GNLX GENELUX CORP

Genelux Corporation Announces First Patient Dosed in Phase 2 Trial Evaluating Systemic Therapy with Olvi-Vec in Non-Small Cell Lung Cancer

Genelux Corporation Announces First Patient Dosed in Phase 2 Trial Evaluating Systemic Therapy with Olvi-Vec in Non-Small Cell Lung Cancer

VIRO-25 trial to assess efficacy & safety of olvimulogene nanivacirepvec (Olvi-Vec) & platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in recurrent non-small cell lung cancer

– Trial represents second indication in the clinic for Olvi-Vec via systemic administration –

– Interim readout expected mid-2025 –

WESTLAKE VILLAGE, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- (NASDAQ: GNLX), a late-stage clinical immuno-oncology company, today announced that the first patient has been dosed in the U.S.-based Phase 2 (VIRO-25) trial evaluating systemically delivered Olvi-Vec in patients with recurrent non-small cell lung cancer (NSCLC) who have failed frontline platinum and immune checkpoint inhibitor (ICI) therapies.

"Today's milestone holds profound significance for patients with recurrent non-small cell lung cancer who face limited therapeutic options," said , President, CEO and Chairman of Genelux. "This Phase 2 trial, in addition to our ongoing Phase 1b/2 trial evaluating intravenous delivered Olvi-Vec in patients with recurrent small cell lung cancer, co-sponsored with Newsoara Biopharma Co. Ltd., signifies the key advancement of Olvi-Vec to potentially be an important systemically administered oncolytic virus treatment option, setting the stage for the future of this promising field."

The VIRO-25 clinical trial (), is an open-label, randomized study in NSCLC designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of ICI compared with docetaxel in patients with advanced or metastatic NSCLC who have shown first disease progression while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care. Olvi-Vec’s previous data suggests a manageable safety profile, and this trial looks to further confirm the hypothesis that Olvi-Vec may resensitize to platinum in multiple tumor types. Genelux expects interim data readout in mid-2025.

About Olvi-Vec

Olvi-Vec is a proprietary, modified oncolytic vaccinia virus, a stable DNA virus with a large engineering capacity. Genelux is developing Olvi-Vec for the treatment of multiple cancers based on the results of preclinical studies that suggest Olvi-Vec has the potential to infect and directly kill a wide range of tumor cell types in vitro and in vivo and produce an anti-tumor immune response. To date, Olvi-Vec has been administered to more than 150 patients in seven clinical trials. In these studies, Olvi-Vec was observed to be generally well tolerated and the data provided evidence of clinical benefit.

About Genelux Corporation

Genelux is a late-stage clinical biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. The Company's most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus. Olvi-Vec currently is being evaluated in OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer. The core of Genelux's discovery and development efforts revolves around its’ 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. For more information, please visit and follow us on Twitter and on .

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “believes,” “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to Genelux’s future plans and prospects, the planned timing of Genelux’s data results in its ongoing clinical trials and continued development of Olvi-Vec, and the potential capabilities and advantages of Olvi-Vec. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Genelux does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

Investor and Media Contacts

Ankit Bhargava, MD

Allele Communications, LLC

Source: Genelux Corporation



EN
22/10/2024

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on GENELUX CORP

 PRESS RELEASE

Genelux Corporation Reports Third Quarter 2024 Financial Results and P...

Genelux Corporation Reports Third Quarter 2024 Financial Results and Provides General Business Updates WESTLAKE VILLAGE, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the third quarter of 2024 and provided general business updates. The Company initiated its second lung cancer trial, a US-based, Phase 2 trial (VIRO-25) treating patients with recurrent advanced or metastatic non-small cell lung cancer (NSCLC) with Olvi-Vec, followed by platinum-doublet chemotherapy + immune checkpoint inhi...

 PRESS RELEASE

Genelux Corporation to Participate in Fireside Chat at the Guggenheim ...

Genelux Corporation to Participate in Fireside Chat at the Guggenheim Inaugural Healthcare Innovation Conference WESTLAKE VILLAGE, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that , President, CEO and Chairman of the Board, will discuss clinical-stage programs, recent announcements, and upcoming milestones in a fireside chat at the Guggenheim Inaugural Healthcare Innovation Conference, taking place November 11-13, 2024, in Boston, Massachusetts. The conversation with Brittany Stopa, MD, Biotech Equity Research ...

 PRESS RELEASE

Genelux Corporation Announces First Patient Dosed in Phase 2 Trial Eva...

Genelux Corporation Announces First Patient Dosed in Phase 2 Trial Evaluating Systemic Therapy with Olvi-Vec in Non-Small Cell Lung Cancer – VIRO-25 trial to assess efficacy & safety of olvimulogene nanivacirepvec (Olvi-Vec) & platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in recurrent non-small cell lung cancer – – Trial represents second indication in the clinic for Olvi-Vec via systemic administration – – Interim readout expected mid-2025 – WESTLAKE VILLAGE, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- (NASDAQ: GNLX), a late-stage clinical i...

 PRESS RELEASE

Genelux Corporation to Participate in the 2024 Maxim Healthcare Virtua...

Genelux Corporation to Participate in the 2024 Maxim Healthcare Virtual Summit WESTLAKE VILLAGE, Calif., Oct. 09, 2024 (GLOBE NEWSWIRE) -- (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced that , President, CEO and Chairman of the Board, will participate at the 2024 Maxim Healthcare Virtual Summit taking place October 15-17, 2024. Mr. Zindrick will discuss clinical-stage programs, recent announcements, and upcoming milestones in a fireside chat with Jason McCarthy, Ph.D., Senior Managing Director, Head of Biotechnology Research, which is scheduled for 2:00 p...

Jonathan Moreland
  • Jonathan Moreland

InsiderInsights.com Daily Ratings Report: September 13, 2024

InsiderInsights Ratings of Companies with Open-Market Form 4 Purchases; Sales Filed at the SEC on the date above. We separate the real investment intelligence from the noise. Saving you time, and improving your research process

ResearchPool Subscriptions

Get the most out of your insights

Get in touch