- Data show that combination of two antibodies
in Immunome’s cocktail successfully neutralized the Omicron variant
in vivo in hamsters -
- IMM20253 antibody also retained activity
against BA.2 subvariant in pseudovirus testing in vitro, with
additional testing underway -
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
published data demonstrating that its COVID-19 antibody cocktail,
IMM-BCP-01, potently cleared the Omicron variant (BA.1) of
SARS-CoV-2 when tested in vivo in hamsters. Additional in vitro
testing of a SARS-CoV-2 pseudovirus also showed that IMM20253, one
of the antibodies in Immunome’s cocktail, successfully neutralized
the Omicron subvariant (BA.2).
When tested in hamster models, IMM-BCP-01 retained full coverage
against the Omicron variant. Specifically, the data suggest strong
activity of two antibodies in the cocktail, IMM20253 and IMM20184,
which target distinct, non-overlapping epitopes of SARS-CoV-2,
against the Omicron variant. IMM20253 showed potency when tested on
its own and enhanced viral load reductions when combined with
IMM20184.
“We are pleased to report this positive in vivo data in
hamsters, which we believe based on historical context is the gold
standard for preclinical testing of COVID-19 therapies,” said
Purnanand Sarma, PhD, President and CEO of Immunome.
Additionally, Immunome published data showing that IMM20253,
which exhibits a novel mechanism of action by promoting a
proteolytic cleavage of the portion of the spike protein needed for
ACE2 binding, retained activity against the BA.2 subvariant in
pseudovirus testing. Based on this result coupled with cryogenic
electron microscopy (cryo-EM) analysis of IMM20253 binding,
Immunome expects its antibody cocktail will retain effectiveness
against BA.2 in a live virus setting, as well as against other
emerging variants of Omicron, including BA.4/BA.5. The results of
Immunome’s research have been published to the preprint website
bioRxiv.
IMM20253 showed consistent neutralization across all former
variants of concern in pseudovirus testing as well as all variants
tested to date in live virus testing, and the combination of
IMM20253 and IMM20184 also neutralized the virus.1 This new in vivo
data reveals additional information about the potency of
IMM-BCP-01, especially the IMM20253 antibody, demonstrating what
may be much greater viral clearance than what was suggested in the
in vitro testing.
Dr. Sarma continued, “Notably, these data indicate that in vitro
viral neutralization assays may not fully predict the in vivo
activity of Immunome’s cocktail. Based on these results showing
enhanced potency and viral clearance in hamsters, we are encouraged
about the dose we selected for our Phase 1b study and are also
optimistic about how IMM-BCP-01 will stand up to BA.2 and other
subvariants in future testing.”
1IMM20190, the third component of IMM-BCP-01, which is effective
against other variants (including Delta) in preclinical testing,
was excluded from live virus testing due to Immunome’s prior
predictive analysis suggesting a lack of binding to Omicron.
About IMM-BCP-01
IMM-BCP-01 is a three-antibody cocktail targeting
non-overlapping regions of the Spike protein of SARS-CoV-2,
including highly conserved, subdominant epitopes, which elicits
both ACE2 and non-ACE2 dependent neutralization and induces natural
viral clearance mechanisms, such as antibody dependent cellular
cytotoxicity, complement activation and phagocytosis. Immunome has
submitted an Investigational New Drug Application with the FDA and
plans to initiate a placebo-controlled dose escalation study of
IMM-BCP-01 in patients infected with SARS-CoV-2.
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 or follow Immunome on Twitter and LinkedIn.
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 ability of IMM-BCP-01 to
neutralize variants of the SARS-CoV-2 virus, the advancement of its
platform and programs, execution of its regulatory, research,
clinical and strategic plans and anticipated upcoming milestones
for its platform and programs, including expectations regarding,
among other things, the timing and results of its preclinical
studies and clinical trials, clinical plans, general regulatory
actions, the translation of preclinical data into clinical safety
and efficacy, the therapeutic potential and benefits of our product
candidates, the possible need and demand for its product candidates
and other statements that are not historical fact. 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; Immunome’s ability to execute on its strategy,
including with respect to its R&D efforts, 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 effectiveness of Immunome’s
product candidates, including the possibility that further
preclinical data and any clinical trial data may be inconsistent
with the data used for advancing the product candidates and that
further variants of concern could emerge; Immunome’s ability to
fund operations and raise capital; 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 28, 2022,
and elsewhere in Immunome’s other 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, including expectations about their
therapeutic potential and benefits thereof. 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
Media Contact Gwen Schanker Account Supervisor LifeSci
Communications gschanker@lifescicomms.com
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