Genelux Corporation (NASDAQ: GNLX) is making strides in its clinical development programs for Olvi-Vec, an oncolytic immunotherapy, targeting platinum-resistant/refractory ovarian cancer (PRROC) and non-small cell lung cancer (NSCLC). The company anticipates key data readouts from its ongoing trials in the coming years.
Advancing Clinical Trials
Patient enrollment is progressing in the Phase 3 OnPrime/GOG-3076 trial (NCT05281471) for PRROC, now active at over 25 sites. This multi-center, randomized, open-label trial is evaluating the efficacy and safety of Olvi-Vec in combination with platinum-doublet chemotherapy and bevacizumab, compared to physician's choice of chemotherapy and bevacizumab. Topline results are anticipated in the latter half of 2025.
In addition, the Phase 2 VIRO-25 trial (NCT06463665) is actively enrolling recurrent NSCLC patients. This trial combines Olvi-Vec with platinum-doublet chemotherapy and an immune checkpoint inhibitor. Interim data are expected by mid-2025. The trial is designed to assess the potential of Olvi-Vec to re-sensitize tumors to platinum-based chemotherapy and enhance the immune response against tumors.
Genelux is also conducting a Phase 1b/2 trial in recurrent small cell lung cancer (SCLC) in China, co-sponsored with Newsoara BioPharma Co., Ltd. Interim results from the Phase 1b portion of this trial are projected by the end of 2024.
Financial Position
As of September 30, 2024, Genelux reported cash and cash equivalents, and short and long-term investments of $35.1 million. The company expects these resources to provide runway into the first quarter of 2026.
For the third quarter of 2024, research and development expenses were $4.1 million, compared to $2.8 million for the same period in 2023. General and administrative expenses were $2.9 million, compared to $2.5 million for the third quarter of 2023. The net loss for the third quarter of 2024 was $6.5 million, or $0.19 per share, compared to a net loss of $5.3 million, or $0.20 per share, for the third quarter of 2023.
Olvi-Vec: A Novel Oncolytic Immunotherapy
Olvi-Vec (olvimulogene nanivacirepvec) is Genelux's lead product candidate, a proprietary, modified strain of the vaccinia virus. It is designed to modify the tumor immune microenvironment and induce platinum re-sensitization in resistant tumors. The ongoing clinical trials are aimed at demonstrating the potential of Olvi-Vec to improve patient outcomes in aggressive and difficult-to-treat solid tumor types.
"With interim data from our SCLC trial anticipated by the end of 2024 and data releases from our Phase 3 registration trial in PRROC and Phase 2 trial in NSCLC anticipated in 2025, we are confident that Genelux is positioned to make a meaningful impact in the lives of cancer patients," said Thomas Zindrick, President, CEO and Chairman of Genelux.
