Previously, on April 28, Orum Therapeutics announced that it had decided to voluntarily discontinue the U.S. Phase 1 clinical trial of its new drug candidate 'ORM-5029', which was being developed as a treatment for HER2-positive metastatic breast cancer and other HER2-overexpressing malignant tumors.
This pipeline was Orum Therapeutics' most advanced, utilizing its proprietary DAC (Drug-Antibody Conjugate) platform technology, which is considered a next-generation advancement in the field of antibody-drug conjugates (ADC). Unlike ADCs, which use cytotoxic payloads, DAC technology combines a targeted protein degrader (TPD) instead.
However, ORM-5029, which received approval for a U.S. Phase 1 clinical trial in 2022, was suspended in November 2024 after a serious adverse event (SAE) occurred in one participant during the ongoing trial. At that time, the company stated that a decision on whether to resume the trial would be made within the second half of the year. Ultimately, instead of resuming the ORM-5029 trial, the company decided to discontinue it and focus on early-stage compounds in its subsequent pipeline.
A representative from Orum Therapeutics explained, "This decision reflects our commitment to prioritizing patient safety and developing therapeutics with a clear risk-benefit profile. It is also intended to strategically concentrate resources on our next-generation pipelines based on our proprietary platform."
Orum Therapeutics has previously succeeded in two global technology out-licensing deals based on its DAC technology. In 2023, the company signed a contract with global pharmaceutical company BMS for ORM-6165, securing an upfront payment of $100 million and milestone payments totaling $80 million. BMS began a Phase 1 clinical trial (NCT06419634) in June 2024, which is currently ongoing. Last year, Orum Therapeutics also signed a deal with gene-editing therapy developer Vertex Pharmaceuticals, receiving an upfront payment of $15 million and securing additional options and milestone payments of up to $310 million for up to three targets.
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