Immunome, Inc. (Nasdaq: IMNM), a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IM-1340, a potential first-in-class antibody-drug conjugate (ADC) for the treatment of advanced solid tumors.

IM-1340 is designed to target a transport receptor with a unique tumor expression profile spanning solid tumors, including neuroendocrine tumors, lung cancer, and colorectal cancer. It incorporates HC74, Immunome’s proprietary topoisomerase I (TOP1) inhibitor payload. Preclinical studies demonstrated encouraging anti-tumor activity across multiple tumor models, supporting the decision to advance this program into clinical development.

“IND clearance for IM-1340 marks another milestone in the advancement of Immunome’s ADC platform and demonstrates our ability to rapidly progress novel HC74-based programs into the clinic,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. “We believe IM-1340 has the potential to treat multiple solid tumor types by combining a differentiated target with the favorable properties of our proprietary HC74 payload. We look forward to initiating clinical evaluation of IM-1340 and continuing to expand our ADC pipeline.”

The Phase 1 study, which Immunome expects to initiate in the fourth quarter of 2026, is an open-label, multicenter dose-escalation and expansion trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1340 in patients with advanced solid tumors.

About IM-1340

IM-1340 is a potential first-in-class ADC incorporating Immunome’s proprietary HC74 topoisomerase I inhibitor payload. The investigational therapy targets a transport receptor with expression across solid tumors, including neuroendocrine tumors, lung cancer, and colorectal cancer. In preclinical studies, IM-1340 demonstrated anti-tumor activity, including tumor regressions following a single dose in multiple in vivo models.

About Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; IM-3050, a clinical-stage FAP-targeted radiotherapy; and IM-1340, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. For more information, visit www.immunome.com.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We use words such as “potential,” “believe,” “expect,” “expects,” “designed to,” “look forward to,” and similar expressions to identify these forward-looking statements. These forward-looking statements include statements regarding: the advancement, development, clinical evaluation and therapeutic benefits of IM-1340, including its potential to treat multiple solid tumor types; Immunome’s expected timing for initiation of a Phase 1 clinical trial of IM-1340; the potential of Immunome’s ADC platform and proprietary HC74 payload; the continued expansion of Immunome’s ADC pipeline; the potential of Immunome’s targeted oncology therapies to be first-in-class or best-in-class therapies; and other statements regarding management’s intentions, plans, beliefs, expectations and forecasts for the future. These forward-looking statements are based on Immunome’s current expectations and involve assumptions that may never materialize or may prove to be incorrect; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including the risk that clinical development of IM-1340 or other product candidates may be delayed or unsuccessful; the risk that preclinical results may not be predictive of clinical performance or that initial clinical results may not be indicative of subsequent results; the risk that regulatory approvals for Immunome’s product candidates are not obtained, are delayed or are subject to unanticipated conditions; the risk that the timing, conduct, enrollment or results of clinical trials may differ from current expectations; the risk that Immunome will not be able to realize the benefits of its strategic transactions; Immunome’s ability to advance and expand its ADC pipeline; and other risks and uncertainties included under the caption “Risk Factors” in Immunome’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the Securities and Exchange Commission on August 11, 2026. These documents can also be accessed on Immunome’s website at www.immunome.com by clicking on the link “Financials” under the “Investors” tab. The forward-looking statements included in this press release are made only as of the date hereof. Except as required by law, Immunome assumes no obligation and does not intend to update any forward-looking statements included in this press release.

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