Product Candidates


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).


An elegant, differentiated, and highly desired immuno-oncology approach

    • Physician-preferred/familiar methods of delivery locate and kill cancer cells to enhance antigen presentation and stimulate an anticancer immune response

Exciting Signals of Differentiated Therapeutic Potential

    • Immunostimulatory backbone, by turning the tumor “hot”, with potential backbone for combination with other therapies, including chemotherapies

Oncolytic Vaccinia (Olvi-Vec) Primed Immunochemotherapy in Platinum-Resistant/ Refractory Ovarian Cancer

    • Patients who received Olvi-Vec-primed immunochemotherapy demonstrated responsiveness to platinum-based therapy, to which they previously were deemed resistant or refractory.
    • Annual Global Meeting of the International Gynecologic Cancer Society (IGCS) 2020 Oral Plenary Presentation on positive data of completed Phase 2 study: Link

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.

V2ACT: How it Works


V2ACT: The Scientific Rationale

    • Vaccinate a patient with the patient’s own neoantigen-containing cancer cells, combined with a powerful immunological adjuvant. Vaccination generates an immune response that produces high numbers of primed cancer neoantigen-specific effector T cell precursors in the patient’s body.
    • Harvest immune cells from a vaccinated patient’s blood and stimulate with T cell activators ex vivo. Convert neoantigen-specific effector T cell precursors into effector T cells and increase their numbers.
    • Treat the patient locally or systemically with Olvi-Vec. Olvi-Vec selectively enters cancer tissue and a) kills cancer cells, b) generates an immunostimulatory acute inflammatory response, a “hot spot” that increases receptivity to the anti-cancer effects of adoptively transferred neoantigen-specific effector T cells, and c) boosts anti-cancer immune responses.
    • Infuse ex vivo-activated neoantigen-specific effector T cells into the patient. Effector T cells are carried to cancer tissue throughout the body, enter cancer tissue and initiate a cascade of immunological events that produce cancer cell killing.
    • Treat the patient with a course of low-dose interleukin 2 (IL-2). IL-2 stimulates continued multiplication of infused cancer neoantigen-specific effector T cells.


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.

Vet and owner comforting dog
Expanded Access Policy

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:

  • The patient has a serious or life-threatening disease or condition with no comparable or satisfactory alternative therapies; and
  • The patient is not eligible for or unable to participate in a clinical trial

In addition, prior to setting up an expanded access program or granting a request from an eligible patient’s physician, Genelux will consider whether:

  • The investigational drug is currently in clinical development with sufficient evidence of safety and effectiveness for patient’s specific condition;
  • Providing the investigational therapy as part of an expanded access program will interfere with clinical trials that could support the investigational therapy’s development or marketing approval for the treatment indication; and
  • We have adequate supply of investigational drug.

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 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.