Our Product Candidates

Olvi-Vec

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).

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An elegant, differentiated, and desirable immuno-oncology approach

  • Physician-preferred 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 for combination therapy, by turning the tumor “hot”, 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.
  • Global Annual Meeting of the International Gynecologic Cancer Society (IGCS) 2020 Oral Plenary Presentation: 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, colon, kidney, lung, prostate and skin (melanoma) cancers.

V2ACT

Virus and Vaccine (Neoantigen)-Enhanced Adoptive Cell Therapy (V2ACT) Immunotherapy is a proprietary, indication-agnostic personalized anticancer 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 (N-ACT) 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 of Genelux and TVAX Biomedical, Inc.

V2ACT: How it Works

V2ACT

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 anticancer effects of adoptively transferred neoantigen-specific effector T cells, and c) boosts anticancer 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

V-VET1, our lead animal health product candidate, is a genetically characterized, veterinary-grade replication-competent oncolytic vaccinia virus that is a naturally attenuated isolate.

Vet and owner comforting dog
Expanded Access Policy

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.

 

  • The patient has a serious or life-threatening disease or condition with no comparable or satisfactory alternative therapies
  • The patient is not eligible for or unable to participate in a clinical trial
  • The investigational drug is currently in clinical development with sufficient evidence of safety and effectiveness for patient’s specific condition
  • A benefit-risk analysis suggests that the benefit from using of the investigational drug outweighs the known or anticipated risks based on evolving clinical data
  • We have adequate supply of investigational drug

 

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.