News Release Details

V2ACT Therapeutics™, LLC Announces FDA Clearance of an IND Application to proceed with a Phase 1/2a Study of V2ACT for the Treatment of Pancreatic Cancer

December 11, 2020

- V2ACT Therapeutics™, LLC is a joint venture of Genelux Corporation and TVAX Biomedical, Inc.

- V2ACT is a proprietary immuno-oncology modality composed of Olvi-Vec (oncolytic immunotherapy) and V-ACT (vaccine-enhanced adoptive cell therapy).

- V2ACT capitalizes on:

- Olvi-Vec as an ideal systemic immunomodulator with its excellent safety profile, favorable immune activation effects on the tumor microenvironment and well-documented anti-cancer effects on a wide range of cancers demonstrated in preclinical and phase 2 clinical studies.

- V-ACT as an ideal neoantigen-specific adoptive T cell therapy, with its favorable safety profile and powerful anti-cancer effects on a wide range of cancers demonstrated in preclinical and phase 2 clinical studies.

SAN DIEGO and OLATHE, Kan., Dec. 11, 2020 /PRNewswire/ -- V2ACT Therapeutics™, LLC today announced that the Company has obtained permission from the U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application and may proceed with the clinical investigation of V2ACT in a Phase 1/2a trial for the treatment of newly diagnosed surgically-resectable pancreatic cancer patients.  

"We are pleased the FDA cleared the IND for V2ACT for the treatment of pancreatic cancer within the initial 30-day review period," said Thomas Zindrick, J.D., President and CEO of V2ACT Therapeutics.  "There is a serious unmet medical need for safer, more effective treatments to address this devastating disease and we believe that V2ACT has the potential to help patients in their fight."

"It is generally accepted there is no effective monotherapy for the treatment of pancreatic cancer, a devastating disease," said Gary Wood, Chief Science Officer of V2ACT Therapeutics. "V2ACT provides complementary immunotherapies in a unique process designed to transform non-immunoreactive pancreatic cancer into an immunoreactive 'hot spot' with cancer neoantigen-specific T cell infiltration and cancer cell killing.  Therefore, V2ACT has the potential to effectively treat any type of cancer, even those considered to be resistant to immunotherapy." 

About V2ACT Therapeutics™, LLC
V2ACT Therapeutics, LLC was formed as a joint venture between Genelux Corporation and TVAX Biomedical, Inc. to develop and test V2ACT.  The rationale for V2ACT stems from compelling scientific evidence that it can safely achieve superior efficacies: vaccination increases the numbers of neoantigen-specific T cells in the body and Olvi-Vec kills cancer cells and potentiates T cells by increasing cancer tissue receptivity to adoptively transferred neoantigen-specific effector T cells. V2ACT is covered by pending patent applications.

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SOURCE Genelux Corporation