Orum Therapeutic unveils clinical design of HER2 target ‘GSPT1 degrader’ at ASCO

Orum Therapeutics (CEO Lee Seung-joo) presented HER2-targeted GSPT1 (G1 to S phase transition) for patients with advanced solid tumors expressing HER2 at the American Society of Clinical Oncology (ASCO) held in Chicago, USA from 2nd (local time) to 5th. We will disclose the design of a phase 1 clinical trial of protein 1) decomposer ‘ORM-5029 (development code name)’. ‘GSPT1’ is a ‘translation termination factor’ that regulates the final step of translation during intracellular protein synthesis.

ORM-5029 is a substance that specializes in degrading GSPT1 only in specific target cells, not general cells, by using Oreum’s first platform technology, TPD (Dual-Precision Targeted Protein Degradation). It is a combined HER2-targeted antibody drug (ADC) that combines a GSPT1 disruptor with ‘Pertuzumab (product name: Perzeta)’. The company explained that it increases the tolerance period compared to the effectiveness of protein degradation and improved drug delivery.

According to the company, this poster presentation is led by Professor Sara A. Hurvitz (Director of Clinical Research in Breast Cancer) at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), who is currently is conducting clinical trials in the United States. Professor Hervitz conducted the clinical study ‘DESTINY-Breast03’ comparing the ADC treatment of HER2-positive breast cancer ‘Enhertu (ingredient trastuzumab deluxtecan)’ and ‘Cascyla (ingredient trastuzumab emtansine)’.

The company is evaluating the safety, tolerability and efficacy of ORM-5029 by intravenous administration through a phase 1 clinical trial. Clinical trials, which began administering the first patient in October last year, are ongoing for approximately 80 patients breast cancer with the aim of developing a treatment for breast cancer that has relapsed or is refractory to existing HER2 targeted treatments such as Enhertu. Clinical trials are underway at more than six institutions, including UCLA, the MD Anderson Cancer Center, and the Dana Farber Cancer Institute.

Lee Seung-joo, CEO of Oreum Therapeutics, said, “Many new alternatives have been proposed for breast cancer treatment,” and “However, there are still areas for breast cancer patients with a poor prognosis. ” He added, “We will introduce an alternative treatment to patients by collaborating with clinicians who have made various attempts to treat breast cancer.”


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