Full Press Release Details
Immunome Provides Update on Investigational New Drug Application for IMM-BCP-01 for the Treatment of COVID-19
PA - January 10, 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, today announced an
update regarding its Investigational New Drug (IND) submission for IMM-BCP-01, a three-antibody cocktail, for the treatment of SARS-CoV-2
received a clinical hold letter from the U.S. Food and Drug Administration (FDA) in response to its recently submitted IND requesting
further information related to the preparation and administration of IMM-BCP-01 at clinical sites. The Company has already initiated the
requisite work and expects to provide the requested information quickly.
the FDA also provided in the same letter valuable guidance on the clinical protocol for IMM-BCP-01, including patient selection criteria.
are thankful for the rapid and insightful feedback that the FDA has provided throughout our ongoing discussions and have already
initiated efforts to provide the requested information," commented Purnanand
Sarma, PhD, President & CEO of Immunome. "In addition, we remain on track to report IMM-BCP-01's activity
against the Omicron variant in live virus testing by a third-party lab in January. We remain confident in our approach to address
COVID-19 and look forward to providing further updates in the coming weeks."
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).
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. When tested in vivo, these mechanisms combine to significantly reduce viral load in lungs
of the hamsters infected with SARS-CoV-2, and broadly neutralize the Delta (B.1.617.2) variant in vitro, with testing against the
Omicron variant ongoing. 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, pending the 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).
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 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 program, execution of its regulatory,
clinical and strategic plans and anticipated upcoming milestones for IMM-BCP-01, including expectations regarding work being done to address
the clinical hold, timing to address the clinical hold, ongoing live virus testing, and general regulatory actions, clinical plans and
therapeutic potential and benefits of IMM-BCP-01. 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; Immunome's ability to execute on its
strategy, including with respect to its R&D efforts, IND submissions and other 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; 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 10-Q filings and 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.
Chief Financial Officer
LifeSci Communications