The ELI-002 and Libtayo® combination 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)
BOSTON, May 16, 2022 – Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, announced today that it 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 ELI-002-202 study, which will be conducted by Elicio Therapeutics, is expected to begin when the Phase 1ab safety evaluation of ELI-002 (in the ELI-002-201 study) completes and the manufacturing disposition has occurred. 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.”
ELI-002 is a structurally novel investigational AMP therapeutic vaccine targeting mutant KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. KRAS drives 32% of lung cancers, 40% of colorectal cancers and 85% to 90% of pancreatic cancer cases. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide CpG adjuvant. The AMP mKRAS peptides and AMP CpG are targeted to the lymph node where they can potentially enhance the action of key immune cells.
ELI-002 is currently being studied in a Phase 1 trial (AMPLIFY-201) in patients with early-stage KRAS-driven solid tumors, following surgery and chemotherapy. Enrollment in the Phase 1 dose escalation study continues, following the dosing of the first patient at MD Anderson in October 2021, with the expectation to move from Cohort 2 to Cohort 3 in the next quarter, and the AMPLIFY-7P (ELI-002-201) Phase 1b/2 trial planned for early 2023. This trial will study the broad spectrum 7-peptide formulation of ELI-002. This formulation is designed to provide immune response coverage against seven of the most common KRAS mutations, thereby increasing the potential patient population for ELI-002 and potentially reducing the chance of bypass resistance mechanisms.
About the Amphiphile Platform
Our proprietary Amphiphile, or AMP, platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. We believe this site-specific delivery of disease-specific antigens, adjuvants, and other immunomodulators may efficiently educate, activate, and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function, and durability. We believe our AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes.
Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential across cancers, infectious diseases, and other disease indications to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.
The Amphiphile platform is thought to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the bloodstream, as it travels to lymphatic tissue. In preclinical models, we have observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function, and durability.
About Elicio Therapeutics
Elicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational Amphiphile immunotherapies that are intended to precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated. Elicio is engineering lymph node-targeted AMPlifiers, immunomodulators, adjuvants and vaccines for an array of aggressive cancers and infectious diseases. Elicio began dosing subjects in AMPLIFY-201, its Phase 1/2 clinical trial for its lead Amphiphile vaccine, ELI-002, targeting KRAS-driven cancers, in October 2021. The Amphiphile platform emerged from the laboratories of Darrell Irvine, Howard Hughes Investigator and Professor of Biomedical Engineering in the Koch Institute of Integrative Cancer Research at MIT. For more information, please visit https://elicio.wpengine.com/.
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties, assumptions and other important factors that could cause our actual results, performance or achievements to differ materially from historical results or any future results, performance or achievements expressed, suggested or implied by such forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding our expectation to move from Cohort 2 to Cohort 3 in the Phase 1 dose escalation study in the next quarter, our AMPLIFY-7P (ELI-002-201) Phase 1b/2 trial planned for early 2023, our expectation that the ELI-002-202 study, which will be conducted by Elicio Therapeutics, will begin when the Phase 1ab safety evaluation of ELI-002 (in the ELI-002-201 study) completes and the manufacturing disposition has occurred, our hope that ELI-002’s immune education in combination with LIBTAYO’s ability to block PD-1 and activate the ELI-002-induced T cells to target cancers will provide a new treatment option for patients living with these difficult to treat cancers, the ability of our proprietary AMP platform to deliver ELI-002 directly to the lymph nodes and our belief that it may stimulate an enhanced immune response with the potential to make a difference in the often-challenging KRAS space, our expectation of having a long partnership with Regeneron, that enrollment in the Phase 1 study will continue, and the general ability and potential of our proprietary Amphiphile, or AMP, platform, to deliver investigational immunotherapeutics directly to the lymph nodes. Applicable risks and uncertainties that could cause our actual results, performance or achievements to differ materially from historical results or any future results, performance or achievements expressed, suggested or implied by our forward-looking statements include, among others: the potential that we experience slower than expected enrollment in our clinical trials, that our collaboration with Regeneron does not yield our expected results, we identify serious side effects or other safety issues, we do not have clinical supply of our product candidate that is adequate in amount and quality and supplied in a timely fashion, and the inherent risks of clinical development; our limited operating history and historical losses; our need to raise capital to fund our research and development programs; the early stage nature of the development of our product candidates; our ability to obtain orphan drug designation from the FDA; competition from various competitors in the markets targeted by our product candidates, including from competitors with substantially greater resources than us; our general dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; the potential complexity of the manufacturing process for our product candidates; our ability to protect our intellectual property; our dependence on the patents we license from the Massachusetts Institute of Technology, or MIT; our compliance with healthcare laws and regulations; and risks relating to the impact on of COVID-19 or other infectious diseases on our business. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we do not undertake and specifically disclaim any obligation to update any forward-looking statements, except as required by law.