Immunome Announces Submission for Publication of Pre-clinical Research Detailing the Importance of Antibody Cocktail for SARS-CoV-2 Treatment and Prophylaxis

Rhea-AI Summary

Immunome (Nasdaq: IMNM) has submitted a preprint manuscript detailing the preclinical efficacy of its SARS-CoV-2 antibody cocktail, IMM-BCP-01. This cocktail includes three monoclonal antibodies targeting regions of the spike protein, showing significant viral load reduction in infected hamsters. In tests, IMM-BCP-01 demonstrated a potent reduction of live viral titers by approximately 3.2 - 4 logs. This research indicates broad protective capabilities against multiple variants, supporting the potential for non-intravenous delivery in humans.

Positive

• Preclinical research shows IMM-BCP-01 reduces SARS-CoV-2 viral load by up to 10,000-fold in hamsters.
• Antibody cocktail demonstrates enhanced anti-viral activity against multiple variants of concern.
• Unique binding mechanisms of antibodies indicate potential for broader protection against variants.

Negative

• Research is still in preclinical stages; clinical efficacy in humans remains unestablished.
• Forward-looking statements present risks and uncertainties regarding future developments.

- IMM-BCP-01 is a cocktail of three antibodies that target unique regions of the spike protein, including highly conserved epitopes.

 -The cocktail exhibits potent anti-viral activity against multiple SARS-CoV-2 isolates, including current and former CDC variants of concern, Delta, Alpha, Beta, and Gamma

EXTON, Pa.--(BUSINESS WIRE)-- Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, today announced that it submitted to bioRxiv a preprint of a manuscript regarding preclinical research of the company’s SARS-CoV-2 antibody cocktail, IMM-BCP-01. The manuscript is concurrently undergoing scientific peer review for potential publication.

IMM-BCP-01 contains three monoclonal, antibodies that bind to non-overlapping regions of the spike protein, including highly conserved epitopes. In preclinical testing, the antibodies exhibit combinatorial effects against multiple SARS-CoV-2 strains, including CDC variants of concern, and significantly reduces viral load in the lungs of hamsters infected with a SARS-CoV-2 reference strain.

Immunome’s preclinical research demonstrates:

• The three antibodies, derived from human immune response, bind to the spike protein in a non-competitive manner.
  • The first antibody binds to a sub-dominant epitope of the spike protein, which appears to be broadly conserved across all current and former SARS-CoV-2 variants of concern as well as other Betacoronaviruses and SARS-COV-1.
  • The second antibody is also directed at a broadly conserved epitope and exhibits an avidity-based binding mechanism.
  • The third antibody binds to a composite epitope involving the receptor binding ridge and an area adjacent to the receptor binding loop.
• As a cocktail, the three antibodies demonstrate enhanced anti-viral activity.
  • Efficacious in pseudovirus neutralization against the CDC variant of concern, Delta.
  • Shows equal or better activity against live virus in the reference and the variants tested to-date (Alpha, Beta and Gamma).
  • Potent activation of phagocytosis and complement fixation – known to be critical for in vivo treatment efficacy
• In both treatment and prophylactic settings, at corresponding doses of up to 9 mg/kg, the cocktail potently reduced live viral titers by approximately 3.2 - 4 logs (or up to 10,000-fold) in the lungs of Syrian hamsters infected with SARS-CoV-2 virus
• Published data² for Sotrovimab (GSK and VIR Biotechnology), at 30 mg/kg, the highest dose tested in the prophylactic setting, show approximately a 2 log (or 100-fold) reduction in live viral titer in the lungs of Syrian hamsters infected with SARS-COV-2

“SARS-CoV-2 and its emerging variants continue to be a major ongoing public health concern,” said Susan R. Weiss, Ph.D., Professor and Vice Chair of the Department of Microbiology at the Perelman School of Medicine at the University of Pennsylvania, Co-Director at the Penn Center for Research on Coronaviruses and Other Emerging Pathogens, and a member of Immunome’s COVID-19 Advisory Board.¹ “Evidence in the literature demonstrates that a combination of antibodies offers better protection than a single antibody and in addition a higher barrier to mutational drift. This factor must be carefully considered in the overall development of antibody therapeutics against this virus.”

“The potency and breadth of activity shown across multiple variants highlights the ability of our antibody cocktail to provide broad protection and potent viral load reduction in the widely used Syrian Hamster model. We believe that the three carefully selected antibodies, from the hundreds that we isolated, each provide unique antiviral properties and that, when combined as a cocktail in our research, these antibodies appear to mimic the natural human immune response,” said Purnanand Sarma, PhD, President & CEO of Immunome. “The preclinical efficacy of IMM-BCP-01 that we observed in Syrian hamsters infected with SARS-CoV-2 is promising and, if translated to humans, supports potential non-intravenous delivery.”

This study was funded by the U.S. Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), in collaboration with the Defense Health Agency (DHA).

1. Weiss receives compensation as member of Immunome’s COVID-19 Advisory Board.
2. Cathcart, A.L et al bioRxiv 2021.03.09.434607

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 engine 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,” “suggest,” “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; 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 generally, and by regulatory authorities; whether the data will be published in a scientific journal and, if so, when and with what modifications; the uncertainties inherent in research and development, including Immunome’s ability to execute on its strategy including with respect to the timing of its R&D efforts, IND filings, initiation and completion of any clinical studies and other anticipated milestones; the effectiveness of Immunome’s antibody cocktail, including the possibility that further preclinical data and any clinical trial data may be inconsistent with the data used for selection of the cocktail; ; Immunome’s ability to fund operations; 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 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. In this press release, 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. Food and Drug Administration or other governmental authority. No representation is made as to the safety or effectiveness of these current or potential future product candidates for the use for which such product candidates are being studied.

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Immunome Contact

Corleen Roche

Chief Financial Officer

Immunome, Inc.

investors@immunome.com

Investor Contact

Laurence Watts

Managing Director

Gilmartin, LLC

laurence@gilmartinir.com

Source: Immunome, Inc.

FAQ

What is the purpose of Immunome's IMM-BCP-01 trial?

The trial aims to evaluate the efficacy of a monoclonal antibody cocktail against SARS-CoV-2.

What are the results of the IMM-BCP-01 preclinical studies?

The studies show a reduction in SARS-CoV-2 viral load by approximately 3.2 - 4 logs in hamsters.

What variants does IMM-BCP-01 target?

IMM-BCP-01 targets multiple SARS-CoV-2 variants, including Alpha, Beta, and Delta.

What are the next steps for IMM-BCP-01 after preclinical studies?

The next steps involve potential clinical trials to further evaluate its safety and efficacy in humans.

When was the IMM-BCP-01 manuscript submitted?

The manuscript was submitted to bioRxiv and is currently undergoing scientific peer review.