Cancer is the second most common cause of death in the United States. Historically, cancer treatment has been limited to surgical removal, cytotoxic chemotherapy and/or radiation, providing incremental benefit.
Targeted therapies specifically interdict a single cellular pathway which may lead to favorable clinical responses in some patients. Unfortunately, many patients either are not eligible for targeted therapy or respond to initial treatment but then relapse.
Immunotherapy comprises several different modalities. Each one activates the immune system by attacking specific genetic changes in individual tumors and redirecting the patient’s immune system to eliminate tumors.
Oncolytic immunotherapy is a promising immunotherapy modality that uses viruses to selectively replicate and kill tumor cells but not normal cells. Viral cell killing has the potential of exposing all the tumor’s neoantigens to the immune system and of establishing long-term antitumor immunity to improve outcomes for cancer patients.
Defined: Oncolytic immunotherapy is the treatment of cancer with viruses that selectively replicate in tumors, but not in normal tissues. Central to the therapeutic thesis is that replication in tumors leads to immunogenic tumor cell death by way of viral oncolysis. This has the further therapeutic benefit of exposing all the tumor’s neoantigens to the immune system.
Enhanced exposure of the tumor’s neoantigens to the immune system [antigen presenting cells (APC)] unleashes the full potential of the innate and adaptive elements of the immune system.
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.
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 flexible, 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 intend to develop one or more therapies derived from this platform which are set forth in the following table:
Our library of 500+ novel constructs and strains have demonstrated the ability to cause:
Lead Clinical Candidate: We selected its lead clinical candidate Olvi-Vec (olvimulogene nanivacirepvec) based on the ability to optimize the natural multi-modal properties of the Lister strain of vaccinia virus (the Olvi-Vec “backbone”).
Outside of our clinical trials, we may provide physician-requested expanded access to its investigational products under limited situations. The request for access to a Genelux investigational drug will be considered only if all the following criteria are met.
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.