SY-005 / Yabao Pharma, Lawson Health Research Institute - LARVOL DELTA

Pharmacokinetics of recombinant human annexin A5 (SY-005) in patients with severe COVID-19. (PubMed, Front Pharmacol) - P2 | "There was no significant plasma SY-005 accumulation 6 h after drug administration and coagulation was not altered during 7 days of treatment. Clinical trials Registration: This study was registered with ClinicalTrials.gov (NCT04748757, first posted on 10 February 2021)."

Clinical • Journal • PK/PD data • Infectious Disease • Inflammation • Novel Coronavirus Disease • Septic Shock • ANXA5

Annexin A5 in Patients With Severe COVID-19 Disease: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Feasibility Trial. (PubMed, Crit Care Explor) - "Although enrollment was low, administration of SY-005 to critically ill patients with COVID-19 every 12 hours for up to 7 days was feasible and safe. Further clinical trials of annexin A5 for the treatment of COVID-19 are warranted. Given reduction of severe COVID-19 disease, future studies should explore the safety and effectiveness of SY-005 use in non-COVID-related sepsis."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Septic Shock • ANXA5

AX-COVID: Annexin A5 in Patients With Severe COVID-19 Disease (clinicaltrials.gov) - P2 | N=18 | Completed | Sponsor: Lawson Health Research Institute | Recruiting ➔ Completed | N=60 ➔ 18

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Septic Shock • ANXA5

SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis (clinicaltrials.gov) - P2a | N=96 | Recruiting | Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2021 ➔ Jan 2022

Enrollment open • Trial initiation date • Infectious Disease • Septic Shock • CCL2 • IL1B • IL6

Therapeutic Potential of Annexins in Sepsis and COVID-19. (PubMed, Front Pharmacol) - "The effects of annexin A5 on inflammation and platelet activation may be particularly beneficial in disease caused by SARS-CoV-2 infection. Safety and efficacy of recombinant human annexin A5 are currently being studied in clinical trials in sepsis and severe COVID-19 patients."

Journal • Review • Cardiovascular • Immunology • Infectious Disease • Inflammation • Myocardial Infarction • Novel Coronavirus Disease • Reperfusion Injury • Respiratory Diseases • Septic Shock

SY-005 in Patients With Sepsis (clinicaltrials.gov) - P2a; N=96; Not yet recruiting; Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.

Clinical • New P2a trial • Infectious Disease • Septic Shock • CCL2 • IL1B • IL6

Single-dose/Multiple-doses Incremental Intravenous Injection of SY-005 in Healthy Subjects (clinicaltrials.gov) - P1; N=96; Completed; Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.; Recruiting ➔ Completed; Trial completion date: Dec 2020 ➔ Aug 2020

Clinical • Trial completion • Trial completion date • Infectious Disease • Septic Shock

AX-COVID: Annexin A5 in Patients With Severe COVID-19 Disease (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Lawson Health Research Institute; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Septic Shock

AX-COVID: Annexin A5 in Patients With Severe COVID-19 Disease (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Lawson Health Research Institute

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Septic Shock

Characterization of two sugar transporters responsible for efficient xylose uptake in an oleaginous yeast Candida tropicalis SY005. (PubMed, Arch Biochem Biophys) - "Growth curve and sugar consumption profiles revealed uptake of both glucose and xylose simultaneously by the recombinant yeast strains, though CtStp1 showed relatively less effect of glucose repression in mixed sugars and was a better transporter of xylose than CtStp2. Such glucose-xylose utilizing efficient transporters can be effective tools for developing co-fermenting yeasts through genetic engineering in future, with noteworthy applications in renewable biomass utilization."

Journal

Engineering an oleaginous yeast Candida tropicalis SY005 for enhanced lipid production. (PubMed, Appl Microbiol Biotechnol) - "The findings of this study will augment the research on lipid metabolic engineering and exploit the enormous potential of C. tropicalis as an industrial lipid feedstock. Key points •A transformation system was established in oleaginous yeast Candida tropicalis SY005 •Activity of host-specific molecular elements was verified by reporter gene expression •SY005 was engineered to ectopically express a transcriptional regulator gene CtRAP1 •The engineered strain exhibited 60% increase in lipid content on galactose induction •The increase in lipid content was correlated with the induced expression of CtRAP1."

Journal • Gene Therapies • Metabolic Disorders

Identification and functional characterization of a lipid droplet protein CtLDP1 from an oleaginous yeast Candida tropicalis SY005. (PubMed, Biochim Biophys Acta Mol Cell Biol Lipids) - "Moreover, CtLDP1 expression in pet10 knock out strain of S. cerevisiae restored multiple LD formation, indicating functional complementation of the protein. Overall, this study documents functional characterization of an LD-stabilizing protein from an oleaginous strain of Candida genus for the first time, and provides insights on the characteristics of LD proteins in oleaginous yeasts for future metabolic engineering."

Journal • PLIN2

Efficient xylose utilization leads to highest lipid productivity in Candida tropicalis SY005 among six yeast strains grown in mixed sugar medium. (PubMed, Appl Microbiol Biotechnol) - "Expression levels of both Ctxyl1 and Ctxyl2, involved in xylose catabolism, were maximum during 24-48 h of growth, indicating that xylose utilization started in the presence of glucose, which was depleted in the medium after 96 h. Together, the present study documents that C. tropicalis SY005 consumes xylose concomitant to glucose during early period of growth, and it is a promising yeast strain for viable production of storage lipid or other high-value oleochemicals utilizing lignocellulose hydrolysate."

Journal

Single-dose/Multiple-doses Incremental Intravenous Injection of SY-005 in Healthy Subjects (clinicaltrials.gov) - P1; N=94; Recruiting; Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.

Clinical • New P1 trial