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

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. Key elements of our strategy include:

  • Advance our lead product candidate, Olvi-Vec, through clinical development and seek regulatory approval.
  • Support our collaborative partner, Newsoara Biopharma Co., Ltd., in the development of Olvi-Vec and other proprietary viral products for human uses in Greater China.
  • Support ELIAS Animal Health, our exclusive worldwide licensee, in the development of V-VET1 for cancer in non-human animals.
  • Support our joint venture, V2ACT Therapeutics, LLC, in the clinical and commercial development of V2ACT Immunotherapy.
  • Seek additional development and commercial collaborations for Olvi-Vec and our other human therapeutic product candidates.
  • Leverage our CHOICETM discovery platform to build a portfolio of oncology product candidates that target a range of immune mechanisms.
  • Broaden and strengthen our internal manufacturing capabilities, utilizing our in-house manufacturing facility.
  • Build our organization into a fully integrated therapeutics 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.
Headquarters
Research & Development
Manufacturing

“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 and familiar routes of administration, offering advantages over other approaches.”  – James L. Tyree, Lead Independent Director

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.