bivalent recombinant trimeric S protein (SCTV01C) / Sinocelltech - LARVOL DELTA

Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants. (PubMed, Expert Rev Vaccines) - P1/2 | "SCTV01C, when administered as both a primary series and a booster vaccination, exhibited encouraging sustained immunogenicity against both antigen-matched and antigen-mismatched variants, with no significant safety concerns. www.clinicaltrials.gov identifier is NCT05148091."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Sinocell's revenue increased by 60% in the first half of the year, with a net profit of 126 million yuan [Google translation] (Sina Corp) - "Sinocell's R&D expenses in the first half of the year were 476 million yuan, a slight decrease from the same period last year. The R&D direction is more focused on accelerating the commercialization of existing products and the echelon R&D construction of high-quality and high-potential innovative drugs. During the reporting period, R&D investment was mainly used for mid- and late-stage clinical research of products such as SCT1000, SCT-I10A, and SCTV01, early clinical investment in newly approved clinical research products, and preclinical development of many products...in terms of products under development, SCT1000....has completed the third dose of Phase III clinical trials and is currently in the follow-up stage with smooth progress..."

Commercial • Trial status • Infectious Disease • Oncology • Solid Tumor

A Study of the Immunogenicity and Safety of SCTV01C in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Sinocelltech Ltd. | N=240 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Sinocelltech Ltd. | N=480 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The Safety, Tolerability and Immunogenicity of COVID-19 Vaccine (SCTV01C) in Healthy, Unvaccinated Adults (clinicaltrials.gov) - P1/2 | N=478 | Completed | Sponsor: Sinocelltech Ltd. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Safety and immunogenicity of multivalent SARS-CoV-2 protein vaccines: a randomized phase 3 trial. (PubMed, EClinicalMedicine) - P3 | "The day 28 geometric mean ratio (GMR) of SCTV01C/BBIBP-CorV for Omicron BA.1 was 6.49 (95% CI: 4.75, 8.88), while the GMR of SCTV01E/BBIBP-CorV was 9.56 (95% CI: 6.85, 13.33). There is evidence to suggest that SCTV01E may have GMT superiority over bivalent vaccine SCTV01C against Delta, BA.1 and BA.5 variants. This study was sponsored by Sinocelltech Ltd., and funded by the Beijing Science and Technology Planning Project [Z221100007922012] and the National Key Research and Development Program of China [2022YFC0870600]."

Journal • P3 data • CNS Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of a tetravalent and bivalent SARS-CoV-2 protein booster vaccine in men. (PubMed, Nat Commun) - P3 | "Day 28 GMT of live virus neutralizing antibodies and seroresponse against Omicron BA.1 and BA.5 with SCTV01E are significantly higher than those with SCTV01C and BNT162b2. These data indicate an overall neutralization superiority with tetravalent booster immunization in men."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SCTV01C-E-01-UAE-1: A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines (clinicaltrials.gov) - P3 | N=1800 | Active, not recruiting | Sponsor: Sinocelltech Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL4

Safety and Immunogenicity of a Bivalent SARS-CoV-2 Protein Booster Vaccine, SCTV01C in Adults Previously Vaccinated with Inactivated Vaccine: A Randomized, Double-blind, Placebo-controlled Phase 1/2 Clinical Trial. (PubMed, J Infect) - No abstract available

Clinical • Journal • P1/2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of a bivalent SARS-CoV-2 protein booster vaccine, SCTV01C, in adults previously vaccinated with mRNA vaccine: A randomized, double-blind, placebo-controlled phase 1/2 clinical trial. (PubMed, EBioMedicine) - P1/2 | "The heterologous booster of SCTV01C was safe, and induced uniformly high cross-neutralization antibody responses against Delta and Omicron variants."

Clinical • Journal • P1/2 data • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Safety and Immunogenicity of a Bivalent SARS-CoV-2 Recombinant Protein Vaccine, SCTV01C in Unvaccinated Adults: A Randomized, Double-blinded, Placebo-controlled, Phase I Clinical Trial. (PubMed, J Infect) - No abstract available

Clinical • Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Development of a thermostable SARS-CoV-2 variant-based bivalent protein vaccine with cross-neutralizing potency against Omicron subvariants. (PubMed, Virology) - "Notably, SCTV01C exhibited cross-neutralization capacity against Omicron subvariants (BA.1, BA.1.1, BA.2, BA.3, and BA.4/5) in mice, superior to a WT (D614G)-based vaccine, which reinforced our previously published findings that SCTV01C exhibited broad-spectrum neutralizing potencies against over a dozen pre-Omicron variants and the Omicron BA.1 variant. In summary, variant-based multivalent protein vaccine could be a platform approach to address the challenging issues of emerging variants, vaccine hesitancy and the needs of affordable and thermal stable vaccines."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Bivalent COVID-19 Vaccine Based on Alpha and Beta Variants Elicits Potent and Broad Immune Responses in Mice against SARS-CoV-2 Variants. (PubMed, Vaccines (Basel)) - "In this study, SCTV01C, a clinical stage bivalent vaccine based on trimeric spike extracellular domain (S-ECD) of SARS-CoV-2 variants Alpha (B.1.1.7) and Beta (B.1.351) with a squalene-based oil-in-water adjuvant was evaluated in comparison to its two corresponding (Alpha and Beta) monovalent vaccines in mouse immunogenicity studies...All three vaccines elicited potent Th1-biased T-cell immune responses. These results provide direct evidence that variant-based multivalent vaccines could play important roles in addressing the critical issue of reduced protective efficacy against the existing and emerging SARS-CoV-2 variants."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines (clinicaltrials.gov) - P3 | N=1800 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=400 | Not yet recruiting | Sponsor: Sinocelltech Ltd. | N=300 ➔ 400

Enrollment change • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4

A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years (clinicaltrials.gov) - P2 | N=480 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Sinocelltech Ltd. | Trial completion date: May 2023 ➔ Aug 2023 | Trial primary completion date: May 2022 ➔ Aug 2022

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4

A Phase II Study of the Immunogenicity and Safety of SCTV01C in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C in Population Aged ≥18 Years and Previously Fully Vaccinated With Either Inactivated or mRNA COVID-19 Vaccine or Previously Diagnosed With COVID-19 (clinicaltrials.gov) - P2 | N=600 | Not yet recruiting | Sponsor: Sinocelltech Ltd.

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL4

The Safety and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Vaccinated With Inactivated COVID-19 Vaccine. (clinicaltrials.gov) - P1/2; N=300; Recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The Safety and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Vaccinated With mRNA COVID-19 Vaccine. (clinicaltrials.gov) - P1/2; N=300; Recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Recruiting; N=540 ➔ 300

Enrollment change • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The Safety, Tolerability and Immunogenicity of COVID-19 Vaccine (SCTV01C) in Healthy, Unvaccinated Adults (clinicaltrials.gov) - P1/2; N=752; Recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • IFNG • IL4

Safety, Tolerability and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Unvaccinated (clinicaltrials.gov) - P1/2; N=752; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • IFNG • IL4

The Safety and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Vaccinated With Adenovirus Vectored or mRNA COVID-19 Vaccine. (clinicaltrials.gov) - P1/2; N=540; Not yet recruiting; Sponsor: Sinocelltech Ltd.; Phase classification: P2/3 ➔ P1/2; N=12420 ➔ 540; Trial completion date: Oct 2022 ➔ Jan 2023

Clinical • Enrollment change • Phase classification • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases