Anyone marvelling at the speed with which the first antibody against Covid-19 entered the clinic will note that the development pace has not slowed. Since Evaluate Vantage covered this space barely a week ago two further projects, from Lilly/Junshi and from Regeneron, have entered phase I. Not to be outdone, the first antibody into the clinic, Lilly/Abcellera’s LY-CoV555, is about to start phase II, an entry just unveiled on Clinicaltrials.gov reveals. While phase I is in hospitalised patients, the phase II study, due to begin tomorrow, will enrol 400 mild to moderate Covid-19 subjects. LY-CoV555 will be compared against placebo in a double-blind fashion, with change in day-11 Covid-19 viral load as primary endpoint. The separate Lilly/Junshi project, JS016, which binds a different epitope on the virus’s spike protein, is now in a healthy volunteer trial. Meanwhile, Regeneron’s multi-antibody cocktail REGN-COV2 has started its first two phase I studies, also in hospitalised and non-hospitalised patients. The combo has been revealed to comprise two antibodies, REGN10933 and REGN10987, and two more trials in the prophylactic setting (in healthcare workers and in people with close exposure to a Covid-19 patient) are planned, Regeneron says.
Selected antibodies and related biologicals in development for Covid-19 | |||
---|---|---|---|
Companies | Lead, if identified | Mechanistic approach | Clinical development? |
Lilly/Abcellera | LY-CoV555/ LY3819253 | IgG1 MAb vs spike protein | Ph2 study in mild to moderates |
Ph1 study in hospitalised subjects | |||
Regeneron | REGN10933 + REGN10987 | Two-Ab cocktail; prophylaxis trials due | Ph1 trial in hospitalised subjects |
Ph1 trial in ambulatory subjects | |||
Lilly/Junshi | JS016 | Fully human MAb vs spike protein | Ph1 in volunteers |
Sab Biotherapeutics | SAB-185 | Polyclonal | Clinical trial due mid-2020 |
Celltrion | CT-P59 | MAb vs spike protein receptor binding domain | Clinical trial due Jul 2020 |
Glaxosmithkline/Vir | VIR-7831 & VIR-7832 | MAbs vs spike protein | Clinical trial in Jul-Sep 2020 |
Astrazeneca | – | MAbs, incl based on recovered patients | Clinical trial in Jul-Sep 2020 |
Sorrento | STI-1499 | Fully human MAb vs spike protein | Clinical trial due Q3 2020 |
Brill Bio | – | Fully human MAb | Clinical trial due Q3 2020 |
Yumab | – | MAbs, incl based on recovered patients | Clinical trial due H2 2020 |
Molecular Partners | – | Darpin proteins | Clinical trial due H2 2020 |
Systimmune | SI-F019 | Bivalent Ace2 fusion protein vs spike protein | IND filing due 2020 |
Xencor/Vir | – | Fc-engineered MAbs | – |
Atreca/Beigene/IGM | – | IgM & IgA MAbs vs novel epitopes | – |
Amgen/Adaptive | – | MAbs based on recovered patients | – |
Ossianix | – | Single-domain VNAR MAbs vs spike protein | – |
Sorrento | STI-4398 | Ace2-Fc protein vs spike protein | – |
Sorrento/Mabpharm | STI-4920 | Bispecific vs 2 domains on spike protein | – |
Fusion Antibodies | – | Fully human MAb vs engineered Ace2 protein | – |
Fusion Antibodies | – | Fully human MAb vs spike protein | – |
Virna | – | Neutralising Abs vs spike protein | – |
Note: excludes anti-IL6, anti-GM-CSF and other MAbs not directly targeting Covid-19. |