Bristol Myers Squibb has discontinued development of ORM-6151, a degrader-antibody conjugate (DAC) acquired from South Korean biotechnology company Orum Therapeutics in 2023, following a review of clinical data from the program.
The decision was disclosed by Orum Therapeutics in a regulatory filing on Thursday. ORM-6151 had been under evaluation in a Phase 1 clinical trial involving patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Phase 1 Program Halted Following Clinical Data Review
According to Orum, Bristol Myers Squibb ended development of the therapy after assessing data generated in the clinical study. The company’s decision also removes its obligation to make any future milestone payments tied to the asset.
Bristol Myers Squibb acquired ORM-6151 for an upfront payment of $100 million, with the agreement including the possibility of up to $80 million in additional milestone payments. Under the terms outlined in Orum’s filing, the biotechnology company is not required to return the upfront payment despite the program’s termination.
ORM-6151, which Bristol Myers Squibb referred to as BMS-986497, was designed to deliver a GSPT1 degrader to cells expressing CD33. Degrading GSPT1 can lead to cell death. AML and MDS cells often express CD33, and ORM-6151 was developed to target those cells.
The Phase 1 study began in 2024 and evaluated ORM-6151 both as a standalone treatment and in combination regimens involving azacitidine and venetoclax. According to the federal clinical trials registry, the study had been scheduled to conclude in February 2027.
Orum Retains Cash Position and Continues Pipeline Development
The termination of the program means Orum will no longer be eligible to receive up to $80 million in milestone payments linked to clinical development progress.
Addressing the status of the asset, Orum Chief Executive Officer SJ Lee said, “BMS acquired this program through an Asset Purchase Agreement. As such, there are no reversion rights to Orum.”
Lee also said the company held approximately $180 million in cash as of the second quarter and does not expect layoffs following the discontinuation of ORM-6151.
Orum plans to continue directing its research and development efforts toward its broader pipeline and DAC technology platform. Among the programs that remain in development is ORM-1153, another DAC generated using the company’s targeted protein degradation approach. Last month, the U.S. Food and Drug Administration cleared an investigational new drug application for ORM-1153, allowing clinical testing in AML and other hematologic malignancies.
DAC Programs Continue to Draw Industry Interest
DACs combine an antibody component that targets specific cells with a degrader payload intended to trigger the destruction of disease-causing cells. Several large pharmaceutical companies have entered the field through partnerships and acquisitions.
In April, Roche agreed to pay C4 Therapeutics $20 million upfront under a deal covering two DAC programs and an option to add a third, with potential milestone payments exceeding $1 billion. Merck KGaA also maintains a collaboration with C4 Therapeutics focused on targeted protein degraders.
Johnson & Johnson expanded its presence in the area in June through the $1 billion acquisition of Firefly Bio, a deal involving technology aimed at KRAS cancers.
AbbVie initiated a Phase 1 study of ABBV-787, a CD33-targeted DAC with a BET degrader payload, in 2023 but terminated the trial last year, citing strategic considerations.
ORM-6151’s antibody component was based on gemtuzumab, the targeting molecule used in Mylotarg, with modifications intended to support manufacturing and improve safety. Orum sold the asset to Bristol Myers Squibb shortly after Christopher Boerner became chief executive officer of the pharmaceutical company in 2023. The discontinuation of the program ends Bristol Myers Squibb’s development of the asset and eliminates the possibility of future milestone payments under the agreement.
Orum Therapeutics has announced that Bristol Myers Squibb (BMS) has discontinued development of ORM-6151, a targeted degrader-antibody conjugate being studied for blood cancers. The decision followed a review of Phase 1 clinical data from the program.
ORM-6151, also known as BMS-986497, was acquired from Orum by BMS in 2023. The transaction included a $100 million upfront payment and the potential for up to $80 million in additional development milestones. Following the discontinuation, BMS will no longer be required to make those future milestone payments, while Orum will retain the upfront payment.
Orum’s ORM-6151 Program
Orum developed ORM-6151 using its targeted protein degradation technology combined with an antibody-based delivery approach. The candidate was designed to target CD33-expressing cells and deliver a GSPT1 degrader, with development focused on acute myeloid leukemia (AML) and myelodysplastic syndromes.
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