Addressing Unmet Medical Needs

Addressing Serious Unmet Medical Needs

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 are either not eligible for targeted therapy or relapse after responding to initial treatment.


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.

nurse comforting cancer patient

Differentiated Potential

Potential utility against a broad range of tumor types and metastatic disease

Physician-preferred/familiar administration

      • Local, regional or systemic routes of delivery
      • “Off-the-shelf” therapeutic


Advanced, non-local delivery oncolytic virus clinical program

Ovarian Cancer Program

      • Actively recruiting patients for Phase 3 OnPrime registration trial in platinum-resistant/refractory ovarian cancer (PRROC)
      • Met preestablished endpoint of our Phase 2 VIRO-15 trial in PRROC


Systemic Delivery Program

      • Actively preparing to initiate a Phase 2 trial in recurrent non-small cell lung cancer
      • Promising early clinical trials in solid tumors demonstrate feasibility of systemic administration


Mechanism of Action

Antitumor activity with demonstrated activity as monotherapy and combination therapy

      • Boosts patient’s own immune system to turn “cold” tumors “hot”
      • Sensitizes (re-sensitizes) resistant tumors to chemotherapy (platinum)


Robust pipeline

      • Second generation product candidates offer multiple ”shots on goal”
      • Active IND in pancreatic cancer for V2ACT Immunotherapy, a novel immuno-oncology modality held by our joint venture, V2ACT Therapeutics LLC; initiation of clinical trial not yet scheduled.
      • 500+ novel strains generated via proprietary CHOICE™ platform



Attractive cost-of-goods

      • Company-controlled GMP manufacturing facility in San Diego
      • Proprietary large-scale cGMP manufacturing process
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.