Genelux aims to provide an elegant therapeutic approach. Our oncolytic immunotherapy drug candidates are “off-the-shelf” personalized therapeutics. In other words, while we administer the same virus product to different patients, the cellular immune response generated is specific to the unique neoantigens in that patient. We believe that our approach may offer significant advantages over other approaches to anticancer treatments.
Oncolytic immunotherapy is the treatment of cancer with viruses that selectively replicate in tumors, but not in normal tissues, which kills cancer cells in two ways. First, oncolytic viruses replicate in the tumor cell until the cell “bursts”, resulting in the lysis of tumor cells. Second, when the cancer cells die, they release tumor neoantigens, which are taken up by cells of the immune system and alert the body’s T-cells to search and destroy other cancer cells in the body. This oncolytic process establishes long-term antitumor immunity to unleash the full potential of the body’s immune system and improve outcomes for cancer patients.
Modulating the Tumor Microenvironment: Overcoming Chemoresistance
Olvi-Vec-primed immunochemotherapy delivers synergistic anti-tumor activities through multifaceted and complimentary mechanisms of action.
Our proprietary ChoiceTM discovery platform is the foundation of our oncolytic immunotherapy product development program and is designed to allow us to generate new product candidates rapidly from conception through the initiation of clinical trials.
Comprehensive Approach: ChoiceTM is powerful and modular and has been used to develop an extensive library of engineered and selected strains of the oncolytic vaccinia virus identified from multiple in vitro (e.g., viral replication rate, plaque size, transgene expression efficiency, etc.) and in vivo (e.g., viral titer, antitumor activities, safety, etc.) selection criteria.
Highly Productive: ChoiceTM has produced more than 500 different versions of the vaccinia virus armed with greater than 110 transgenes, having a variety of engineered attributes, including immune modulatory and cell killing properties.
Unmeasured Potential: These provide potential utility in multiple tumor types in both monotherapy and combination therapy settings, via physician-preferred routes of administration techniques, including regional (e.g., intraperitoneal) and systemic (e.g., intravenous) delivery routes.
We have generated an extensive portfolio of oncolytic vaccinia immunotherapy clinical candidates, having a variety of engineered attributes, including the immune modulatory and cell killing payloads set forth below:
Our library of over 500 different oncolytic vaccinia constructs and strains armed with greater than 110 transgenes have demonstrated the ability to cause:
We intend to develop one or more therapies derived from this platform to address multiple types of tumors.
Lead Product Candidate: Olvi-Vec (olvimulogene nanivacirepvec), our lead product candidate, was selected from our library based on the ability to optimize the natural multi-modal properties of the Lister strain of vaccinia virus (the Olvi-Vec “backbone”).
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.