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, 5 of Viva's portfolio companies have achieved significant results and progress. Keep reading for more details.

AceLink Therapeutics Receives FDA Clearance to Initiate a Phase 2 Study of AL1211 in Patients with Fabry Disease

NEWARK, Calif.--AceLink Therapeutics, Inc., invested and incubated by Viva BioInnovator (VBI), is a clinical-stage biopharmaceutical company developing the next generation of 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. Recently it announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial of its lead program, AL1211.

HAYA Therapeutics Adds Douglas L. Mann, M.D. as Chairperson of the Clinical Advisory Board

LAUSANNE, Switzerland & SAN DIEGO–HAYA Therapeutics, SA, invested and incubated by Viva BioInnovator (VBI), is a company developing RNA-guided programmable precision medicines focused on long non-coding RNAs. Recently they announced that Douglas L. Mann, M.D.  joined as Chairperson of the company’s Clinical Advisory Board.

DTx Pharma Receives FDA Orphan Drug Designation for DTx-1252 for the Treatment of Charcot-Marie-Tooth Disease Type 1A (CMT1A)

SAN DIEGO, June 7, 2023 -- DTx Pharma, invested and incubated by Viva BioInnovator (VBI), is a biotechnology company addressing the delivery challenges of oligonucleotide therapeutics with its Fatty Acid Ligand Conjugated OligoNucleotides (FALCON) platform. Recently they announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to DTx-1252, an investigational FALCON small interfering RNA (siRNA) therapeutic for the treatment of Charcot-Marie-Tooth Disease Type 1A (CMT1A). CMT1A is a progressive, neuromuscular, autosomal-dominant disease that leads to life-long loss of muscle function and disability.

VVN539, a Dual-target Innovative Drug for Glaucoma Independently Developed by VivaVision, Reached the Primary Research Endpoint in Phase II Clinical Trial in the United States

Recently, VivaVision Biotech-an innovative ophthalmic drug company, which is invested in and incubated by Viva BioInnovator (VBI), announced that its dual-target drug VVN539 has reached the primary study endpoint in the US phase II clinical trial for patients with open-angle glaucoma or ocular hypertension.

Compared with the vehicle group, the 0.04% VVN539 dose group achieved statistical significance and clinical significance at all time points, and the intraocular pressure reduction range was about 5-6 mmHg. The 0.02% VVN539 dose group also achieved statistically significant reductions in IOP compared to the vehicle group at most time points. No significant treatment-related adverse events were observed in the study.

Domain Therapeutics Announces Nomination of First-in-class PAR2 NAM Candidate, DT-9045, to Unlock New Cancer Treatment Possibilities

Strasbourg, France – Montreal, Canada, [June 5th, 2023] – Domain Therapeutics (“Domain” or “the Company”), invested and incubated by Viva BioInnovator (VBI), is a clinical-stage biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs). Today they announces the nomination of a drug candidate, a Negative Allosteric Modulator (NAM) of protease-activated receptor 2 (PAR2), DT-9045, with first-in-class potential for immuno-oncology, particularly for fibrotic tumors. 

Domain nominated DT-9045 as a first-in-class PAR2 NAM clinical candidate based on its added-value, unique properties, and greater therapeutic potential in comparison to biologics targeting PAR2 currently in the clinic by several competitors. DT-9045 has demonstrated proof-of-concept efficacy in syngeneic models potentiating the antitumor activity of an anti-PD1 treatment.

About AceLink Therapeutics, Inc.

Founded in 2018, AceLink Therapeutics is a clinical-stage pharmaceutical company developing the next generation of 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. The company is developing a pipeline of breakthrough therapeutics including a Phase II program for Fabry Disease and Type 1 Gaucher Disease. For more information, please visit www.acelinktherapeutics.com.

About HAYA Therapeutics

HAYA Therapeutics is a precision therapeutics company that discovers and develops innovative tissue- and cell-selective genomic medicines for fibrotic diseases and other serious health conditions associated with aging, including cancer. The company’s discovery engine focuses on long non-coding RNAs (lncRNAs) within the “dark matter” of the human genome -- key tissue and cell-specific drivers of fibrosis and other disease processes -- to identify novel targets and drug candidates with the potential for greater efficacy and safety than existing treatments.

About DTx Pharma

DTx Pharma, Inc. is a privately held biotechnology company, addressing the challenges associated with delivering RNA-based therapeutics beyond the liver with the company's proprietary Fatty Acid Ligand Conjugated OligoNucleotides (FALCON™) technology platform. The FALCON platform leverages fatty acids for enhanced biodistribution and cellular uptake to tissues and cell types throughout the body. In preclinical studies, FALCON siRNAs have demonstrated potent and durable repression of target genes in the peripheral nervous system (PNS), skeletal muscle, heart, skin, and central nervous system (CNS). FALCON siRNAs can be delivered by intravenous, subcutaneous, and intrathecal routes of administration and can be manufactured at low cost. The company has a pipeline focused on PNS, neuromuscular, and CNS diseases. DTx Pharma has raised more than $115M in combined investment from several of the world's leading healthcare investors including RA Capital Management and Access Biotechnology, and research foundations such as the CMT Research Foundation (CMTRF).

To learn more about DTx Pharma, please visit www.dtxpharma.com

About VivaVision Biotech

VivaVision is a clinical-stage pharmaceutical company focused on best-in-class and first-in-class therapies for ocular diseases. VivaVision's current pipeline includes VVN001 for treating dry eye syndrome, VVN539 for the treatment of Glaucoma or Ocular Hypertension, and VVN461 for the treatment of non-infectious ocular inflammation of Uveitis. VivaVision is also engaged in the discovery and development of novel therapies for the treatment of other anterior and posterior eye diseases. For more info, visit www.vivavisionbio.com.

About Domain Therapeutics

Domain Therapeutics, a biopharmaceutical company operating in France and Canada, is dedicated to the discovery and development of new drug candidates targeting G Protein-Coupled Receptors (GPCRs), one of the most important classes of drug targets. The company focuses on developing high-value drug candidates to tackle GPCR-mediated immunosuppression in immune-oncology and raised €39 million in early 2022. For more info, visit www.domaintherapeutics.com