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BOSTON, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (NASDAQ:ELTX, "Elicio Therapeutics" or "Elicio"))))), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced a Trial in Progress poster presentation on the Phase 1/2 (AMPLIFY-7P) study design at the ASCO Gastrointestinal Cancers ("ASCO GI") Symposium being held January 18-20, 2024 in San Francisco, CA.
The poster describes AMPLIFY-7P, a Phase 1 and randomized Phase 2 study of ELI-002 7P, an investigational therapeutic cancer vaccine, administered as an adjuvant monotherapy treatment for patients with KRAS-mutated pancreatic ductal adenocarcinoma ("PDAC").
"ELI-002 is an off-the-shelf cancer vaccine candidate developed with our proprietary Amphiphile ("AMP") platform which provides a new ability to deliver these treatments effectively to the ‘command center' of the immune response – the lymph nodes – where tumor-fighting T cells are generated and equipped," said Christopher Haqq, M.D., Ph.D., Elicio's Executive Vice President, Head of Research and Development, and Chief Medical Officer. "We are progressing our AMP-powered, lymph node-targeted cancer vaccine, ELI-002 7P, as a monotherapy in an adjuvant setting for patients with pancreatic cancer, and recently dosed the first patient in the randomized Phase 2 cohort. This study builds on positive preliminary data demonstrating our 2-peptide formulation of ELI-002 induced robust and durable tumor-directed mKRAS-specific T cell responses which correlated with tumor biomarker reduction or clearance, and reduced risk of relapse and death."
Zev A. Wainberg, M.D., Professor of Medicine, University of California, Los Angeles (UCLA), Co-Director, the UCLA GI Oncology Program, added, "Patients with RAS mutated pancreatic cancers who have positive circulating tumor DNA post-surgery are often quick to relapse. Our current standard of care for these patients is observation – there are no treatments given during this ‘wait and see' observation window before relapse. As we progress to Phase 2 of the study, we seek to compare ELI-002 7P to our current standard of care to further evaluate its antitumor activity and clinical benefit in the adjuvant setting as well as with bulkier cancer treated at the time of relapse in crossover patients with mKRAS-driven pancreatic cancer."
Poster Presentation Highlights
Title: AMPLIFY-7P: Phase 1 and randomized phase 2 study of amphiphile immunotherapy ELI-002 7P as adjuvant treatment for subjects with G12D, G12R, G12V, G12C, G12A, G12S and G13D Kirsten rat sarcoma (KRAS)-mutated pancreatic ductal adenocarcinoma
Session Title: Trial in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Session Time: January 19, 2024, 12:30-2:00 PM PT
Presenter: Zev A. Wainberg, M.D., Professor of Medicine, University of California, Los Angeles (UCLA), Co-Director, the UCLA GI Oncology Program
Abstract #: TPS720
Poster Bd #: Q9
About ELI-002
ELI-002 is a structurally novel investigational AMP therapeutic immunotherapy targeting mutant KRAS-driven cancers. KRAS mutations are among the most prevalent human cancers. The seven KRAS driver mutations targeted by the ELI-002 7P formulation are present in 25% of all solid tumors. In particular, 93% of pancreatic ductal adenocarcinoma and 52% of colorectal cancers, those most prevalent in the AMPLIFY-201 study, are positive for KRAS mutations. In addition, 27% of non-small cell lung cancers are positive for KRAS mutations. ELI-002 is comprised of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified immune-stimulatory oligonucleotide CpG adjuvant available as an off-the-shelf subcutaneous administration. 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 2P is currently being studied in a Phase 1 trial ("AMPLIFY-201") in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P, is currently being studied in AMPLIFY-7P, a Phase 2 trial in patients with high relapse risk mKRAS-driven solid tumors (NCT05726864). The ELI-002 7P 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.
Posted In: ELTX