel is the first company that has established a staged pipeline of HPV therapeutic vaccines for the large female population burdened by this unmet medical need.
The proof of concept data of GTL002 demonstrated that an in vivo immune response was induced against each of the 6 HPV-derived proteins present in the therapeutic vaccine. In addition, in vivo therapeutic efficacy was shown by tumor eradication in the most widely used and broadly accepted reference model.
"These positive results, coupled with robust manufacturing data that met stringent reproducibility, quality and yield criteria, provide a solid foundation to advance our multivalent HPV vaccine towards clinical development," stated Marie-Christine Bissery, Chief Scientific Officer of Genticel. She added: "Genticel can now initiate the formal preclinical pharmacology, toxicology studies and GMP clinical lot production required for the preparation of an IND or a phase 1 trial in Europe that could start as early as 2017."
GTL002 is the first product candidate based on Genticel's proprietary Vaxiclase technology. This next-generation technology platform can be used with many antigens in multiple indications. In February 2015, Genticel signed a first licensing agreement with the Serum Institute of India Ltd. (SIIL), the world's largest producer of vaccine doses, to evaluate Vaxiclase for use in multivalent vaccines containing pertussis antigens. Under the terms of the agreement, Genticel receives up to $57 million in upfront and milestones payments, plus royalties on sales.
"Achieving in vivo preclinical proof of concept of GTL002 efficacy is an important milestone in strengthening Genticel's HPV therapeutic vaccine pipeline," concluded Benedikt Timmerman, Chief Executive Officer of Genticel. "These positive data show our ability to deliver a follow-on HPV product candidate and support our confidence in Vaxiclase's substantial value in other therapeutic indications."