Blue Steens in Aug-Sep 2020
Catch up on Blue Steens articles and venture further
Dear reader,
I didn’t forget about you last month! August was incredibly busy and intense. So, I decided to postpone and combine the August and September newsletters. Thank you for your patience! 💐
Aug/Sep on Blue Steens
Plasma vs virus
Convalescent plasma (CP) therapy gained FDA emergency use authorisation (EUA) in August. This is surrounded by some controversy and suspicion of politicisation. The FDA hasn’t been doing too well on that front lately. Others have offered sufficient critical thoughts on those aspects. I decided to cut out the noise in writing my commentary.
Animaker
I took some time to chill in September and played with Animaker, a video animation creator. Loads of features in the free version. The interface is fairly intuitive and has a Canva feel to it. Both platforms look great for marketing on a low budget.
You may have noticed my “happy dance” animation elsewhere. In my next trial I created a little teaser for this very newsletter. Enjoy!
Beyond Blue Steens
Coronavirus
⊳ Testing
It seems that after an initial frenzy when seemingly almost any old test could somehow make it on the market (check out April edition for comments on quality issues), we’re now seeing quality kits with added features appear (see also July & June editions).
Abbott’s latest COVID-19 test has received FDA EUA and is quickly being snapped up. Point-of-care 15-minute antigen test that detects an active infection from nose swabs. Results are transferred to a test card that uses lateral flow technology for analysis. (FYI, pregnancy tests also use lateral flow.) The card can be hooked up to a free mobile app that provides people who test negative with a temporary encrypted digital health pass.
Pioneering Triple Antibody Test developed by University of Exeter spin-out Attomarker can give accurate quantitative results in 7 min. It has received MHRA approval. Developed as point-of-care test to be connected to mobile devices. Unlike other COVID-19 kits that only detect 1 biomarker, this test detects 3 virus proteins and 3 classes of antibodies (IgM/G/A). Thus, it gives an indication of current and past infection.
Eurobio Scientific and BGI Genomics obtained CE mark for multiplex PCR tests that distinguish in a single run between main viruses responsible for flu-like symptoms.
⊳ Treatment
Drug repurposing has drawn lots of attention during this healthcare crisis. - Eli Lilly's rheumatoid arthritis drug baricitinib (Olumiant) accelerates recovery when used in combination with remdesivir. After mixed results previously, placebo-controlled phase 3 trial of flu drug Avigan also promises faster recovery (see also May & July editions).
Big-name consortia are definitely on the rise. Here’s a recent example: The COVID R&D Alliance (Amgen, Takeda, AbbVie & 18 others) is recruiting hospitalised patients to test 3 different drugs.
AI tool in development to predict disease course and customise treatment to reduce mortality.
Passive immunisation:
Takeda-led CoVIg-19 Plasma Alliance set to launch international trial of CP-derived antibody product.
NIH launches clinical trials using a monoclonal (one target) antibody developed by Eli Lilly to tackle the early disease stage. The intended therapeutic mechanism is principally similar to CP, as CP is essentially a mix of antibodies that recognises many viral targets.
Kamada initiates a Phase 1/2 trial for its plasma-derived antibody product.
⊳ Vaccination
Whilst some wealthy countries have started securing supplies, WHO’s COVAX facility has gathered 172 contributing nations and plans are in progress to secure supplies for less wealthy countries. In addition, a Gates Foundation-Serum Institute of India partnership aims to make vaccines available for < US$3 a dose to low- and middle-income countries.
A good few new trials have been launched around the globe. Check out RAPS’ vaccine tracker.
Russia’s Sputnik V is the first vaccine to gain approval.
China approved clinical trial of intranasal spray.
After voluntarily pausing its trial due to safety concerns, AstraZeneca (Oxford vaccine, see also May & June editions) has resumed UK and Brazil trials but not US arm.
Novavax is starting phase 3 trial in the UK. The vaccine is a lab-made antigen (virus protein) combined with an enhancer (adjuvant) to stimulate a strong immune response.
Pfizer/BioNTech, Moderna, AstraZeneca and Johnson & Johnson published trial protocols to overcome suspicions of politicisation. A critical review suggests that trial designs focus on assessing whether vaccines eliminate symptoms but are less concerned with prevention of infection, hospitalisation or death. Various organisations have called on FDA to complete stringent and transparent review before approving any vaccine, and FDA has proposed stricter guidelines for vaccine EUA.
⊳ Blockchain
US Health and Human Services (HHS) has launched blockchain-based coronavirus data hub. Check out Robert Miller’s write-up for more.
Health n Go completed trials of blockchain-based COVID-19 health certificate.
Biotech
Blood test for prostate cancer determines cancer presence and stage with 99% accuracy based on immune system markers. This will improve detection of early cases and reduce need for invasive biopsies and scans.
Painless biodegradable microneedle patch developed at University of Tokyo as simple, low-cost test for prediabetes screening. The needles are porous to allow fluids to be absorbed from the skin and travel to the paper sensor, which changes colour according to glucose levels. Human trials pending.
Medtech
B-Temia’s exoskeleton helps stroke patients walk by detecting movements and supporting these with motors.
CereGate aims to use ‘mind writing’ with computer-brain interfaces to help patients with neurological disorders or sensory deficits. After successful proof-of-concept study this year and new financing, they are heading in the direction of clinical trials.
AIgnostics develops histopathological AI-based image analysis for routine diagnostics and drug development. The tool handles black-box AI limitations by providing outputs that are verifiable by medical specialists.
Miscellaneous
Novartis issues EUR 1.85 billion sustainability-linked bond.
Insightful: COVID-19 is not a pandemic - “Approaching COVID-19 as a syndemic will invite a larger vision, one encompassing education, employment, housing, food, and environment.”
Out and about
13 Aug: Episode 006 Enterprise DLT Live - Carsten Stöcker, Spherity [replay]
26 Aug: COVID-19 Veterans Health Summit, ConsenSys Health [playlist]
15 Sep: Distributed Healthcare Interoperability and the Coalesce Health Alliance [replay]
17 Sep: Towards a US Research Data Framework, STM [replay]
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In this newsletter I share personal views and observations only. For more information and the privacy policy visit Blue Steens.