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Immunome to Present Initial First-in-Human Clinical Data for IM-1021 in Advanced B-Cell Lymphomas at ASH 2026

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  • Initial results demonstrate objective responses across all dose levels evaluated in heavily pretreated patients with B-cell non-Hodgkin lymphoma (B-NHL)
  • Objective response rate of 53% observed in response-evaluable patients with B-NHL, including complete responses

Immunome, Inc. (Nasdaq: IMNM), a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class cancer therapies, today announced the presentation of initial first-in-human clinical data from the ongoing Phase 1 study of IM-1021, an investigational ROR1-targeted antibody-drug conjugate (ADC) for the treatment of advanced B-cell lymphomas, at the 68th American Society of Hematology (ASH) Annual Meeting.

The poster will include initial results demonstrating responses across all dose levels evaluated in heavily pretreated patients with B-cell non-Hodgkin lymphoma (B-NHL). Among 19 response-evaluable patients with B-NHL, the objective response rate (ORR) was 53% (10/19), including five complete responses (CRs) and five partial responses (PRs). Among 11 response-evaluable patients with diffuse large B-cell lymphoma (DLBCL), the ORR was 64% (7/11), including three CRs and four PRs.

“At this interim read, we were encouraged to see clinical activity with IM-1021 in these heavily pretreated patients, including patients whose disease had progressed following T-cell redirecting therapies,” said Bob Lechleider, M.D., Chief Medical Officer of Immunome. “These early results support our dose optimization efforts as we work to advance IM-1021 and further evaluate its potential for patients with B-cell lymphomas. The study is ongoing, and we look forward to presenting an updated dataset at ASH.”

As of the June 26, 2026, abstract data cutoff, 35 patients had received IM-1021, including 25 patients with B-NHL. Treatment-emergent adverse events (TEAEs) were reported in 92% of B-NHL patients. Grade ≥3 TEAEs occurred in 52% of B-NHL patients, of which the most common was neutropenia (44%). The patients with B-NHL had received a median of four prior lines of therapy, and prior T-cell redirecting therapy was common. Responses were observed across all dose levels tested. Dose optimization across multiple dosing regimens remains ongoing.

Presentation Details

Title: Initial results from first-in-human study of IM-1021, a ROR1-targeted antibody-drug conjugate with TOP1-inhibitor payload, in adults with advanced B-cell lymphomas

Presenter: Dr. Krish Patel (Sarah Cannon Research Institute)

Session: 629: Aggressive Lymphomas, Non-Cellular Immunotherapy including Bispecific Antibodies: Poster III

Publication Number: 5457

Location: MCCNO - Hall F

Date/Time: December 14, 2026, 6:00p.m. - 8:00p.m.

About the IM-1021-101 Trial

The Phase 1 IM-1021-101 study (ClinicalTrials.gov Identifier: NCT06823167) is an ongoing, first-in-human, open-label, multinational, multicenter dose-escalation and expansion study evaluating IM-1021 in patients with advanced B-cell lymphomas and advanced solid tumors. The study is designed to evaluate the safety and tolerability of IM-1021 and select recommended dose(s) for further study, as well as characterize preliminary antitumor activity and pharmacokinetics.

About IM-1021

IM-1021 is an investigational ROR1-targeted ADC currently being evaluated in a Phase 1 study in patients with advanced B-cell lymphomas. ROR1 is expressed in liquid and solid tumors but is largely absent in most mature tissues. IM-1021 incorporates an antibody designed to promote internalization and Immunome’s proprietary TOP1 inhibitor payload, HC74. Immunome designed IM-1021 to optimize ADC-mediated killing of ROR1-positive tumor cells. The company initiated enrollment in the Phase 1 study in the first quarter of 2025.

About Immunome, Inc.

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class 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, oral, once-daily 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 “will,” “committed to,” “look forward,” “potential,” and similar expressions to identify these forward-looking statements. These forward-looking statements include statements regarding the potential of IM-1021, including its potential therapeutic benefits; the continued clinical development and dose optimization of IM-1021; the expected presentation of an updated dataset at ASH; and other statements regarding management’s intentions, plans, beliefs, expectations or 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 due to a number of factors, including risks related to the clinical development of IM-1021, including the possibility that preliminary clinical results may not be indicative of future results; risks related to the safety and efficacy of IM-1021; risks related to the timing and results of ongoing clinical studies; Immunome’s ability to grow and advance its pipeline and 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 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 of this press release. 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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