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Immuneering to Present Data from Three Arms of its Ongoing Phase 2a Trial of IMM-1-104 in Early January 2025

By: Immuneering Corporation via GlobeNewswire

December 17, 2024 at 08:00 AM EST

- The company will provide additional data from IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer -

- The company will also provide initial data from IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer, as well as IMM-1-104 monotherapy in second-line pancreatic cancer -

CAMBRIDGE, Mass., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced that it will hold a virtual Investor Event in early January 2025 to discuss data from its ongoing Phase 2a trial of IMM-1-104.

Specifically, the company plans to present:

Additional data from IMM-1-104 in combination with mGnP in first-line pancreatic cancer.
Initial data from IMM-1-104 in combination with mFFX in first-line pancreatic cancer.
Initial data from IMM-1-104 monotherapy in second-line pancreatic cancer.
In addition, the company will provide initial PK, PD and safety data from the Phase 1 portion of the company’s Phase 1/2a trial of IMM-6-415.

Details of how to access the Investor Event will be provided in due course.

“We are excited to soon share additional data from our Phase 2a study of IMM-1-104 in patients with pancreatic cancer,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “Pancreatic cancer patients urgently need new options that enable them to live longer and feel better. The FDA has recently granted IMM-1-104 Orphan Drug designation in pancreatic cancer, along with Fast Track designations in first and second-line pancreatic cancer, and advanced melanoma. We look forward to building on our September update with additional data from the Phase 2a study of IMM-1-104.”

About Immuneering Corporation

Immuneering is a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy. The company aims to achieve universal activity through Deep Cyclic Inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells. Immuneering’s lead product candidate, IMM-1-104, is an oral, once-daily Deep Cyclic Inhibitor currently in a Phase 1/2a trial in patients with advanced solid tumors including those harboring RAS mutations. IMM-6-415 is an oral, twice-daily Deep Cyclic Inhibitor currently in a Phase 1/2a trial in patients with advanced solid tumors harboring RAS or RAF mutations. The company’s development pipeline also includes several early-stage programs. For more information, please visit www.immuneering.com.

Forward-Looking Statements

This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: Immuneering’s plans to develop, manufacture and commercialize its product candidates; the treatment potential of IMM-1-104 and IMM-6-415, alone or in combination with other agents, including chemotherapy; and the timing for release of additional results from the Phase 2a portion of the trial for IMM-1-104 and the Phase 1 portion of the trial for IMM-6-415.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding and ability to continue as a going concern; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports.

These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for period ended September 30, 2024, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Media Contact:
Gina Nugent
gina@nugentcommunications.com

Investor Contact:
Laurence Watts
619-916-7620
laurence@newstreetir.com