SA55 / Sinovac - LARVOL DELTA

Safety, tolerability, and pharmacokinetics of anti-SARS-CoV-2 monoclonal antibody SA55 injection in healthy participants. (PubMed, Antimicrob Agents Chemother) - P1 | "The neutralizing activity peaked at 3-4 days post-administration, with the 600 mg dose exhibiting comparable activity to the 900 mg dose and superior activity to lower doses, suggesting it as a potential target dose. In conclusion, SA55 injection demonstrated excellent safety, tolerability, and neutralizing activity against SARS-CoV-2 in healthy populations, with the 600 mg dose emerging as a promising candidate for further development.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT06050460."

Journal • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy and Safety of the Anti-COVID-19 Antibody SA55 for Injection in Patients With Hematological Disorders Who Are Persistently Positive for COVID-19 (clinicaltrials.gov) - P=N/A | N=31 | Completed | Sponsor: Beijing Boren Hospital | Recruiting ➔ Completed | N=160 ➔ 31

Enrollment change • Trial completion • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease

Entry Efficiency, Protease Dependence, and Antibody-Mediated Neutralization of SARS-CoV-2 Sublineages KP.3.1.1 and XEC. (PubMed, Vaccines (Basel)) - "Our findings demonstrate that JN.1, KP.3.1.1, and XEC, like their predecessor BA.2.86, rely on TMPRSS2 for lung cell entry and remain sensitive to certain neutralizing monoclonal antibodies. However, these variants differ in their ability to utilize ACE2 species orthologs for cell entry."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Quantitative Characterization and Prediction of the Binding Determinants and Immune Escape Hotspots for Groups of Broadly Neutralizing Antibodies Against Omicron Variants: Atomistic Modeling of the SARS-CoV-2 Spike Complexes with Antibodies. (PubMed, Biomolecules) - "In this study, we performed molecular dynamics simulations, an ensemble-based deep mutational scanning of SARS-CoV-2 spike residues, and binding free energy computations for two distinct groups of broadly neutralizing antibodies: the E1 group (BD55-3152, BD55-3546, and BD5-5840) and the F3 group (BD55-3372, BD55-4637, and BD55-5514)...The results of this study and the energetic analysis demonstrate excellent qualitative agreement between the predicted binding hotspots and critical mutations with respect to the latest experiments on average antibody escape scores. We argue that the E1 and F3 groups of antibodies targeting binding epitopes may leverage strong hydrophobic interactions with the binding epitope hotspots that are critical for the spike stability and ACE2 binding, while escape mutations tend to emerge in sites associated with synergistically strong hydrophobic and electrostatic interactions."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

AlphaFold2 Modeling and Molecular Dynamics Simulations of the Conformational Ensembles for the SARS-CoV-2 Spike Omicron JN.1, KP.2 and KP.3 Variants: Mutational Profiling of Binding Energetics Reveals Epistatic Drivers of the ACE2 Affinity and Escape Hotspots of Antibody Resistance. (PubMed, Viruses) - "Structural and energetic analysis provided a rationale to the experimental results showing that BD55-5840 and BD55-5514 antibodies that bind to different binding epitopes can retain neutralizing efficacy against all examined variants BA.2.86, JN.1, KP.2 and KP.3. The results support the notion that evolution of Omicron variants may favor emergence of lineages with beneficial combinations of mutations involving mediators of epistatic couplings that control balance of high ACE2 affinity and immune evasion."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Atomistic Prediction of Structures, Conformational Ensembles and Binding Energetics for the SARS-CoV-2 Spike JN.1, KP.2 and KP.3 Variants Using AlphaFold2 and Molecular Dynamics Simulations: Mutational Profiling and Binding Free Energy Analysis Reveal Epistatic Hotspots of the ACE2 Affinity and Immune Escape. (PubMed, bioRxiv) - "Structural and energetic analysis provided a rationale to the experimental results showing that BD55-5840 and BD55-5514 antibodies that bind to different binding epitopes can retain neutralizing efficacy against all examined variants BA.2.86, JN.1, KP.2 and KP.3. The results support the notion that evolution of Omicron variants may favor emergence of lineages with beneficial combinations of mutations involving mediators of epistatic couplings that control balance of high ACE2 affinity and immune evasion."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SA55 Injection Phase II Study in the Treatment of Mild/Moderate COVID-19 Patients (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Sinovac Life Sciences Co., Ltd. | Trial primary completion date: Oct 2023 ➔ Mar 2024

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

SA55 Injection: a Potential Therapy for the Prevention and Treatment of COVID-19 (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Sinovac Life Sciences Co., Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease

SA55 Injection Phase II Study in the Treatment of Mild/Moderate COVID-19 Patients (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Sinovac Life Sciences Co., Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease

Efficacy and Safety of the Anti-COVID-19 Antibody SA55 for Injection in Patients With Hematological Disorders Who Are Persistently Positive for COVID-19 (clinicaltrials.gov) - P=N/A | N=160 | Recruiting | Sponsor: Beijing Boren Hospital | N=72 ➔ 160

Enrollment change • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease