DXP-593 / Singlomics, BeOne Medicines - LARVOL DELTA

SARS-CoV-2-neutralising antibody BGB-DXP593 in mild-to-moderate COVID-19: a multicentre, randomised, double-blind, phase 2 trial. (PubMed, EClinicalMedicine) - P2 | "Although nasopharyngeal swab SARS-CoV-2 viral RNA copy number was not significantly decreased compared with placebo, viral RNA copy number was inconsistently reduced by Day 8 in saliva at some doses as low as 5 mg/kg. BeiGene, Ltd."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P2; N=181; Completed; Sponsor: BeiGene; Trial completion date: Jan 2021 ➔ May 2021; Trial primary completion date: Jan 2021 ➔ May 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

BeiGene Reports Third Quarter 2021 Financial Results (Businesswire) - P2, N=181; NCT04551898; Sponsor: BeiGene; "Received results from the Phase 2 trial...evaluating investigational SARS-CoV-2 neutralizing antibody BGB-DXP593 in patients with mild to moderate COVID-19, licensed from Singlomics outside of China. The trial did not meet the primary efficacy endpoint of viral load change in nasopharyngeal swabs at Day 8. The license rights of the two Singlomics candidates (DXP593 and DXP604) outside of the U.S. and the development rights of the candidates in the U.S. have been returned to Singlomics under a reversion agreement signed by the parties, with BeiGene retaining U.S. commercial rights."

Licensing / partnership • P2 data • Infectious Disease • Novel Coronavirus Disease

BGB-DXP604 Alone and in Combination With BGB DXP593 in Healthy Participants (clinicaltrials.gov) - P1; N=25; Completed; Sponsor: BeiGene; Active, not recruiting ➔ Completed

Trial completion • PCR

BGB-DXP604 Alone and in Combination With BGB DXP593 in Healthy Participants (clinicaltrials.gov) - P1; N=24; Active, not recruiting; Sponsor: BeiGene; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • PCR

Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants (clinicaltrials.gov) - P1; N=18; Completed; Sponsor: BeiGene; Recruiting ➔ Completed; N=30 ➔ 18; Trial completion date: Jun 2021 ➔ Feb 2021

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

BGB-DXP604 Alone and in Combination With BGB DXP593 in Healthy Participants (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: BeiGene

Clinical • Combination therapy • New P1 trial • PCR

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P2; N=181; Completed; Sponsor: BeiGene; Not yet recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline. (PubMed, MAbs) - "We describe the structure, mechanism of action, and ongoing trials for VIR-7831, LY-CoV555, LY-CoV016, BGB-DXP593, REGN-COV2, and CT-P59. We speculate also on the next generation of these mAbs."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: BeiGene; Trial completion date: Dec 2020 ➔ Jun 2021; Trial primary completion date: Oct 2020 ➔ Feb 2021

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

BeiGene Announces Exclusive License Agreement for Neutralizing COVID-19 Antibodies Developed by Singlomics Biopharmaceuticals (Businesswire) - "BeiGene, Ltd...and Singlomics (Beijing DanXu) Biopharmaceuticals Co., Ltd., today announced that the companies have executed an exclusive license agreement for BeiGene to develop, manufacture and commercialize...DXP-593 and DXP-604....A Phase 1 randomized, double-blind, and placebo-controlled clinical trial is expected to begin enrolling up to 30 healthy subjects in Australia in September. The Phase 1/2 multinational trial in patients with mild to moderate COVID-19 is also expected to begin enrollment by early October."

Licensing / partnership • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody in Healthy Subjects (clinicaltrials.gov) - P1; N=8; Not yet recruiting; Sponsor: BeiGene

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody in Healthy Subjects (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: BeiGene; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P2; N=180; Not yet recruiting; Sponsor: BeiGene

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease