Investors

The Genelux Difference

 

Genelux is a clinical-stage biopharmaceutical company evaluating flexible and powerful therapeutics that could potentially redefine immuno-oncology. The Company is developing a pipeline of next-generation oncolytic viral immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types.

 

 

Addressing Significant Unmet Medical Needs:

Advanced, non-local delivery oncolytic virus clinical program

Ovarian Cancer Program

      • Preparing for Phase 3 registration trial in platinum-resistant/refractory ovarian cancer (PRROC)
      • Met preestablished endpoint of our Phase 2 in PRROC

 

Systemic Delivery Program

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

 

Potential utility against broad spectrum of tumor types and metastatic disease

Physician-preferred administration

      • “Off-the-shelf” therapeutic
      • Flexible routes of delivery: local, regional or systemic routes

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 – affords multiple ”shots on goal”

      • Active IND in pancreatic cancer for V2ACT, a novel immuno-oncology modality (initiation of clinical trial not yet scheduled)
      • 500+ novel strains generated via proprietary CHOICE™ platform
      • Clinical-stage Animal Health program (Phase 1 completed; Phase 2 ready)

 

Manufacturing

      • Company-controlled GMP manufacturing facility in San Diego
      • Proprietary large-scale cGMP manufacturing process
Doctor and patient with hands/heart sign
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.