Company Overview

Melanovus Oncology is a privately held, late pre-clinical stage company focused on discovering, developing and commercializing innovative new therapeutics, diagnostics and topically delivered compounds for late stage melanoma and other skin cancers. Founded in early 2012, the company has been undertaking the studies that would lead to investigational new drug (IND) status from the Food and Drug Administration (FDA) for its lead compound. Almost twelve years of research has led to the development of the company’s portfolio. An exclusive global license to a library of compounds and related IP was obtained from the Penn State Research Foundation.

The company’s portfolio includes multiple compounds that address a significant unmet medical need. The lead compound has demonstrated activity against B-RAF that are resistant to other therapies. These compounds have demonstrated clear anti-tumor activity in pre-clinical animal studies. These first-in-class compounds are known as Multi-Target Inhibitors?(MTIs) due to their unique ability to selectively inhibit multiple pathways expressed in melanoma with a single agent, including the mutant B-RAF and the B-RAF that are resistant to other agent. They are highly differentiated by their activity against the AKT3 pathway, which has been described as a “master switch?in melanoma development and progression. Nanilipolee-007 is the most advanced of these MTI compounds and could enter Phase I clinical trials in mid to late 2013. The long-range plan for the company is to develop these unique compounds through Phase 2 clinical trials (either alone or with a strategic partner) and to identify partners that can help Melanovus to realize the full commercial potential of each compound in the US and abroad. A full range of collaboration opportunities will be considered.

A companion diagnostic is also in development that could detect the presence of the multiple key targets in blood. Such a diagnostic test will be useful in helping to determine which patients are likely to respond to the therapeutic, and in monitoring patients during their therapy.

More About Us

Melanovus Oncology is a privately held late pre-clinical stage oncology company focused on discovering and developing innovative therapeutics and diagnostics for the management of melanoma and other skin cancers. The Melanovus Oncology team includes individuals with proven success in research, product development, clinical development, and product commercialization. This small core team is supported by a network of seasoned professionals with legal, regulatory, financial and manufacturing expertise.

  • Melanovus Oncology is a late pre-clinical stage oncology company. Most pre-clinical work has been completed and a phase I trial for its lead compound could begin in late-2013
  • A significant unmet medical need exists for effective new therapies for treatment of advanced melanoma, and for melanoma prevention
  • The Melanovus approach is unique: Multiple tumor targets and pathways are recognized and inhibited by a single agent (First-In-Class Multi-Target InhibitorsTM)
  • The lead compound has been shown to be both safe and effective in pre-clinical animal studies
  • In animal studies, the lead compound, Nanolipolee-007 slowed or prevented disease progression of advanced melanoma
  • Nanolipolee-007 has shown excellent activity against the mutant B-RAF and B-RAF that can become resistant to currently available therapies
  • A companion diagnostic is also in development that can detect the presence of targeted pathways in serum
  • The Company has a single focus on developing agents to treat or prevent melanoma
  • Development of drugs to treat melanoma will likely benefit from incentives provided by the FDA for the treatment of rare diseases (Orphan drug status)
  • Pipeline of compounds with demonstrated anti-tumor activity in animal studies in melanoma
  • Experienced leadership team - well networked with leading melanoma centers, thought leaders, and leading life-science service providers
  • Global license to patents, IP, and related know-how acquired from Penn State Research Foundation, Patents issued, filed or pending in US and ex-US markets