ELTX Elicio Therapeutics Inc

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 that the first patient has been dosed at Northwell Health Cancer Institute and the Feinstein Institutes for Medical Research, New York, as part of the randomized Phase 2 (AMPLIFY-7P) study of ELI-002 7P as an adjuvant monotherapy in KRAS mutated pancreatic ductal adenocarcinoma (“PDAC”).

ELI-002 7P is an investigational therapeutic cancer vaccine developed with Elicio’s proprietary lymph node-targeting Amphiphile (“AMP”) technology to treat cancers driven by seven common mutations in KRAS (G12D, G12R, G12V, G12A, G12C, G12S and G13D) present in 25% of all solid tumor cancers and 88% of PDAC patients. This is in contrast to other KRAS-targeted therapeutics in development — particularly small molecule KRAS inhibitors — which target fewer mutations, potentially limiting the number of patients that can be treated and also limiting duration of benefit due to development of escape mutants.

“Approximately 90% of pancreatic cancers are positive for KRAS mutations, with only rare G12C mutations, about 1%, amenable to small molecule treatment,” said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. “ELI-002 represents a cancer vaccine approach that could potentially address the much broader spectrum of pancreatic cancer KRAS mutations.   The Phase 2 study builds on positive findings from our 2-peptide formulation of ELI-002 published in Nature Medicine demonstrating a significantly improved decrease in tumor biomarkers, along with strong T cell responses that correlated with a reduced risk of relapse and death.   We anticipate results from this study will yield definitive data to support clinical efficacy assessment.”

Elicio will present a Trial in Progress poster on the design of the AMPLIFY-7P trial at the ASCO Gastrointestinal Cancers Symposium taking place January 18-20, 2024 in San Francisco, CA. Initial interim data on ELI-002 7P monotherapy from Phase 1A arm will be shared in the first half of 2024.

About ELI-002ELI-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.

About Elicio TherapeuticsElicio Therapeutics is a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer. By combining expertise in immunology and immunotherapy, Elicio is engineering investigational Amphiphile (“AMP”) immunotherapies 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.

Cautionary Note on Forward-Looking Statements

Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding Elicio’s planned clinical programs, including planned clinical trials, the potential of Elicio’s product candidates, and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Elicio undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on our expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including, but not limited to, Elicio’s plans to develop and commercialize its product candidates, including ELI-002; the timing of the availability of data from Elicio’s clinical trials, including the anticipated availability of initial interim data from the Phase 1A arm of the ELI-002 7P monotherapy study; plans to participate and present at upcoming conferences; the potential for the ELI-002 7P Phase 2 to yield definitive data to support clinical efficacy assessment; and Elicio’s plans to research, develop and commercialize its current and future product candidates.

New factors emerge from time to time, and it is not possible for us to predict all such factors, nor can we assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed in the current report on Form 8-K that was filed with the SEC on June 2, 2023 and Elicio’s periodic reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law.

Media ContactKristin PolitiLifeSci Communicationskpoliti@lifescicomms.com646-876-4783

Investor Relations ContactHeather DiVecchiaElicio TherapeuticsIR@elicio.com        857-209-0153