Candidate: SAB-185
Type: High-potency immunotherapy delivering human polyclonal antibodies targeted to SARS-CoV-2, generated from SAB’s proprietary DiversitAb™ platform
2021 Status: Advancing to Phase III—SAb Biotherapeutics said September 24 that its SAB-185 will advance to Phase III of the ACTIV-2 trial (NCT04518410) upon recommendation of the study’s independent Data Safety Monitoring Board (DSMB) after it completed a prespecified interim analysis data review of the safety and efficacy of SAB-185 in the Phase II portion of the ACTIV-2.
The ACTIV-2 trial is sponsored by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). Both low and high doses of SAB-185 tested in Phase II met the pre-defined efficacy goal for advancement to Phase III and appeared safe at the interim analysis, SAb said. NIAID and SAb researchers are finalizing the preferred dose to assess in Phase III.
The Phase III portion of ACTIV-2 is a randomized, unblinded, active comparator-controlled adaptive platform study that will assess the clinical safety and efficacy of SAB-185 compared to active control monoclonal antibody treatment in people with mild to moderate COVID-19 who are at higher risk for progression to hospitalization, 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 III trial will include safety and non-inferiority for the prevention of a composite endpoint of either hospitalization or death from any cause through study day 28.
First Patient Dosed in ACTIV-2–SAb Biotherapeutics said April 21 that he first patient had been dosed in its Phase II/III study evaluating the safety and efficacy of SAB-185, in non-hospitalized adults with mild to moderate COVID-19 as part of the NIH’s ACTIV-2 master protocol. As of the announcement date, SAB-185 was being evaluated in Phase 1 and Phase 1b studies for the treatment of COVID-19, both of which have completed enrollment.
2020 Status: SAb Biotherapeutics said November 30 that as part of Operation Warp Speed, the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) awarded SAb $57.5 million in expanded scope for its DiversitAb™ Rapid Response Antibody Program contract for the manufacturing of SAB-185. As of the announcement date, SAB-185 was under study in an ongoing Phase 1 trial in healthy volunteers and an ongoing Phase Ib trial in patients with mild or moderate COVID-19.
On April 8, CSL Behring and SAb Biotherapeutics said they will partner to develop SAB-185, which they said is expected to be ready for clinical evaluation as early as summer 2020.
CSL Behring has provided seed funding to offset some of SAB’s initial development costs, while SAB earlier this year secured approximately $7.2 million in funding from the Biomedical Advanced Research and Development Authority (BARDA) through an interagency agreement with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO – CBRND). That funding will support SAB efforts to complete manufacturing and preclinical studies. CSL Behring has agreed to commit clinical, regulatory, manufacturing and supply chain expertise and resources to deliver the therapeutic to the market as soon as possible, on terms to be agreed with SAB.
Earlier this year, the companies agreed to apply DiversitAB technology as a new source for human immunoglobulin G (IgG), and the potential for new therapies to treat challenging autoimmune, infectious and idiopathic diseases.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
