Immunome gains FDA IND clearance for IM‑1340 solid tumour study

A first human study of an experimental cancer drug can move ahead after Immunome, Inc. NASDAQIMNM said on Sept. 30 that the U.S. Food and Drug Administration cleared its investigational new drug application for IM-1340. The company expects to initiate the Phase 1 first human study in the fourth quarter of 2026.

The Sept. 30 release describes an open-label, multicentre study with dose escalation followed by expansion. It is designed to assess safety, tolerability, pharmacokinetics and preliminary antitumour activity in people with advanced solid tumours.

Immunome is a targeted oncology developer based in Bothell, Washington, with antibody-drug conjugates and a desmoid tumour treatment in its pipeline.

The NASDAQIMNM quote put Immunome shares at US$21.51 on Nasdaq at the Sept. 30 close, down 1.74 per cent as of 4 p.m. EDT. The same NASDAQIMNM quote at 4 p.m. EDT on Sept. 30 showed volume of 1.31 million shares against a 1.27 million daily average.

The Study Will Test Safety and Early Activity

IM-1340 targets a transport receptor that Immunome says is expressed in neuroendocrine, lung and colorectal tumours. The antibody-drug conjugate carries HC74, the company's topoisomerase I inhibitor payload. The planned first human study will assess safety and tolerability and look for preliminary antitumour activity.

The company reported tumour regressions after a single dose in multiple preclinical models in its Sept. 30 release. Immunome cited those findings in outlining a study designed to collect early safety and activity data across escalating doses.

“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,” Immunome chief executive Clay Siegall said in the release.

IM-1340 is the company's fifth program in clinical development, according to the announcement. Immunome said in its August results that it dosed the first patient in an IM-1617 study in June 2026. The Phase 1 program tests a separate solid-tumour ADC built around HC74 and is also designed to assess safety and preliminary activity.

Its other clinical programs include IM-1021, an ADC being tested in lymphoma, and IM-3050, an investigational radioligand therapy for solid tumours. The latter dosed its first patient in July 2026, according to the company's August update.

The August results put cash, cash equivalents and marketable securities at US$520.0 million on June 30, 2026. Immunome said the position should fund operations into 2028 and reported a US$73.1 million net loss for the quarter ended June 30. Its varegacestat application for adults with desmoid tumours is further along: the FDA assigned an April 28, 2027 target action date to that new drug application.

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Approved ADCs Set a Later Benchmark

Gilead Sciences, Inc. NASDAQGILD described its Trodelvy as a TROP2-directed antibody-drug conjugate being studied in first-line metastatic triple-negative breast cancer in a May 21, 2026 oncology update. AstraZeneca PLC LONAZN NYSEAZN said in a June 23, 2025 release that its jointly developed Datroway, another TROP2-directed ADC, received accelerated U.S. approval for a group of previously treated lung cancer patients.

Those marketed ADCs target TROP2, while Immunome describes IM-1340 as targeting a transport receptor. Its planned trial will test a different target in people at an earlier development stage. The iShares Biotechnology ETF NASDAQIBB closed Sept. 30 at US$210.53, down 0.24 per cent on Nasdaq as of its 4 p.m. EDT quote.

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Immunome expects to initiate the IM-1340 Phase 1 first human study in the fourth quarter of 2026. Once underway, the study is designed to test safety and tolerability and measure preliminary antitumour activity in patients with advanced solid tumours.