Sydney, Australia, CHICAGO, Ill USA and Gyeonggi-do, South Korea. May 03, 2021. Today, Xennials Therapeutics Australia Pty, Ltd., subsidiary of Xennials Therapeutics, Inc., a clinical stage biotechnology company dedicated to the development of transformative therapies and platforms that improves outcomes for cancer patients, announced that it has received Human Research Ethics Committee approval from Bellberry Limited, the South Australian based firm providing national streamlined scientific and ethical review of human research projects across Australia. Ethics approval was granted for the company’s Phase 1/2 study of NTX-301, a DNMT1 inhibitor, in advanced stage cancers. The study is being conducted in partnership with PinotBio, Inc., Gyeonggi-do, South Korea.
“We are excited to initiate study XNTR-20-02 and believe that there is compelling scientific rationale for NTX-301 to be further explored as a single agent and in combination therapy with platinum-based and potentially temozolomide in patients with advanced solid tumors” said Xennials Therapeutics Inc., President and CEO., Dr. Majid Tabesh.
“The PinotBio and Xennials Therapeutics team have worked together to bring NTX-301, a DNMT1 inhibitor that has the potential to be best-in-class and satisfy the serious unmet needs of cancer treatment, into clinic in a very short time. We are excited to see the progress of the study XNTR-20-02 to bring NTX-301 closer to cancer patients” said PinotBio, Inc., CEO., Dr. Doo Young Jung.
The XNTR-20-02 study, which is expected to enroll patients with advanced solid tumors, is a multi-center, ascending dose safety and efficacy, Phase 1/2 study of NTX-301 as monotherapy, in combination with platinum-based therapies, and an optional cohort in combination with temozolomide. The primary objective of the trial is to evaluate the safety and tolerability of NTX-301; endpoints for efficacy, pharmacokinetics, and pharmacodynamic responses to NTX-301 therapy will also be evaluated. Please visit ClinicalTrials.gov listing link for more information about the study (Identifier: NCT04851834).
About NTX-301: Is an orally bioavailable inhibitor of human DNA methyltransferase 1 (DNMT1), with potential antineoplastic activity. Upon oral administration, DNMT1 inhibitor NTX-301 targets and binds to DNMT1, thereby inhibiting the activity of DNMT1. This may prevent DNA methylation, induce DNA hypomethylation, and activate tumor suppressor genes silenced by hypermethylation. This may inhibit tumor cell proliferation. DNMT1, a member of the DNA methyltransferase (DNMT) family, plays an important role in maintaining the DNA methylation pattern. Dysregulation of DNMT1 has been associated with a number of cancers.
About Xennials Therapeutics, Inc.
Xennials Therapeutics, Inc. is a privately-held, clinical-stage company, commencing operation in 2018 to develop novel drugs and delivery technologies to improve outcomes for patients in global markets. The company’s focus is to address unmet needs in treatment paradigms by developing novel cancer and immune therapies and significantly increasing precise delivery of multiple therapeutics to the target, potentially increasing efficacy and patient compliance, whilst aiming to reduce side effects and costs by introducing novel assets and proprietary platform technologies. Study XNTR-20-02 is being locally sponsored in Australia by Xennials’ subsidiary, Xennials Therapeutics Australia Pty Ltd.
About PinotBio, Inc.
PinotBio, Inc. (“PinotBio”) is a South Korea based, clinical stage biotech company focusing on the development of innovative new drugs for the treatment of refractory/resistant cancers. PinotBio was founded in 2017 and is developing 2 phase 1 stage candidates (NTX-301, oral targeted anticancer agents for both hematological and solid malignancies, and NTX-101, topical glaucoma treatment) along with a
preclinical ADC platform. The company’s focus is to provide new treatment candidate to address cancer resistance problems by combining the principle of well-designed multi-target inhibition and cancer selective drug delivery. PinotBio’s leading pipeline NTX-301 is an orally available Best-in-class DNMT1 inhibitor primarily targeting cancers with high unmet needs (Pt resistant solid tumors, Adult recurrent hematological malignancies, including elderly AML and T-cell ALL). Since 2020, PinotBio is working together with Xennials Therapeutics to develop NTX-301.