Immunome (IMNM) FDA Events

Immunome's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Immunome (IMNM). Over the past two years, Immunome has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as IM-1021. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

IM-1021 FDA Regulatory Events

IM-1021 is a drug developed by Immunome for the following indication: In Cancer therapies. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Dosing Update - March 10,2025

Phase 1

• Drug: IM-1021
• Announced Date: March 10, 2025
• Indication: In Cancer therapies

Immunome, Inc. announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC.

Immunome, Inc. has reached an exciting milestone by dosing the first patient in its Phase 1, first‐in‐human trial of IM-1021, a ROR1-targeted antibody-drug conjugate (ADC). This trial is designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of IM-1021. The study will enroll patients with advanced B-cell lymphomas and solid tumors, aiming to address a significant unmet medical need.

IM-1021 uses Immunome’s proprietary TOP1 inhibitor, HC74, to target cancer cells by homing in on the ROR1 protein. This innovative approach could potentially improve treatment outcomes for patients with difficult-to-treat cancers. As the trial progresses, researchers will closely monitor how the drug performs in patients, focusing on its dosing, pharmacokinetics, and effectiveness, which marks a notable step forward in the field of targeted cancer therapies.

Immunome FDA Events - Frequently Asked Questions

Has Immunome received FDA approval?

As of now, Immunome (IMNM) has not received any FDA approvals for its therapy in the last two years.

What drugs has Immunome submitted to the FDA?

In the past two years, Immunome (IMNM) has reported FDA regulatory activity for IM-1021.

What is the most recent FDA event for Immunome?

The most recent FDA-related event for Immunome occurred on March 10, 2025, involving IM-1021. The update was categorized as "Dosing Update," with the company reporting: "Immunome, Inc. announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC."

What conditions do Immunome's current drugs treat?

Currently, Immunome has one therapy (IM-1021) targeting the following condition: In Cancer therapies.