Sydney, Australia, CHICAGO, Ill USA and GYEONGGI-DO, South Korea. 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. Bellberry Ltd is a South Australian-based firm providing national streamlined scientific and ethical review of human research projects across Australia.
Ethics approval was granted to expand the dosing options in the company’s Phase 1/2 study of NTX-301, a DNMT1 inhibitor and allowing treatment to commence in combination with platinum-based chemotherapy for patients with platinum resistant or refractory advanced ovarian cancer, bladder cancer and other solid tumours, (including neuroendocrine small cell lung cancer (SCLC), neuroendocrine prostate cancer (NEPCa), treatment induced NEPCa and others). This follows from the initial Ethics approval for Phase 1a granted in 2021. The study is being conducted in partnership with PinotBio, Inc., Gyeonggi-do, South Korea.
“We are excited to move forward to the next stage of the XNTR-20-02 study and believe that there is compelling scientific data to support the rationale for NTX-301 to be further explored in combination with platinum-based therapies in advanced solid tumors, and potentially Temozolomide (TMZ) in patients with high-grade Glioma” 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 in the treatment of cancer patients, into clinics in a very short time. We are excited to see the continuing progress of this important study, XNTR-20-02, to bring NTX-301 closer to an expanded population of cancer patients,” said PinotBio, Inc., CEO, Dr. Doo Young Jung.
The XNTR-20-02 study is a multi-center, multiple ascending dose, safety and efficacy study exploring NTX-301 as monotherapy, and in combination with platinum-based Chemotherapy for patients with platinum-resistant or refractory advanced ovarian cancer, bladder cancer, and other solid tumours. In addition, there is an optional cohort, which is yet to be activated and open to recruitment, offering NTX-301 in combination with Temozolomide (TMZ), Standard of Care, as adjuvant (maintenance) treatment to Patients with Isocitrate Dehydrogenase 1 (IDH1) mutated or Wild-Type high-grade Glioma. The primary objective of the trial is to evaluate the safety and tolerability of NTX-301. Other study objectives include efficacy, pharmacokinetics, and pharmacodynamic responses to NTX-301 therapy. Please visit clinicaltrials.gov 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.