On September 28, 2021 Genelux entered into an exclusive rights agreement with Newsoara Biopharma Co., Ltd for Olvi-Vec and the Genelux oncolytic virus library in the Greater China Region. 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. READ RELEASE
V2ACT – Joint Venture
In January 2019, V2ACT Therapeutics, LLC was formed as a joint venture between Genelux Corporation and TVAX Biomedical, Inc. to develop and test V2ACT Immunotherapy, a novel immunotherapy modality.
V2ACT Therapeutics was formed to clinically explore compelling scientific evidence that combining oncolytic virotherapy and adoptive cell therapy can safely achieve superior efficacies for the treatment of pancreatic and other solid tumor cancers: vaccination increases the numbers of neoantigen-specific T cells in the body and Olvi-Vec kills cancer cells and potentiates T cells by increasing cancer tissue receptivity to subsequently-administered adoptively transferred neoantigen-specific effector T cells. READ RELEASE
ELIAS Animal Health
On November 21, 2021, Genelux entered into an exclusive worldwide licensing agreement for V-VET1, its clinical stage animal health product candidate, with ELIAS Animal Health.
ELIAS is a biotechnology company working to advance its novel T cell-based immunotherapies for the treatment of cancer in veterinary medicine. V-VET1 is a vaccinia viral strain which selectively replicates in cancer cells causing cell death (apoptosis). READ RELEASE
As an innovative drug developer, we are committed to establishing mutually-beneficial, long-term partnerships, grounded in trust and transparency, to develop cutting edge science and differentiated pharmaceutical products to deliver transformational benefits to patients and the healthcare system.
Genelux Corporation is committed to developing safe and effective next-generation immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. Our goal is to ensure access to our investigational therapies at the appropriate time and in a clinically appropriate manner for patients.
Outside of our clinical trials, we may provide physician-requested expanded access to its investigational products under limited situations. This is initiated when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient, which is different from a clinical trial where more comprehensive safety and efficacy data are collected. At Genelux, we recognize and understand the need for an early/expanded access policy for patients who have serious or immediately life-threatening disease and have limited available treatment options.
The request for access to a Genelux investigational drug will be considered only if the patient is an eligible patient, meaning:
In addition, prior to setting up an expanded access program or granting a request from an eligible patient’s physician, Genelux will consider whether:
At this time, based on these factors, Genelux believes that participation in one of our clinical trials is the only appropriate way to access our investigational therapies.
If the investigational drug is approved by a regulatory agency for commercial use, including provisional approval, existing expanded access programs will be phased out or modified accordingly.
Patients interested in seeking an expanded access to a Genelux investigative drug should talk to their physician. All requests must be made by the patient’s treating physician by email at EAP@genelux.com. We will, in general, acknowledge receipt of a request for expanded access within five business days. We may ask for more detailed information to fully evaluate a request.
The request for access to an investigative drug can only be considered if the requesting physician agrees to obtain applicable regulatory and ethics committee approvals. We may deny access if the treating physician cannot guarantee an appropriate storage and handling of the investigative drug, which typically requires a temperature controlled deep freezer and follows Biosafety Level 2 safety procedures and precautions. The treating physician must agree to comply with regulatory obligations, including safety monitoring and reporting.
For more information on expanded access from the FDA, click here.