Stem Cell Clinic

Approval of Phase I/II Clinical Trial of ATG-016 (Eltanexor), a Second Generation Selective Inhibitor of Nuclear Export (SINE), in Mainland China for…

SHANGHAI and HONG KONG, Nov. 25, 2020 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", HKSE stock code: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-inclass therapeutics in hematology and oncology, announced that the National Medical Products Administration (NMPA) has approved the clinical trial of ATG-016 (eltanexor) in patients with intermediate and higher risk myelodysplastic syndrome (MDS) according to the Revised International Prognostic Scoring System (IPSS-R) after the failure of hypomethylating agents (HMA) based therapy. The trial is a Phase I/II, single-arm, open-label clinical study, aiming to evaluate the pharmacokinetics, safety and efficacy of ATG-016 (eltanexor) monotherapy.

MDS is a heterogeneous group of clonal disorders of the bone marrow hematopoietic stem cells (HPSCs), characterized by ineffective hematopoiesis with peripheral blood cytopenia and a higher risk for developing acute myeloid leukemia (AML). Patients with high-risk MDS refractory to hypomethylating agents have a median overall survival (OS) of only 4 to 6 months with limited options for follow-up treatment. Pre-clinical studies have demonstrated that selective inhibitor of nuclear export (SINE) compounds are able to block the nuclear export of many tumor suppressor proteins (e.g. p53, IkB, p21) leading to their accumulation and activation in the nucleus thereby exerting anti-tumor effects. In addition, SINE compounds can also reduce the nuclear export and translation of many oncogenic mRNA (c-Myc, Bcl-2, Bcl-6, cyclin D) which are bound to elF4E and result in selective apoptosis of tumor cells. ATG-016 is a member of the latest-generation of SINE compounds. Compared to the first-generation nuclear export inhibitor, ATG-016 demonstrates minimal blood-brain barrier permeability and a broader therapeutic window. It has shown preliminary anti-cancer activity in high-risk MDS patients.

Dr. Jay Mei, the Founder, Chairman and CEO of Antengene expressed, "The approval of the ATG-016 clinical trial demonstrates the efficient execution of the Antengene R&D team and is also the first clinical trial approval obtained by Antengene in mainland China after its listing." He also mentioned, "Selinexor, the first-generation selective inhibitor of nuclear export, has shown extensive activity against hematological malignancies and solid tumors, and has been approved by the FDA for relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma. As a second-generation orally available SINE compound, ATG-016 can reduce the blood-brain barrier penetration, thereby representing a broader therapeutic window with potentially less adverse events and better drug tolerability."

About ATG-016

ATG-016 (eltanexor) is a second-generation selective inhibitor of nuclear export compound. Compared to the first-generation SINE compound, ATG-016 has lower blood-brain barrier penetration and broader therapeutic window which allows more frequent dosing and a longer period of exposure at higher levels with better tolerability. Therefore, ATG-016 may be used to target a wider range of indications. We plan to conduct phase I/II clinical studies for MDS in China, and plan to further develop ATG-016 for cancers with high prevalence in the Asia-Pacific region (such as KRAS-mutant solid tumors) and virus infection related malignancies (such as nasopharyngeal carcinoma).

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage Asia-Pacific biopharmaceutical company focused on innovative oncology medicines. Antengene aims to provide the most advanced anti-cancer drugs to patients in China, the Asia Pacific Region and around the world. Since its establishment, Antengene has built a pipeline of 12 clinical and pre-clinical stage assets, obtained 10 investigational new drug (IND) approvals and has 9 ongoing cross-regional clinical trials in Asia Pacific. At Antengene, we focus on developing drug candidates with novel mechanisms of action (MoAs) and first-in-class/best-in-class potential to address significant unmet medical needs. The vision of Antengene is to "Treat Patients Beyond Borders" through research, development and commercialization of first-in-class/best-in-class therapeutics.

Forward-looking statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

SOURCE Antengene Corporation Limited

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Approval of Phase I/II Clinical Trial of ATG-016 (Eltanexor), a Second Generation Selective Inhibitor of Nuclear Export (SINE), in Mainland China for...

Researchers grow first plant-based gel to help organoid development for biomedical applications – Microbioz India

Monash University researchers have created the worlds first bioactive plant-based nanocellulose hydrogel to support organoid growth and help significantly reduce the costs of studies into cancer and COVID-19.

This discovery by researchers at BioPRIA (Bioresource Processing Institute of Australia), Monash Universitys Department of Chemical Engineering and the Monash Biomedicine Discovery Institute will develop organoids cheaper, faster and more ethically.

The hydrogel can also improve drug screening and disease modelling for infectious diseases, like COVID-19; metabolic diseases, such as obesity and diabetes; and cancer.

The findings, published inAdvanced Science, emerge as a promising finding for growth of organoids for essential laboratory testing across the world. With additional testing, this hydrogel could be available to researchers and health professionals across the world in less than 12 months.

Nanocellulose gels cost just cents for every 10ml used, compared to $600 or more for the current gold standard.

Above all, nanocellulose gels are completely plant-based, preventing the harvesting of animal organs and unknown biomolecules for any advanced medical testing.

Professor Gil Garnier and Dr Rodrigo Curvello from BioPRIA within Monash Universitys Department of Chemical Engineering led the study.

Organoids provide a robust model for key applications in biomedicine, including drug screening and disease modelling. But current approaches remain expensive, biochemically variable and undefined.

Gil Garnier, Director of BioPRIA, Monash University

These are major obstacles for fundamental research studies and the translation of organoids to clinics. Alternative matrices able to sustain organoid systems are required to reduce costs drastically and to eliminate the unreliability of unknown biomolecules.

As nanocellulose hydrogel is animal-free, its composition is controlled perfectly and reproducible unlike the current progress and fully mimic the human body conditions.

Organoids are three-dimensional, miniaturised and simplified versions of organs produced in vitro that can replicate behaviours and functionalities of developed organs.

Commonly referred to as organs in a dish or mini-organs, organoids are an excellent tool to study basic biological processes. Through organoids, we can understand how cells interact in an organ, how diseases affect them and the effects of drugs in disease reduction.

Organoids are generated from embryonic, adult, pluripotent orinduced pluripotent stem cells, as well as from primary healthy or cancerous tissues.

For long-term use, organoids are commonly embedded within an Engelbreth-Holm Swarm (EHS) matrix derived from the reconstituted basement membrane of mouse sarcoma.

Currently, organoid culture is dependent of this expensive and undefined tumour-derived material that hinders its application in high-throughput screening, regenerative medicine and diagnostics.

Our study was essentially able to use an engineered plant-based nanocellulose hydrogel that can replicate the growth of small intestinal organoids derived from mice, Dr Curvello said.

It is essentially made from 99.9% water and only 0.1% solids, functionalised with a single cell adhesive peptide. Cellulose nanofibers are linked with salts that provide the microenvironment needed for small intestinal organoid growth and proliferation.

Engineered nanocellulose gel represents a sustainable alternative for the growth of organoids, contributing to reducing the costs of studies on diseases of global concern, particularly in developing countries.

Source:

Journal reference:

Curvello, R.,et al.(2020) Engineered PlantBased Nanocellulose Hydrogel for Small Intestinal Organoid Growth.Advanced Science.doi.org/10.1002/advs.202002135.

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Researchers grow first plant-based gel to help organoid development for biomedical applications - Microbioz India