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Immunome Antibody Cocktail (IMM-BCP-01) Neutralizes the SARS-CoV-2 Delta Variant in Pre-clinical Testing

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Immunome (Nasdaq: IMNM) announced promising results for its three-antibody cocktail, IMM-BCP-01, which showed potent neutralizing activity against the SARS-CoV-2 Delta variant in pre-clinical tests. The company received a $17.6 million award from the U.S. Department of Defense to support its COVID program. With concerns over potential COVID-19 resurging due to new variants, Immunome plans to expedite the development of IMM-BCP-01 and submit an IND application to the FDA this quarter, potentially positioning the drug as a long-term solution to COVID-19.

Positive
  • Demonstrated potent neutralizing activity of IMM-BCP-01 against the Delta variant.
  • Received $17.6 million funding from the U.S. Department of Defense for COVID program.
  • Plans to expedite development and submit IND application to the FDA this quarter.
Negative
  • Potential uncertainty regarding the timing and effectiveness of antibody therapeutic development.

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 its three-antibody cocktail (IMM-BCP-01) has demonstrated potent neutralizing activity against the SARS-CoV-2 Delta variant in pre-clinical pseudovirus testing. Furthermore, IMM-BCP-01 showed in-vitro activity via non-neutralizing mechanisms, such as complement fixation, which Immunome expects will enable viral clearance.

“IMM-BCP-01’s ability to maintain neutralizing activity against emerging SARS-CoV-2 variants, including the Delta variant, potentially positions our drug candidate as a long-term solution to the changing threat posed by COVID-19. We believe our lead candidate’s mechanism of action, targeting at least three non-overlapping epitopes - informed by authentic human immune response - provides a robust defense against future mutational drift,” said Purnanand Sarma, PhD, President & CEO of Immunome. “Currently, the delta variant accounts for a majority of coronavirus cases in the United States.”

Immunome was awarded a $17.6 million technology award 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.

Given the near-term potential for a resurgence of COVID-19 infections driven by emerging variants, Immunome intends to explore opportunities to expedite the development of this potential therapeutic. The Company plans to submit an IND application with the U.S. Food and Drug Administration (FDA) this quarter.

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 COVID-19 therapeutic antibody programs, execution of its regulatory, clinical and strategic plans, anticipated upcoming milestones for IMM-BCP-01, including expectations regarding therapeutic potential and benefits thereof, and IND submission. 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; Immunome’s IND submission and other regulatory filings, timing of these filings and governmental authority feedback regarding the same; 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.

FAQ

What are the results of Immunome's IMM-BCP-01 against the Delta variant?

IMM-BCP-01 showed potent neutralizing activity against the SARS-CoV-2 Delta variant in pre-clinical pseudovirus testing.

How much funding did Immunome receive for its COVID program?

Immunome was awarded $17.6 million from the U.S. Department of Defense for its COVID program.

What are Immunome's plans regarding the IND application for IMM-BCP-01?

Immunome plans to submit an IND application to the FDA this quarter to expedite the development of IMM-BCP-01.

What does the pre-clinical testing of IMM-BCP-01 indicate?

The pre-clinical testing indicates that IMM-BCP-01 has not only neutralizing activity but also non-neutralizing mechanisms for viral clearance.

What is the significance of the Delta variant in relation to Immunome's announcement?

The Delta variant currently accounts for a majority of coronavirus cases in the U.S., making the development of effective therapies such as IMM-BCP-01 crucial.

Immunome, Inc.

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