Olvi-Vec: Lead clinical candidate Olvi-Vec leverages a modified form of the oncolytic vaccinia virus; Genelux intends to initiate a Phase 3 clinical trial for the treatment of platinum-resistant/refractory ovarian cancer

Why Oncolytic Immunotherapy?

Oncolytic immunotherapy is a promising immunotherapy modality that uses viruses to selectively replicate and kill tumor cells but not normal cells.

 

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:

MOST ADVANCED clinical development program involving non-local delivery oncolytic virus

    • Completed proof-of-concept Phase 2 in platinum-resistant/refractory ovarian cancer
    • Early-stage clinical trials in solid tumors supports advancement of intravenous systemic administration
    • Potential in multiple clinical settings as a monotherapy or in combination therapy

 

FLEXIBLE AND PERSONAL potential utility against broad range of tumor types and metastatic disease

    • Physician-preferred route(s) of administration
    • Demonstrated antitumor activity as monotherapy and combination therapy
    • Large-scale manufacturing process produces “off-the-shelf” therapeutic eliciting patient-specific immune responses.
Genelux Leadership

“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 and Chief Executive Officer

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.