Latest Updates of Viva's Portfolio Companies

HONG KONG, Sept. 26, 2023 /PRNewswire/ -- Even with the ever-changing situation, technological innovation is still the most critical component for biopharmaceutical companies' long-term development. This continuous innovation keeps companies up to date and promotes the evolution of R&D and the success of commercialization. Recently, Viva's portfolio companies have new updates. Keep reading for more details.

AcuraStem Enters into a License Agreement with Takeda to Advance PIKFYVE Therapeutics

MONROVIA, Calif., Sept. 25, 2023 - AcuraStem, invested and incubated by Viva BioInnovator (VBI), is a patient-based biotechnology company pioneering how treatments are developed for neurodegenerative diseases. Recently they announced that it has entered into a license agreement with Takeda to develop and commercialize AcuraStem's PIKFYVE targeted therapeutics 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, worldwide license to AcuraStem's PIKFYVE program. AcuraStem will receive an upfront and milestone payments totaling up to approximately $580 million if all future clinical, regulatory, and commercial milestones are achieved during the term of the agreement plus tiered royalties on potential net sales of any commercial products resulting from this license.

ABM-1310 Receives FDA Fast Track Designation Following Orphan Drug Status, First Patient Dosed in China Phase I Trial for Primary Malignant Brain Tumors, and Its MEK inhibitor-ABM-168 IND Approved by NMPA

San Diego, USA/Shanghai, China - September 26, 2023 - ABM Therapeutics, invested and incubated by Viva BioInnovator (VBI), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABM-1310 for the treatment of glioblastoma multiforme (GBM) harboring a BRAF V600E mutation. This follows the previously announced Orphan Drug designation for ABM-1310 for the treatment of malignant glioma, including GBM, granted in July 2022. In addition, the first patient has been successfully dosed in its multicenter Phase I study of ABM-1310 in patients with relapsed and drug resistant primary malignant brain tumors in Beijing Tiantan Hospital, Capital Medical University. Furthermore, on August 25^th, ABM Therapeutics announced that an investigational new drug (IND) application for ABM-168, an orally bioavailable, brain-penetrant MEK 1/2 inhibitor, was approved by the China National Medical Products Administration (NMPA). This allows ABM Therapeutics to initiate a Phase 1 trial recruiting patients with advanced solid tumors, particularly those with brain metastases or primary brain tumors, to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity of ABM-168.

QureBio's Bispecific Antibody Q-1802 Project Selected for Shanghai 2023 Sci-Tech SME Innovation Fund

On September 5, 2023, the Science and Technology Commission of Shanghai Municipality officially announced the list of proposed projects for the Shanghai 2023 Sci-Tech SME Innovation Fund. QureBio, invested and incubated by Viva BioInnovator (VBI), had its bispecific antibody Q-1802 project selected for the proposed project list of this fund. QureBio independently developed the selected bispecific antibody Q-1802 project and is the first product in the CLDN18.2 bispecific and PD-L1 bispecific series to enter clinical stage as a First-in-Class CLDN18.2 bispecific antibody. At present, Q-1802 has gradually verified excellent safety and efficacy in clinical trials and has already obtained positive Phase I clinical data with an outstanding risk-benefit ratio among products targeting similar biomarkers.

Arthrosi Therapeutics AR882 Prepares to Enter into Global Phase 3 Study

San Diego, USA, Aug. 18th, 2023 - Arthrosi Therapeutics, Inc., invested and incubated by Viva BioInnovator (VBI), is a clinical-stage biotechnology company. Recently they have announced they have received written response from the U.S. Food and Drug Administration (FDA) related to their End-of-Phase 2 briefing package for AR882, its lead drug candidate for gout treatment. AR882 is a highly potent, selective, and once daily dosing next-gen URAT1 inhibitor. The feedback from the FDA supports Arthrosi progressing with its planned Phase 3 clinical program.

AceLink Opens First Clinical Site in China for Phase 2 Study in Fabry Disease

NEWARK, Calif., Aug. 10th, 2023 - AceLink Therapeutics, Inc., invested and incubated by Viva BioInnovator (VBI), is a clinical stage biopharmaceutical company. Recently they announced the opening of the first clinical trial site in China for its Phase 2, open‐label study of the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary measures of physiological efficacy of AL01211 in males with classic Fabry disease who have not been previously treated with other Fabry disease therapies. AceLink is developing the next generation oral substrate reduction therapies (SRTs) to address significant unmet medical needs and improve the quality of life of patients with inherited disorders of glycosphingolipid metabolism.

About AcuraStem
AcuraStem is a patient-based biotechnology company pioneering treatments for neurodegenerative diseases including sporadic ALS and FTD. AcuraStem's best-in-class disease modeling platform, iNeuroRx®, enables the discovery of innovative, effective, and broadly acting treatments. The team's strong expertise in ASO technology provides for the rapid advancement of treatments to the clinic. AcuraStem's research is funded in part by support 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
A clinical-stage biopharmaceutical company with a mission to focus on small molecule research and development of novel drugs for the treatment of cancer, with an emphasis on blood–brain barrier (BBB) penetration and brain metastases. ABM's pipeline includes several programs in various stages of discovery and development, most of which have improved brain permeability to address the unmet needs of treating cancers and metastases in the brain.

About QureBio Ltd.
QureBio Ltd. is a clinical-stage biopharmaceutical company focusing on innovative biopharmaceuticals for urgent and unmet clinical needs, such as the treatment of refractory cancers, inflammation and other serious disorders. Founded by experienced scientists from the relevant fields, QureBio Ltd. has built up a series of proprietary technologies for engineered bio-macromolecules, including innovative platforms for bi-specific and tri-specific antibodies.

About Arthrosi
Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, was established in 2018. The company's goal is to develop potential treatments aimed at uric acid levels and minimizing joint damage for gout patients. Arthrosi's research and development have produced end of phase 2b data.

For more information about Arthrosi, please visit www.arthrosi.com.

About AceLink Therapeutics, Inc.
Founded in 2018, AceLink Therapeutics is an innovative biopharma startup focusing on developing safe and effective medicines to address genetic diseases with high unmet needs. The company's initial focus is to develop novel therapeutics for Fabry disease. For more information, please visit www.acelinktherapeutics.com.

SOURCE Viva Biotech Holdings