“Discontinued 바카라 에볼루션5029 After Reviewing Preclinical and Clinical Data”
[by Ji, Yong Jun] Orum Therapeutics, Inc. (“Orum” or the “Company”), a public biotechnology company pioneering the field of degrader-antibody conjugates (DACs), announced on April 29 a strategic update to its pipeline. Orum has discontinued further clinical development of ORM-5029, a HER2-targeted GSPT1 degrader-antibody conjugate (DAC). This decision follows an internal assessment of the program’s clinical progress and incorporates information previously disclosed. Concurrently, Orum announced the nomination of a new drug candidate, ORM-1153, in development for the treatment of hematologic malignancies.
ORM-1153 is a novel DAC engineered using 바카라 에볼루션’s proprietary Dual-Precision Targeted Protein Degradation (TPD²®) approach, which combines the catalytic protein degradation mechanism of TPDs with the tumor-targeting capabilities of therapeutic antibodies. The candidate targets GSPT1, a translation termination factor highly relevant in hematologic malignancies, and an undisclosed tumor-associated antigen to enhance selectivity and broaden the therapeutic window.
In preclinical studies, ORM-1153 demonstrated potent anti-tumor activity and a favorable safety profile, including in non-human primate models. ORM-1153 demonstrated picomolar potency in target-expressing cell lines and showed greater potency than existing small molecule GSPT1 degraders. In vivo, a single dose of ORM-1153 led to strong anti-tumor activity in relevant xenograft models. 바카라 에볼루션 plans to advance the program into IND-enabling studies and anticipates presenting additional data at a scientific conference later this year.
“After careful review of available clinical and preclinical data, we have concluded clinical development of ORM-5029,” said Sung Joo (SJ) Lee, Ph.D., Founder and CEO of 바카라 에볼루션 Therapeutics. “This decision reflects our continued commitment to patient safety and our strategic focus on advancing the next generation of degrader-antibody conjugates with a clearly defined risk-benefit profile. We look forward to advancing next-generation programs emerging from our proprietary platform, like ORM-1153.”
Dr. Lee continued, “바카라 에볼루션1153 leverages learnings from all our programs and clinical experience to build potent, selective, and tumor-targeted protein degrader therapeutics that address serious unmet needs in oncology. We remain confident in the promise of our Dual-Precision Targeted Protein Degradation GSPT1 platform and are excited to progress this new candidate toward the clinic.”