Genelux Corporation


Genelux Corporation is a publicly traded late clinical-stage company developing a pipeline of next-generation oncolytic viral immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. The Company’s most advanced product candidate, Olvi-Vec, is a proprietary, modified strain of the vaccinia virus, a stable DNA virus with a large engineering capacity.
The core of Genelux’s discovery and development efforts revolves around the company's proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec.
The company is currently entered its pivot Phase 3 study in Platinum resistant/refractory ovarian cancer.  Trial design based on VIRO-15 Phase 2 trial which showed independent anti-tumor activity of Olvi-Vec and reversal of platinum resistance in the TME.
WWW genelux.com

Locations

Genelux Corp. is headquartered in Westlake Village, California, with additional facilities in San Diego, California.

Olvi-Vec

Genelux’s lead oncology compound is Olvi-Vec, c is a proprietary, oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and therapeutic potential. Vaccinia virus is a non-human pathogen. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Olvi-Vec has been administered to more than 150 patients in clinical studies. In these studies, Olvi-Vec was generally well tolerated and the data provided evidence of clinical benefit. Most recently, Genelux announced the publication of positive topline results from its Phase 2 VIRO-15 trial of Olvi-Vec-primed immunochemotherapy in heavily pretreated patients with platinum-resistant or -refractory ovarian cancer in JAMA Oncology.
Key Findings of Viro-15 Trial
  • All patients completed both Olvi-Vec infusions and chemotherapy. Median follow-up duration was 47.0 months.
  • ORR by RECIST1.1 was 54%, with Duration of Response of 7.6 months. Disease Control Rate was 88%. Overall, 19 of 22 evaluable patients showed tumor shrinkage. ORR by tumor biomarker CA-125 was 85%, and 25 of 26 evaluable patients exhibited decreased CA-125 levels.
  • Median PFS by RECIST1.1 was 11.0 months, and 6-month PFS rate was 77%. Median PFS was 10.0 months in the platinum-resistant group and 11.4 months in the platinum-refractory group.
  • Median overall survival was 15.7 months in all patients, with median OS of 18.5 months in platinum-resistant group and 14.7 months in platinum-refractory group.
  • Most frequent treatment-related adverse events were pyrexia and abdominal pain. There were no grade 4 treatment-related adverse events and no treatment-related discontinuations or deaths.

V2ACT

V2ACT Immunotherapy is a proprietary immuno-oncology modality composed of Olvi-Vec and TVAX Immunotherapy®. V2ACT capitalizes on the lead assets of both Genelux and TVAX as a combination therapy. The rationale for V2ACT Immunotherapy stems from compelling scientific evidence that vaccination generates an immune response which increases the number of neoantigen-specific T cells in the body and that Olvi-Vec induces an acute inflammatory response that increases cancer tissue receptivity for the clinical effects of adoptively transferred neoantigen-specific effector T cells. This generates compelling support for the view that V2ACT Immunotherapy may safely achieve superior efficacies against a wide range of cancers. TVAX Immunotherapy provides a unique neoantigen-specific adoptive T cell therapy, with an excellent safety profile and powerful anti-cancer effects on a wide range of cancers demonstrated in preclinical and Phase 2 clinical trials.
In June of 2023, the companies announced the issuance of a United States patent covering the combination of an adoptive T cell therapy/oncolytic viral cancer treatment that is exclusively licensed to V2ACT Therapeutics™, LLC, a joint venture between Genelux Corporation and TVAX Biomedical, Inc.