SEOUL, South Korea I January 02, 2024 I Ubix Therapeutics, Inc., a biotechnology company developing innovative oncology therapeutics based on targeted protein degradation (TPD), announced that U.S. Food and Drug Administration (FDA) has authorized to proceed for the company’s investigational new drug (IND) application for UBX-303-1, an oral degrader candidate for treatment of relapsed/refractory B-cell malignancies.

In connection with the authorization, Ubix will initiate a phase 1 study in the United States with plans to later expand the study to clinical sites in Europe and South Korea. The phase 1a/1b study is an open-label, does escalation and dose expansion study to evaluate the safety, pharmacokinetics, and pharmacodynamics of UBX-303-1 in patients with relapsed/refractory B-cell malignancies. The company anticipates the first patient dosing in the first half of 2024.

UBX-303-1 is a potential best-in-class small molecule degrader targeting Bruton’s tyrosine kinase (BTK). BTK plays a central role in B cell receptor (BCR) signaling, a key driver of proliferation and survival of tumor cells in B-cell malignancies when misregulated. Nearly half of patients on current BTK inhibitors, despite their well demonstrated efficacy, discontinue the treatment due to adverse effects such as atrial fibrillation, bleeding, heart failure and emergence of drug-resistance mutations. In preclinical studies, UBX-303-1 has demonstrated enhanced target selectivity and robust tumor growth inhibition activity both in vitro and in vivo. UBX-303-1 is also effective in degrading BTK proteins across a wide range of resistance mutations.

BK Seo, CEO of Ubix therapeutics, said “Clearance of IND of UBX-303-1 is a significant milestone for the company and to the TPD field. UBX-303-1 is the first TPD drug designed by our proprietary TPD technology, Degraducer®, to enter clinical development. We believe that UBX-303-1 may offer new treatment options for patients with relapsed/refractory B-cell malignancies. With Ubix’ growing TPD pipeline, we will continue to innovate to provide new therapies that benefit patients in need.

About Ubix Therapeutics, INC.

Ubix Therapeutics is a biotechnology company dedicated to development of TPD therapeutics. Ubix’ proprietary TPD platform technology, Degraducer®, leverages the body’s own natural protein degradation machinery to eliminate diseased proteins, thereby leading to near-complete inactivation of disease-causing pathways. Ubix’ wholly-owned TPD pipeline include UBX-303-1, BTK degrader for treatment of relapsed or refractory B cell malignancies, UBX-103, AR degrader for treatment of patients with metastatic castration-resistant prostate cancer, and multiple discovery stage degraders. For additional information, please visit

SOURCE: Ubix Therapeutics