On December 11, 2020 V2ACT Therapeutics, LLC reported 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 (Press release, V2ACT Therapeutics, DEC 11, 2020, View Source [SID1234572777]).
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"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."