Olvi-Vec, our lead product candidate, is a modified vaccinia virus that utilizes a triple mode of action: it directly kills cancer cells, stimulates a tumor-specific immune response and converts the tumor microenvironment from an immunosuppressive (cold state) to an immunoreactive (hot state).
We believe our pre-clinical and clinical data support the broad development of Olvi-Vec in patients with liquid or (metastatic) solid tumors, as a monotherapy or in combination with other therapies.
Our current plan is to expand our clinical development program by pursuing additional indications via intravenous delivery. Other indications will be selected from the balance of more than 20 major human cancers against which Olvi-Vec has shown activity in pre-clinical studies, including blood (leukemia/lymphoma), breast, cervical, colon, head & neck, kidney, lung, mesothelioma, ovarian, pancreatic, prostate and skin (melanoma) cancers.
Virus and Vaccine (Neoantigen)-Enhanced Adoptive Cell Therapy (V2ACT) Immunotherapy is a proprietary, indication-agnostic personalized anti-cancer designed to safely maximize the number and effect of cancer neoantigen-specific effector T cells within cancer tissues. It combines immunotherapeutic modalities, neoantigen-specific effector T cell immunotherapy (TVI) and oncolytic immunotherapy (initially, Olvi-Vec), each of which is supported by extensive preclinical and clinical proof-of-concept data, including Phase 1 and 2 clinical trials in various cancer indications. V2ACT Immunotherapy is being developed by V2ACT Therapeutics, LLC a joint venture in collaboration with TVAX Biomedical, Inc.
V-VET1, an animal health product candidate, is a genetically characterized, veterinary-grade replication-competent oncolytic vaccinia virus that is a naturally attenuated isolate. It has been tested in a clinical study of canine cancers.
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.