HBM9022 / Utrecht University, Erasmus MC, Harbour BioMed, AbbVie - LARVOL DELTA

Mutation profiling, evolution analysis, molecular dynamics simulation, and functional characterization of Omicron sub-strains. (PubMed, Virus Res) - "Moreover, we revealed that the ABBV-47D11 monoclonal antibody could widely bind to the RBD mutation sites of various mutant strains. Our findings may help understand the evolution of SARS-CoV-2 variants and develop novel strategies against SARS-CoV-2 infection."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 1 study of safety, pharmacokinetics, and antiviral activity of SARS-CoV-2 neutralizing monoclonal antibody ABBV-47D11 in patients with COVID-19. (PubMed, Pharmacol Res Perspect) - "The exploratory anti-SARS-CoV-2 activity revealed a reduction of viral load at and above the 600 mg dose of ABBV-47D11 regardless of patient demographics and baseline characteristics, however; because of the high inter-individual variability and small sample size a statistical significance was not reached. There is potential for anti-SARS-CoV-2 activity with ABBV-47D11 doses of 600 mg or higher, which could be evaluated in future clinical trials designed and powered to assess viral load reductions and clinical benefit."

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

Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P1; N=25; Completed; Sponsor: AbbVie; Active, not recruiting ➔ Completed

Adverse events • Clinical • Combination therapy • Monotherapy • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

In vivo monoclonal antibody efficacy against SARS-CoV-2 variant strains. (PubMed, Nature) - "Exceptions were mAb LY-CoV555 and LY-CoV555/LY-CoV016 mono- and combination therapy, which lost all protective activity, and AbbVie 2B04/47D11, which showed partial loss of activity. When administered after infection as therapy, higher doses of several mAb cocktails protected in vivo against viruses with a B.1.351 spike gene. Thus, many, but not all, of the antibody products with Emergency Use Authorization (EUA) should retain substantial efficacy against the prevailing SARS-CoV-2 variant strains."

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

Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P1; N=24; Active, not recruiting; Sponsor: AbbVie; Recruiting ➔ Active, not recruiting; N=54 ➔ 24

Adverse events • Clinical • Combination therapy • Enrollment change • Enrollment closed • Monotherapy • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 and IV ABBV-2B04 Given Alone and in Combination Moves Through the Body of Adult Participants With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P1; N=54; Recruiting; Sponsor: AbbVie; N=24 ➔ 54

Adverse events • Clinical • Combination therapy • Enrollment change • Monotherapy • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 Moves Through the Body of Adult Participants Hospitalized With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: AbbVie; Not yet recruiting ➔ Recruiting

Adverse events • Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Harbour BioMed and Utrecht University Announce License Agreement with AbbVie and Initiation of COVID-19 Antibody Clinical Trials (PRNewswire) - "Harbour BioMed (HBM)(HKEX:02142), and Utrecht University (UU) today announced that they licensed to AbbVie their fully human, SARS-CoV-2 neutralizing antibody, 47D11 and program...and that AbbVie has initiated a Phase 1 clinical trial of the antibody. AbbVie will initially conduct the initial clinical program in the U.S. and expand it into Europe....AbbVie will conduct clinical development of ABBV-47D11, and if successful, will manufacture and commercialize the product worldwide. AbbVie will pay HBM and UU a one-time license fee; payments upon achievement of certain development, regulatory and sales-based milestones; and tiered royalties on commercial net sales of the antibody."

Licensing / partnership • Trial status • Infectious Disease • Novel Coronavirus Disease

Study to Assess Adverse Events and How Intravenous (IV) ABBV-47D11 Moves Through the Body of Adult Participants Hospitalized With Coronavirus Disease 2019 (COVID-19) (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: AbbVie

Adverse events • Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases