• V2ACT Therapeutics™, LLC is a joint venture between Genelux Corporation and TVAX Biomedical, Inc.
  
• V2ACT Immunotherapy is a proprietary immuno-oncology modality composed of Olvi-Vec (oncolytic viral immunotherapy) and TVAX Immunotherapy^® (vaccine-enhanced adoptive T cell therapy).
• The patent expiry for the combination, prior to any patent term extension, will be in 2036.

WESTLAKE VILLAGE, Calif., June 29, 2023 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX) and TVAX Biomedical, Inc. today announced that the United States Patent and Trademark Office granted a patent claiming methods of combining vaccine-enhanced adoptive T cell therapy with oncolytic virus adjunct therapy.

The patent has been exclusively licensed to V2ACT Therapeutics, LLC, a joint venture between Genelux and TVAX that was established for the purpose of developing and testing V2ACT Immunotherapy. The patent expiry, prior to any patent term extension, will be in 2036 and will add substantial intellectual property protection for V2ACT Immunotherapy.

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.

V2ACT capitalizes on the lead assets of both Genelux and TVAX as a combination therapy. Olvi-Vec has demonstrated systemic immunomodulation, an excellent safety profile, powerful immune modulation of the cancer microenvironment and well-documented anti-cancer effects over a wide range of cancers both in preclinical and Phase 2 clinical trials. 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.

“We believe a strong intellectual property portfolio, supported by this issued patent, further validates our assessment of the clinical and commercial potential of combining Olvi-Vec and TVAX Immunotherapy to treat patients who are under-served by current modalities,” said Thomas Zindrick, President, CEO and Chairman of Genelux.

“TVAX Biomedical is very excited to work with Genelux in the V2ACT joint venture. We believe there is tremendous scientific and clinical synergy that is affirmed by the granting of this patent,” said Wayne Carter, President and CEO of TVAX Biomedical.

About Genelux Corporation

Genelux is a late clinical-stage biopharmaceutical company focused on 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 (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable DNA virus with a large engineering capacity. Olvi-Vec currently is being evaluated in OnPrime, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in patients with platinum-resistant/refractory ovarian cancer. The core of Genelux' 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. For more information please visit www.genelux.com.

About TVAX Biomedical, Inc.

TVAX Biomedical likewise is a late clinical-stage biopharmaceutical company focused on developing next-generation T cell immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid cancers. TVAX Immunotherapy, the company’s proprietary therapy, offers the promise of significantly improved clinical outcomes with low toxicity. TVAX Immunotherapy has the potential to fundamentally change the way immunotherapy is used to treat cancer. TVAX’s most advanced product candidate, TVI-Brain-1, is currently being evaluated in a multi-center, randomized, open-label Phase 2b/3 registrational trial evaluating the efficacy and safety of TVI-Brain-1 in patients with newly diagnosed MGMT unmethylated glioblastoma patients. TVAX received Fast Track designation for this ground-breaking clinical trial. Unlike other forms of immunotherapy that are effective against a limited number of cancer types, TVAX Immunotherapy has demonstrated the potential to effectively treat a wide range of cancers. The power of T cells is their demonstrated ability to kill cancer cells, including cancer stem cells, and cause significant numbers of objective clinical responses in treated patients. For more information visit: www.tvaxbiomedical.com.

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 the potential for V2ACT Immunotherapy to safely achieve superior efficacies against a wide range of cancers, the potential of combining Olvi-Vec and TVAX Immunotherapy to treat patients who are under-served by current modalities, the extent of intellectual property protection provided by this new patent, and the ability of V2ACT Therapeutics, LLC to develop, test and commercialize V2ACT Immunotherapy. 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’ 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

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