Immunome Announces First Patient Dosed in Phase 1 Trial Evaluating IM-1617, a Potential First-in-Class ADC, in Patients with Advanced Solid Tumors
- IM-1617 is a potential first-in-class solid tumor antibody-drug conjugate (ADC) that incorporates HC74, Immunome's proprietary topoisomerase I (TOP1) inhibitor payload
- Immunome ADC pipeline momentum anticipated to continue with investigational new drug (IND) submissions for IM-1340 and IM-1335 planned for mid- and late 2026, respectively
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-1617, a potential first-in-class ADC directed at an undisclosed solid tumor target and incorporating HC74, Immunome's proprietary TOP1 inhibitor payload.
"The first patient dosed with IM-1617 is a significant milestone for Immunome's ADC platform and a meaningful step toward our mission of delivering targeted therapies for patients with cancer," said Clay Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We are encouraged by the pace of progress across our portfolio and look forward to advancing IM-1617 while continuing to expand the clinical potential of our proprietary HC74 payload through additional ADC programs."
The Phase 1 trial is an open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1617. The study is expected to include participants with advanced solid tumors, including colorectal cancer, non-small cell lung cancer, and breast cancer.
About IM-1617
IM-1617 is a clinical-stage solid tumor ADC. It targets an undisclosed receptor tyrosine kinase that promotes tumor cell survival and mediates immune cell exclusion, and it incorporates HC74, Immunome's proprietary TOP1 inhibitor. Preclinical in vivo efficacy studies showed impressive tumor regression after a single, clinically relevant dose of IM-1617 in a variety of solid tumor 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 submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, an IND-cleared FAP-targeted radiotherapy. 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 "potential," "anticipated," "planned," "look forward to," "expected," 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-1617; Immunome's expected timing for IND submissions for IM-1340 and IM-1335; the potential of Immunome's ADC platform; 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-1617 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 Immunome will not be able to realize the benefits of its strategic transactions; uncertainties related to Immunome's capital requirements and Immunome's expected cash runway; Immunome's ability to grow and advance its pipeline and successfully execute on its business plan; 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 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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Investor Contact:
Max Rosett
Chief Financial Officer, Immunome
investors@immunome.com