GENELUX

GENELUX

A Phase 3 biopharmaceutical company developing powerful therapeutics with the potential to redefine immuno-oncology across multiple indications

REDEFINE

REDEFINE

Redefining immuno-oncology by developing compounds that can overcome some of the most significant challenges associated with cancer

RESET

RESET

Re-sensitize resistant tumors to chemotherapy, re-setting the life clock of late-stage ovarian cancer patients

CHOICE<sup>TM</sup>

CHOICETM

Proprietary discovery platform is the foundation of its oncolytic (anti-tumor) immunotherapy product development program

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Olvi-Vec: Lead clinical candidate Olvi-Vec is a modified form of the oncolytic vaccinia virus; Genelux is actively recruiting patients in our OnPrime Phase 3 clinical trial for the treatment of platinum-resistant/refractory ovarian cancer

Why Oncolytic Immunotherapy?

Oncolytic immunotherapy is an immunotherapy modality where viruses selectively replicate and kill tumor cells while leaving normal cells intact.

 

Viral cell killing has the potential to expose all the tumor’s neoantigens to the immune system and to establish long-term antitumor immunity to improve outcomes for cancer patients.

Our Approach

We utilize vaccinia virus (VACV) as the backbone of our therapeutics and diagnostics platform. VACV has a number of characteristics which we consider desirable in an oncolytic virus for clinical applications:

 

  • No genomic integration
  • Highly modular and customizable
  • Broad spectrum of activity
  • Robust lytic capabilities and high replication and proliferation
  • Powerful immune activator (Th1-type immune response)

 

The CHOICE™ discovery platform is the proprietary foundation of our oncolytic immunotherapy product development program and allows us to rapidly generate new product candidates from conception through the initiation of clinical trials. CHOICE™ has produced more than 500 different versions of the vaccina virus armed with more than 110 transgenes, and has a variety of engineered attributes, including immune modulatory and cell killing properties.

The OLVI-VEC difference:

BELIEVED TO BE THE MOST ADVANCED clinical development program involving non-local delivery oncolytic virus

    • Actively recruiting patients for our registrational OnPrime Phase 3 clinical trial in platinum-resistant/refractory ovarian cancer
    • Actively preparing for Phase 2 trial in recurrent non-small cell lung cancer
    • Demonstrated antitumor activity as monotherapy and combination therapy

 

VERSATILE AND PERSONAL potential utility in multiple additional clinical settings

    • Physician-preferred/familiar route(s) of administration: early-stage clinical trials in solid tumors supports intravenous systemic administration
    • Potential against difficult-to-treat solid tumors and metastatic disease, and liquid tumors
    • Large-scale manufacturing process produces “off-the-shelf” therapeutic eliciting patient-specific immune responses
Genelux vision
Genelux Leadership
Genelux newsroom

“We believe Olvi-Vec will add an important weapon to the medical armamentarium in the fight against the most difficult-to-treat cancers.”


-Thomas Zindrick, JD, President. Chief Executive Officer and Chairman

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 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.