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IMNM 資訊
IMNM 事件
Immunome Receives FDA Clearance for IM-1340 IND Application
Immunome announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for IM-1340, a potential first-in-class antibody-drug conjugate 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 inhibitor payload. Preclinical studies demonstrated encouraging anti-tumor activity across multiple tumor models, supporting the decision to advance this program into clinical development. 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.
Immunome Cash and Securities Total $520 Million
As of June 30, 2026, cash, cash equivalents and marketable securities totaled $520.0 million. Immunome expects its current cash position to fund operations into 2028. "We continue to execute against our strategy of building a diversified targeted oncology company with multiple opportunities to bring needed therapies to patients," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "For varegacestat, the presentation of detailed Phase 3 RINGSIDE data at ASCO and subsequent FDA acceptance of our NDA with a PDUFA target action date of April 28, 2027 represent important steps toward a potential approval and launch. We are also continuing to advance our broader pipeline, with three additional clinical-stage programs now enrolling patients. We believe this momentum positions us well for a milestone-rich second half of 2026."
Immunome Doses First Patient in IM-3050 Trial
Immunome 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. 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.
Immunome Submits NDA for Varegacestat, FDA Target Date April 28, 2027
Immunome announced the FDA has accepted its New Drug Application, or NDA, for varegacestat, an investigational, oral, once-daily gamma secretase inhibitor, or GSI, for the treatment of adults with desmoid tumors. The FDA assigned a Prescription Drug User Fee Act target action date of April 28, 2027. Desmoid tumors - also known as aggressive fibromatosis or desmoid-type fibromatosis - are aggressive non-metastatic soft tissue tumors that are prone to recurrence. The NDA is based on results from the Phase 3 RINGSIDE trial evaluating varegacestat in patients with progressing desmoid tumors. The registrational trial met its primary endpoint of improving progression-free survival vs. placebo, with a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death. The trial also met all key secondary endpoints, including achieving an objective response rate of 56% vs. 9% with placebo. Varegacestat demonstrated statistically significant improvement in worst pain intensity at week 12. In an exploratory analysis, varegacestat showed a median best change in tumor volume of -83% vs. +11% with placebo. Varegacestat was generally well tolerated with a manageable safety profile.
Immunome Doses First Patient in IM-1617 Trial
Immunome 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.
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