Candidates: CA1 and CB6
Type: Human neutralizing monoclonal antibodies (MAbs) capable of keeping an infectious agent, usually a virus, from infecting a cell by neutralizing or inhibiting its biological effect. It could potentially facilitate virus clearance, altering the course of infection, Junshi reasons.
Status: Junshi said May 26 that it and Eli Lilly intend to file an IND and initiate clinical trials in the U.S. and China in the second quarter of 2020 of CA1 and CB6, both isolated from a recovered COVID-19 patient. The decision followed publication of research results in Nature Communications showing that CA1 and CB6 both showed substantial neutralization activity in vitro against SARS-CoV-2.
Junshi said CB6 exhibited superior neutralizing activity that included reducing virus levels by about 3 logs in rhesus monkeys when administered one day after infection. When given one day before viral challenge, CB6 was able to keep viral load at no more than 103 RNA copies/ml, demonstrating strong prophylactic protection, the company added. Structural studies showed that CB6 recognizes epitopes in SARS-CoV-2 receptor binding domain that overlap with angiotensin converting enzyme 2 (ACE2)-binding sites, thereby directly obstructing virus/receptor interactions. The Fc portion of CB6 was modified to lower the risk of Fc mediated acute lung injury.
In March, Junshi said that it signed a collaboration agreement with IMCAS to jointly develop neutralizing antibodies against COVID-19. The partners said they obtained multiple strains of neutralizing antibodies capable of effectively blocking viral invasion in laboratory assays and have conducted animal experiments. Preliminary in vitro and in vivo studies have verified the blocking activity of the NAb strains, Junshi said.
The company added that it was verifying the preclinical toxicology and in vivo activity of the antibodies in order to file IND applications with regulatory agencies in and outside China.
COVID-19: 200 Candidates and Counting
To navigate through the >200 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: