• Antibody cocktail (IMM-BCP-01) is a combination of three antibodies that bind to complementary, non-overlapping regions of the SARS-CoV-2 spike protein.

• Efficacious in Syrian hamsters infected with SARS-CoV-2 (USA-WA1/2020) in both prophylactic and treatment schedules.

• Neutralizes South Africa (B.1.351) and UK (B.1.1.7) in live virus testing; Brazil (P.1) and California (B.1.429, also containing B.1.427 mutations) in pseudovirus testing, all of which are CDC-designated “Variants of Concern.”

• Investigational New Drug (IND) Filing planned for late 2Q/early 3Q 2021.

Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its patient memory B cell platform to develop antibody therapeutics, announced antibody selection for its IMM-BCP-01 antibody cocktail and shared data showing that IMM-BCP-01 neutralizes CDC SARS-CoV-2 "Variants of Concern" in preclinical testing.

IMM-BCP-01 contains three monoclonal antibodies that bind to non-overlapping regions of the spike protein with picomolar affinity. The antibodies exhibit combinatorial effects in vitro against multiple SARS-CoV-2 variants, including those exhibiting both increased transmission in the United States and resistance to current antibody therapeutics and vaccines. In summary, the Immunome antibodies have shown to be effective against the current SARS-CoV-2 and its variants.

Preclinical testing results:

• In Syrian hamsters infected with live SARS-CoV-2 virus (USA-WA1/2020), IMM-BCP-01 reduced lung viral load as a treatment and prophylaxis.
• Live virus studies demonstrated full neutralization by IMM-BCP-01 of CDC-designated “Variants of Concern,” South Africa (B.1.351) and UK (B.1.1.7), as well as the U.S. and European reference strains USA-WA1/2020 and BavPat1/2020.
• Pseudovirus studies demonstrated full neutralization by IMM-BCP-01 of CDC-designated “Variants of Concern,” Brazil (P.1) and California (B.1.429, which also contains B.1.427 mutations).
• Mechanistic studies demonstrate the selected antibodies bind not only to SARS-CoV-2 spike proteins with complex mutations, including the UK (B.1.1.7), SA (B.1.351), Brazil (P1/P2) and California (B.1.429/427) variants, but also to those with several individual mutations, including E484Q and L452R, which are associated with the recently emerged double mutant (B.1.617, or the India variant).
• Two of the three selected antibodies bind to areas of the Spike protein that may be resistant to evolutionary change.
• In addition to viral neutralization, the antibodies also demonstrated additional mechanisms in vitro that may be of relevance in viral clearance.

“Put simply, the preclinical results we have shared today bear witness to our discovery engine’s ability to rapidly identify powerful and rare antibodies for inclusion in our IMM-BCP-01 antibody cocktail,” said Purnanand Sarma, Ph.D., President & CEO of Immunome. “The strength of our data gives us the confidence to continue advancing IMM-BCP-01 towards an IND filing. We believe that a combination of antibodies targeting epitopes conserved across known variants is an important, and potentially necessary, aspect of addressing the mutational drift currently seen with SARS-CoV-2.”

“Despite the numerous challenges created by the COVID-19 pandemic, it provided an opportunity to enhance government-industry partnerships to rapidly identify solutions,” said Dr. Jason Roos, the Joint Program Executive Officer for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). “Demonstrating the ability to collect blood from convalescent patients and quickly identify multiple antibodies as preventatives or therapeutics may not only combat the current pandemic, but can also establish a platform to combat future novel viruses. We are very encouraged by the current results of testing and product development.”

In July 2020, Immunome was awarded a $13.3 million agreement from the U.S. Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in collaboration with the Defense Health Agency, to support Immunome’s COVID program. The research discussed in this press release is part of that program.

Immunome anticipates filing an IND for its IMM-BCP-001 program in late Q2/early Q3 2021.

About Immunome

Immunome is a biopharmaceutical company that utilizes its proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics that are designed to change the way diseases are treated. The company’s initial focus is on developing therapeutics to treat oncology and infectious diseases, including COVID-19. Immunome’s proprietary discovery platform identifies novel therapeutic antibodies and their targets by leveraging the highly-educated components of the immune system, memory B cells, from patients whose bodies have learned to fight off their disease. For more information, please visit www.immunome.com.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements” intended to qualify for the “safe harbor” from liability established by the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding Immunome’s beliefs and expectations regarding the advancement of its oncology and COVID-19 therapeutic antibody programs, execution of its clinical and strategic plans, anticipated upcoming milestones for IMM-BCP-01 and IMM‐ONC‐01, including expectations regarding therapeutic potential and benefits thereof, and IND filings. Forward-looking statements may be identified by the words “anticipate,” believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “may,” “will,” “could,” “should,” “seek,” “potential” and similar expressions. Forward-looking statements are based on Immunome’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, those risks and uncertainties associated with: the impact of the COVID-19 pandemic on Immunome’s business, operations, strategy, goals and anticipated milestones; Immunome’s ability to execute on its strategy including with respect to the timing of its R&D efforts, IND filings, initiation of clinical studies and other anticipated milestones; the timing and effectiveness of any antibody therapeutics which may be developed by Immunome; Immunome’s ability to fund operations; 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 filings and reports with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Immunome undertakes no duty to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law.

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