LYB001 / Luye Group - LARVOL DELTA

Immunogenicity and safety of SARS-CoV-2 recombinant protein vaccine (CHO cell) LYB001 as a heterologous booster following two- or three-dose inactivated COVID-19 vaccine in adults aged ≥18 years: interim results of a randomized, active-controlled, double-blinded, phase 3 trial. (PubMed, Expert Rev Vaccines) - P3 | "LYB001 is highly immunogenic and retains a well-characterized safety profile in adults aged ≥18 years. www.clinicaltrials.gov, identifier is NCT05664932."

Journal • P3 data • P3 data: top line • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and immunogenicity of the SARS-CoV-2 LYB001 RBD-based VLP vaccine (CHO cell) phase 1 in Chinese adults: a randomized, double-blind, positive-parallel-controlled study. (PubMed, Expert Rev Vaccines) - P1 | "Therefore, further larger-scale clinical studies are warranted. This trial was registered with ClinicalTrials.gov (NCT05552573)."

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

Safety and immunogenicity of a heterologous booster with an RBD virus-like particle vaccine following two- or three-dose inactivated COVID-19 vaccine. (PubMed, Hum Vaccin Immunother) - "Additionally, RBD-specific IFN-γ, IL-2, IL-4 secreting T cells dramatically increased at 14 days after a single LYB001 booster. Our data confirmed the favorable safety and immunogenicity profile of LYB001 and supported the continued clinical development of this promising candidate that utilizes the VLP platform to provide protection against COVID-19."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • IL4

Efficacy and Safety of COVID-19 Vaccine as Booster Vaccination in Adults 18 Years of Age or Older (clinicaltrials.gov) - P3 | N=3000 | Terminated | Sponsor: Guangzhou Patronus Biotech Co., Ltd. | Trial completion date: Jan 2024 ➔ Jun 2023 | Active, not recruiting ➔ Terminated; According to the development of the novel coronavirus epidemic situation and the company's R&D decision

Trial completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety of COVID-19 Vaccine in Population Aged 18 Years and Above (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Guangzhou Patronus Biotech Co., Ltd. | N=720 ➔ 0 | Trial completion date: Jun 2024 ➔ Jun 2023 | Initiation date: Jun 2023 ➔ Jan 2023 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Dec 2023 ➔ Jun 2023

Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The Immunogenicity and Safety Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine LYB001 (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: Guangzhou Patronus Biotech Co., Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety of COVID-19 Vaccine in Population Aged 18 Years and Above (clinicaltrials.gov) - P2 | N=720 | Not yet recruiting | Sponsor: Guangzhou Patronus Biotech Co., Ltd. | Trial completion date: Dec 2023 ➔ Jun 2024 | Initiation date: Dec 2022 ➔ Jun 2023 | Trial primary completion date: Mar 2023 ➔ Dec 2023

Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenicity and Safety of COVID-19 Vaccine as a Booster Vaccination in Population Aged 18 Years and Above (clinicaltrials.gov) - P3 | N=1200 | Active, not recruiting | Sponsor: Guangzhou Patronus Biotech Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

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

Efficacy and Safety of LYB001 as Booster Vaccination in Adults 18 Years of Age or Older (clinicaltrials.gov) - P3 | N=3000 | Active, not recruiting | Sponsor: Guangzhou Patronus Biotech Co., Ltd.

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

Immunogenicity and Safety of COVID-19 Vaccine as a Booster Vaccination in Population Aged 18 Years and Above (clinicaltrials.gov) - P3 | N=3600 | Not yet recruiting | Sponsor: Guangzhou Patronus Biotech Co., Ltd.

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

Immunogenicity and Safety of COVID-19 Vaccine in Population Aged 18 Years and Above（Negative Antibody Against COVID-19） (clinicaltrials.gov) - P2 | N=720 | Not yet recruiting | Sponsor: Guangzhou Patronus Biotech Co., Ltd.

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

The Phase Ⅱ/Ⅲ Trial of LYB001 (clinicaltrials.gov) - P2/3 | N=18000 | Not yet recruiting | Sponsor: Yantai Patronus Biotech Co., Ltd.

New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of COVID-19 Vaccine in Population Aged 18 Years and Above (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: Guangzhou Patronus Biotech Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL2 • IL4

Safety and Immunogenicity of COVID-19 Vaccine in Population Aged 18 Years and Above (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Guangzhou Patronus Biotech Co., Ltd.

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL2 • IL4