8-K
Elicio Therapeutics, Inc. (ELTX)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (date of earliest event reported): January 9, 2024
Elicio Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39990 | 11-3430072 |
|---|---|---|
| (State or other jurisdiction of incorporation or organization) | (Commission File Number) | (IRS Employer Identification No.) |
451 D Street, 5th Floor
Boston,
Massachusetts 02210
(Address of principal executive offices, including zip code )
(857) 209-0050
Registrant’s telephone number, including area code
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| (Title of each class) | (Trading Symbol) | (Name of exchange on which registered) |
|---|---|---|
| Common Stock, $0.01 par value per share | ELTX | The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 8.01 | Other Events. |
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On January 9, 2024, Elicio Therapeutics, Inc. (the “Company”) issued a press release announcing the publication of updated preliminary data from the Company’s ongoing Phase 1 (AMPLIFY-201) solid tumor study of its lead asset, ELI-002, in Nature Medicine. A copy of the press release is attached as Exhibit 99.1 to this Current Report and is incorporated herein by reference. Attached as Exhibit 99.2 and incorporated herein by reference is an updated version of the Company’s corporate presentation, which was uploaded to the Company’s website on January 9, 2024.
| Item 9.01. | Financial Statements and Exhibits. |
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| (d) | Exhibits. |
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| Exhibit<br><br> <br>Number | Exhibit<br><br> <br>Description |
| --- | --- |
| 99.1 | Press Release of Elicio Therapeutics, Inc., dated January 9, 2024 |
| 99.2 | Corporate presentation dated January 9, 2024 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Elicio Therapeutics, Inc. | ||
|---|---|---|
| By: | /s/ ROBERT CONNELLY | |
| Robert Connelly<br><br> <br>President and Chief Executive Officer<br><br> <br>(Principal Executive Officer) | ||
| Date: January 9, 2024 |
Exhibit 99.1
Nature Medicine Publishes Updated Preliminary Phase 1 Data From Elicio Therapeutic’s AMPLIFY-201 Phase 1 Solid Tumor Study of ELI-002
| ● | Data showed ELI-002 administered as a monotherapy induced robust, polyfunctional<br> and durable KRAS specific CD4+ and CD8+ T cell responses |
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| ● | Tumor biomarker reduction was observed in 84% of patients correlating with a median relapse-free survival of 16.3 months |
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| ● | Phase 2 trial of ELI-002 monotherapy in pancreatic ductal adenocarcinoma (“PDAC”) planned to initiate in early 2024 |
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BOSTON, January 9, 2024 – 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 data from the Phase 1 (AMPLIFY-201) study of ELI-002 2P in Nature Medicine. The paper, “Lymph Node Targeted, mKRAS-specific Amphiphile Vaccine in Pancreatic and Colorectal Cancer: The phase 1 AMPLIFY-201 Trial”, details expanded and updated results originally presented at the 2023 American Society of Clinical Oncology (“ASCO”) Annual Meeting and the 2023 AACR Special Conference on Pancreatic Cancer.
“When tumor DNA or protein persists or recurs after treatment, patients with pancreatic and colorectal cancers are unfortunately not left with many options and are often incurable,” said study author Shubham Pant, M.D., Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “These are promising early findings from the AMPLIFY-201 study with follow up ongoing. Most patients reduced their tumor biomarkers with some having complete clearance following treatment with ELI-002.”
Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer, added, “Our lymph node-targeted cancer vaccine candidate induced direct ex vivo mKRAS-specific T cell responses in 84% of patients, with 59% of patients demonstrating a response with two key types of T cells – helper cells and killer cells. Past studies have not seen this large a fraction of patients respond, this high a magnitude of a response or the expansion of both key populations of T cells. Importantly, these T cell responses were specific to tumor-driver mutant KRAS neoantigens, correlated with reduced risk of relapse and we saw a pool of memory T cells form that we believe hold promise to confer long-term protection. We look forward to progressing ELI-002 into a randomized phase 2 trial as a monotherapy for patients with PDAC.”
Nature Medicine Publication Highlights
| ● | The data is as of September 6, 2023, based on 25 patients with solid tumors (20 pancreatic, 5 colorectal) who were positive for minimal residual mKRAS disease after locoregional<br> treatment. |
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| ● | Direct ex vivo mKRAS-specific T cell responses were observed in 21/25 patients (84%; 59% both CD4+ and<br> CD8+). |
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| ● | Tumor biomarker responses were observed in 21/25 patients (84%) and biomarker clearance in 6/25 patients, as determined by tumor-informed circulating tumor DNA (24%; 3<br> pancreatic, 3 colorectal). |
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| ● | At 8.5 months median follow-up the median RFS of the 25-patient cohort was 16.33 months. |
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| ● | Efficacy correlated with T cell response (≥ versus < median: 12.75-fold over baseline): |
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| o | Median tumor biomarker reduction was -76.0% compared to -10.2% in above versus below median T cell responders, respectively (p<0.0014). |
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| o | Median RFS was not reached compared to 4.01 months in above versus below median T cell responders, respectively (HR 0.14, 95% CI 0.03 to 0.63, p=0.0167). |
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| o | Patients with greater than median T cell response had an 86% reduction in the risk of progression or death. |
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| ● | The association of RFS with T cell response was not correlated to baseline prognostic variables including tumor stage, recovery from prior cytotoxic therapy as assessed by<br> absolute neutrophil count or immune system subsets such as %CD4+ or %CD8+ of CD3+ lymphocytes. |
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| ● | RFS was shorter in patients who began treatment with a low absolute lymphocyte count. |
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| ● | No safety concerns were identified, and no dose limiting toxicities and no ≥ grade 3 treatment related adverse events were observed. |
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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 1/2 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 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; Elicio’s plans to initiate a randomized phase 2 trial studying ELI-002 as a monotherapy in adjuvant PDAC patients early in 2024; 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 Contact
Kristin Politi
LifeSci Communications
kpoliti@lifescicomms.com
646-876-4783
Investor Relations Contact
Heather DiVecchia
Elicio Therapeutics
IR@elicio.com
857-209-0153
Exhibit 99.2
Targeting the Lymph Nodes to AMPlify Immunotherapy January 2024
Disclaimers Forward-Looking Statements This presentation contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. Statements in this presentation that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding our planned clinical programs, including planned clinical trials and the potential of our product candidates, the unmet need and potential addressable market for our product candidates, the potential clinical utility, potential benefits and market acceptance of our product candidates, the potential advantages of our product candidates over those of existing therapeutics and/or those of our competitors, the expected receipt of clinical data, the timing of initiation of our planned clinical trials, and the advancement of and funding for our developmental programs generally. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, our ability to raise the additional funding we will need to continue to pursue our business and product development plans; our expected use of proceeds; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company, including in collaboration with other parties; our ability to develop, complete clinical trials for, obtain approvals for and commercialize any of our product candidates, including our ability to recruit and enroll patients in our studies; our ability to address the requests of the U.S. Food and Drug Administration or other regulatory agencies; our dependence on intellectual property; competition in the industry in which we operate; delays or disruptions due to COVID-19 or geo-political issues, including the conflicts in Ukraine and the Middle East; and market conditions. These forward-looking statements are made as of the date of this presentation, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. You should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents we file with the Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation the Company's Current Report on Form 8-K filed on June 2, 2023, the Company’s Quarterly Reports on Form 10-Q for the quarters ended June 30, 2023 and September 30, 2023, and the Company's other filings from time to time with the SEC. 2
Company HighlightsClinical-stage biotech pioneering novel lymph node targeted cancer immunotherapies 3 Novel Approach to Immunotherapy Amphiphile or “AMP” platform traffics payloads to lymph nodes to generate robust immune responses ELI-002: A Unique Lymph Node Targeted Vaccine Designed to target 7 KRAS mutations that drive ~25% of solid tumors Initial focus is PDAC where ELI-002 could address 88% of incident tumors Phase 1a Clinical Data 84% of patients showed T cell responses with an average 58x increase in T cell numbers 84% of patients showed a decline in tumor biomarker, 24% having complete clearance Patients achieving large T cell response have an 86% decrease in risk of progression or death Anticipated Near Term Catalysts Ongoing: Two Phase 1 trials with additional data available through 2024-2025 Initiation of Phase 2 PDAC monotherapy 1Q 2024
PipelineInnovative pipeline of cancer immunotherapies addressing critical unmet needs 4 CRC: colorectal carcinoma | PDAC: Pancreatic pancreatic ductal adenocarcinoma mKRAS: mutant Kirsten rat sarcoma | mBRAF: mutant homolog B of the Rapidly Accelerated Fibrosarcoma | mTP53: mutant tumor protein p53 Candidate Target Indications Preclinical Phase 1 Phase 2 Phase 3 ELI-002 mKRAS PDAC, CRC ELI-007 mBRAF GI Tumors ELI-008 mTP53 GI Tumors PDAC PDAC Planned Ongoing
Elicio: Amplifying Immunotherapy
The AMP PlatformHarnessing the untapped potential of the lymph nodes for immunotherapy 6 Most immune cells are located in lymph nodes, yet these critical sites are not engaged by conventional immunotherapies AMP promotes targeted delivery of payloads to the lymph nodes via “albumin hitchhiking” AMP harnesses the unique biology of the lymph nodes to enhance the magnitude, potency, and durability of immune responses Blood Lymph Small Molecules Large Molecules (e.g. Albumin) Blood Vessel Lymph Vessel Lymph Nodes Blood Circulation Tissue Injection Site Targeting Immunity in the Lymph Nodes
ELI-002 CompositionLymph node targeted therapeutic vaccine comprised of AMP-peptides and AMP-CpG 7 G12X G13X D R V C S A D ELI-002 Albumin Binding Lipid for Lymph Node Targeting CpG DNA: TLR-9 Agonist X X Albumin Binding Lipid for Lymph Node Targeting mKRAS Peptide PEG Linker • 2 or 7 AMP-peptides • CD8 and CD4 epitopes • Potent TLR-9 immune activator AMP-mKRAS Peptide Antigen AMP-CpG Adjuvant NH NH O O
Mechanism of ActionAMP immunotherapy generates an anti-tumor immune response via the lymph nodes 8 Tumor Eradication 5 Subcutaneous injection 1 Lymph Node Lymph node targeting 3 Antigen Presenting Cell Delivery to immune cells 4 Albumin-bound Amphiphiles Albumin-bound Amphiphiles Endogenous Albumin Amphiphiles Tissue Injection Site Albumin binding 2 Tumor T Cell
The mKRAS OpportunityELI-002 targets the 7 most common KRAS mutations driving 25% of solid tumors 9 Incidence for the 7 Major Markets (MM): US, France, Germany, Italy, Spain, UK, and Japan Sources for tumor incidence obtained from GLOBOCAN (2020). PDAC: 90% of pancreatic cancers (O’Reilly, 2021), NSCLC 84.3% of lung cancers (SEER, 2021), BTC: 15% of liver cancers + gallbladderSources for KRAS mutation data: Waters & Der, 2018; Ji Luo, 2021, Meng 2021; Hofmann 2022, AACR Project GENIE Registry; Froesch et al, 2022, Gordon et al, 2023 ELI-002 addressable Incidence: ~128k Other KRAS mutations 88% Pancreatic Ductal Adenocarcinoma ~88% Colorectal Cancer ~88% Non-Small Cell Lung Cancer Other mKRAS Opportunities 36% Other KRAS mutations 25% 17% 3-11% No KRAS mutation ELI-002 addressable Incidence: ~192k No KRAS mutation ELI-002 addressable Incidence: ~128k No KRAS mutation ~88% Biliary Tract Cancer Total incidence: ~40k Ovarian CancerTotal incidence: ~62k Other KRAS mutations
ELI-002’s Differentiated Approach to mKRASEarly mKRAS-targeting efforts in the clinic, while promising, leave significant white space 10 7 key mutations Reduced risk of resistance mechanisms Potent activation of immune mechanisms Expansion/activationof T cell response Promotion of anti-tumor T cell function Validates immune-targeting, and affects multiple mutations BUT Poor lymph node targeting and weaker T-cell activation May affect more than one mutation BUT Unlikely to affect all mutations, still subject to bypass resistance mechanisms FDA approvals for LUMAKRAS® & KRAZATI® validate target BUT Only affects one mutation (G12C), subject to multiple resistance mechanisms Lymph Node Targeted Vaccine vs Mutant KRAS Vaccines TargetingMutant KRAS Small Molecules Indirectly Inhibiting Mutant KRAS Small Molecules Directly Inhibiting Mutant KRAS
ELI-002: Clinical Development Program
ELI-002 At-a-GlancemKRAS immunotherapy eliciting strong T cell activity leveraging the AMP platform’s lymph node targeting design 12 2 Peptide (2P) & 7 Peptide (7P) Formulations 2P used in Phase 1 AMPLIFY-201 for clinical proof-of-concept while 7P CMC finalized Program now switches to full 7P formulation, to maximize efficacy and opportunity AMPLIFY Clinical Program Underway Phase 1 AMPLIFY-201 fully enrolled with positive tumor and mechanism of action (T cell) biomarker responses correlating with clinical outcome reported Phase 1/2 AMPLIFY-7P enrollment underway, randomized Phase 2 in PDAC expected to start in 2024 Distinct Clinical & Operational Advantages Vs comparable vaccines including targeting driver mutations and “off-the-shelf”
AMPLIFY-201 Study OverviewPhase 1 dose-ranging study to assess safety and efficacy of ELI-002 2P as adjuvant treatment in patients who completed standard therapy and have molecular disease 13 20-Months Follow-up Boost(4 doses over 4 weeks) Prime(6 doses over 8 weeks) Local Therapy(e.g., Surgery, Chemo) CLINICAL PROGRAM OVERVIEW: NCT04853017 Basket Trial Enrollment Pancreatic Ductal Adenocarcinoma (PDAC) Colorectal Cancer (CRC) n=20 n=5 mKRAS G12D / R – aligned to 2 peptide formulation No metastatic disease after locoregional treatment No radiographic evidence of disease (NED) High risk of relapse (MRD+ ctDNA/serum biomarkers) Key Criteria 1-2 months 3 months 2 months Safety Maximum Tolerated Dose (MTD) or RP2D ctDNA/serum biomarker change from baseline Immunological Responses Relapse Free Survival (RFS) Endpoints 25 patients enrolled across 5 dose cohorts, 23 evaluable at database cutoff (4/25/2023) Advanced: 68% had stage III or oligometastatic resected stage IV disease Pre-treated: All received prior chemo and surgery, 28% had prior radiation Baseline Characteristics
AMPLIFY-201: Tumor Biomarker ResponsesRobust responses observed across tumor types and KRAS mutations with ELI-002 monotherapy 14 24% of patients (6/25) showed complete clearance of ctDNA Most patients (84%, 21/25) showeddecline from baseline in ctDNA or CEA/CA19-9 levels 44% (11/25) showed a >30% reduction in biomarker levels Waterfall displays best response of ctDNA or serum tumor biomarker * Patient biopsied, exhibited T cell infiltration and continued study treatment S Patient underwent splenectomy Data cutoff 6-Sept-23 P P P P P P C P P P P P P P P C P P P P P C P C C Tumor Type D D D D D D D R R D D D D D D D R D R D D D R D D KRAS Biomarker D G12D R G12R P PDAC C CRC ctDNA CEA / CA19-9 -9 -11 -18 -2 S S S S * -2 -11 -17 Cohort 1: 0.1 mg Cohort 2: 0.5 mg Cohort 3: 2.5 mg Cohort 4: 5.0 mg Cohort 5: 10.0 mg AMPLIFY-201 Waterfall Plot: Biomarker Reduction/Clearance Tumor Biomarker Responses
AMPLIFY-201: 84% patients generated mKRAS specific T Cells 15 84% of patients showed T cell responses 100% in two highest dose cohorts, including at the RP2D (10 mg) 58x average fold-change in T cell numbers from baseline (median 13x; range 2-423x) T cells detectable by standard directex vivo FluoroSpot and flow cytometry, with no expansion required AMP-CpG Dose Level ex vivo T cell response (n, %) Average fold-change 0.1 mg 2/3 (67%) 30 0.5 mg 4/6 (67%) 101 2.5 mg 4/5 (80%) 113 5.0 mg 5/5 (100%) 19 10.0 mg 6/6 (100%) 36 Total 21/25 (84%) 58 Responses shown are best overall responses vs baseline for each patient at any timepoint during the assessment period. Data cutoff 6-Sept-23 Median = 13x AMPLIFY-201 T Cell Fold-Changes by Dose Level mKRAS T Cell Responses Baseline Max Response Direct Ex Vivo T Cell Response Response per Dose Level
Clearance Reduction Non-Responder AMPLIFY-201: T Cell Fold-Change Predicts Tumor Biomarker ResponseAll patients with T cell responses over median showed tumor biomarker response 16 Strength of T cell response to ELI-002 is strongly correlated to tumor biomarker response 100% of the above median T cell group respond to ELI-002; in the below median group 67% (8/12) respond to ELI-002 All (100%) of the observed tumor biomarker clearances (6/6) are in the above median T cell group Statistically significant, p-value per Mann Whitney Test (P < 0.0014) Data cutoff 6-Sept-23 P = 0.0014 ≥ Median < Median mKRAS T Cell Response Tumor Biomarker Response Best Overall Tumor Biomarker Response
17 Strength of T cell response to ELI-002 is correlated to tumor response and duration of ELI-002 administration Patients with both CD4 and CD8 T cell responses have favorable clinical outcomes mKRAS T Cell Response Clinical Response AMPLIFY-201: Majority of Above Median T Cell Responders Include CD4+ and CD8+ Above median mKRAS-specific T cell response correlates to improved clinical outcome Data cutoff 6-Sept-23
AMPLIFY-201: Above Median T Cell Responders Median RFS Significantly Prolonged86% reduction in the risk of progression or death in above median T cell responders 18 At a median follow up of 8.5 months, median RFS was not reached for above median T cell responders1 compared to 4.01 months among below median T cell responders (HR 0.14, 95% CI 0.03-0.63, P=0.0167) 86% Reduction in Risk of Progression or Death in T cell responders to ELI-002 Median overall survival was not reached for either group ≥ Median T Cell Response (n = 13) < Median T Cell Response (n = 12) P = 0.0167 HR: 0.14 (0.03 – 0.63) Median RFS: not reached Median RFS: 4.01 months 1 Above median T cell responder: T cell response ≥ median increase of 12.75 Database cutoff 6-Sept-23 mKRAS T Cell Response Clinical Response Relapse-free Survival
AMPLIFY-201: Safety & TolerabilityELI-002 was well tolerated at all dose levels, with no DLTs or SAEs 19 No Grade 3/4 TEAEs, no CRS, no DLTs at time of data cutoff (6-Sept-2023) 11/25 (44%) had Grade 1 or 2 AEs 3/25 (12%) had injection site reactions 10 mg dose selected as RP2D for Phase 1/2 AMPLIFY-7P study TEAE: Treatment Emergent Adverse Event | CRS: Cytokine release syndrome | DLT: Dose-limiting toxicity | SAE: Serious adverse event | RP2D: Recommended Phase 2 Dose Cohort 1 (0.1 mg) n = 3 Cohort 2 (0.5 mg) n = 6 Cohort 3 (2.5 mg) n = 5 Cohort 4 (5.0 mg) n = 5 Cohort 5 (10.0 mg) n = 6 Overall n = 25 Adverse Event Terma Patients with Any Related TEAE, n (%) 1 (33.3) 3 (50.0) 2 (40.0) 2 (40.0) 4 (66.7) 12 (48.0) Fatigue 0 2 (33.3) 2 (40.0) 1 (20.0) 1 (16.7) 6 (24.0) Injection site reaction* 1 (33.3) 1 (16.7) 0 2 (40.0) 0 4 (16.0) Myalgia 0 0 0 1 (20.0) 2 (33.3) 3 (12.0) Anemia 1 (33.3) 0 1 (20.0) 0 0 2 (8.0) Headache 1 (33.3) 1 (16.7) 0 0 0 2 (8.0) Hot flush 0 1 (16.7) 0 0 1 (16.7) 2 (8.0) Nasal congestion 0 1 (16.7) 0 1 (20.0) 0 2 (8.0) Nausea 1 (33.3) 0 0 1 (20.0) 0 2 (8.0) TEAE: Treatment Emergent Adverse Events with incidence ≥ 5%; data cutoff 6-Sept-2023 a Preferred terms per the Medical Dictionary for Regulatory Activities, version 25.0 *Injection Site Reaction = Injection Site Erythema, Injection Site Induration, Injection Site Swelling, Contusion, Pruritis ELI-002 Safety / Tolerability
AMPLIFY-201: T Cell Tumor InfiltrationPreliminary clinical evidence shows dense T cell tumor infiltration following ELI-002 therapy 20 72 T cells/hpf at time of progression,29x the expected 2-3 T cells / hpf in PDAC 1 T cell tumor infiltration was associated with complete ctDNA clearance in this patient T cell tumor infiltration has been associatedwith increased survival in pancreatic cancer 2 Tumor Biopsy CD3 Immunohistochemistry: T Cell Receptor (brown)Pancreatic tumor, 2.5 mg dose level 1 Ademmer 1988 Clin Exp Immunol 112:21 2 Ino, Y., Yamazaki-Itoh, R., Shimada, K. et al. Immune cell infiltration as an indicator of the immune microenvironment of pancreatic cancer. Br J Cancer 108, 914–923 (2013). https://doi.org/10.1038/bjc.2013.32 Hpf: High-powered field T Cell Tumor Infiltration Tumor Biopsy: CD3 Immunohistochemistry
AMPLIFY-201: Clinical Data SummaryELI-002 monotherapy generates robust immune response that correlates with clinical benefit 21 Well Tolerated No Dose Limiting Toxicity No Grade 3/4 TEAEs, no CRS, No DLTs; 11/25 (44%) had Grade 1 or 2 AEs Promising Preliminary Data Significant reduction in risk of progression or death with large T cell response Tumor biomarker reductions, clearance across different tumor types and KRAS mutations T cell response strongly correlates with tumor biomarker reduction/clearance and relapse free survival benefit Robust mKRAS T Cell Responses T cell response and tumor infiltration observed in AMPLIFY-201 historically associated with survival in PDAC Able to generate KRAS-specific CD4+ and CD8+ response in majority of patients with large T cell response Among evaluable patients 100% of patients maintained elevated KRAS-specific T cell response post-boost 90% of patients developed T cell responses to two or more KRAS antigens RP2D Selected AMPLIFY-7P IDMC has recommended the phase 2 dose of ELI-002 7P Randomized PDAC Phase 2 next portion of study to open (Q1 2024)
ELI-002 Differentiation*Distinct clinical and operational advantages over comparable cancer vaccines 22 ELI-002 SLATE-KRAS - - GRANITE - - - ** - Autogene-cevumeran - - ** - mRNA-4157 - - ** - Enhanced immune responses, no spleen requirement Broadest coverage vs driver mutations, limits resistance Fast, predictable, lower cost, no manufacturing risk *** Immunogenicity against tumor neoantigens Activates immune system while still strong 4 7 Anti-Tumor Immune Responses Clinical ProgramsIn Early Disease Lymph Node Engagement Exclusively Targeting KRAS Mutations “Off-the-Shelf” Shared KRAS Neoantigen Vaccines Personalized Neoantigen Vaccines * Based on publicly available information** Personalized neoantigen vaccines encode for multiple neoantigens which may or may not include KRAS neoantigens, but do not exclusively target KRAS driver mutations *** No risk associated with ‘just-in-time’ manufacturing that impacts availability; Product candidates not evaluated in a head-to-head study; comparisons based on public information KRAS mutations targeted: Elicio 7P: G12D, G12R, G12V, G12C, G12A, G12S, G13D, SLATE: G12C, G12D, G12V, Q61H
Continuing Execution Momentum into 2024 23 AMPLIFY-201 Updated Clinical data (1Q-2024) AMPLIFY-7P PDAC Phase 2 Initiation (1Q-2024) AMPLIFY-7P Phase 1a data (1H-2024) AMPLIFY-201 Clinical Immune (1H-2024) Response follow up 2024 Anticipated Milestones 2023 Accomplishments AMPLIFY-201 Completed Phase 1a enrollment AMPLIFY-7P Initiated Phase 1a study AMPLIFY-201 Presented Preliminary Safety, Immune and Biomarker Response data from Phase 1a study (ASCO) Received second GIRF grant to fund p53/ BRAF program AMPLIFY-201 Presented T Cell response and Relapse Free Survival data (AACR Special Conference Pancreas) Presented positive preclinical data for p53 / BRAF program (SITC) Presented AMPLIFY-201 Immune Response durability data (SITC)
Targeting the Lymph Nodes to AMPlify Immunotherapy January 2024