Early data has been released by Inhibrx about INBRX-109's Phase 1 trial, focused on Ewing Sarcoma treatment

Inhibrx, Inc., a biopharmaceutical firm in the clinical stage that focuses on formulating treatments for cancer and rare conditions, declared the initial results concerning efficacy and safety from the Phase 1 trial. This trial was for INBRX-109, used in conjunction with Irinotecan and Temozolomide, designed for treating advanced or metastatic, non-removable Ewing sarcoma.

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Out of the 13 assessable patients including 7 with classical Ewing sarcoma and 6 with round cell sarcoma, a disease control rate of 76.9% was recorded, signifying 10 out of 13 patients, as evaluated by RECISTv1.1. A durable clinical advantage was noted in 4 people (30.8%) who demonstrated disease control for more than 6 months. As of September 8, 2023, the longest period of steady disease was over 10 months and ongoing and 7 of the 13 remained part of the study.

INBRX-109 is a tetravalent death receptor 5 (DR5) agonist antibody which has been precision-engineered to leverage the tumor-inclined cell death brought about by DR5 activation. Overall, the combination of INBRX-109 with IRI/TMZ was well tolerated. Diarrhea, nausea, and fatigue were the most frequent unfavorable events, all aligning with the known safety characteristics of IRI/TMZ. No liver-related incidents of grade 3 or superior occurred.

"I am optimistic about the preliminary data in relapsed/refractory Ewing sarcoma patients. This group of patients have a high unfulfilled need and limited efficient therapy options," expressed Dr. Rashmi Chugh, MD, a Professor of Internal Medicine at the Division of Hematology/Oncology at the University of Michigan Rogel Comprehensive Cancer Center. "I anticipate the continued recruitment in this group of patients and am eager to see the outcomes of the enlargement."

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According to the data provided by the Synapse Database, As of November 9, 2023, there are 33 investigational drugs for the DR5 target, including 48 indications, 51 R&D institutions involved, with related clinical trials reaching 55, and as many as 4368 patents.

In June 2021, Inhibrx initiated a randomized, blinded, placebo-controlled, registration-enabling Phase 2 trial of INBRX-109 in conventional chondrosarcoma, which is currently ongoing. In January 2021, the FDA granted Fast Track designation to INBRX-109 for the treatment of patients with unresectable or metastatic conventional chondrosarcoma and orphan-drug designation to INBRX-109 for chondrosarcoma in the United States.