Company

Vision and Mission

Our vision is to build a pre-eminent immuno-oncology company that addresses serious unmet medical needs.

 

Our mission is to develop immunotherapeutics that deliver the full complement of tumor neo-antigens with the power to stimulate a personalized immune system response to fight cancer, individual by individual.

Woman cancer patient with scarf hugging another woman

Our Strategy

Our strategy is to leverage our deep internal capabilities in the clinical development of oncolytic virotherapies to create a leading immunotherapy company. We plan to discover, develop and commercialize next-generation products for the treatment of a broad range of cancers, including solid tumors, many of which are among the most difficult cancers to treat. We are focused on the execution and success of our clinical programs and, over time, on building our organization into a fully integrated therapeutics company. Key elements of our strategy include:

  • Advance our lead program, Olvi-VecTM, through clinical development and seek regulatory approval.
  • Initiate and pursue the collaborative development of our second-most advanced human therapeutic candidate, V2ACT Immunotherapy.
  • Leverage our CHOICETM discovery platform to build a portfolio of oncology product candidates that target a range of immune mechanisms and progress these product candidates into clinical development.
  • Broaden and strengthen our internal manufacturing capabilities, utilizing our in-house manufacturing facility.
  • Retain significant economic and commercial rights to our human therapeutic product candidates in key geographic areas.
  • License our V-VET1 clinical program, which involves the administration of a proprietary oncolytic vaccinia virus to canine patients with cancer, to a leading animal health company.

Facilities

We have operations in several locations in Southern California.

  • Our headquarters and business office facilities are located in the Los Angeles region, an emerging biotech hub.
  • Our R&D and manufacturing facilities are located in San Diego, one of the premier biotech hubs In the United States.
2625-Townsgate-Rd-Westlake-Village-CA-Front-1-HighDefinition

“Our vision is to redefine the Immuno-Oncology space through the discovery and development of next-generation oncolytic viruses, with the potential to improve outcomes for patients fighting cancer, particularly those with limited therapeutic options. Our anticancer drug candidates can be administered using physician-preferred routes of administration, offering advantages over other approaches.”  – James L. Tyree, Board Member

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.