ELTX Elicio Therapeutics Inc

Elicio Therapeutics (NASDAQ:ELTX), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, provides a corporate update on a series of advancements for the company, including the completion of its reverse merger earlier this month in an all-stock transaction. The Company will continue to be led by Robert Connelly, Chief Executive Officer, and the rest of the Elicio leadership team, including Brian Piekos who joined as the company’s Chief Financial Officer in May. Elicio’s primary focus will continue to be the advancement of lead candidate, ELI-002, an investigational immunotherapy, through clinical trials. ELI-002 has been designed with the Company’s proprietary lymph node-targeting Amphiphile (AMP) technology and is currently being studied in patients with mutant KRAS (mKRAS)-driven cancers who have minimal residual disease (MRD) following surgery and chemotherapy.

“I’m proud to lead Elicio at this exciting time when we’ve executed a successful merger and have presented positive data on ELI-002 at this year’s ASCO Meeting,” said Robert Connelly, Chief Executive Officer at Elicio Therapeutics. “Over the last two years, our team has worked tirelessly to meet our financial and pipeline milestones. I’m pleased to welcome Brian and his public company experience to the leadership team as we transition to a Nasdaq-listed company. Since the January merger announcement, we have been gathering the critical resources that will allow us to continue moving the ELI-002 program forward to meet the significant unmet need in the KRAS oncology space.”

The AMPLIFY clinical program currently includes the study of both the 2-peptide (2P) and 7-peptide (7P) formulations of ELI-002 in patients with mKRAS-driven tumors who are at high risk for relapse due to detection of MRD following standard surgery and chemotherapy. The 2P formulation is designed to treat cancers driven by the G12D and G12R mutations in KRAS. The 7P formulation is designed to expand treatment potential to include the seven most common KRAS mutations: G12D, G12V, G12R, G12C, G12S, G12A and G13D.

The first data from the Phase 1 AMPLIFY-201 (NCT04853017) dose escalation study evaluating ELI-002 2P was recently presented at the 2023 ASCO Annual Meeting in Chicago. ELI-002 2P was well-tolerated, with no dose limiting toxicity or cytokine release syndrome across 5 cohorts that evaluated ascending doses of the adjuvant component of ELI-002, AMP-CpG-7909, from 0.1 to 10.0 mg. Responses were observed at all dose levels, with a high proportion of patients having tumor biomarker reduction (77%) including a subset achieving complete clearance (32%). Robust mKRAS-specific T cell responses were induced in 87% of patients with an average of a 56-fold [range 2-423-fold] increase measured directly ex vivo. 100% of patients responded at the final dose levels. Additional follow-up data from AMPLIFY-201 is expected to read out in the second half of 2023.

The 7-peptide formulation of ELI-002 is being studied in a Phase 1/2 clinical trial, AMPLIFY-7P (NCT05726864). Initiated earlier this year, the trial is currently enrolling patients with certain mKRAS-driven cancers as part of the Phase 1a safety run-in portion of the study. Anticipated milestones for AMPLIFY-7P include an analysis of the Phase 1a cohort, projected to occur in the second half of 2023. The initiation of the Phase 1b portion is expected to take place in Q4 2023, with a first interim analysis expected in the first half of 2024.

Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development, and Chief Medical Officer, said, “With 25% of human solid cancers having a KRAS mutation, it’s critical to identify new approaches for treatment. Our ELI-002 program could be a game-changer for patients who have a history of these aggressive mKRAS tumors and are left with no treatment options for their KRAS mutation. Our AMP technology allows us to target the lymph nodes, the ‘brain center’ of the immune response. Our ASCO data is an encouraging early sign that ELI-002 is well-tolerated and has the potential to elicit a strong T cell response that reduces tumor biomarkers. With the validation of the lymph node-targeting platform, I look forward to advancing the ELI-002 program and the rest of our pipeline including candidates targeting additional antigens (BRAF and p53) that are shared across many cancer patients.”

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. 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. A new formulation, ELI-002 7P, is currently being studied in AMPLIFY-7P, a Phase 1/2 trial in patients with high relapse risk mKRAS-driven solid tumors. 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 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 based upon preclinical studies.

Our AMP platform, originally developed at the Massachusetts Institute of Technology, or MIT, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The Amphiphile platform has been shown 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 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. 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.

Elicio began dosing subjects in AMPLIFY-201, its Phase 1 clinical trial in solid tumor subjects for its lead AMP vaccine, ELI-002 2P, targeting mKRAS-driven cancers, in October 2021 and began dosing subjects with the new formulation, ELI-002 7P, in April 2023. The AMP 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.

Cautionary Statement Regarding 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 initiation of Elicio’s planned clinical trials; the timing of the availability of data from Elicio’s clinical trials; the timing of any planned investigational new drug application or new drug application; Elicio’s plans to research, develop and commercialize its current and future product candidates; Elicio’s ability to successfully collaborate with existing collaborators or enter into new collaborations, and to fulfill its obligations under any such collaboration agreements; the clinical utility, potential benefits and market acceptance of Elicio’s product candidates; Elicio’s commercialization, marketing and manufacturing capabilities and strategy; Elicio’s ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to Elicio’s competitors and our industry; the impact of government laws and regulations; Elicio’s ability to protect its intellectual property position; and Elicio’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

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 proxy statement/prospectus/information that is included in the registration statement on Form S-4 (File No. 333-269741) that was filed with the SEC 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 Contact

Gloria GasaaturaLifeSci Communicationsggasaatura@lifescicomms.com 646-970-4688

Investor Relations Contact

Heather DiVecchiaElicio Therapeutics IR@elicio.com857-209-0153