This Project Grant award from the National Cancer Institute (NCI), under the Cancer Treatment Research program (CFDA 93.395), supports the clinical testing of a novel immunotherapeutic approach combining Listeria-TT (a Listeria monocytogenes bacteria engineered to deliver the tetanus toxoid antigen) and the chemotherapeutic agent gemcitabine (Gem) for the treatment of metastatic, unresectable pancreatic ductal adenocarcinoma (PDAC).
The key objectives of this $294,962 award, with a project period from June 1, 2024 to May 31, 2025, are to: 1) manufacture the Listeria-TT+Gem therapy under GMP conditions for use in a Phase 1 clinical trial, 2) establish the pathology and toxicology profiles of Listeria-TT in mice, and 3) submit an Investigational New Drug (IND) application and Institutional Review Board (IRB) protocol to enable the Phase 1 clinical trial in PDAC patients. This work is being conducted by the awardee, Loki Therapeutics, Inc., which has licensed the relevant intellectual property from the Albert Einstein College of Medicine.
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