Recent Developments of Five Viva BioInnovator-Backed Portfolio Companies: Pipeline Progress, Partnerships, and Regulatory Milestones

ShanghaiSeptember 26, 2023PR Newswire -- In the face of an ever-changing landscape, technological innovation remains the eternal main theme for the long-term development of biopharmaceutical companies, continuously injecting vitality into enterprises and driving the "from 0 to 1" transformation in research and development as well as commercialization success. Recently, there have been new developments from Viya Bio's investment-incubated companies: AcuraStem reached a significant licensing agreement, BrainVTA and Arthrosi reported smooth R&D progress, AceLink opened a clinical trial center in China, and Qiyue Bio received prestigious honors.

AcuraStemEntered into a licensing agreement with Takeda to advance PIKFYVETherapeutic Drugs

Monrovia, California, September 25, 2023 — AcuraStem, a biotechnology company invested by Viva Biotech that is patient-focused and dedicated to developing treatments for neurodegenerative diseases, announced that it has entered into a licensing agreement with Takeda to develop and commercialize AcuraStem's PIKFYVE-targeted therapies, including AS-202, an innovative antisense oligonucleotide (ASO) for the treatment of amyotrophic lateral sclerosis (ALS). Under the terms of the agreement, Takeda will receive an exclusive global license for AcuraStem’s PIKFYVE program. If all future clinical, regulatory, and commercial milestones are achieved within the term of the agreement, AcuraStem could receive upfront and milestone payments totaling up to approximately $580 million, as well as tiered royalties on potential net sales of any commercial products arising from this license.

Bicheng Pharmaceutical ABM-1310Following the Orphan Drug Designation, it was also granted by the FDAGranting Fast Track Designation in China for Primary Malignant Brain Tumors IThe first patient in the Phase clinical trial successfully received medication, and its MEKInhibitor ABM-168 INDApproved by the China National Medical Products Administration

United States, San Diego / China, Shanghai — September 26, 2023 — BCBioMed, invested in and incubated by Viva Biotech, announced today that following the "Orphan Drug" designation granted to its self-developed ABM-1310 for the treatment of malignant gliomas, including GBM, in July this year, the U.S. Food and Drug Administration (FDA) has also granted ABM-1310 Fast Track designation for the treatment of BRAF V600E-mutant glioblastoma (GBM). Recently, in a Phase I clinical study targeting patients with recurrent and drug-resistant primary malignant brain tumors, the first patient was successfully enrolled and dosed at Beijing Tiantan Hospital, Capital Medical University.。Moreover, on August 25, Bicheng Pharmaceutical announced that its self-developed brain-penetrant MEK1/2 inhibitor ABM-168 has been approved by the National Medical Products Administration (NMPA) of China. The company is permitted to recruit patients with advanced solid tumors, particularly those with brain metastases or primary brain tumors, to explore the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ABM-168 in such patients.

QureBiotech Bispecific Antibody Q-1802Project Selected for Shanghai 2023Annual Innovation Fund Plan for Technology-Based Small and Medium Enterprises

On September 5, 2023, the Shanghai Science and Technology Commission officially announced the list of proposed projects for the 2023 Shanghai Science and Technology Innovation Fund Plan for Small and Medium-sized Enterprises. The project "Bispecific Antibody Q-1802 Combined with Standard Chemotherapy for the Treatment of Gastric Cancer and Other Gastrointestinal Malignancies," developed by Qiyue Biotherapeutics, a company invested in and incubated by Viva Biotech, has been selected for this innovation fund plan. The bispecific antibody Q-1802 project, which was independently developed by Qiyue Biotherapeutics, is a First-In-Class CLDN18.2 bispecific antibody and the first in its series targeting CLDN18.2 and PD-L1 to enter clinical trials. Currently, Q-1802 has gradually demonstrated excellent safety and efficacy in clinical trials and has obtained positive Phase I clinical data, showing an outstanding risk-benefit profile compared to similar targeted therapies.

Arthrosi TherapeuticsGout Drug AR882Prepare to Enter Global Phase IIIPhase Research

August 18, 2023, San Diego — Arthrosi Therapeutics, Inc., a clinical-stage biotechnology company incubated and invested in by Viva Biotech, announced that it has received written feedback from the U.S. Food and Drug Administration (FDA) regarding the End-of-Phase 2 meeting package for its lead drug candidate AR882 for the treatment of gout. AR882 is a highly effective, selective, once-daily oral next-generation URAT1 inhibitor. The FDA's feedback supports Arthrosi in advancing its planned Phase III clinical program.

AceLinkThe First Fabry Disease (Fabry Disease) in China）2Phase Clinical Research Center

NEWARK, California – August 10, 2023 – AceLink Therapeutics, a clinical-stage biopharmaceutical company incubated and invested in by Viva Biotech, announced the opening of its first clinical trial site in China for a Phase 2 open-label study. The study focuses on treatment-naïve male patients with the classical phenotype of Fabry disease and aims to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary physiological effects of AL01211. AceLink is developing next-generation oral substrate reduction therapies (SRT) to address significant unmet medical needs and improve the quality of life for patients with inherited glycolipid metabolism disorders.

About AcuraStem

AcuraStem is a patient-based biotechnology company dedicated to developing treatments for neurodegenerative diseases, including sporadic amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). AcuraStem's top-tier disease modeling platform, iNeuroRx®, enables the discovery of innovative, effective, and broad-spectrum treatments. The team's strong expertise in antisense oligonucleotide (ASO) technology helps accelerate the clinical application of treatments. AcuraStem's research has been supported by investments from Viva Biotech, as well as funding from the Alzheimer’s Drug Discovery Foundation, Harrington Discovery Institute, Alzheimer’s Association, Rainwater Charitable Foundation, Department of Defense, and the National Institute of Neurological Disorders and Stroke.

About ABM Therapeutics

ABM Therapeutics is a clinical-stage new drug research and development company. The company focuses on the development of small molecule drugs capable of crossing the blood-brain barrier. Its pipeline includes small molecule targeted inhibitors that can cross the blood-brain barrier, significantly improving drug delivery to the brain and offering potential solutions for brain metastases in tumors. Since its establishment, ABM has experienced steady growth and has set up operational centers in both the United States and China. Through independent research and development, the company has built a robust pipeline of brain-penetrating drugs and has become a distinctive platform for the development of anticancer drugs and brain-penetrating small molecule drugs, known as the Blood-Brain Penetrant Kinase Drug Discovery Platform (BPKddTM).

About Qiyue Bio

Qiyue Bio is an international company focused on the research and development of innovative large-molecule biopharmaceuticals, dedicated to addressing unmet clinical needs in refractory cancers and autoimmune diseases. Founded by senior scientists in the relevant fields, the company has developed proprietary technologies for large-molecule biologic development, including innovative platforms for bispecific and trispecific antibodies.

About Arthrosi

Arthrosi Therapeutics, Inc. was founded in 2018 and is headquartered in San Diego, California. Its goal is to develop potential treatments for gout patients to regulate uric acid levels and minimize joint damage. Arthrosi's research and development has yielded complete data from Phase 2b clinical trials. For more information about Arthrosi, please visit www.arthrosi.com.

About AceLink Therapeutics，Inc.

AceLink Therapeutics, founded in 2018, is an innovative biopharmaceutical startup focused on developing safe and effective drugs to address the significant unmet clinical needs of genetic diseases. The company’s initial focus is on developing novel treatments for Fabry disease.