Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, has entered into a clinical supply agreement with Regeneron to evaluate the safety and efficacy of Elicio’s lead asset, ELI-002, an investigational KRAS-targeted cancer vaccine, in combination with Regeneron’s Libtayo (cemiplimab), a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells, in patients with KRAS-driven tumors.
 
The combination therapy will be studied in KRAS-driven tumors including Stage III and IV non-small cell lung cancer (NSCLC), Stage IV colorectal cancer (CRC) and unresectable, locally advanced or oligometastatic pancreatic ductal adenocarcinoma (PDAC). The study, which is expected to begin in 2023, will be conducted by Elicio Therapeutics. Each party will provide their respective agent for the trial. Libtayo is being jointly developed by Regeneron and Sanofi.
 
“We’re investigating ELI-002’s immune education in combination with the ability of Libtayo to block PD-1 and potentially activate the ELI-002-induced T cells to target cancers. This combination may provide a new treatment option for patients living with these difficult to treat cancers,” said Dr. Christopher Haqq, executive vice president, head of Research and Development, and chief medical officer at Elicio. “ELI-002 includes mutated KRAS peptides that are delivered directly to the lymph nodes, ‘the schoolhouse of the immune system.’ The AMP technology allows for ELI-002 to be delivered in high quantities to the lymph nodes and remain there, where it will ‘educate’ the immune cells to target tumor cells for killing.”
 
Dr. Annette Matthies, chief business officer at Elicio, added, “Regeneron is a leading biotech company, and this clinical supply agreement supports the development of our ELI-002 therapeutic cancer vaccine program as well as our AMP platform. With the ongoing Phase 1 trial studying ELI-002 as a monotherapy and this upcoming combination study, we believe that ELI-002 has the potential to make a difference in the often-challenging KRAS space.”