• Based on structural mapping of Omicron’s mutations and insights from direct preclinical testing of Alpha, Beta, Gamma and Delta variants, Immunome expects its cocktail to be active against the Omicron variant
• The Omicron variant has a number of mutations across the ACE2 receptor binding site, which may reduce the neutralization potency of some other antibodies under development and Emergency Use Authorization (EUA)
• Two of IMM-BCP-01’s antibodies target epitopes outside of the ACE2 receptor binding site
• Immunome is aggressively working to confirm IMM-BCP-01’s activity against Omicron in laboratory testing; expects availability of initial results in January 2022

Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, announced today that it has conducted an assessment of the reported mutations in the new SARS-CoV-2 variant, Omicron (B.1.1.529). Based upon mapping of those mutations and activity against previous and current CDC variants of concern, Immunome expects its antibody cocktail, IMM-BCP-01, to neutralize the Omicron variant. The Company is diligently working to confirm this activity in laboratory testing and expects initial results to be available in January 2022.

IMM-BCP-01 is an antibody cocktail designed to target three distinct, non-overlapping epitopes. Immunome used its discovery engine to interrogate the body’s immune response to SARS-CoV-2 through isolation of human memory B cells. The technology rapidly led to isolation of rare and potent antibodies including those targeting novel and highly conserved epitopes.

“Immunome designed its cocktail with multiple points of attack to be resilient in the face of a rapidly evolving virus,” stated Matthew Robinson, PhD, Sr. Vice President of R&D of Immunome. “Furthermore, similar to the natural human immune response, we believe that a cocktail approach significantly enhances viral neutralization and clearance, as evidenced by our preclinical testing to date with multiple variants of SARS-CoV-2.”

The Omicron Variant

The Omicron variant has a more extensive mutational burden than current and former CDC variants of concern including >30 mutations in the Spike protein. These mutations include a large number of changes that form a ring around the ACE2 binding site. The ACE2 binding site is a common site targeted by the endogenous neutralizing antibody response from natural infection and vaccination. The evolution of SARS-CoV-2, along with increasing immune pressure, continues to drive the emergence of new variants with mutations in the Spike protein and ACE2 binding site, as shown most recently by Omicron.

The Omicron variant includes a combination of mutations seen in previous variants of concern along with novel mutations. The spectrum of changes include escape variants and binding residues within the epitopes of some of the antibody therapeutics and cocktails that are currently in clinical trials or available under an EUA.^{1, 2, 3, 4}

IMM-BCP-01

As previously described, IMM-BCP-01 includes three antibodies:

- IMM20190, targets an epitope within the ACE2 binding site and operates via an ACE2 dependent mechanism of action

- IMM20184, targets an epitope outside the ACE2 binding site but still operates via an ACE2 dependent mechanism of action

- IMM20253, targets an epitope outside the ACE2 binding site and operates via an ACE2 independent mechanism of action

Immunome believes that IMM-BCP-01’s cocktail approach, by design, makes it highly unlikely that a single variant will evade all three antibodies at the same time, resulting in a broad spectrum of activity. Based upon structural mapping and insights from direct preclinical testing of Alpha, Beta, Gamma and Delta variants, Immunome expects the IMM-BCP-01 cocktail to retain activity against Omicron.

Our testing of the cocktail’s activity against these variants demonstrates that not all antibodies within the cocktail need to be active against the variants for the cocktail to be effective. Specifically in the case of Beta, the activity of two antibodies in the cocktail was sufficient to neutralize the virus in vitro and significantly reduce the viral lung load in infected hamsters. With Omicron, we expect a similar result in preclinical testing and the cocktail to continue to perform as designed.

“The emergence of the Omicron variant has the potential to shift the therapeutic antibody landscape, and highlights the critical need for novel approaches,“ said Purnanand Sarma, PhD, President & CEO of Immunome. “Following the acceptance of our IND, we plan to rapidly advance IMM-BCP-01 into the clinic.”

About IMM-BCP-01

IMM-BCP-01 is a three-antibody cocktail targeting non-overlapping regions of the Spike protein, including highly conserved, subdominant epitopes, which elicits both ACE2 and non-ACE2 dependent neutralization, and induce natural viral clearance mechanisms, such as antibody dependent cellular cytotoxicity, complement activation and phagocytosis. When tested in vivo, these mechanisms combine to significantly reduces viral load in lungs of the hamsters infected with SARS-CoV-2. Immunome has submitted an Investigational New Drug Application with the US-FDA and plans to initiate a placebo-controlled dose escalation study of IMM-BCP-01 in patients infected with SARS-CoV-2, pending FDA’s acceptance of Immunome’s IND submission. This investigational work was funded by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Defense Health Agency (DHA). (Contract number: W911QY-20-9-0019).

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 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 “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, as amended. These forward looking statements may include, but not be limited to, statements about the execution of Immunome’s regulatory, clinical and strategic plans and achievement of future milestones for IMM-BCP-01 as and when planned; expectations regarding the design, attributes and therapeutic potential and benefits of IMM-BCP-01, including its anticipated neutralizing and clearance activity against Omicron and other emerging variants; our ability to obtain and maintain regulatory approvals for IMM-BCP-01; and our ability to continue development of IMM-BCP-01 as and when planned.

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. The forward-looking statements in this press release are based on Immunome’s current expectations, are neither promises nor guarantees, and you should not place undue reliance on them because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Immunome’s control, that could cause actual results to differ materially from those expressed or implied by these forward-looking statements.

Factors that could cause actual results to differ include, but are not limited to, those risks and uncertainties associated with the following: the impact of the COVID-19 pandemic on Immunome’s business, operations, strategy, goals and anticipated milestones; Immunome’s ability to execute on its R&D strategy; the effectiveness of IMM-BCP-01, including the possibility that further preclinical data and any clinical trial data may be inconsistent with the data used for its advancement; Immunome’s ability to fund operations; Immunome’s 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 form 10-Q filings and other filings and reports with the SEC. Forward-looking statements contained in this announcement are made as of the date of this press release, and Immunome specifically disclaims any intention or duty to update or revise any forward looking statements, whether as a result of new information, future events or otherwise, except as required under applicable law.

References

1. REGN EUA document (https://www.fda.gov/media/145611/download)
2. LLY EUA document (https://www.fda.gov/media/145802/download)
3. Pinto et al Cross neutralization of SARS-CoV-2 by human monoclonal SASR-CoV antibody. Nature 583:290-295; 2020
4. Rappazzo et al Broad and potent activity against SARS-like viruses by an engineered human monoclonal antibody. Science 371:823-829; 2021 

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