SAB-185 / CSL Behring, SAb Biotherap - LARVOL DELTA

Safety and Efficacy of SAB-185 for Non-hospitalized Adults with COVID-19: A Randomized Clinical Trial. (PubMed, J Infect Dis) - "SAB-185 had an acceptable safety profile with faster symptom resolution in the Omicron population. Additional studies are needed to characterize its efficacy for COVID-19."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease

No evidence for enhanced disease with human polyclonal SARS-CoV-2 antibody in the ferret model. (PubMed, PLoS One) - "Signs of pathology in the lungs were noted in infected ferrets but no differences were found between control and antibody groups. The results of this study indicate that healthy, young adult ferrets of both sexes are a suitable model of mild COVID-19 and that low doses of specific IgG in SAB-185 are unlikely to enhance the disease caused by SARS-CoV-2."

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

Transchromosomic bovine-derived anti-SARS-CoV-2 polyclonal human antibodies protects hACE2 transgenic hamsters against multiple variants. (PubMed, iScience) - "Human ACE2 transgenic Syrian hamsters, which exhibit lethal SARS-CoV-2 disease, were protected from mortality after challenge with the Munich, Alpha, Beta, Delta, and Δ144-146 variants and clinical signs after non-lethal Omicron BA.1 infection. This suggests that SAB-185 may be an effective immunotherapy even in the presence of ongoing viral mutation."

IO biomarker • Journal • Preclinical • 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

Phase 2 safety and antiviral activity of SAB-185, a novel polyclonal antibody therapy for non-hospitalized adults with COVID-19. (PubMed, J Infect Dis) - "SAB-185 was safe and generally well tolerated and demonstrated modest antiviral activity in predominantly low-risk non-hospitalized adults with COVID-19."

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

SAB-185 protects human ACE2 transgenic Syrian hamsters against multiple SARS CoV-2 variants including Omicron (OPTIONS XI 2022) - No abstract available

Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: SAb Biotherapeutics, Inc. | Active, not recruiting ➔ Completed

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

Transchromosomic bovines (TcB)-derived broadly neutralizing antibodies as potent biotherapeutics to counter important emerging viral pathogens with a special focus on SARS-CoV-2, MERS-CoV, Ebola, Zika, HIV-1 and Influenza A virus. (PubMed, J Med Virol) - "Although these variants possess different mutations, such as N501Y, E484K, K417N, K417T, L452R, T478K, and P681R, SAB-185 has shown broad neutralizing activity against VOCs, such as Alpha, Beta, Gamma, Delta, and Omicron variants, and VOIs, such as Epsilon, Iota, Kappa, and Lambda variants...This article highlights recent developments in the field of bovine-derived biotherapeutics, which are seen as a practical platform for developing safe and effective antivirals with broad activity, particularly considering emerging viral infections such as SARS-CoV-2, Ebola, MERS-CoV, Zika, HIV-1, and Influenza A virus. Antibodies in the bovine serum or colostrum, which have been proved to be more protective than their human counterparts, are also reviewed."

IO biomarker • Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SAB Biotherapeutics Provides Company Update for Q1 2022 Financial Results (GlobeNewswire) - "Pipeline Updates and Anticipated Milestones: Phase 2 data for SAB-185 expected to be available from NIH NIAID for ACTIV-2 trial later this year."

P2 data • Infectious Disease • Novel Coronavirus Disease

"SAB-185 is better than convalescent plasma and requires no human donors for the same approach @SABBantibody - $SABS - - full Phase 2 readout mid 2022" (@_Randomless)

P2 data

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

SAB Biotherapeutics Reports NIH is Discontinuing Phase 3 ACTIV-2 Trial Assessing SAB-185 for Treatment of COVID-19 Due to Declining COVID Hospitalizations (GlobeNewswire) - "SAB Biotherapeutics...today reported that due to low hospitalization and death rates in the trial, the National Institutes of Health’s (NIH) ACTIV-2 Program is discontinuing enrollment in its Phase 3 COVID-19 trial....While SAB-185 previously met the initial pre-specified safety and efficacy criteria to continue to the next phase of the Phase 3 ACTIV-2 trial, the independent Data and Safety Monitoring Board (DSMB) recommended that the study be stopped for reasons of 'operational futility', meaning that hospitalization rates had declined to the point where the study was no longer large enough to ensure that statistically significant findings could be obtained....'The good news is that infections and hospitalizations are now falling sharply in the US. But this decrease also has had the effect of making the current ACTIV-2 Phase 3 study design statistically unworkable, and the NIH has therefore decided to stop patient enrollment.'"

DSMB • Enrollment status • Infectious Disease • Novel Coronavirus Disease

SAB Biotherapeutics Provides Company Update and Reports Full Year 2021 Financial Results (GlobeNewswire) - "Generated robust data set, demonstrated proof-of-concept and validated platform through accelerated clinical development of SAB-185, a high-potency fully-human polyclonal therapeutic, to address pandemic need for novel treatments against emerging biothreats, respiratory viruses and viral mutations....Phase 2 Full Data Readout for SAB-185 Expected to be Available Mid-2022."

P2 data • Infectious Disease • Novel Coronavirus Disease

SAB Biotherapeutics Announces Publication of Nonclinical Data Demonstrating SAB-185 Has High Potency for Effectively Neutralizing Circulating and Emerging SARS-CoV-2 Variants (GlobeNewswire) - "SAB Biotherapeutics...today announced the publication of nonclinical data from a study conducted in collaboration with the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Division of Viral Products highlighting that SAB-185 effectively neutralizes multiple SARS-CoV-2 strains and that it is superior to convalescent plasma in neutralizing COVID variants...for the treatment of high-risk non-hospitalized patients with mild to moderate COVID-19, is currently being assessed in the US National Institutes of Health (NIH) COVID-19 Phase 3 ACTIV-2 Trial....The article, 'Increased antibody avidity and cross-neutralization of SARS-CoV-2 variants by hyperimmunized Tc-Bovine derived human immunoglobulins for treatment of COVID-19,' is published in the online edition of The Journal of Infectious Diseases."

Preclinical • Infectious Disease • Novel Coronavirus Disease

PHASE-2 STUDY OF SAB-185, A POLYCLONAL ANTIBODY TREATMENT FOR COVID-19 IN ACTIV-2 (CROI 2022) - "No differences were observed in the proportion with NP SARS-CoV-2 RNA SAB-185 was safe in this phase 2 study. While no significant differences to placebo were seen in symptom duration and proportion of participants with NP SARS-CoV-2 RNA"

Late-breaking abstract • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SAB Biotherapeutics Announces Update to the Phase 3 NIH ACTIV-2 Trial Design Evaluating SAB-185 for Treatment of COVID-19 (GlobeNewswire) - "SAB Biotherapeutic...today announced an update to the design of the ongoing Phase 3 ACTIV-2 trial evaluating the clinical efficacy and safety of SAB-185 for the treatment of participants with mild-moderate COVID infections at higher risk for progression to hospitalization....The study endpoints remain unchanged....The trial is expected to restart in the coming weeks, allowing for minimal disruption of data collection."

Clinical protocol • Infectious Disease • Novel Coronavirus Disease

Increased antibody avidity and cross-neutralization of SARS-CoV-2 variants by hyperimmunized Tc-Bovine derived human immunoglobulins for treatment of COVID-19. (PubMed, J Infect Dis) - "In contrast to CP, sera and SAB-185 derived from hyperimmunized Tc bovines demonstrated higher antibody avidity and more potent cross-neutralizing activity of VOCs/VOIs. Thus, SAB-185 is a potential promising therapeutic candidate for the treatment of patients infected with SARS-CoV-2 variants."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SAB Biotherapeutics Reports Positive Phase 2 Virology Data Demonstrating SAB-185 Met Criteria for Advancement to Phase 3 in NIH ACTIV-2 Trial for Treatment of COVID-19 (GlobeNewswire) - P2/3, N=8,797; ACTIV-2 (NCT04518410); "SAB-185 was safe and well-tolerated at both doses tested in Phase 2....SAB Biotherapeutics...today reported positive Phase 2 safety and efficacy data demonstrating that SAB-185...met the criteria for advancement to Phase 3 with Day 3 viral load data from a pre-specified interim data analysis reviewed by the Data Safety Monitoring Board (DSMB) in September....'The Phase 3 study in high-risk patients is more than 50% enrolled, and we look forward to those results later this year'...The Phase 2 interim analysis showed nasopharyngeal viral qRT-PCR reductions of 1.48 log10 (low dose, Probability 0.91) and 0.67 log10 (high dose, Probability 0.75) versus placebo. The full enrollment Phase 2 data showed viral load reductions of 0.5 log10 versus placebo for both the low and high doses."

Enrollment status • P2 data • P3 data • Infectious Disease • Novel Coronavirus Disease

SAB Biotherapeutics Announces SAB-185 Retains Neutralization Against Omicron SARS-CoV-2 Variant In Vitro (GlobeNewswire) - "SAB Biotherapeutics...today announced data demonstrating that SAB-185, the company’s therapeutic candidate for the treatment of COVID-19 infections, retains neutralization activity against the Omicron SARS-CoV-2 variant in an in vitro pseudovirus model. The data were generated by scientists at the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER)....'These in vitro data demonstrate that SAB-185 retains neutralization activity against the Omicron variant as has been consistently shown with previous SARS-CoV-2 variants of concern,'....Preclinical data has also indicated that SAB-185 is significantly more potent than human-derived convalescent immunoglobulin G (IgG)."

Preclinical • Infectious Disease • Novel Coronavirus Disease

SAB Biotherapeutics Reports Third Quarter 2021 Financial Results and Provides Company Update (GlobeNewswire) - "SAB Biotherapeutics...today reported financial results for the third quarter ended September 30, 2021 and provided a company update....R&D expenses were $46.5 million for the nine months to date September 30, 2021, compared to $12.6 million for the same period in 2020. The increase was primarily due to the advancement of SAB-185 for COVID-19."

Commercial • Infectious Disease • Novel Coronavirus Disease

Medical organization investigates possibility of using an inhaler to treat coronavirus [Google translation] (Meganoticias) - "This association is the global network that is dedicated to researching treatments for the Human Immunodeficiency Virus (HIV) , but in the face of the health crisis they included Covid-19 in their work....It is a combination of monoclonal antibodies known as BRII-196 / BRII-198 and SAB-185. 'This nebulized and inhaled version of interferon beta expands treatment options for people who have Covid-19, but are not hospitalized,' explained ACTG President Dr. Judith Currier."

Media quote • Novel Coronavirus Disease

Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants (clinicaltrials.gov) - P1; N=28; Active, not recruiting; Sponsor: SAb Biotherapeutics, Inc.; Trial completion date: Jul 2021 ➔ Nov 2021

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

SAB Biotherapeutics Announces First Patient Dosed in Phase 3 NIH ACTIV-2 Trial Evaluating SAB-185 for Treatment of COVID-19 (Businesswire) - "SAB Biotherapeutics...today announced that the first patient has been dosed with SAB-185 in the Phase 3 ACTIV-2 COVID-19 trial...for the treatment of non-hospitalized patients with mild to moderate COVID-19....It is enrolling approximately 600 participants to receive the investigational agent SAB-185 and 600 to receive an active comparator. The primary outcome measures of the Phase 3 trial include safety and non-inferiority for the prevention of a composite endpoint of either hospitalization or death from any cause through study day 28."

Trial status • Infectious Disease • Novel Coronavirus Disease

ACTG announces graduation of novel polyclonal antibody therapy SAB-185 to phase 3 study in ACTIV-2 (Eurekalert) - "The AIDS Clinical Trials Group (ACTG)...today announced that SAB-185, a novel polyclonal antibody therapy, has demonstrated safety and efficacy in phase 2 that meet the criteria for graduation to phase 3 in the ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial (ACTG A5401)....'We are pleased to advance a second agent to phase 3 in the ACTIV-2 study,' said Babafemi Taiwo, M.B.B.S...."

Media quote • Novel Coronavirus Disease

SAB Biotherapeutics Announces SAB-185 Receives Positive DSMB Review and Advances to Phase 3 in NIH-Sponsored ACTIV-2 Trial for Treatment of COVID-19 (Businesswire) - "SAB Biotherapeutics...announced that an independent Data Safety Monitoring Board (DSMB) has completed its prespecified interim analysis data review of the safety and efficacy of SAB-185 in the Phase 2 portion of the ACTIV-2 trial and has recommended advancement to Phase 3....SAB-185 is advancing to the Phase 3 trial based on meeting pre-defined graduation criteria....'We now look forward to the completion of the Phase 3 trial and if successful, the opportunity to make SAB-185 widely available to the many COVID-19 patients battling this persistent and evolving disease.'"

DSMB • Infectious Disease • Novel Coronavirus Disease