💉 WHO prequalifies R21; A Sanofi ADC disappoints; CEPI, Oxford, Barinthus partner to fight MERS
#499 | A carcinogenic cocktail; No more happy feet?; Multiple flu strains, a single class of antibodies
Hello, and welcome back to The Kable for one last time this year. Team Kable is taking a break for the rest of the year and will return to your mailboxes in 2024.
On to the news.
In Zimbabwe, the cholera outbreak has been unrelenting. In just the first 19 days of December, the country recorded 2,519 suspected new cases.
In India, the contaminated cough syrup saga continues to be investigated. Currently, authorities have nearly finished investigating a complaint that prior to samples being tested at a government lab in India, a state drug regulator accepted a bribe to help switch samples of cough syrups linked to children’s deaths in the Gambia.
CEPI has added yet another vaccine development partnership to its portfolio of deals. It is partnering with the University of Oxford and Barinthus Biotherapeutics (which will be awarded up to $34.8 million) to accelerate the development of VTP-500, a vaccine candidate for the prevention of Middle East Respiratory Syndrome caused by the MERS coronavirus. Importantly, the partnership is aligned with CEPI’s Equitable Access Policy; regardless of ability to pay, populations will be given access to the potential vaccine when and where they need it to end an outbreak. CEPI also has the ability to support tech transfer to appropriate regional manufacturers to enable supply for LMICs.
Meanwhile, MeiraGTx has granted J&J the remaining interests and manufacturing capabilities for its rare eye disease gene therapy. The product in question is botaretigene sparoparvovec, or bota-vec, which was developed in partnership with J&J’s Janssen. J&J will shell out $130 million upfront and in near-term milestone payments, and potentially another $285 million on first commercial sales in the US and EU.
The animal genomics-focused biotech Fauna Bio has inked a multi-year agreement with Eli Lilly to apply Fauna’s Convergence AI platform to bolster preclinical drug discovery for obesity. Fauna is set to receive an undisclosed upfront payment, including an equity investment. In future, the biotech is eligible to receive up to a total of $494 million in pre-clinical, clinical and commercial milestone payments and royalties.
Cancer-fighting antibody-drug conjugates (ADCs) have been all the rage this year, with Big Pharma shelling out billions to get in on the ADC game. However, the year isn’t exactly ending on a high for the area, with Sanofi scrapping one of its top ADC prospects (acquired from ImmunoGen) after a late-stage study in advanced lung cancer missed both its main goals.
And finally, a reminder from the WHO that in Gaza, the combination of hunger and disease will lead to even more deaths. While food and other aid must flow into the Strip in much greater quantities, the only real solution is a ceasefire. 🍉
The Week That Was
This last Kable week of the year began with the story of Naprod Life Sciences, an Indian drugmaker who manufactured substandard and contaminated cancer drugs which killed four children in Colombia in 2019. Bloomberg exposed the weaknesses of not only Naprod’s own quality processes but also those of regulatory authorities in developing countries – countries where the market for such specialised cancer drugs is only growing.
The 2023 UN Regional Overview of Food Security and Nutrition revealed that the rates of obesity and overweight in Latin American and Caribbean (LAC) countries have tripled in the last 50 years. Economic inequality, extensive monocultures of soybeans and wheat, unfair trade practices affecting small farmers, and poverty have led to the simultaneous emergence of the seemingly contradictory problems of overweight/obesity and food insecurity in the region.
On Tuesday, a milestone for vaccine manufacturing in Africa as BioNTech inaugurated its mRNA BioNTainer site in Kigali, Rwanda. The company intends to complete all buildings at this site and begin local training of specialised personnel here in 2024. If BioNTech’s development of vaccines for tuberculosis, malaria, HIV, and mpox is successful, these shots will be produced at the new site.
Riding high on massive Wegovy sales, the Novo Nordisk Foundation – which owns a controlling stake in Danish drugmaker Novo Nordisk – announced that it would commit up to 1.8 billion Danish kroner (~$260 million) to fund vaccine research for respiratory diseases like tuberculosis, influenza, and group A streptococcus. In partnership with the Statens Serum Institut and the University of Copenhagen, the Foundation will be the first globally to focus solely on learning how to generate immunity in the airway.
On Wednesday, CEPI announced a partnership with the Rwandan-US Akagera Medicines to improve existing mRNA technology by reducing reactogenicity and improving equitable access through improvements like eliminating the need for frozen storage and potentially also enhancing shelf life, reducing the cost of goods, and having a smaller required effective dose.
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) published a collaborative and coordinated strategy to maximise the benefits of artificial intelligence (AI) in regulation.
Politico broke the news that European countries have destroyed at least 215 million unwanted Covid vaccine doses valued at more than €4 billion. In the 19 countries surveyed, 0.7 doses per resident were dumped, with Estonia and Germany being the most wasteful.
Yesterday, in addition to several promising updates concerning pharma localisation in Africa, The Lancet revealed that antimicrobial resistance (AMR) is now linked to more deaths than AIDS and malaria in the WHO African region. Four pathogens — Streptococcus pneumoniae, Klebsiella pneumoniae, Escherichia coli, and Staphylococcus aureus — were the main culprits; each was responsible for over 100,000 AMR deaths in the region.
And finally, amidst concerns about the promotion of an unapproved anti-cold formulation for infants, India’s drugs regulator, the Central Drugs Standard Control Organisation (CDSCO), banned a popular anti-cold cocktail medicine in children below four years of age. As issued in a letter by the Drugs Controller General (India) on 18 December, all manufacturers of the fixed-dose combination (FDC) of chlorpheniramine maleate IP 2mg (an antiallergic drug) with phenylephrine HCL IP 5 mg per ml drops (a decongestant) are mandated to mention an appropriate warning on the label and package insert.
R21 prequalified! In October 2023, the WHO recommended the use of the R21/Matrix-M malaria vaccine, developed by Oxford University and manufactured by the Serum Institute of India. Now, the WHO has finally added R21 to its list of prequalified vaccines! Prequalification, which is a prerequisite for vaccine procurement by UNICEF and deployment funding from Gavi, will help this shot become accessible to the populations that most need it, especially in African countries like Nigeria, which bear the highest malaria burdens. After GSK’s RTS,S/AS01 shot, this is only the second malaria vaccine ever to be prequalified by the WHO. We couldn’t have asked for a better way to end the year 🙌🏽
No more happy feet? 🐧 But alas, all good things must be balanced by the bad, it seems. According to a report by OFFLU – which gathers experts from the World Organisation of Animal Health (WOAH) and the UN’s Food and Agriculture Organisation (FAO) – bird flu is likely to spread further in the Antarctic region. The H5 strain of the bird flu virus was detected on 8 October in a brown skua on Bird Island, which is part of the British Overseas Territory of South Georgia and the South Sandwich Islands. The virus was also detected in fulmars and albatrosses in the nearby Falkland Islands. The anticipated spread of H5 will likely cause unprecedented damage to wildlife, potentially infecting 48 bird species and 26 marine mammal species. The dense colonies of seals and birds are likely to facilitate the spread and possibly cause high mortality.
Pittsburgh profs punch out pan-influenza antibodies. Researchers at the University of Pittsburgh School of Medicine have discovered a new class of antibodies effective against multiple H1 and H3 influenza virus strains. This groundbreaking finding indicates that these antibodies can neutralise both H3 strains and certain H1 strains, even those with a specific hemagglutinin (HA) mutation. The study shows the potential for developing flu vaccines that provide broader protection by targeting these newly identified antibodies. This advancement suggests a promising direction for flu vaccine research, moving towards more universally effective vaccinations.
AI's antibiotic bonanza. As 2023 draws to a close, artificial intelligence has hit a jackpot in the medical field. It's uncovered a novel class of antibiotics, delivering a knockout punch to tough, drug-resistant bacteria. This savvy AI hasn't just been mixing and matching in the chemistry lab—it's been predicting how these new compounds would work in the real world. And guess what? It's been a roaring success against villains like MRSA in mouse tests. This isn't just a one-time show; AI's got its sights set on other big targets, including cancer. It's a rare and exciting win in the antibiotics arena, as unique as spotting a unicorn in your backyard!
Fat’s new journey. Researchers at the University of Cologne and the University of Hamburg have uncovered a fat tale. Turns out, our cells' powerhouses, mitochondria, are also traffic cops for dietary fats in our intestines. When these mitochondria go on strike, fat gets a bit too comfy in our gut cells, causing a traffic jam and stopping it from reaching other organs. This not only shakes up our understanding of fat transport but could also lead to new ways to treat mitochondrial diseases. Next time you blame mitochondria for not burning enough calories, remember they're also keeping your fats moving!
Lung cancer’s hazy history with air quality. From the 1950s, scientists began linking lung cancer to air pollution and smoking. Decades later, it's clear that while cigarettes are a known culprit, air quality can't dodge the blame. The American Cancer Society found strong ties between air pollution and lung cancer, even in non-smokers. Fast forward to the 21st century, and we're seeing lung cancer's relationship with air quality getting murkier, like a bad smog day. Studies now show that long-term exposure to pollutants, especially particulate matter, ups lung cancer risks. It's not just smokers coughing up trouble; air quality is a sneaky accomplice. And like a bad neighbour, climate change is making it worse, with increased wildfires adding to the carcinogenic cocktail. So while quitting smoking is good, nay imperative, it may just also be time to maybe do something about air pollution too.
An important announcement
When we return in 2024, we will have transitioned to a free-to-read Friday-only format. This change allows us to concentrate our efforts, ensuring each edition is packed with the most pertinent and impactful stories from the life sciences sector. We look forward to continuing to be your go-to source for weekly insights and updates, especially for updates from LMICs, with a primary focus on developments from Africa.
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Hope you have as great a time as possible ringing in the new year. And see you Kable-side in 2024.
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