Anti-Covid antibodies move quickly into the clinic

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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. 

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