Genelux Corporation, a clinical-stage immunotherapy company, and Newsoara BioPharma Co., Ltd., announced a collaboration and exclusive license for the development and commercialization of Olvi-Vec and other oncolytic viruses.
According to the terms of the agreement, Newsoara shall have exclusive rights in Greater China (mainland China, Hong Kong, Macau and Taiwan) to Olvi-Vec for which Genelux currently is planning a U.S. based Phase 3 registration trial in platinum resistant/refractory ovarian cancer. Newsoara also shall have exclusive rights in Greater China to Genelux's proprietary oncolytic virus platform, and the parties will collaborate on the development of novel oncolytic immunotherapeutics.
Newsoara, at its cost and expense, will be responsible for development and commercialization and will have the future right to manufacture licensed products in Greater China. The parties also will collaborate on a Phase 2 clinical trial for the intravenous delivery of Olvi-Vec in a new indication using clinical sites in China and the U.S. Newsoara will be responsible for all trial costs.
Under terms of the agreement, Genelux will receive up-front and near-term payments totaling $11 million and will be eligible to receive additional per-product payments of up to $160.5 million, contingent on certain development, regulatory and commercial milestones, plus tiered royalties on net sales ranging from mid-single-digit to mid-double-digit percentages. Genelux shall have an exclusive license outside of Greater China to oncolytic virus products derived by Newsoara and will pay Newsoara milestones and royalties on sales of any such products which Genelux elects to develop.
We are delighted to be working with Newsoara on developing Olvi-Vec, as well as on our broader collaboration. It is a dynamic organization with a commitment to advancing cutting-edge therapeutics, whose strength in research, development and manufacturing in China is a perfect complement to our focus on the discovery and clinical development of novel virotherapies. Together we look forward to accelerating the development of Olvi-Vec and to strengthening and broadening our pipeline of next-generation oncolytic viral immunotherapies.
- Thomas Zindrick, J.D., President and CEO of Genelux.
About Olvimulogene Nanivacirepvec (Olvi-Vec)
Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and therapeutic potential. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Olvi-Vec has been administered to more than 150 patients in clinical studies. In these studies, Olvi-Vec was generally well tolerated and the data provided evidence of clinical benefit.
Newsoara is a clinical-stage biopharmaceutical company with the mission to develop and commercialize life changing medicines for the treatment of patients with cancer, autoimmune, metabolic and other major diseases in China and around the world. With fully integrated drug discovery, CMC and clinical development capabilities, Newsoara has built a robust and broad pipeline for treating major diseases with unmet needs. Newsoara has assembled a world-class management team with extensive experience in novel drug development that is motivated to improve and impact human health worldwide.
About Genelux Corporation
Genelux is a clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. The Company's most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable DNA virus with a large engineering capacity. The core of Genelux's discovery and development efforts revolves around the company's proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec.