Neoviaoncology a privately-held biotechnology company engaged in the development and commercialization of novel, multi-function drugs for overcoming drug-resistant cancers, announced that it has met with the U.S. Food and Drug Administration (FDA) to discuss requirements for the filing of an Investigational New Drug (IND) application for its lead compound NEV-801.
As a result of the meeting, Neovia has clarified details of the development path and expects to submit its first IND application as planned.
“Neovia appreciates the positive instruction and interactions we received in our face to face pre-IND meeting with the FDA,” said Trevor G. Blake, Chief Executive Officer of Neovia. “Their clear advice will greatly assist our IND application planned for the third quarter of 2015, and the subsequent initiation of Neovia’s “First in Man,” U.S. clinical trial. Based on the meeting, we are excited that a regulatory path is in place for the initiation of Neovia’s U.S.-based human clinical trials.”
Nev-801 is a novel dual-functioning drug for improved treatment of resistant colon and lung cancers and targeted-therapy resistant chronic myelogenous (or myeloid) leukemia.
About Neovia Oncology
Neovia Oncology is a joint-venture company founded by Seattle-based ANU and Beijing-based PUMC Pharmaceutical. Neovia is an incubator company for the early-stage development of novel oncology compounds to treat urgent unmet medical needs. Neovia has the exclusive, worldwide rights to develop and commercialize a portfolio of over 68 novel anti-cancer compounds, covered under global chemical composition IP. Neovia’s streamlined management team enables a clear decision making process, and allows a very flexible approach to partnering, investment, or licensing scenarios.