💉 Winner in sight for RSV race; AstraZeneca dumps $855 million rare disease drug; Eli Lilly sees success in obesity drug trial
#329 | Oceans get hotter; Big Pharma’s R&D pipeline gets lighter; Mammalian genomes remain unchanged
Hello, and welcome to the final Kable of a busy week and an even busier month. On this last day in April, life sciences news shows no signs of slowing down. Big Pharma is going full steam ahead with its restructuring plans, with companies streamlining their efforts by dumping some R&D projects and investing in more commercially-viable ones. Today’s Kable also brings crucial drug and vaccine approvals, evolving regional disease burdens keep things fresh and exciting, and global efforts make the most of World Immunization Week.
First, Therini Bio has raised a $36 million Series A round, fuelled by funding from Eli Lilly, Sanofi and Merck. This round will further clinical research on the use of the biotech’s antibody, THN391, in controlling inflammation and tackling Alzheimer’s and diabetic macular oedema.
Taking over an Illinois facility and its employees from Novartis, Bristol Myers Squibb is set to acquire an additional viral vector production site to keep up with the demand for its two CAR-T cell therapies for cancer.
Merck & Co, AstraZeneca and AbbVie are all in search of new future revenue sources. The pharma biggies claim that they are ramping up R&D spending and are open to acquisitions. This development comes as the companies are set to lose patent protections for key revenue-generating drugs in the coming years. Bristol Myers Squibb, too, is on the lookout for deals in its core areas of solid tumours, haematology, immunology, and cardiovascular disease.
But putting money in new places means taking some out from elsewhere. AstraZeneca is dumping its rare disease drug candidate, which was once estimated to be worth $855 million. Eli Lilly is handing the rights for a T regulatory cell stimulator treatment back to Nektar Therapeutics after a failed phase 2 lupus study. The company is also cutting two other treatments, one for Alzheimer’s and another for pain. Amgen is shelving its lupus programmes, and AbbVie is letting go of its cystic fibrosis and Crohn’s disease candidates.
Meanwhile, AstraZeneca is making moves in China. As its Covid vaccine revenue dwindles, it plans to invest $450 million in a factory in Qingdao to manufacture inhalers for “smoker’s lung”.
Eli Lilly’s drug Mounjaro – which already has US FDA approval to treat diabetes – successfully helped overweight people with diabetes lose about 30 pounds over the course of 18 months, according to new trial results. With a rolling submission already underway, the company is hoping to gain approval for the drug as a weight loss treatment by the end of the year. However, considering that the drug is still fairly new, we know very little about the rebound effect when patients stop taking the drug; it’s possible that patients using Mounjaro for obesity may have to use it for their entire lives.
Nevertheless, today’s a good day for US FDA approvals, with the agency granting accelerated approval to Biogen for its ALS drug Tofersen and a green light to Pfizer for the use of the Prevnar 20 pneumococcal disease vaccine for infants, children and adolescents.
Merck, too, has good news from the US FDA, after the agency lifted a partial hold on its HIV combo trial.
Over in Asia, Singapore’s Temasek Trust is partnering with the US’s Wellcome Leap to increase health spans. South Korea’s Theragen Bio has signed an MoU with the US’s Agilent Technologiesin the field of precision oncology, aiming to use bioinformatic solutions for cancer genomic profiling. Additionally, the Indian Drug Manufacturers’ Association and the Pharmaceuticals Export Promotion Council of India have separately signed MoUs with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association to promote bilateral cooperation in the sector.
Meanwhile, the global alliance for diagnostics, FIND, has announced agreements with Ireland’s Abbott, Korea’s i-SENS and Germany’s Siemens to improve access to diabetes testing in LMICs.
In the GCC, Dubai-listed Amanat’s acquisition of a majority stake in Sukoon has resulted in the creation of the largest post-acute care platform in the region.
Recently, we covered LatAm countries’ intention to work towards regional regulatory harmonisation. Mexico, Cuba and Colombia have now signed the Declaration of Acapulco, formalising the creation of the Regulatory Agency for Medicines and Medical Devices of Latin America and the Caribbean.
Argentina has cause for celebration, as the National Administration of Medicines, Food and Medical Technology has authorised the use of Takeda’s dengue vaccine, Qdenga, for everyone over four years of age. It will likely become available in Argentina in the spring. The vaccine is already approved for use in Indonesia, the EU, the UK and Brazil.
Nigeria, Bangladesh, Cambodia, Ethiopia, Indonesia, Kenya, Togo and Zambia, too, have reason to rejoice as they are set to receive support from Gavi to increase coverage of the HPV vaccine to 86 million adolescent girls in the coming year.
In Africa, the new CDC head has a novel proposal to fund the agency’s health interventions on the continent: tax airline passengers.
In India, chicken pox and measles cases are on the rise, with the former even infecting vaccinated adults. Post-pandemic dips in immunity may be to blame.
In Bangladesh, 13 more dengue patients have been hospitalised. Now, a total of 37 dengue patients are receiving treatment in hospitals across the country. The total caseload this year includes 962 cases and 10 deaths.
In South Korea, 6 new mpox cases have brought the country’s total caseload to 40. Most of the recent infections are believed to be locally transmitted.
In Senegal, a case of Crimean-Congo haemorrhagic fever has been confirmed.
In Nigeria, the WHO reports 1,686 suspected cases of meningitis and 124 deaths from 1 October 2022 to 16 April 2023.
In South America, the PAHO is warning that the region may experience a chicken supply shortage, all thanks to bird flu, of course.
But we love our chicken, as does the US. Not willing to give up on poultry, the US government has commenced testing bird flu vaccines for our delicious friends. Two vaccines – one developed by Zoetis and another by Merck Animal Health – will be tested by the US Department of Agriculture. We can expect initial data by May. But even if everything goes well, it’ll take about 18 to 24 months to make commercially-available a vaccine that matches the currently circulating virus strain.
And finally, India’s QP Pharmachem is responding to the WHO’s medical alert concerning its cough syrups, saying it is all a conspiracy to defame the Government of India.
The week that was
This week kicked off with news of Abbott joining the Climate Amplified Disease and Epidemics (CLIMADE) consortium, which comprises over 100 global scientists from public health agencies, academia, and industry. The consortium aims to use data science and diagnostic testing to assess and potentially mitigate the impact of climate change on disease outbreaks. CLIMADE will begin with disease surveillance in Africa and expand to other countries frequently impacted by infectious disease outbreaks.
In Africa, Stellenbosch University (SU) launched the state-of-the-art Biomedical Research Institute (BMRI), placing it at the forefront of biomedical sciences in Africa. Located in Cape Town, the facility houses over 500 researchers and students, focusing on diseases afflicting South Africa and the African continent.
As the global community marked World Immunization Week, a number of global partners – the WHO, UNICEF, Gavi, the Vaccine Alliance, and the Bill & Melinda Gates Foundation – and other partners announced ‘The Big Catch-Up’, an extended initiative to lift vaccination levels to at least where we were pre-pandemic. The Big Catch-Up will focus particularly on the 20 countries – including Afghanistan, Korea, the DRC, Ethiopia, India, Pakistan, Somalia and Myanmar – which saw three-quarters of missed vaccinations in 2021.
On the climate front, we found that as El Niño heats up the world beginning this year, mosquitoes are breeding in the tropics and spreading malaria and dengue fever like they're going out of style. Keep an eye on places with a mix of rain and warm months, like India, Pakistan, and California, because they're prime spots for a mosquito invasion.
But it's not just the mosquitoes causing a ruckus. Ticks, cholera bacteria, and poisonous algae are also getting in on the El Niño action. Ticks carrying rickettsiosis might head north, while cholera could have a field day in places with flooding or drought.
As for bird flu, we’ve already seen mammals like sea lions, mink and other mammals affected in large numbers. But with ferret-to-ferret transmission now confirmed, we know for sure that the avian influenza virus can spread from mammal to mammal. This suggests that H5N1 with specific adaptations that enable a higher degree of replication, pathogenicity and transmission may be circulating. Which translates to an increased risk for us humans. The research is a reminder that this is no time for post-pandemic complacency.
Over in Europe, Brussels released the much-anticipated draft of the proposed changes to the laws governing the pharmaceutical industry this week. This move marks the EU's biggest overhaul of these laws in 20 years, with the intention of making new treatments and generics accessible to all Europeans and eliminating divergences in price and accessibility between different countries. The hope is that the reforms will create a unified European market for pharmaceutical drugs and that about 70 million more Europeans will get access to new medicines. But pharma and biotech firms say that the legislation will bring about the opposite of the intended effect.
And finally, the world has effective malaria vaccines, but the supply is far from adequate. By 2026, the world will need approximately 40-60 million doses of malaria vaccines. By 2030, that demand is expected to go up to 80-100 million doses per year. Gavi recently released a white paper outlining an action plan that governments, manufacturers and health agencies should adopt to meet the world’s malaria vaccine supply goals.
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A win by a nose. RSV is not good news for the very young or the very old. But luckily, the vaccine race for lower respiratory tract disease may finally have a winner. The much-awaited RSV vaccines may soon make their way to the public as the European Medicines Agency (EMA) recommended authorisation of GSK’s RSV vaccine, Arexvy, for adults aged 60 years and over. The European Commission’s final approval is awaited. This puts both GSK and Europe at the forefront of the race to get an RSV vaccine to market.
The RSV vaccine market is estimated to stand at over $5 billion, crossing the $10 billion mark by 2030. The EMA’s recommendation places GSK ahead of Pfizer, but in the US, both companies gained the backing of an FDA advisory panel earlier this year and are expecting final decisions by May. Moderna left behind but not forgotten, is also planning to submit its mRNA-based RSV vaccine for approval worldwide in the first half of this year.
Resisting malarial resistance. In the Sahel, seasonal malaria chemoprevention, or SMC, is a commonly used drug combo intervention for malaria prevention in children younger than five years of age. This lifesaving intervention has protected over 160 million children from infection and 700,000 from death in the past decade. But taking SMC to eastern and southern Africa comes with a challenge: high parasite resistance.
Pilots conducted in recent years outside the Sahel, in Mozambique and South Sudan, have been overwhelmingly positive, but the fear is that these results are only temporary. While the WHO made its recommendations on SMC use more flexible last year - loosening geographic and age-related restrictions - experts are afraid that, over time, the efficacy of these drugs will be affected. So in addition to rigorous monitoring of the situation, experts are also emphasizing the need to develop alternative treatments like recombinations of existing antimalarial drugs, long-acting injectables, and monoclonal antibodies. These measures require time and money, so we can’t afford to wait around to get in on the malaria prevention race. Especially for the sake of Africa, where children younger than five years of age account for close to 80% of all malaria deaths.
Take a shot. As we mark the end of World Immunization Week, we want to highlight more data and interventions that can aid the fight against the recent backslide in childhood immunisation around the world. According to UNICEF, more than 4.3 million children in the Middle East and North Africa did not get a single dose of the measles vaccine between 2019 and 2021. During the same period, about 3.8 million children were under-vaccinated for DTP, with 2.27 million not receiving even a single dose. 80% of the measles zero-dose children in MENA are from five countries only. Conflicts, displacement and weak WASH systems are to blame for the increase in disease spread, and Covid did nothing to help improve vaccination coverage to prevent this.
Countries all over the world have heightened their focus on achieving pre-pandemic immunization levels, if not more. We’ve mentioned them in previous editions this week. Now countries of the Caribbean have signed the Declaration of Nassau, committing governments to take evidence-based measures to fortify national immunization programmes in the region. Meanwhile, Gavi is partnering with Girl Effect to use mass media to reach missed communities in Ethiopia and Tanzania and improve vaccine coverage across the region.
(UNICEF, PAHO, Gavi)
Battling a broad range of bacteria. Scientists have discovered an exception to the rule of T cells typically responding to the antigen of a microbe and generating protective immunity. They’ve found that a group of divergent bacterial pathogens have a highly conserved protein sequence which our T cells can recognise and target to generate broad antibacterial immunity. In future, these findings could lead to the development of techniques to efficiently fight cholesterol-dependent cytolysins-related bacterial diseases.
Pee and tell. Cancer diagnosis could become highly accessible in the future if this research continues to show promise. MIT engineers have designed a nanoparticle sensor which could allow early cancer diagnosis with a simple urine test. Not only can the sensor detect cancerous proteins, but it can also deduce the type of tumour and its treatment response. Like an at-home Covid test, this one can also potentially be performed using a strip of paper.
Bridging the gap. Scientists have created computer-generated models to establish the associations between in vitro, in vivo, and in silico brain cells. By deducing the specific type and function of each neuron in our brain, these findings could someday advance the development of neurological disease treatments.
The sound of silence. Scientists have found a new genetic therapy which can ‘silence’ genes to address dementia and Alzheimer’s disease. The drug, BIIB080, stops RNA from producing the tau protein, which is associated with the neurodegenerative condition. These phase 1 results are promising, but only further research will determine if this intervention will have any clinical benefit.
Zap your heart. Radiation is ordinarily reserved for cancer treatments, but doctors are now experimenting with radiation to treat irregular heartbeats, or ventricular tachycardia, in patients for whom no other intervention has worked.
Same, same, but different. A research team took a peek at the genomes of 240 mammalian species, including humans, bats, bison and a famous sledge dog. They compared the genomic sequences of these animals, and voila! They found that certain regions of the genomes have remained unchanged across mammal species over the course of millions of years of evolution. A minimum of 10% of the human genome is mostly unaltered across species.
But there have been changes, too, naturally. This far into our evolutionary history, mammals have adapted to survive pretty much anywhere, whether by developing new genes or losing pieces of DNA. In fact, the researchers discovered that some species underwent a lot of changes in fairly short periods of time, indicating modifications to the environments to which they were adapting.
Head over to the Zoonomia Project to see what else you share with your mammalian cousins. Get some insights into human diseases, mammals’ abilities to Rip Van Winkle their way through the winter, and what made sledge dog Balto so capable of surviving harsh Alaskan conditions.
(The Zoonomia Project)
Climate mystery. In the past few weeks, ocean temperatures have suddenly spiked well over record levels. From early March to now, the world’s average ocean surface temperature jumped 0.2 °C, which is huge for such a short time period. In the Pacific and Indian Oceans, sea temperatures rose 0.4 °C in about two weeks. Is this El Nino wreaking havoc? But what about the marine heat waves in the northern Pacific, near Alaska and Spain? El Nino doesn’t completely explain those away. But it looks like whatever the cause, things are only going to get hotter from here on.
Climate change up to no good. Europeans lost ski season. East Africans got a drought. World Weather Attribution, an international group of climate scientists, is saying that the current drought in Eastern Africa has been exacerbated by climate change, a phenomenon which made the drought more likely to happen in the first place. Climate change has made the long rains season drier and the short rains season wetter, resulting in a “one of a kind” situation in East Africa. More than 20 million people have been affected, 2.2 million have been displaced, and 15 million children are vulnerable to acute malnourishment. Severe disease outbreaks are also wreaking havoc in the region. Other than the temperature, nothing is looking up.
(World Weather Attribution)