Immunome Announces First Patient Dosed in Phase 1 Trial Evaluating IM-3050, an FAP-Targeted Radioligand Therapy, in Patients with FAP-Expressing Advanced Solid Tumors

• IM-3050 is a fibroblast activation protein (FAP)-targeted radioligand therapy designed to deliver radioactive lutetium-177 directly to FAP-expressing cells.
• The Phase 1 trial is designed to evaluate the safety, tolerability, dosimetry, pharmacokinetics, and preliminary anti-tumor activity of IM-3050 in participants with FAP-expressing advanced solid tumors.

BOTHELL, Wash.--(BUSINESS WIRE)--Immunome, Inc. (Nasdaq: IMNM), a biotechnology company committed to developing first-in-class and best-in-class targeted cancer therapies, today announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-3050, an investigational FAP-targeted radioligand therapy being evaluated in patients with FAP-expressing advanced solid tumors.

“FAP is a high-potential target with expression in 75% of solid tumors,” said Bob Lechleider, M.D., Chief Medical Officer of Immunome. “We believe an optimized radioligand therapy is well-suited to FAP’s intriguing biology. IM-3050 is designed to deliver radioactive lutetium-177 directly to FAP-expressing cells, and we look forward to evaluating its potential in patients with advanced solid tumors.”

The Phase 1 trial is an open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, dosimetry, pharmacokinetics, and preliminary anti-tumor activity of IM-3050 in participants with FAP-expressing advanced solid tumors. The dose escalation portion of the study will evaluate escalating repeated doses of IM-3050 to determine the maximum tolerated dose and/or recommended expansion dose; the expansion portion is designed to further evaluate safety and tolerability at the candidate recommended dose.

About IM-3050

IM-3050 is an investigational lutetium-177 radioligand therapy targeting fibroblast activation protein (FAP), which is broadly expressed on cancer-associated fibroblasts in the tumor microenvironment. IM-3050 is designed to deliver radioactive lutetium-177 directly to FAP-expressing cells, where emitted beta particles may damage or kill nearby tumor cells through a bystander effect.

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 submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

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 “designed,” “committed,” “potential,” “look forward,” “will,” and similar expressions to identify them. The forward-looking statements include statements regarding: the potential, advancement, development, clinical evaluation and therapeutic benefits of IM-3050; 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-3050 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; and other risks and uncertainties included under the caption “Risk Factors” in Immunome’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the Securities and Exchange Commission on May 12, 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 of this press release. Except as required by law, Immunome undertakes no obligation and does not intend to update any forward-looking statements included in this press release.