💉 Valneva's Ixchiq the first approved chikungunya vaccine; Moderna, others leveraging mRNA magic; Takeda gets two FDA approvals
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💉 Valneva's Ixchiq the first approved chikungunya vaccine; Moderna, others leveraging mRNA magic; Takeda gets two FDA approvals
#469 | A breakthrough in RA research; Improved T-cell therapies; Coca-Cola safe to drink in Croatia
Hello, and welcome back to your favourite life sciences newsletter for the last time this week. Climate-resilient health systems are making recurring appearances in today’s edition. Our first story is an African perspective on approaches to enhance climate-resilient and low-carbon health systems.
Developing countries like South Africa have been pushing back against unfair intellectual property (IP) protections globally, especially in the context of the pandemic. But back home, there is much to be desired. Industry experts have highlighted the urgent need to develop IP rights in the Southern African Development Community (SADC) region to build an effective end-to-end pharma manufacturing ecosystem and achieve medicine supply security.
In South Africa, malaria cases are on the rise. Between January and October this year, the country recorded 7,400 cases. Only 17% of them are locally-acquired, while the rest are imported cases. At least 66 malaria deaths have been reported during the same period.
Saudi Arabia’s Tamer Healthcare is acquiring a 30% stake in United Company of Pharmacists (UCP), Egypt’s largest pharma distributor. Tamer is buying a portion of American conglomerate Cencora’s 50% stake in UCP. The potential sale value is estimated to be $35 million.
India-headquartered Lupin has inked an exclusive licensing and supply agreement with Amman Pharmaceuticals from the MENA region. The agreement concerns the marketing and commercialisation of Ranibizumab, a biosimilar of Lucentis meant to treat a range of eye conditions, in Jordan, Saudi Arabia, UAE, Iraq, Lebanon and other GCC countries.
In Colombia, the burden of malaria has been growing in recent years. The Ministry of Health and Social Protection has issued an alert that nearly 12 million people are at risk of contracting the disease.
Hilleman Laboratories, a JV between MSD and the Wellcome Trust, has opened an SGD27 million (~$20 million) GMP facility in Singapore. The large-scale facility is part of a five-year SGD80 million investment by Hilleman. The new facility will supply materials for the early-stage development of affordable vaccines for common diseases in the Southern Asian country; it will also be able to rapidly switch to the production of a new vaccine in case of another pandemic. It will work in tandem with an R&D lab for biopharma products intended for Singapore and LMICs.
Japan currently relies heavily on China for APIs for antibiotics. But the Japanese government has now designated antibiotic APIs as a “specified critical product” under the Economic Security Promotion Law. Accordingly, Japanese pharma companies are set to resume producing APIs for antibiotics for the first time in about three decades, with subsidies for two company groups. The goal is to start production by 2024 and establish a self-sufficient supply system by 2030.
Bayer and US-based Recursion Pharmaceuticals have announced that they have updated the focus of their research collaboration to precision oncology. The collab will leverage Bayer’s small molecule compound library and Recursion’s AI-guided drug discovery platform to identify novel therapeutic targets for oncology indications with high unmet need. The partners may initiate up to 7 oncology programmes. Recursion is eligible to receive potential future payments of up to $1.5 billion, plus royalties.
Takeda has two new approvals from the US FDA: one for Fruzaqla for previously treated metastatic colorectal cancer and another for Adzynma, designed to treat congenital thrombotic thrombocytopenic purpura, which is an ultra-rare blood clotting disorder.
Novavax’s latest contribution to the layoff wave: a second round of job cuts just 6 months after announcing a first wave of cost-cutting. The company is looking to reduce another $300 million in spending. Exact decisions about the cost reductions have not yet been made, but they are likely to affect majorly R&D and SG&A.
The US FDA yesterday approved Ixchiq, Valneva’s single-shot chikungunya vaccine for adults at increased risk of exposure to the virus! This is the first shot for the mosquito-borne disease to be approved in the US. Still, the FDA has asked Valneva to conduct a post-marketing study to assess the risk of adverse reactions following administration of the shot.
And finally, in a very quick resolution to yesterday’s ban on some Coca-Cola products in Croatia, the country’s state inspection office has cleared all Coca-Cola products of safety concerns. Go on, keep chugging those sugar-sweetened beverages.
Every Friday, we relax our paywall so you can see for yourself the value of paying ₹500/month (or ₹4500/year) for a concise download of the day’s top news and events at the intersection of human and animal health, climate change and environmental science. Please consider becoming a paid subscriber.
The Week That Was
Here's a quick look back at some of the highlights from the week that went by.
The beginning of the end is here. At least, that’s what the European Federation of Pharmaceutical Industries and Associations (EFPIA) claims. The European Commission (EC) proposed a major overhaul to pharma rules in April this year, including shortening the time a new medicine remains patented. But the industry group says that this could see Europe’s share in global R&D contract by a third, from 32% to 21%, by 2040 - that is €2 billion ($2.15 billion) per year in lost R&D investments.
At the recently concluded AfriCaribbean Trade and Investment Forum, ACTIF23, countries leveraged the power of South-South cooperation. The trade potential between Africa and the Caribbean is estimated to be about $16 trillion. The President of Guyana urged the region’s private sector to collaborate with African counterparts to develop a consortium to take on challenges that have long plagued the region, especially with the support of Afreximbank. Notably, as we mentioned last week, Afreximbank is championing a vaccines and medicines production collab between Rwanda, Guyana, and Barbados, with logistical and financial support from the Africa Medical Supplies Platform.
The Africa CDC and the EU Commission recently inked an agreement to support access to health products and local manufacturing in Africa. Part of the Team Europe Initiative on Manufacturing and Access to Vaccines, Medicines, and Health Technologies (TEI MAV+), this agreement aims to improve access to quality health products in Africa. The EU is contributing €134 million for the sustainable implementation of national plans in 6 African countries.
The UK announced £34.5 million ($42.8 million) in funding for four hubs meant to develop vaccines for diseases with epidemic potential in LMICs. The hubs will be part of the UK Vaccine Network (UKVN) project. The Future Vaccine Manufacturing Research Hub will focus on economical manufacturing and deployment of vaccines in countries like Vietnam, Bangladesh, and South Africa. The Chanjo Hub will lead the endeavour to establish local vaccine manufacturing in Kenya and Ghana. The third hub will research vaccine platform tech to accelerate appropriate vaccine development to meet the needs of LMICs. The fourth will prioritise developing a vaccine manufacturing ecosystem in Southeast Asian countries, focusing on dengue and hand, foot, and mouth disease.
The Federal Trade Commission (FTC), the guardian of consumer rights in the US, has been scrutinising the build-up of patents that has prevented generic competition from emerging. This week, the FTC challenged over 100 patents, claiming that they were improperly or inaccurately listed in the FDA’s Orange Book, which is the registry of patents on approved medicines. AbbVie, AstraZeneca, Boehringer Ingelheim, GSK, Teva, and five other manufacturers are under fire. Such improper listings – over asthma inhalers, epinephrine autoinjectors, and other drugs – can stall drug development, stifle innovation, and trigger regulatory delays for potential generics challengers by throwing up legal hurdles.
The antimalarial drug Spaq (sulfadoxine-pyrimethamine plus amodiaquine) is often used to prevent malaria in children during peak transmission periods, like the monsoons. Thus far, demand for drugs like Spaq in Africa has been met by generic imports from India and China. But in very, very good news for pharma localisation efforts in Africa, the Kenyan pharma company Universal Corporation Limited has become the first in Africa to receive WHO pre-qualification to produce the lifesaving malaria drug.
The Rockefeller Foundation announced the first round of funding from its $1 billion, five-year climate strategy. The Foundation is granting over $11 million to 25 grantees to advance various climate solutions in LMICs in Africa, Asia, LatAm, the Caribbean, and communities across the US. This also includes grants to tackle food and health security, curb coal, increase solar energy, grow climate finance, scale up regenerative agriculture, and more. You can find the full list of grants here.
Over the past half-century, Africa’s cities have become some of the most polluted in the world. As populations grow and industrialisation gathers speed, air quality will almost certainly worsen. As of now, a miniscule 0.01% of global air pollution funding is spent in Africa. Researchers from the University of Birmingham, the University of Cambridge, Imperial College London, South Eastern Kenya University, and the African Centre for Clean Air have released a new perspective piece in Nature Geoscience. They argue that this isn’t Africa’s problem alone.
Sanofi-Aventis Nigeria has announced an “exciting transformation of its business model in Nigeria”. According to our Nigerian namesake The Cable, February 2024 will mark the end of Sanofi’s direct operations in Nigeria. The French supplier of injectable polio, influenza, meningitis and rabies vaccines will adopt a third-party model to distribute its products in Nigeria. Sanofi’s head of communications and CSR in Africa has blamed Nigeria’s economic situation for the company’s decision, with the foreign exchange crisis making it difficult to import medicines. Sanofi is the second big pharma company to transition to a third-party model in Nigeria after GSK made a similar announcement in August.
Newsworthy
Magical mRNA. Cell therapies currently involve collecting a patient’s immune cells and engineering them in a lab setting before reinfusing them into the body. This process is highly intensive, requires chemotherapy, and comes with a bunch of side effects. This is where mRNA can intervene.
A few biotechs like Moderna, Carisma Therapeutics, Capstan Therapeutics, and Orna Therapeutics have their eyes set on simple mRNA infusions which supply genetic instructions to immune cells for the cancer-targeting chimeric antigen receptor (CAR). Their approaches bypass the complex manufacturing processes needed to make current cell therapies by engineering cells directly in the body rather than outside. Such therapies would be off-the-shelf, ready to administer while still achieving the benefits of cell engineering. The main limitation of such an approach, however, is that mRNA is short-lived, so multiple doses will be required. Recently, at the Society for Immunotherapy of Cancer’s annual meeting, Carisma and Moderna revealed data from their collab to use mRNA to engineer macrophages (CAR-M), while Capstan and Orna presented data from their efforts to use different types of mRNA to engineer T cells to target cancer. This method is still untested in humans. Orna is planning to begin its first clinical trial in 2024. If successful, such mRNA infusions can revolutionise the treatment of cancers and autoimmune diseases. Endpoints News offers a glimpse at the future of CAR-T therapies.
(Endpoints News)
Zoonotic viruses coming for us. How long have you been rejoicing at the end of the Covid pandemic? Travelling all over the world, unmasked and unconcerned about the threat of a viral outbreak? We hate to burst your bubble but, well, this too shall pass. The biotech company Ginkgo Bioworks has released an analysis of historical data about infectious disease outbreaks, and the trends look anything but encouraging. Outbreaks reported from four zoonotic viruses – SARS coronavirus 1 and the filoviruses Ebola, Machupo virus (the cause of Bolivian haemorrhagic fever), and Nipah virus – rose by nearly 5% annually between 1963 and 2019. Deaths rose by 8.7% annually. Outbreaks of these diseases appear to be fragmented, few, and far between, but researchers emphasise that these epidemics aren’t random – there is an underlying trend which is only rising. If this trend continues, by 2050, we should expect to see 4x the number of spillover events; the total number of deaths from these four diseases alone will be at least 12x what it was in 2020. And this isn’t even accounting for Covid-19-scale pandemics.
(BMJ Global Health)
DNA doses. mRNA vaccines have definitely been game-changing when it comes to controlling infectious disease spread, but DNA vaccines may go a step further. DNA vaccines have many potential advantages – rapid manufacturing, easy storage, relative cost-effectiveness, and protection effectiveness as high as conventional live virus-containing vaccines. Like mRNA vaccines, DNA vaccines also get our cells to do the difficult part of manufacturing viruses or viral proteins. One perk that DNA offers is that it is more stable than mRNA. But a challenge is presented by the fact that a DNA vaccine would require specialised delivery, such as injection via microneedles. The DNA-based Covid vaccine ZyCoV-D earned emergency authorisation in India in 2021, but no DNA vaccine has ever received full approval so far.
The US company Medigen has told New Scientist that it is seeking approval from the US FDA to conduct the first human trials of such DNA vaccines – the hope is that trials in people will begin next year. Medigen has circumvented the DNA delivery problem by coding its DNA vaccine for live viruses; to prevent mutation back to the wild viral form, it has deleted some genes and rearranged others. Medigen has already tested two potential DNA vaccines in mice for chikungunya and for yellow fever. Both vaccines protected the mice from future infections. It is also developing similar shots for Japanese encephalitis and Lassa fever. We can’t wait to see where this research leads!
(New Scientist)
R&D
Breakthrough in T-cell cancer therapy. Researchers at Duke University have made significant advancements in enhancing T-cell cancer therapies using CRISPR technologies. They discovered that a master regulator transcription factor (TF) gene, BATF3, can reprogram thousands of genes in T cells, boosting their ability to kill cancer cells. This breakthrough offers a substantial improvement to current T cell therapies, which are already used for treating various leukaemias, lymphomas, and multiple myeloma. The Duke team's approach could potentially extend the efficacy of these therapies to solid tumours, which currently pose a challenge due to T-cell exhaustion. The new methods for identifying, testing, and manipulating these genes could lead to more effective treatments for cancer and other diseases like autoimmune disorders.
The team employed a novel CRISPR-Cas9-based method that modulates genes without cutting them. This approach allows for the exploration and modification of the "dark genome," which influences T cell states. The researchers identified 120 master regulator genes, including BATF3, that control T-cell activity. Significantly, when BATF3 was over-expressed in T cells, it not only enhanced their potency but also their resistance to exhaustion, particularly in a mouse model of human breast cancer. This method holds promise not just for individualised T-cell therapies but also for developing universal T-cell treatments for a wide range of cancers. The success of this methodology marks a critical step in overcoming limitations in T-cell therapy and expanding its effectiveness to more cancer types and patients.
(Nature Genetics)
Cracking the RA code. Researchers at the University of Colorado School of Medicine have made a significant breakthrough in rheumatoid arthritis (RA) research, potentially paving the way for more targeted treatments. Their research analysed over 300,000 cells from synovial tissue of 70 RA patients. This comprehensive cell atlas revealed six distinct RA subgroups, each with unique cellular compositions. This finding, enabled by advanced computational analysis and classification methods, marks a departure from the traditional guess-and-check approach in RA treatment, offering a more precise method for matching patients with effective therapies. This groundbreaking work not only holds promise for RA treatment but also has broader implications for understanding and treating other autoimmune diseases and immune responses in conditions like cancer or infections. The study represents years of collaborative and interdisciplinary effort, emphasising the potential of big data and AI in advancing precision medicine in rheumatology.
(Nature)
Breathing new life into medicine. Northwestern University researchers, funded by a DARPA contract, have made a significant stride in developing an implantable "living pharmacy" designed to control the human body's sleep/wake cycles. Their innovative device, the electrocatalytic on-site oxygenator or ecO2, successfully produces oxygen at the site to keep cells alive longer within the implant. This advancement is crucial because the viability and therapeutic efficacy of cells in such implants depend on their sustained health. The ecO2, through a low-energy, water-splitting process, generates oxygen without harmful byproducts, maintaining 70-80% cell viability for up to a month in vitro and for weeks in vivo. This contrasts starkly with control groups, where only about 20% of cells survived after 10 days. The ecO2 technology, using materials like sputtered iridium oxide, offers a more compact and efficient solution compared to previous oxygen delivery methods, showing promise for chronic applications in treating diseases like obesity, diabetes, and cancer. The team's next focus is on long-term deployment, aiming to develop materials for the device that can function inside the body for extended periods, moving closer to clinical application for chronic disease treatment.
(Nature Communications)
Bottom line
Climate resilience in the health sector. Health systems globally are vulnerable to the effects of climate change, but they also contribute to it. The health sector is responsible for almost 5% of global greenhouse gas emissions. In the lead-up to the UN Framework Convention on Climate (COP-28), the WHO has released a new operational framework for building climate-resilient and low-carbon health systems. This framework gives countries a roadmap to simultaneously enhance the resilience of health systems and reduce greenhouse gas emissions. It offers different pathways for health systems with different capacities, emissions, and overall performance. It also addresses the challenges of low-income countries which need to increase energy access and health service provision to achieve universal health coverage.
(WHO)
Oh, and Gopal Nair doesn't want you to see this.
Every Friday, we relax our paywall so you can see for yourself the value of paying ₹500/month (or ₹4500/year) for a concise download of the day’s top news and events at the intersection of human and animal health, climate change and environmental science. Please consider becoming a paid subscriber.