Elicio Therapeutics Announces Publication of Preclinical Data Demonstrating TCR-T Cell Therapy in Combination with Lymph Node-Targeted Amphiphile-Immunotherapy Enhanced Anti-Tumor Function and Eradicated Solid Tumors

• Published data shows lymph node-targeted Amphiphile (“AMP”)-peptide and CpG combination with TCR-T cell therapy led to complete eradication and durable responses against established murine solid tumors refractory to TCR-T cell monotherapy
  
• Long-term protection against tumor recurrence in AMP-treated mice was associated with antigen spreading to additional tumor-associated antigens not targeted by the treatment
• Preclinical efficacy in solid tumors, including those with KRAS mutations, provides a strong rationale for the clinical advancement of a combination AMP immunotherapy strategy with TCR-T cell therapies to augment anti-tumor activity
  

BOSTON, Jan. 25, 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 the publication of promising preclinical data in Cancer Immunology Research, a journal of the American Association for Cancer Research (“AACR”). These preclinical data demonstrate that Elicio’s proprietary “AMP” lymph node-targeting immunotherapy platform, carrying cognate peptide and adjuvant cargos, boosted T cell receptor-modified T cell therapies (“TCR-T cells”) enhancing anti-tumor function and eradicating solid tumors.

“Optimization of TCR-T cell therapy could potentially have wide-ranging therapeutic benefits in many previously intractable solid tumors,” said Peter DeMuth, Ph.D., Chief Scientific Officer at Elicio Therapeutics. “In this study, we’ve demonstrated that boosting TCR-T cell therapy directly in the lymph nodes with AMP immunotherapy resulted in durable anti-tumor T cell responses and tumor eradication. The AMP treatment uniquely promoted potent mechanisms for immune activation in lymph nodes to invigorate both adoptive and endogenous anti-tumor T cell immunity. Simple application to a variety of cancer targets including mKRAS, HPV E7 and NY-ESO-1 could elevate existing TCR-T cell therapies to generate powerful new combinations for hard-to-treat solid tumors.”

Previous Elicio studies have demonstrated that AMP immunotherapy promoted specific trafficking and retention of payloads into lymph nodes, yielding enhanced T cell numbers, persistence and functional quality. Preliminary Phase 1 data from the ongoing study of Elicio’s lead asset, ELI-002, an mKRAS-specific AMP vaccine, demonstrated significant T cell responses including both CD4+ and CD8+ when administered as an adjuvant monotherapy in patients with pancreatic and colorectal cancers. The strength of the T cell response induced by ELI-002 was further correlated to significant improvements in tumor biomarker response, and reduced risk of progression and death indicating an association between the ELI-002 mechanism of action and clinical outcome.

Robert Connelly, Chief Executive Officer at Elicio Therapeutics, added, “This study adds to our growing body of preclinical and clinical evidence demonstrating the importance of the lymph nodes and the robust efficacy that our AMP immunotherapy strategy can potentially achieve for patients with solid tumors, both as a monotherapy and in combination with other strategies. The AMP platform provides attractive potential for broad and rapid application to clinical and developmental TCR-T cell programs. We look forward to finding the right partner to advance this promising combination into the clinic for patients with solid tumors.”

Key Study Findings:

• AMP immunotherapy in combination with TCR-T cell therapy led to complete eradication and durable responses against established murine solid tumors refractory to TCR-T cell monotherapy.
• AMP immunotherapy led to enhanced lymph node delivery and correlated with pro-inflammatory lymph node transcriptional reprogramming and increased antigen-presenting cell maturation, resulting in TCR-T cell expansion and functional enhancement.
• Enhanced anti-tumor efficacy was correlated with simultaneous in vivo invigoration of adoptively transferred TCR-T cells and in situ expansion of the endogenous anti-tumor T cell repertoire.
• AMP immunotherapy enhanced the infiltration and function of TCR-T cells in the tumor microenvironment and led to epitope spreading against diverse tumor targets.
• Long-term protection against tumor recurrence in AMP-treated mice was associated with antigen spreading to additional tumor-associated antigens not targeted by the treatment.
• In vitro evaluation of AMP peptides with matched human TCR-T cells targeting NY-ESO-1, mutant KRAS and HPV16 E7 illustrated the clinical potential of AMP to enhance human TCR-T cell proliferation, activation and anti-tumor activity.

About the Amphiphile Platform
Our proprietary Amphiphile (“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 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 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.

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 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, including the potential of the AMP platform’s application to clinical and developmental TCR-T cell programs, 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; Elicio’s plans to research, develop and commercialize its current and future product candidates; Elicio’s ability to enter into new collaborations, in-licensing arrangements or partnerships, and to fulfill its obligations under any such 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; and developments and projections relating to Elicio’s competitors and our industry.

New factors emerge from time to time, and it is not possible for Elicio to predict all such factors, nor can Elicio assess the impact of each such factor on Elicio’s 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 Elicio’s 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.

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