DXP-604 / BeOne Medicines, Singlomics - LARVOL DELTA

Conversion of monoclonal IgG to dimeric and secretory IgA restores neutralizing ability and prevents infection of Omicron lineages. (PubMed, Proc Natl Acad Sci U S A) - "In human angiotensin converting enzyme 2 (ACE2) transgenic mice, a single intranasal dose of the dimeric IgA DXP-604 conferred prophylactic and therapeutic protection against Omicron BA.5. Thus, dimeric or secretory IgA delivered by nasal administration may potentially be exploited for the treatment and prevention of Omicron infection, thereby providing an alternative tool for combating immune evasion by the current circulating subvariants and, potentially, future VOCs."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Clinical observation of neutralizing antibody DXP-604 for treatment critical COVID-19 patients infected with SARS-CoV-2 Delta variant. (PubMed, J Med Virol) - "Moreover, DXP-604 reduced the invasive mechanical ventilation and mortality of high-risk SARS-CoV-2 infected patients. The ongoing clinical trials of DXP-604 neutralizing antibody will clarify its utility as a new attractive countermeasure for high-risk COVID-19."

Journal • Critical care • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CRP • IL6

A Study to Evaluate the Efficacy and Safety of DXP604 in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Wuhan Institute of Biological Products Co., Ltd

New P2 trial • Infectious Disease • Novel Coronavirus Disease

China Biotech introduced the new coronavirus neutralizing antibody DXP-604 project from Peking University, which can treat the new crown [Google translation] (Sina Corp) - "China Bio-Wuhan Institute of Biological Products and Danxu Biology signed an agreement on the DXP-604 project , and China Bio-Wuhan Institute of Biological Products will receive the project. Development, production and commercialization rights worldwide....It is currently in the clinical phase II development stage for the treatment of COVID-19."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies. (PubMed, Nature) - "Regarding NAb drugs, the neutralization potency of LY-CoV016/LY-CoV555, REGN10933/REGN10987, AZD1061/AZD8895, and BRII-196 were greatly reduced by Omicron, while VIR-7831 and DXP-604 still function at reduced efficacy. Together, data suggest Omicron would cause significant humoral immune evasion, while NAbs targeting the sarbecovirus conserved region remain most effective. Our results offer instructions for developing NAb drugs and vaccines against Omicron and future variants."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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

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

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