Immunome provides update on demand for new investigational drug for IMM-BCP-01 for the treatment of COVID-19 | Nation / World
EXTON, Pa .– (BUSINESS WIRE) – January 10, 2022–
Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that uses its human memory B-cell platform to discover and develop first-class therapeutic antibodies, today announced an update regarding its submission of an investigational new drug. (IND) for IMM-BCP -01, a cocktail of three antibodies, for the treatment of SARS-CoV-2 (COVID-19).
The Company received a clinical withdrawal letter from the United States Food and Drug Administration (FDA) in response to its recently submitted IND requesting additional information regarding the preparation and administration of IMM-BCP-01 in clinical sites. The Company has already initiated the required work and expects to provide the requested information promptly.
The unrelated FDA also provided valuable clinical protocol advice for IMM-BCP-01, including patient selection criteria, in the same letter.
“We are grateful for the quick and insightful comments that the FDA has provided throughout our ongoing discussions and have already undertaken efforts to provide the requested information,” commented Purnanand Sarma, PhD, President and CEO of ‘Immunoma. “Additionally, we remain on track to report activity of IMM-BCP-01 against the Omicron variant in live virus testing performed by a third-party lab in January. We remain confident in our approach to tackling COVID-19 and look forward to providing further updates in the coming weeks. “
This research work was funded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) of the United States Department of Defense (DOD) in collaboration with the Defense Health Agency (DHA) (contract number : W911QY-20- 9-0019).
IMM-BCP-01 is a cocktail of three antibodies targeting non-overlapping regions of the SARS-CoV-2 Spike protein, including highly conserved subdominant epitopes, which cause both ACE2-dependent neutralization and non-ACE2, and induces natural viral clearance mechanisms such as antibody-dependent cell cytotoxicity, complement activation, and phagocytosis. Once tested in vivo, these mechanisms combine to significantly reduce the viral load in the lungs of hamsters infected with SARS-CoV-2 and largely neutralize the Delta variant (B.1.617.2) in vitro, with ongoing testing against the Omicron variant. Immunome has submitted an investigation for a new drug to the FDA and plans to initiate a placebo-controlled dose escalation study of IMM-BCP-01 in patients with SARS-CoV-2, in awaiting FDA acceptance of the IND submission for Immunoma. This research work was funded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) of the United States Department of Defense (DOD) in collaboration with the Defense Health Agency (DHA). (Contract number: W911QY-20-9-0019).
Immunome is a biopharmaceutical company that uses its proprietary human memory B cell platform to discover and develop first-class therapeutic antibodies designed to change the way diseases are treated. The company’s initial goal is to develop therapies to treat oncology and infectious diseases, including COVID-19. Immunoma’s proprietary discovery engine identifies novel therapeutic antibodies and their targets by taking advantage of highly educated components of the immune system, memory B cells, in patients whose bodies have learned to fight their disease. For more information, please visit www.immunome.com.
This press release includes certain disclosures that contain “forward-looking statements” intended to qualify for the “safe harbor” of liability established by the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to limit, express or implied statements regarding beliefs and expectations regarding the advancement of its COVID-19 therapeutic antibody program, the execution of its regulatory, clinical and strategic plans and the next steps planned for IMM-BCP-01, including the expectations regarding the work in progress to remedy the clinical suspension, the timeline for resolving the clinical wait, ongoing live virus testing and general regulatory actions, clinical plans and the 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”, “could “,” Power “,” 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, risks and uncertainties associated with: the impact of the COVID-19 pandemic on business, operations, strategy, goals and planned stages of Immunoma; the fact that research and development data are subject to different interpretations and evaluations, including during the peer review / publication process, in the scientific community in general and by regulatory authorities; whether the data will be published in a scientific journal and, if so, when and with what modifications; The ability of Immunome to execute its strategy, including with respect to its R&D efforts, IND submissions and other regulatory filings, the timing of such filings and the timing and nature of government authorities’ comments thereon, the initiation and completion of any clinical studies, confirmatory testing and other planned milestones as planned; the efficacy of Immunoma product candidates, including the possibility that other preclinical data and all clinical trial data may be incompatible with the data used to advance the product candidates and that other variants of concern may emerge; Immunoma’s ability to finance its operations; Immunome’s dependence on suppliers; the competitive landscape; and the additional risks and uncertainties set out in more detail under “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 10- Immunoma. Q filings and other filings and reports with the SEC. The forward-looking statements contained in this announcement are made as of this date, and Immunome assumes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except if it may be required by law. In this press release, we may discuss our current and potential product candidates that have not yet been in clinical trials or have not yet been approved for sale by the US Food and Drug Administration- United or other government authority, including expectations regarding their therapeutic potential and benefits. No representation is made as to the safety or efficacy of these current or potential product candidates for the use for which these product candidates are being investigated.
View source version on businesswire.com:https://www.businesswire.com/news/home/20220110005987/en/
CONTACT: Immunoma Contact
[email protected] Investor Contact
[email protected] Media contact
KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA
INDUSTRY KEYWORD: FDA BIOTECHNOLOGY INFECTIOUS DISEASES PHARMACEUTICAL HEALTH
SOURCE: Immunome, Inc.
Copyright Business Wire 2022.
PUB: 01/10/2022 16:15 / DISC: 01/10/2022 16:17