Loki Therapeutics Announces Publication in Science Translational Medicine Demonstrating Potential of AWAKE-LM-TT as a Treatment for Pancreatic Cancer

Novel approach developed at Albert Einstein College of Medicine leverages childhood tetanus vaccination to direct immune system against pancreatic tumors

LONG ISLAND CITY, N.Y., March 28, 2022 /PRNewswire/ -- Loki Therapeutics, a company developing next-generation therapeutics that leverage vaccination recall antigens to enhance longevity and treat immune-system related diseases, including cancer, today announced the publications of research in the journal, "Science Translational Medicine", demonstrating the potential of AWAKE-LM-TT in the treatment of pancreatic cancer. AWAKE-LM-TT, which was developed by Claudia Gravekamp, Ph.D., Loki's Co-Founder and Associated Professor of Microbiology & Immunology at Albert Einstein School of Medicine, capitalizes on the childhood vaccination for tetanus to generate a powerful and immediate immune response to solid tumors and metastases presenting the tetanus antigens.

The manuscript titled, "Listeria Delivers Tetanus Toxoid Protein to Pancreatic Tumors and Induces Cancer Cell Death in Mice," and co-authored by Dr. Gravekamp, Ph.D., describes research involving a novel approach to treating pancreatic cancer whereby Listeria monocytogenes are used to deliver highly immunogenic tetanus toxoid (TT) proteins directly into tumor cells.  This delivery, Listeria-TT, was demonstrated to elicit an immune response, activating tetanus toxoid–specific memory T cells to kill pancreatic ductal adenocarcinoma (PDAC) tumor cells in mice. When combined with gemcitabine (Listeria-TT + GEM), researchers observed an 80% reduction of PDAC tumor burden and an 87% reduction of metastases with an increased survival by 40% compared to nontreated mice, suggesting that Listeria-delivered recall antigens could be an alternative to neoantigen-mediated cancer immunotherapy.

Loki Co-founder and CEO Chris Bradley said, "This study is just the tip of the iceberg when it comes to identifying and finding effective therapeutics to treat difficult cancers. Pancreatic cancer is difficult to identify at an early stage, which makes finding a treatment even more challenging, since it is usually detected at an advanced or late stage. This research demonstrates the significant potential of Loki's AWAKE-LM-TT as a novel treatment for pancreatic cancer given its ability to harness the childhood vaccination for tetanus toxoid to generate a powerful and immediate immune response to solid tumors and metastases presenting the tetanus antigens."

Dr. Gravekamp commented, "Because of this research, we have a new strategy that can not only be a successful immunotherapy in treating pancreatic cancer, but other cancers as well. Pancreatic tumors are very challenging to treat in that, to the immune system, these tumors do not appear sufficiently 'foreign' to attract the immune system's attention and can usually suppress any immune responses that does occur. Our approach essentially makes these immunologically 'cold' tumors hot enough for the immune system to attack and destroy."

Loki is preparing to file an Investigational New Drug (IND) application with the U.S. Food & Drug Administration for a first-in-human clinical program investigating AWAKE-LM-TT in the treatment of pancreatic cancer.  Upon receiving FDA clearance for the IND, Loki anticipates initiating a Phase 1 clinical trial in the second half of 2022.

About Loki Therapeutics
Loki Therapeutics is developing next-generation therapeutics that leverage vaccination recall antigens to enhance longevity and treat immune-system related diseases, including cancer, by delivering vaccine recall antigens to tumor cells with genetically attenuated bacterial vectors. Loki's AWAKE™ platform offers a completely new approach to treating cancer and other diseases caused by immune-system breakdown by activating and redirecting pre-existing memory T cells created during vaccination to target and eliminate cancer cells, as well as target other immune-related diseases. Key to AWAKE is its utilization of attenuated Listeria Monocytogenes for the precise delivery of recall antigens to tumor environments and into the tumor cell.  Loki's lead development program – AWAKE-LM-TT – capitalizes on the childhood vaccination for tetanus toxoid (TT) to generate an immune response to solid tumors and metastases presenting the tetanus antigens.  Loki is currently advancing AWAKE-LM-TT as a potential treatment for metastatic pancreatic cancer, as well as metastatic ovarian cancer.  Loki is also pursuing additional development programs based on other childhood vaccines, including polio (AWAKE-LM-PV) and mumps.  For more information on Loki Therapeutics please visit www.lokitx.com.

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SOURCE Loki Therapeutics