ogalvibart (C-135-LS) / Rockefeller University, BMS - LARVOL DELTA

Safety, Efficacy, and Pharmacokinetics of Combination SARS-CoV-2 Neutralizing Monoclonal Antibodies BMS-986414 (C135-LS) and BMS-986413 (C144-LS) Administered Subcutaneously in Non-Hospitalized Persons with COVID-19 in a Phase 2 Trial. (PubMed, Pathog Immun) - "While safe, the BMS mAbs delivered subcutaneously were not effective at treating COVID-19 at low risk for progression. The lack of clinically significant activity may relate to the pharmacokinetics of subcutaneous administration of mAbs."

Journal • P2 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

ACTIV-2: A Study for Outpatients With COVID-19 (clinicaltrials.gov) - P2/3 | N=4044 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers (clinicaltrials.gov) - P1 | N=23 | Completed | Sponsor: Rockefeller University | Active, not recruiting ➔ Completed | Trial completion date: Jun 2022 ➔ Feb 2022

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

ACTIV-2: A Study for Outpatients With COVID-19 (clinicaltrials.gov) - P2/3 | N=4044 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting | N=8797 ➔ 4044 | Trial completion date: Dec 2023 ➔ Jun 2023 | Trial primary completion date: Dec 2023 ➔ Mar 2022

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

ACTIV-2: A Study for Outpatients With COVID-19 (clinicaltrials.gov) - P2/3; N=8797; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); N=2000 ➔ 8797; Trial completion date: May 2023 ➔ Dec 2023; Trial primary completion date: May 2023 ➔ Dec 2023

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers (clinicaltrials.gov) - P1; N=23; Active, not recruiting; Sponsor: Rockefeller University; Trial primary completion date: Jun 2021 ➔ Mar 2022

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

Early treatment with a combination of two potent neutralizing antibodies improves clinical outcomes and reduces virus replication and lung inflammation in SARS-CoV-2 infected macaques. (PubMed, PLoS Pathog) - "We investigated the therapeutic efficacy of a combination of two potent monoclonal antibodies, C135-LS and C144-LS that carry half-life extension mutations, in the rhesus macaque model of COVID-19. Compared to the control animals, animals treated with either dose of the anti-SARS-CoV-2 antibodies showed similarly improved clinical scores, lower levels of virus replication in upper and lower respiratory tract, and significantly reduced interstitial pneumonia, as measured by comprehensive lung histology. In conclusion, this study provides proof-of-concept in support of further clinical development of these monoclonal antibodies against COVID-19 during early infection."

Clinical • Clinical data • Journal • Immunology • Infectious Disease • Inflammation • Interstitial Lung Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

ACTG announces the addition of two monoclonal antibodies to ACTIV-2 outpatient treatment study for COVID-19 (Eurekalert) - "The AIDS Clinical Trials Group (ACTG), the largest global HIV research network, today announced the addition of two monoclonal antibodies, BMS-986414 and BMS-986413, to the COVID-19 outpatient treatment study, ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial. BMS-986414 and BMS-986413 will be administered as subcutaneous injections (shots) given at one visit....ACTIV-2 is a randomized, blinded, controlled adaptive platform...ACTIV-2 has completed enrollment for phase 2 studies evaluating AZD7442 (AstraZeneca)..."

Enrollment closed • Trial status • Infectious Disease • Novel Coronavirus Disease

Xencor and Bristol Myers Squibb Enter License Agreement for Use of Xtend XmAb Technology in SARS-CoV-2 Neutralizing Monoclonal Antibody Combination for the Treatment of COVID-19 (Businesswire) - "Xencor, Inc....has entered into a technology license agreement with Bristol-Myers Squibb Company (NYSE:BMY) under which Bristol Myers Squibb will have non-exclusive access to Xencor’s Xtend™ Fc technology to extend the half-life of a novel antibody combination therapy that is intended to neutralize the SARS-CoV-2 virus ('SARS-CoV-2 mAb Duo')...Phase 1 clinical evaluation to assess dosing and safety of the antibody combination is being conducted by investigators at Rockefeller University Hospital, while the initial Phase 2 and 3 studies are being planned as part of the NIH ACTIV-2 trial...Bristol Myers Squibb will have sole responsibility for supporting and advancing the research, development, regulatory and commercial activities for SARS-CoV-2 mAb Duo. Xencor is eligible to receive royalties from net sales of products including these antibodies."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers (clinicaltrials.gov) - P1; N=23; Active, not recruiting; Sponsor: Rockefeller University; Recruiting ➔ Active, not recruiting; N=15 ➔ 23

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

Bristol Myers Squibb and The Rockefeller University Announce License Agreement for SARS-CoV-2 Neutralizing Monoclonal Antibody Combination for the Treatment of COVID-19 (Businesswire) - "Bristol Myers Squibb...and The Rockefeller University today announced that they have entered into a definitive agreement under which Bristol Myers Squibb has been granted a global exclusive license to develop, manufacture and commercialize Rockefeller’s novel monoclonal antibody ('mAb') duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19....Phase 1 clinical trials to assess dosing for IV and subcutaneous formulations, and to assess safety for the mAb duo, were initiated by Rockefeller in mid-January. Planning is underway with the goal of moving rapidly to a registrational program following readout of the phase 1 study taking place at Rockefeller University Hospital."

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

RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers (clinicaltrials.gov) - P1; N=15; Recruiting; Sponsor: Rockefeller University; Not yet recruiting ➔ Recruiting

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