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LONDON – The combined strength of Belgian life sciences has combined at the launch of Exevir Bio BV, which arrives on the scene with a 23 million euro (US$27 million) series and a position for a Phase I exam of its new antiviral treatment in COVID-19 inpatients.
The company made all this progress since a detained departure in February, when Xavier Saelens and Nico Callewaert of the Flemish Biotechnology Institute (VIB) reviewed their past paintings to isolate a single-domain flame antibody, or nanobody, that can simply neutralize SARS. CoV-1.
The two researchers found that the nanobody they raised opposite SARS-CoV-1 also reacted in a cross-response to SARS-CoV-2, triggering the effort to conduct preclinical research, create and finance the company, and call the Belgian pharmaceutical company UCB Pharma SA for the manufacture of clinical trial inputs.
Serie A led through FundArray together with VIB, UCB’s venture capital firm, UCB Ventures, the Belgian public budget and several offices of the Belgian circle of relatives.
“You can simply say that this is a very much-focused organization in Belgium, which helped to establish it very quickly,” said Torsten Mummenbrauer, executive director. “This is an exceptional commitment from everyone involved,” he told BioWorld.
Armed with Serie A, Exevir is completing the arrangements for Phase I, where, in addition to pharmacokinetics and dosing, it hoped to demonstrate that the intravenous product, HV72-Fc, prevents less severe patients from deteriorating to the point where they require it. mechanical ventilation.
“We hope to show the effect of reducing viral load so patients don’t want extensive care,” Mummenbrauer said. Assuming positive results, Exevir then plans to verify a subcutaneous formulation, with the aim of filling the healing hole between diagnosing SARS-CoV-2 infection and having poor enough health to be admitted to the hospital.
“At the moment, if your check is positive, they send you home to wait to see if you get seriously ill,” Mummenbrauer said. “We need viral load, inflammation and avoid progression.”
The next step will be to expand an inhaled edition of VHH72-Fc, which is thermally and chemically sound and is a format to which nanocorps adapt. “This would allow us to use prophylactic,” Mummenbrauer said.
It is very likely that many progressive COVID-19 vaccines will not be effective in a single dose, and an inhaled edition of VHH72-Fc may serve simply as a useful supplement. It can also be used for physical care personnel and others with comorities, who are most at risk of serious illness.
Mummenbrauer said regulators in Germany and Belgium had supported the immediate review of the data. This has contributed to the non-new technology of nanobodyes, having been announced through the Belgian biotechnology Ablynx NV, which is now part of Sanofi SA.
“Regulators have allowed us to do it first in humans without producing monkey toxin, which is a great savings,” Mummenbrauer said. “We can take credit for all those accelerated delays.”
Exevir is preparing for the option that there are not enough patients with COVID-19 to conduct the trial in Europe and has had pre-IND discussions with the FDA. The company is also setting up exam sites in South America.
Evidence from laboratory studies is that its shorter length allows VHH72-Fc to join an epitope in the SARS-CoV-2 receptor binding domain that is not available for normal-length antibodies. The epitope was shown to be preserved in SARS-CoV-1 samples, and between SARS-CoV-1 and SARS-CoV-2, VHH72-Fc was also found to be similar to a very similar bat coronavirus.
In addition to the likelihood that its retention through other coronaviruses means that the target is less likely to die, Mummenbrauer stated that only two amino acids of 10,000 DNA sequences of the SARS-CoV-2 epitope taken from patients had been mutated.
Exevir’s founding scientists resolved the crystalline design of VHH72-Fc in complex with its viral epitope, showing how the nanobody blocks the interface of the receptor binding domain in which the virus activates the angiotensin 2 conversion enzyme in the host cell.
Researchers also demonstrated that VHH72-Fc can be generated with the best yields in a Chinese hamster ovarian mobile system. UCB has accepted paints as a contract manufacturer of Exevir and will produce materials for clinical trials.
The core science, conducted in collaboration with scientists from the University of Texas at Austin and the U.S. National Institute of Allergy and Infectious Diseases. In Bethesda, Maryland, published in Cell on May 5, 2020.
In addition to the two SARS coronaviruses, it shows that flame nanocorps can be activated as opposed to MERS. In the past, Array Ablynx has brought to the clinic an inhaled nanocorp opposed to breathing the syncytial virus.
This shows that the generation provides the basis for a broad-based anti-infection specialist, Mummenbrauer said. “We’re just a COVID-19 company,” he said. “We need to position the generation as an antiviral reaction platform in the process of a pandemic.”
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