Full Press Release Details
Immunother.(2021) 70:123 1200 1000 800 600 400 200 CD3 (/mm 2 ) LLC - vector LLC IL38 800 700 600 500 400 300 200 100 0 CD8 (/mm 2 ) LLC - vector LLC IL38 Demonstration of Anti-Tumor Activity (B16F10 Model) Induction of Anti-Tumor Memory (EMT6 Model) - Immunologically cold tumor model - IMM-ONC-01 significantly inhibits B16.F10 tumor growth in vivo at 10 or 50 mg/Kg doses - ~40% response rate upon treatment with IMM-ONC-01 - Animals with complete cures resistant to tumor re-challenge Strongly suggests immunological memory Consistent with indirect effect on T cells 33 IMM-ONC-01 Copyright 2022 Immunome, Inc.
(https://www.sotrovimab.com/hcp/clinical-safety-variant-info/) Viral Clearance Mechanisms Are Necessary to Maintain Therapeutic Efficacy Neutralization is not sufficient in treatment setting Mutating the Fc domain (LALA-PG) of anti-Spike antibodies does not alter in vitro neutralization potency, but destroys efficacy in a mouse treatment model of COVID-19 1.
Combinatorial effects quantified by Highest Single Agent model (HSA). Synergism (>10), additivity (-10 10), antagonism (<-10) 1. Nikitin PA et al BioRxiv (https://doi.org/10.1101/2021.10.18.464900) 2. Hamster Cmax (total antibody); based upon 9 m/kg dose in hamster IMM-BCP-01 Neutralizes Broad Array of Variants - Activity maintained over 20 single point and complex mutations - Neutralization of all clinically relevant variants tested to date Cmax 2 Neutralizes Prior Variants of Concern Retains Neutralization Activity Against Omicron1 Neutralization potency against Beta variant translates into robust lung viral load reduction in the hamster model Less than 5x shift in IC50 between: - WA1/2020 and Omicron for both IMM20184/IMM20253 and S309 (Sotrovimab) - IMM20184/IMM20253 and S309 (Sotrovimab) in head-to-head assays 17 IMM-BCP-01 Exhibits Broad Neutralization Across Live Virus Variants Copyright 2022 Immunome, Inc.
Induces conformational change in Spike that enhances proteolysis and S2 release EPITOPE 2: IMM20184 (ACE2 Dependent) - Broadly conserved epitope across SARS-CoV-2 strains - Antibody exhibits an avidity-based binding mechanism EPITOPE 3: IMM20190 (ACE2 Dependent) - Antibody is a potent ACE2 competitor - A composite epitope involving the receptor binding ridge and an area adjacent to the receptor binding loop Three antibody cocktail exhibits synergy across neutralization and non-neutralization mechanisms Copyright 2022 Immunome, Inc.
DoD for IMM-BCP-01 program awarded, up to $17.6M in funding Isolate and functionally characterize anti-viral antibodies COVID - Summary Current COVID Vaccines and Antibody Therapeutics Not Sufficient - Breakthrough infections despite vaccine use1 - FDA Emergency Use Authorization of antibody therapeutics for treatment of mild to moderate COVID-192 - First-generation antibody therapeutics developed based on virus neutralization to treat COVID-193 Loss of activity against Omicron resulted in FDA limiting use of REGN and LLY EUAs4 IMM-BCP-01 Preclinical Testing Shows Potential to Change Standard of Care - Three antibody cocktail with multi-modal action Strong viral neutralization and clearance in vitro Retains potency against key mutations, former and current CDC variants of concern (VOCs) IMM20253/IMM20184 effective against Omicron in in vitro live virus testing 1. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/effectiveness/why-measure-effectiveness/breakthrough-cases.html 2. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs 3.
Chief Legal Officer Dennis Giesing, PhD Chief Development Officer Matthew Robinson, PhD SVP, Research & Development Former CEO of Taris Biomedical Sold to Johnson & Johnson in 2019 Former US CFO Biogen Former CFO, Global Vaccines, Wyeth/Pfizer Former Partner at Duane Morris Life Sciences practice group leader Former CSO at Taris Biomedical Led DTRA funded pandemic flu program at MediVector Oversaw cancer, immunology and anti-bacterial drug discovery at Pfizer Antibody Structure Function Expert formerly at Fox Chase Cancer Center Copyright 2022 Immunome, Inc.
These statements and predictions involve risks and uncertainties based on various factors and evolution over time and, therefore, actual dates for these milestones may differ. In this presentation and oral commentary, we may discuss our current and potential future product candidates that have not yet undergone clinical trials or been approved for marketing by the U.S.
While we believe that information provides a reasonable basis for these statements, it may be limited or incomplete and we may have not independently verified it. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review or verification of, all relevant information. We may make statements or predictions about future dates for achievement of milestones related to our platform and our programs.
Statements that we believe and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this presentation, including independent market research, industry publications and surveys, governmental agency publications and other publicly available information.
All statements contained in this document are made as of the date specified on the cover, and we undertake no duty to publicly update or revise any such statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law. This document may contain product names, trade names, trademarks and service marks of Immunome and of other organizations, which are the properties of their respective owners.
Factors that could cause actual results to differ include, but are not limited to, the following: the impact of the COVID-19 pandemic on our business, operations, strategy, goals and anticipated milestones; our ability to execute on our strategy, including with respect to R&D efforts, IND submissions and other regulatory filings, timing of these filings and the timing and nature of governmental authority feedback regarding the same, initiation and completion of any clinical studies, confirmatory testing and other anticipated milestones as and when anticipated; the fact that research and development data are subject to differing interpretations and assessments, including during the peer review/publication process in the scientific community and by regulatory authorities; whether our data will be published in a scientific journal and, if so, when and with what modifications; the effectiveness of our product candidates, including the possibility that further preclinical data and any clinical trial data may be inconsistent with earlier-published data and/or data used for advancing the product candidates; the fact that changes in the profile of the diseases that our programs target could emerge that could impact our ability to address those changes; our ability to fund operations; our reliance on vendors; the competitive landscape; and the additional risks and uncertainties set forth more fully under the caption Risk Factors in Immunome's Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) on March 25, 2021, and elsewhere in Immunome's 10-Q filings and other filings and reports with the SEC.
Forward-looking statements may be identified by the words anticipate, believe, estimate, expect, intend, plan, project, suggest, may, will, could, should, seek, potential and similar expressions. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict.