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Product Development

BioNTech, Pfizer complete exploratory talks with the European Commission for 200M COVID-19 vaccine doses

Plus computationally designed antivirals from the Institute for Protein Design, non-human primate data for BioNTech’s lead vaccine and more

Sep 10, 2020 | 12:10 AM GMT

BioNTech, Pfizer vaccine to supply vaccine to EU
On Wednesday, BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) became the sixth group of COVID-19 vaccine developers to complete exploratory talks on procurement with the European Commission. The EC is looking to BioNTech and Pfizer to supply 200 million doses of BNT162 to EU members, with an option for extra 100 million doses, beginning by YE20 if BNT162b2 is authorized. The partners also said they have provided an expression of interest to supply BNT162 to the COVID-19 Vaccine Global Access (COVAX) facility.

Computationally designed COVID-19 antivirals
A team led by David Baker, an investigator at University of Washington’s Institute for Protein Design, has designed 10 miniproteins that inhibit SARS-CoV-2 replication in cells with IC50 values  of 24 pM–35nM. The proteins, described Wednesday in Science paper, block the interaction between the SARS-CoV-2 spike protein and its host cell receptor ACE2. The researchers, which included Washington University in St. Louis professor Michael Diamond, generated the miniproteins by optimizing computational scaffolds built around either the spike domain that binds ACE2, or the portion of ACE2 that interacts with the spike.

Monkey data for BioNTech’s pivotal vaccine candidate
On Tuesday, BioNTech revealed in bioRxiv that prime-boost administration of 100 µg BNT162b2 — about three times the Phase II/III dose of 30 µg — on days 0 and 21 enabled rapid prevention of viral replication in the lungs of rhesus macaques challenged with SARS-CoV-2 55 days after boost. Three days after simultaneous intranasal and intratracheal infection, six out of six monkeys had no detectable viral RNA in lung fluid and nasal samples; and four out of six had no detectable viral RNA at the time point in throat swabs. By contrast, all three control animals had positive throat samples and two had positive lung fluid and nasal samples at day three.
The company also showed in the macaques that 30 and 100 µg BNT162b2 led to the generation of spike-responsive CD4+ and CD8+ T cells; and neutralizing titers 8.6 and 17.9 times higher, respectively, seven days after boost than in a convalescent sera panel. Titers at 28 days after boost were about three times higher than convalescent levels.

Convalescent plasma fails in open-label trial
In the Indian open-label, randomized, controlled Phase II PLACID trial to treat hospitalized patients with moderate COVID-19, convalescent plasma missed the composite primary endpoint of reducing mortality or progression to severe disease. In medRxiv, the investigators reported a mortality rate of 13.6% in patients who received convalescent plasma plus best standard-of-care (BSC) vs. 14.6% for BSC alone (adjusted odds ratio=1.06, 95% CI: -0.61, 1.83).

NCATS portal for sharing assays, datasets
NIH’s National Center for Advancing Translational Sciences (NCATS) is making publicly available the results from its screens of SARS-CoV-2-related assays against all approved drugs. The datasets, as well as the assay protocols used, are accessible on its OpenData COVID-19 website immediately after the screens are completed.

Verily EUA for pooled testing
FDA granted this week emergency use authorization for a pooled testing approach by Verily Life Sciences LLC. In a blog post, the company said the method requires one quarter to one half the number of tests as standard PCR tests when the expected positive detection rate is low, for example if the chance that one person in the pool is positive is under 10%.

Ampio gears up for Phase II/II testing
Ampio Pharmaceuticals Inc. (NYSE-A:AMPE) said Ampion (AP-013) resulted in stronger clinical improvement than standard of care therapies including remdesivir in a Phase I study to treat hospitalized COVID-19 patients on supplemental oxygen. The company, which did not disclosed detailed data, will use the safety and efficacy readout to support a Phase II/III trial.

ACE2 – Angiotensin-converting enzyme 2

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