On March 15, 2022 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported its move from Cambridge, MA to a larger facility in Boston’s Seaport District and an update on its programs for 2022 (Press release, Elicio Therapeutics, MAR 15, 2022, View Source [SID1234610146]). Elicio joins a growing collection of emerging and established biotech companies in the Seaport District, which has become Boston’s new hub for biotech innovation. The move will allow for further expansion given the promising advances being made with the Company’s lead asset, ELI-002, an investigational KRAS-targeted cancer vaccine designed with Elicio’s proprietary lymph node-targeting Amphiphile (AMP) platform. In addition, the move will also allow for the continuing development of the Company’s TCR-T and infectious disease programs.
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"As someone who’s been with the Company from the very beginning, I’m immensely proud of how we have continued to expand our team and our pipeline over the last few years. We have had a 50% increase in staff over the last two years. In addition, we are collecting our first set of clinical data for ELI-002 and continuing to take key steps in developing the cell therapy and infectious disease parts of our pipeline," said Peter DeMuth, Ph.D., Elicio’s Chief Scientific Officer. "We believe in the potential of our lymph node-targeted approach to build a niche within the immunotherapy space and to meet the unmet need in a number of aggressive cancers and infectious diseases. I’m proud of our team of scientists who are doing the important groundwork and look forward to our progress this year."
Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer, added, "We’re excited to progress the ELI-002 program which holds promise to induce durable remissions in early-stage KRAS-mutated cancers. There is an initial focus on patients with minimal residual disease (MRD) and patients with low volume metastases while planning has begun for trials to explore all cancer stages and combination therapies. With approximately 25% of tumors containing KRAS mutations, this is a critically important target for cancer treatment. We are extremely encouraged by the preclinical data generated so far and expect AMPLIFY-201 readouts in the coming months to validate the mechanism of ELI-002 and to support a Phase 1b/2 trial early next year."
ELI-002 is poised to address the shortcomings of past cancer vaccine development efforts by hijacking the body’s natural biodistribution to traffic AMP mKRAS peptides, alongside ELI-004, an activity-boosting AMP adjuvant, directly to the lymph nodes. The lymph nodes are often considered "the schoolhouse of the immune system" as they host the selection and activation of T cells to elicit an immune response. Through this approach, ELI-002 has shown the ability to significantly enhance immune responses in preclinical models across a wide range of KRAS mutations versus conventional peptides, leading to greater infiltration and elimination of tumors.
The clinical development strategy for ELI-002 takes advantage of recent advances in therapy response monitoring to rapidly assess the clinical activity of ELI-002 as adjuvant therapy in patients with early-stage KRAS-driven cancers who have MRD following surgery and chemotherapy.
In the Phase 1 AMPLIFY-201 study, circulating tumor DNA (ctDNA) and serum tumor biomarkers will be measured as a biomarker indicating anti-tumor response, in addition to the primary safety endpoint and identification of a recommended Phase 2 dose.
This novel approach will allow Elicio to validate the clinical activity of ELI-002 more efficiently, before moving into a Phase 1b/2 trial with a more traditional endpoint of Relapse-Free Survival (RFS).
Enrollment in the Phase 1 AMPLIFY-201 study continues, following the dosing of the first patient at MD Anderson in October 2021, with the expectation to move from Cohort 1 to Cohort 2 in the next quarter, and the Phase 1b/2 trial planned for early 2023.
The anticipated Phase 1b/2 trial will study the broad spectrum 7-peptide formulation of ELI-002. This formulation is designed to provide immune response coverage against the 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. Most other KRAS-targeted therapeutics in development — particularly small molecule KRAS inhibitors —are only able to target one or two KRAS mutations.
Elicio’s pipeline of preclinical and clinical programs originates from the Company’s proprietary AMP platform technology. Each program seeks to anticipate and solve challenges in conventional immunomodulation through targeted delivery of payloads (e.g., peptides, proteins, small molecules, nucleic acids) to the lymph nodes. Elicio has investigated the platform in preclinical models across several modalities and therapeutic areas, beyond its focus on cancer vaccines. This also includes Elicio’s universal CpG adjuvant, ELI-004, which is being explored in a variety of indications besides in the lead ELI-002 program.
In addition, with TCR-T cell therapies, Elicio’s "AMP-lification" approach has shown enhanced immune activation as well as tumor infiltration and elimination against several TCR-T targets with evaluation of further targets underway. Peptide and protein subunit vaccines against infectious diseases are another area of interest, with vaccines that include Elicio’s AMP adjuvants demonstrating potent T cell responses against a range of antigens such as influenza, Epstein-Barr virus (EBV), human papillomavirus (HPV) and SARS-CoV-2, including in non-human primates. The Company has a development pipeline of adjuvants with differentiated profiles to meet the needs for the full infectious disease vaccine part of the pipeline.
Annette Matthies, Ph.D., Elicio’s Chief Business Officer, added, "We view Elicio as the partner of choice for the enablement of immunotherapies via lymph node-targeting. By concentrating an immunotherapeutic molecule’s effect in the lymph node, the AMP platform has shown it can enable that molecule’s full therapeutic potential, from enhancing immunogenicity with increased T cell activation and proliferation to improving risk-benefit by reducing systemic exposure. We have had particular success in boosting TCR-T cell therapies as well as traditional peptide and protein-based infectious disease vaccines, and consider these to be prime partnership opportunities."
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.