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: ABM Therapeutics and Arthrosi Therapeutics have made smooth R&D progress, and AceLink Therapeutics has opened its first clinical trial center in China. Keep reading for more details.
ABM Therapeutics Receives IND Approval in China for MEK Inhibitor ABM-168, and Its ABM-1310 Granted FDA Orphan Drug Designation
San Diego, USA / Shanghai, China, Aug. 25th, 2023 - ABM Therapeutics, invested and incubated by Viva BioInnovator (VBI), announced today that its IND application for ABM-168, a self-developed MEK1/2 inhibitor has been approved by the National Medical Products Administration (NMPA) to conduct Phase 1 clinical trials in patients with advanced solid tumors, especially patients with brain metastases or primary brain tumors, aiming to explore the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ABM-168. ABM-168 has been granted its IND by the U.S. FDA in October 2022. A first in human Phase 1 clinical trial (NCT05831995) has been opened in several cancer centers in the United States.
In addition, on Aug. 2nd, ABM also announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABM-1310, a novel small molecule BRAF inhibitor developed by the company, for the treatment of patients with glioblastoma (GBM) bearing BRAF V600 mutation.
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.
