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Nventa Biopharmaceuticals Corporation is developing innovative therapeutics for the treatment of viral infections and cancer, with a focus on diseases caused by the human papillomavirus (HPV). Using its unique, proprietary technology , Nventa is assembling a pipeline of CoVal™ therapeutic candidates to treat serious diseases of significant unmet medical need.
Nventa’s CoVal™ fusions harness the immunostimulatory powers of heat shock proteins to trigger the immune system to recognize specific diseases. By using recombinant technology, CoVal™ proteins are fused, or covalently linked to a heat shock protein to create a single hybrid protein, also referred to as a therapeutic vaccine or immunotherapeutic, designed to recognize a disease-specific antigen.
The Company’s lead program is HspE7, an investigational CoVal™ therapeutic vaccine in development for the treatment of patients with cervical dysplasia, recurrent respiratory papillomatosis and genital warts. Nventa technology has also yielded preclinical candidates for the treatment of hepatitis B and influenza.
The Company plans to conduct a Phase 1 trial testing the safety of HspE7 plus adjuvant in patients with cervical dysplasia (CIN), which it expects to begin mid-2007. Once completed, Nventa is planning a Phase 2 efficacy trial in CIN patients; if enrollment goes as expected, his Phase 2 trial could be completed rather quickly and provide the fastest path to data.
In addition to the CIN Phase 2 trial, Nventa is planning additional efficacy trials in other HPV-related indications, such as HIV-positive women with LSIL CIN, genital warts, and recurrent respiratory papillomatosis (RRP). With orphan drug designation and fast-track status from the U.S. Food and Drug Administration, conducting a pivotal trial in RRP patients may be the fastest route to market.
CIN = Cervical dysplasia
RRP = Recurrent Respiratory Papillomatosis
*Dysplasias refer to precancerous lesions. The dysplasias caused by HPV infection are graded into two main categories, Low Grade Squamous Intraepithelial Lesions (“LSIL”) and High Grade Squamous Intraepithelial Lesions (“HSIL”), with HSIL being a later progression of the disease relative to LSIL.
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