Nventa Biopharmaceuticals Corporation
4370 La Jolla Village Drive
Nventa Biopharmaceuticals Corporation is developing innovative therapeutics incorporating its proprietary CoVal™ fusions for the treatment of viral infections and cancers, with a focus on diseases caused by the human papillomavirus (HPV). The Company’s lead candidate, HspE7, is a novel therapeutic vaccine intended for the treatment of HPV-related diseases.
The human papillomavirus is the most common sexually transmitted disease. At least 80 percent of sexually active people contract it at some point in their lives and at least 20 million people in the U.S. are already infected with sexually transmitted HPV infections. Although HPV can remain latent or regress spontaneously in some people, it can also manifest itself physically as warts, dysplasias and cancers. More than 35 of the over 100 different types of HPV can be sexually transmitted and infect the genital area. Some types also infect oral and anal epithelial cells. Relatively benign types of HPV cause plantar and common warts.
HspE7 is a proprietary therapeutic vaccine targeting the E7 protein of human papillomavirus type 16 – the most common subtype of HPV virus and responsible for a significant percentage of CIN cases. Nventa is investigating the utility of HspE7 in combination with the adjuvant Poly ICLC (a TLR3 agonist) in the treatment of HPV-related diseases. The vaccine produces potent, specific T-cell responses in preclinical models and, most notably, induces regression of HPV-dependent tumors in the TC-1.K mouse tumor model.
The vaccine recently completed a Phase 1 clinical trial in patients with cervical intraepithelial neoplasia (CIN), or cervical dysplasia. The purpose of the trial was to determine the safety, tolerability and immunogenicity of HspE7 plus escalating doses of Poly-ICLC (50, 500, 1,000 and 2,000 mcg).
All dose regimens were found to be safe and well tolerated and the adjuvant potently enhanced HPV16 E7-specific T-cell responses in subjects who demonstrated no or low responses at baseline. Positive results from this trial verify the company’s predicted mechanism of action for HspE7 as demonstrated by early preclinical models and support the compound’s potential to treat HPV16 induced CIN. Of particular importance, the data suggests that HspE7 may potentially provide a needed treatment option for patients with CIN 1. Current practices typically call for patients with CIN 1 to simply monitor their condition without therapeutic intervention, a process referred to as ‘watchful waiting’.
Based on the positive Phase 1 trial results, Nventa’s next planned initiatives include Phase 2 clinical studies that will evaluate HspE7 as a potential treatment for both low-grade cervical dysplasia (CIN 1) and high-grade cervical dysplasia (CIN 2/3). The planned Phase 2 trials will consist of multi-center, randomized, double-blind, placebo-controlled studies in the U.S., Canada, Europe and Latin America. Protocol development, discussions with the U.S. Food and Drug Administration and site evaluations have been completed for the CIN 2/3 study. A second protocol for the CIN 1 indication is near completion. Based on an analysis of HPV16 E7-specific T-cell responses across all of the Phase 1 study’s four cohorts, Nventa has identified a dose regimen of 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC for these subsequent clinical studies.
Given the versatility of Nventa’s core technology platform, there are many additional therapeutic applications where we have potential.
Headquartered in San Diego, CA, Nventa Common Stock trades on the Toronto Stock Exchange (TSX) under the symbol: NVN.
Last Updated: 01-30-2009
Nventa Biopharmaceuticals Corporation