Blue Steens in April 2020

Catch up on Blue Steens articles and venture further

Apr 29, 2020

Federated learning in healthcare

Federated learning is a machine learning paradigm that allows to train algorithms collaboratively without the need for source data exchange between the parties.

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The winding path from lab to patient

Despite potential short-cuts, drug development is a lengthy and risky process that culminates in marketing approval. However, just because a drug achieves regulatory approval, does not mean that it will be instantly available to those in need.

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Beyond Blue Steens

Coronavirus

⊳ Testing

For a quick explanation of the difference between genetic (PCR) and antibody (serological) tests, check out last month’s COVID-19 Testing section. Note that a newly-infected person does not yet have antibodies but will have genetic virus material. In contrast, a person who has overcome the infection, may not have detectable genetic material anymore but will have antibodies. Hence, timing of these tests is important.

Antibody tests:
Overall, these tests are still very unreliable and have been criticised, e.g. here and here. However, the FDA tightens its enforcement.
Meanwhile:
- Authorisations: Cellex (US), Biolidics (Singapore), DiaSorin (US, Italy)
- Hangzhou Biotest Biotech/Premier Biotech’s test was used for screening by the University of Southern California and LA Department of Public Health.
PCR tests:
- US saliva tests from Rutgers University, MicroGen DX. Using spit instead of swabs makes sample collection easier.
- Emergency use authorisation for point-of-care kit that yields positive results in 5 min, negative results in 13 min.
Inflatable P2 Lab for Emergency Testing
🏴󠁧󠁢󠁳󠁣󠁴󠁿 Glasgow University to host new Covid-19 testing facility - The uni lab will be staffed by > 500 volunteers and begin work in mid-April. A few companies, Wellcome Trust and University of Dundee also involved.

⊳ Treatment

Plasma therapy uses blood plasma from survivors (i.e. the cell-free liquid part of blood containing antibodies) as treatment for patients:
Remdesivir:
- Noticed that this one escaped me in March: Gilead requested to lose (!) orphan drug designation due to public backlash.
- Gilead supersizes trials
- After struggling previously to supply patients (March review), Gilead has promised to donate 1.5M doses.
(Hydroxy-) Chloroquine:
- FDA authorisations & FDA warning
- However, a preliminary meta-analysis casts doubts.
- Trials announced: Novartis (450 patients planned), GNS561 (Phase 2)
- Meanwhile, production is being ramped up: W Balkan, Novartis (30M of 130M promised doses shipped), Sanofi
- India lifted export ban
Immunosuppressants:
These drugs aim to prevent a potentially fatal overreaction of the immune system to the infection.
- InflaRx uses anti-C5a antibodies. [German]
- Tiziana develops handheld inhaler/nebuliser to be used to deliver anti-IL-6 receptor antibodies directly into patient’s lungs.
BioCryst launches early-stage study of galidesivir for COVID-19 - Phase 1 trial of broad-spectrum antiviral in Brazil.
Clinical trial with heartburn drug famotidine
Collaboration of 15 pharma companies with Gates Foundation includes sharing of proprietary compound libraries.
Phase 3 trial with diabetes drug, dapagliflozin, to reduce C-19 disease progression and complications.
🏴󠁧󠁢󠁳󠁣󠁴󠁿 NovaBiotics’s Nylexa to treat potentially lethal secondary bacterial lung infections in C-19 patients. Trials could start in 2nd half of 2020.

⊳ Vaccination

Pharma collaborations:
- BioNTech & Pfizer [German] - Phase-1/2 trial OK in Germany
- Pfizer collaborating within healthcare ecosystem
- NIH & 16 drug companies (treatments & vaccines)
- Sanofi & GSK - Clinical trials expected in 2nd half of 2020.
- VBI Vaccines & National Research Council of Canada - Aiming to develop a vaccine against various coronaviruses to induce wider immunity.
China approves two experimental vaccines to enter clinical trials
Novavax fast-tracks phase 1 testing - Start by mid-May.
Johnson & Johnson identifies a lead COVID-19 vaccine candidate - Human trials expected by Sep 2020. J&J intend to provide it on a not-for-profit basis.
University of Pittsburgh found potential vaccine - Animal results promising. FDA application for clinical trials underway.

⊳ Other news

Number and severity of COVID-19 mutations: NextStrain (at least 8 strains), Zhejiang University (at least 30 mutations, medRxiv source)
Virological assessment of hospitalized patients with COVID-19 - Analysis of 9 patients with mild symptoms. Some key takeaways: patients highly contagious in 1st week and still potentially contagious after symptoms have gone; antibodies detectable after 7-14 days.

Biotech

Scientists have created a new type of robot that is literally alive - The so-called xenobots are part living cells, part machine. They are programmable to take on different forms, self-heal and complete tasks. Their life span is about 1 week. Let’s hope bioethics catch up quickly with the tech evolution.
Flagship raises $1.1B to create biotechs for post-pandemic world - Whilst loads of funding is currently pouring into finding solutions for the COVID-19 crisis, Flagship Pioneering is thinking about opportunities in the 3 years after this crisis and is ready to fund a “new generation of companies”. A significant focus area is disease prevention.