ExeVir doses first patients with llama-derived anti-Covid antibody
A little over five months after pulling in a $50 million Series A, ExeVir is ready to take the next step with its llama-derived Covid-19 antibodies.
The Belgium-based biotech is officially launching a Phase I study in healthy volunteers for the llama antibody program, known as XVR011, announcing the dosing of its first patients Wednesday morning. Looking at the safety profile and pharmacokinetics of the candidate, the study will examine three ascending doses of an IV formulation in a randomized and double-blinded setting.
Given ExeVir launched only in June 2020, CEO Torsten Mummenbrauer told Endpoints News the trial launch marks an important milestone.
“We’re damn proud,” Mummenbrauer said in an interview.
The quick rise actually stems from research regarding the SARS outbreak in the early 2000s, also known as the SARS-CoV-1 virus. Scientists who helped launch ExeVir studied the llama antibody in SARS about five years ago, giving the biotech a solid base to coalesce around Covid-19.
“In February 2020, when the sequence was published, they were able to immediately set up an assay for the new virus,” Mummenbrauer said.
There are two key aspects in which the llama antibody is different from other Covid-19 antibodies that are out there, Mummenbrauer said. The first is simply that the antibodies are much smaller, allowing for binding in very small groups on the spike protein.
And second, ExeVir has identified a “special epitope” hidden within the spike protein that allows for an additional mechanism of action. Preclinical data have shown high conservation of the epitope, Mummenbrauer said, reducing the risk of viral escape across the original strain of the coronavirus and the four most prominent variants that first originated in the UK (Alpha), South Africa (Beta), Brazil (Gamma) and India (Delta).
For now, the plan is to recruit healthy volunteers through the end of October and randomize them into three dosage groups: 250 mg, 500 mg and 1 gram. The biotech is also running a Phase Ib study in parallel looking at hospitalized patients.
Eventually, however, ExeVir has ideas for a subcutaneous formulation of the antibody, which could potentially allow for a prophylactic use. That’s a bit farther off into the future, Mummenbrauer said, and will come as part of their second-gen push, once ExeVir gets the IV formulation across the finish line.
“In this setting we have silenced the Fc element of the antibody to avoid an increase in disease in patients,” Mummenbrauer said. “We are working on second-gen, and there the tech also allows us to do a binary molecule where we fuse two different antibodies and are mimicking the combination approach of Eli Lilly in one molecule.”
For a look at all Endpoints News coronavirus stories, check out our special news channel.