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Inhibrx, Genialis Partner to Identify Predictive Biomarker for INBRX-109

NEW YORK – Inhibrx and Genialis on Monday announced a collaboration to use Genialis' machine-learning platform to identify a predictive biomarker of response for Inhibrx's INBRX-109.

INBRX-109 targets death receptor 5, or DR5, and Inhibrx is studying the drug in two Phase I trials, one in pancreatic cancer and malignant pleural mesothelioma, and another looking at the activity of the drug in various locally advanced or metastatic solid tumors. Within the latter basket trial, the company has a cohort that is enrolling chondrosarcoma patients.

Last year, the US Food and Drug Administration granted INBRX-109 fast-track designation as a treatment for unresectable or metastatic conventional chondrosarcoma. In June 2021, Inhibrx reported data from its Phase I basket study on 16 patients with unresectable or metastatic conventional chondrosarcoma. Two patients achieved a partial response and 12 patients reached stable disease, leading to a disease control rate of 87.5 percent. Preliminary results also showed a median progression-free survival of 7.6 months.

At the time, the company said it would enroll a dozen additional chondrosarcoma patients with IDH1 or IDH2 mutations and "support ongoing biomarker discovery efforts." Inhibrx has also initiated a potentially registration-enabling Phase II INBRX-109 trial in conventional chondrosarcoma.

In the deal announced today, Boston-based Genialis will use its biomarker discovery platform ResponderID to analyze data sets from Inhibrx's preclinical studies and clinical programs, the public domain, and its own proprietary database. The companies together will explore the biology of response to DR5 agonism.

"Genialis' ResponderID platform has enabled the capture of specific, sophisticated signals related to INBRX-109 sensitivity in both preclinical and clinical samples," Brendan Eckelman, CSO of Inhibrx, said in a statement. "As we move forward in the clinic and generate more data, we anticipate Genialis' platform will allow us to better understand the relevant biology, and leverage that understanding into a predictive biomarker."

Inhibrx, based in La Jolla, California, has two other oncology drugs in its pipeline: INBRX-106, a drug targeting OX40 that it is studying in solid tumors, and INBRX-105, which it is exploring in patients with PD-L1-expressing tumors.