Leading The Way To Better Women's Health
By
Preventing Cancer Before It Begins
Unmet Medical Need
Infection with HPV is the world’s most common sexually transmitted disease. Just in the United States, there are 79 million people infected with HPV at any one time and 14 million new infections each year.
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Although most resolve, infection with certain high-risk HPV sub-types becomes persistent and gives rise to devastating diseases such as head and neck, anal, and cervical cancer.
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Despite the availability of prophylactic vaccines, cancers caused by HPV still present a significant burden on women’s health and health systems around the world. Cervical cancer, for example, is the fourth most common cancer in women and results directly from HPV infection. In the U.S., over 170,000 cases of precancerous cervical lesions are detected yearly, necessitating surgical intervention, all due to persistent, currently incurable HPV infections.
Company
Innovene is developing the world’s first antiviral to combat the unbearable burden of HPV disease. By
targeting infection, Innovene’s will prevent HPV disease at its source, before it develops into precancer or cancer.
Unique Antiviral Approach
Innovene’s lead drug, INV-015, is an advanced proprietary formulation comprising four naturally occurring compounds in an easy-to-apply intravaginal cream, intended for the treatment of infections with high-risk HPV sub-types. Strategic drug screening has yielded a synergistic mixture of compounds that not only directly inhibit viral replication but also effectively modulate the patient’s immune system to clear HPV-infected cells.
INV-015 has demonstrated potent activity both in vitro and in vivo, utilizing multiple unique papillomavirus animal models through the NIH/NIAID In Vivo Drug Testing Program. Following the successful filing of the IND, Innovene is poised to initiate Phase I clinical studies in patients infected with high-risk HPV subtypes. These Phase I studies are designed to assess endpoints related to efficacy, such as viral load and biomarkers, in addition to those pertaining to safety and tolerability.
Advanced Formulation and Ease of Manufacturing
Innovene has formulated the components of INV-015 in a proprietary cream that both stabilizes the active ingredients and enhances tissue permeation for optimized bioavailability. Importantly, INV-015 manufacturing is capable of being scaled to meet demands for the clinical program. The local delivery of INV-015 in an easy-to-apply intravaginal cream makes Innovene’s lead product a potentially invaluable addition to the treatment of HPV-induced disease in women.
Meet the Team
The Way Forward
01
Clinical Development: The intravaginal INV-015 Cream is set for IND-enabling studies, with the first human trial focusing on women with persistent cervical HPV infection. Following successful Phase I trials, we aim to launch a comprehensive Phase II study.
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With the completion of these critical trials, Innovene is on the verge of introducing a first-in-class antiviral therapy, fixing up the management of HPV infections and its variable health implications.