Sydney, Australia, CHICAGO, Ill USA and Gyeonggi-do, South Korea. September 02, 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 improve outcomes for cancer patients, announced that it enrolled the first patient to 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 have the first patient enrolled in our study XNTR-20-02. We hope that further exploration of NTX-301 as a single agent and later in combination therapy with platinum-based therapies and potentially temozolomide in patients with advanced solid tumors will demonstrate NTX-301 as a potentially beneficial therapy for patients suffering from these deadly cancers” said Xennials Therapeutics Inc., President and CEO., Dr. Majid Tabesh.
“The PinotBio and Xennials Therapeutics teams 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 patients, into the clinic. We are excited to see the continuous progress of the XNTR-20-02 study and bringing NTX-301 closer to cancer patients as a treatment option” 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: NTX-301 is an orally bioavailable inhibitor of human DNA methyltransferase 1 (DNMT1), with potential antineoplastic activity. Upon oral administration, 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 Korean 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 two 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 candidates 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 DNMT1 inhibitor primarily targeting cancers with high unmet needs (platinum resistant solid tumors, adult recurrent hematological malignancies, including elderly AML and T-cell ALL). Since 2020, PinotBio has been working together with Xennials Therapeutics to develop NTX-301.