On October 6, 2021 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported that the first patient has been dosed with ELI-002, an investigational lymph node-targeted therapeutic vaccine, by Shubham Pant, M.D. at MD Anderson as part of a Phase 1/2 (AMPLIFY-201) study evaluating its safety and efficacy as a treatment for patients with KRAS-driven tumors who have minimal residual tumor cells following surgery to remove the tumor (Press release, Elicio Therapeutics, OCT 6, 2021, View Source [SID1234590860]). The trial is expected to enroll patients with mKRAS+ solid tumors, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and other solid tumors. ELI-002 is an Amphiphile (AMP) KRAS investigational therapeutic vaccine containing AMP mKRAS peptides and a proprietary AMP CpG adjuvant, administered subcutaneously.
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"Our unique trial design will study the ability of ELI-002 to generate RAS-specific killer T cells that target the microscopic residual tumor cells that remain following surgery. With its design to target lymph nodes, the ’schoolhouse’ where T cells are educated, we believe ELI-002 holds promise to lengthen remission and could prevent future recurrence. We expect to share initial data by the first half of 2022," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer.
Cancers related to KRAS mutations are among the most prevalent, accounting in studies for as much as 27% of patients with lung adenocarcinomas, 49% of metastatic colorectal cancer, or CRC patients, and 93% of all PDAC. Approximately 74% of patients who undergo surgery with curative intent develop a recurrence of pancreatic cancer, despite adjuvant chemotherapy.[1]The Phase 1 trial for ELI-002 (AMPLIFY-201) employs an investigational in vitro diagnostic device, or IVD, that detects circulating tumor DNA, or ctDNA, to identify patients who show signs of minimal residual disease in their blood, but before relapse is detected in traditional radiographic scans.
Julian Adams, Ph.D., Elicio’s Chairman, added, "The AMPLIFY-201 trial is a great example of the use of liquid biopsies to identify patients with minimal residual disease (MRD) who test positive for circulating tumor DNA following surgery and chemotherapy. An estimated 25% of all cancer patients have RAS mutations present in their tumor. ELI-002 targets the seven most common KRAS mutations and has the potential to become a multi-targeted mKRAS therapy that can prevent disease recurrence in patients with KRAS-driven tumors."
About AMPLIFY-201
AMPLIFY-201 is a Phase 1/2 clinical trial of ELI-002 in patients with solid tumors, including colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). The AMPLIFY-201 trial is being conducted at multiple sites, including U.S. cancer treatment institutions such as MD Anderson, Memorial Sloan Kettering, Massachusetts General Hospital, City of Hope, Washington University St. Louis, and Henry Ford Health System. Following an initial dose escalation phase, we intend to continue to evaluate the potential of ELI-002 as a treatment for a number of KRAS-mutated cancers. AMPLIFY-201 is strategically constructed to target patients with minimal residual disease, or MRD, a stage where tumor burden and immunosuppressive effects within the tumor are lower. The Phase 1/2 trial employs an investigational in vitro diagnostic device, or IVD, that is intended to detect circulating tumor DNA, or ctDNA, and identify patients who show signs of minimal residual disease in their blood before relapse is detected in traditional radiographic scans.
Endpoints including safety, determination of maximum tolerated dose, ctDNA change from baseline, relapse free survival and immunological responses including lymph node enlargement, cytokine activity and immune response will be assessed. We anticipate initial safety, dose escalation, and correlative biomarker data from the Phase 1 portion of the trial to be available by the first half of 2022.
The purpose of the Phase 1/2 multi-center, dose-escalation study is to evaluate the safety and preliminary efficacy of ELI-002 in patients with KRAS-driven cancers with minimal residual disease following surgery to remove the tumor. Each cohort will receive escalating doses of ELI-002 to determine safety and tolerability and to assess preliminary antitumor activity. The primary endpoints are, to define the maximum tolerable dose (MTD), recommended Phase 2 dose (RP2D), and incidence of adverse events (AE) for Phase 1 and relapse-free survival (RFS) for Phase 2. The secondary endpoints are ctDNA response rate for Phase 1, incidence of AEs, 1-year RFS, overall survival (OS) and the objective response rate (ORR) for Phase 2, among other endpoints. Please refer NCT04853017 on clinicaltrials.gov for additional clinical trial information.
About ELI-002
ELI-002 is a structurally novel investigational AMP therapeutic vaccine targeting KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide adjuvant. The AMP mKRAS peptides and AMP CpG are targeted to the lymph node where they potentially enhance action on key immune cells.
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.