Oncolytic immunotherapy is an immunotherapy modality where viruses selectively replicate and kill tumor cells while leaving normal cells intact.
Viral cell killing has the potential to expose all the tumor’s neoantigens to the immune system and to establish long-term antitumor immunity to improve outcomes for cancer patients.
We utilize vaccinia virus (VACV) as the backbone of our therapeutics and diagnostics platform. VACV has a number of characteristics which we consider desirable in an oncolytic virus for clinical applications:
The CHOICE™ discovery platform is the proprietary foundation of our oncolytic immunotherapy product development program and allows us to rapidly generate new product candidates from conception through the initiation of clinical trials. CHOICE™ has produced more than 500 different versions of the vaccina virus armed with more than 110 transgenes, and has a variety of engineered attributes, including immune modulatory and cell killing properties.
BELIEVED TO BE THE MOST ADVANCED clinical development program involving non-local delivery oncolytic virus
VERSATILE AND PERSONAL potential utility in multiple additional clinical settings
-Thomas Zindrick, JD, President. Chief Executive Officer and Chairman
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.