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Precigen Announces Clearance of IND to Initiate Phase I/II Study for First-in-Class PRGN-2009 AdenoVerse™ Immunotherapy to Treat HPV-positive (HPV+) Solid Tumors
- First off-the-shelf AdenoVerse™ immunotherapy to enter the clinic - - Immunotherapy designed to activate the immune system to recognize and target HPV+
About this update from Precigen, Inc.
[{"type":"text","content":"- First off-the-shelf AdenoVerse™ immunotherapy to enter the clinic -\n - Immunotherapy designed to activate the immune system to recognize and target HPV+ solid tumors -\n\n\nGERMANTOWN, Md., April 20, 2020 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase I/II trial for Precigen's PRGN-2009, a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse™ platform designed to activate the immune system to recognize and target HPV+ solid tumors. HPV+ cancers represent a significant health burden in indications such as head and neck, cervical, vaginal and anal cancer. \n\n \n \n \n \n \n \n\n \nThe Phase I portion of the study will follow 3+3 dose escalation to evaluate the safety of PRGN-2009 administered as a monotherapy and to determine the recommended Phase II dose (R2PD) followed by an evaluation of the safety of the combination of PRGN-2009 at the R2PD and an investigational bifunctional fusion protein in patients with recurrent or metastatic HPV-associated cancers. The Phase II portion of the study will evaluate PRGN-2009 as a monotherapy or in combination with the bifunctional fusion protein in patients with newly-diagnosed stage II/III HPV16-positive oropharyngeal cancer.\nPRGN-2009 leverages Precigen's UltraVector® and AdenoVerse platforms to optimize HPV antigen design in combination with its gorilla adenovector with a large payload capacity and the ability for repeat administration due to very low to non-existent seroprevalence in the human population.\nPRGN-2009 is under development through a Cooperative Research and Development Agreement, or CRADA, within the laboratory of Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology (LTIB), Center for Cancer Research (CCR), National Cancer Institute (NCI). This CRADA has allowed Precigen to rapidly and cost-effectively advance PRGN-2009 to the clinic. The Phase I/II clinical trial of PRGN-2009 will be conducted at the NIH Clinical Center and will be led by Dr. Julius Strauss, Co-Director of the LTIB's Clinical Trials Group, and Dr. James Gulley, Chief of t...