UBX-103

SEOUL, South Korea I July 01, 2024 I Ubix Therapeutics, Inc., a biotechnology company discovering and developing innovative oncology therapeutics based on targeted protein degradation (TPD), announced today that it has entered into an exclusive license agreement with Yuhan to develop and commercialize preclinical androgen receptor (AR) degrader program, UBX-103. Under the terms of the agreement, Yuhan will have exclusive, worldwide rights for the preclinical and clinical development and commercialization of UBX-103. Ubix will receive an upfront payment of more than 3.6 million US dollars (5 billion Korean won). Ubix will be also eligible to receive up to 105 million US dollars (145 billion Korean won) as additional development, regulatory, and commercial milestones, as well as high single digit royalty payment. In the case of sublicensing to a third party, Ubix is eligible for profit sharing. UBX-303-1 is a potential best-in-class, orally bioavailable degrader that targets androgen receptor (AR), a key driver of growth and survival of prostate cancer. While hormone deprivation therapy (ADT) stands as the standard of care for patients with metastatic prostate cancer, tumors frequently develop into castration resistant metastatic prostate cancer due to AR gene amplification or treatment-induced gain-of-function mutations of AR. Preclinical data demonstrated UBX-103’s potency as an AR degrader with picomolar DC 50 (half-maximal degradation concentration) and efficacy against a broad spectrum of treatment-induced resistance mutations. Notably, UBX-103 exhibits the ability to inhibit growth of the tumor that is resistant to next generation hormonal therapy in the in vivo preclinical model. “The two companies will enhance technology exchange and collaborative efforts to develop next-generation therapies leveraging targeted protein degradation.” stated Wook-Je Cho, CEO of Yuhan. “This aims to offer better treatment opportunities for patients with limited options under current therapeutics, fostering innovative transformations in the fields of medicine and life sciences.” BK Seo, CEO of Ubix therapeutics, said “Yuhan is a distinguished pharmaceutical company with globally recognized achievements in R&D and the commercialization of innovative drugs. Through this partnership, we are confident that Yuhan’s expertise and commitment will enhance the development and potential commercialization of UBX-103.” About Ubix Therapeutics, INC. Ubix Therapeutics is a biotechnology company dedicated to discovery and 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. In addition to UBX-103, Ubix TPD pipeline includes its clinical program UBX-303-1, a BTK degrader for treatment of relapsed or refractory B cell malignancies as well as multiple other research and lead optimization stage degrader assets in targeted and immune-oncology. For additional information, please visit http://en.ubixtrx.com . SOURCE: Ubix Therapeutics

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 http://www.ubixtrx.com. SOURCE: Ubix Therapeutics