Today, we look at some of the most interesting developments in the biotech and MedTech sector, including the latest breakthroughs in tackling Covid-19. We will discuss the upgrade from the mRNA vaccines, the saRNA vaccines as a possibility to gain immunity to a variety of diseases, CRISPR tools that can tackle the diseases spread by mosquitoes, eureKARE raising $60 million for their niche microbiome research, WHO’s approval of the Sinovac vaccine, a new breakthrough study by Kaiser Permanente researching the impact of continuous glucose on patients with type 2 diabetes, the author of the non-invasive spine stabilization tool, Empirical Spine, with a fresh round of funding, FDA approving the marketing of ML-powered tools detecting ADS and more.
As the mRNA vaccines became widely known to anybody due to their prevalence in protecting the population from the Covid-19 virus, scientists globally are working on an update. The goal of the researchers is to reach the saRNA stage (self-amplifying vaccines)
One of the most up-and-coming startups introducing the saRNA vaccines is the Belgian biotech Ziphius Vaccines. The company just closed its €29.3M funding round and plans to produce a variety of vaccines. Being one of the few in the saRNA space, Ziphius wants to create a niche in the market.
The saRNA technology builds on the concept of mRNA that delivers genetic instructions to our cells. That allows for the creation of proteins that can teach our immune system how to fight against a virus. With saRNA, as opposed to mRNA, cells can replicate all the instructions which will boost the effectiveness of the vaccine.
“Startups that use RNA technologies have gained a lot of interest from investors,” said Chris Cardon, the CEO of Ziphius. “From a scientific point of view, it is clear that saRNA has many advantages compared to conventional mRNA.”
“[Self-amplifying RNA technology offers] the advantage of stretching supplies to allow more doses to be manufactured and given — especially critical in an emerging infectious disease outbreak,” said Amesh Adalja, an expert in infectious diseases at the Johns Hopkins Center for Health Security.
Currently, the medical benefits and safety of saRNA are being researched, however, from the preliminary findings, we learn that introducing saRNA vaccines could result in for example fewer side effects, more varied immune responses, or even being able to tackle diseases that were immune to vaccines so far.
One of the examples is Malaria, as shown by the Yale University researcher Richard Bucala that is currently studying saRNA technology for this purpose.
“In malaria, which remains the second leading cause of infectious disease in the world, the use of self-amplifying RNA to vaccinate against the parasite product responsible for immune evasion was associated with an exceptional level of protection in experimental studies,” said Bucala.
“Self-amplifying RNA offers a powerful and potentially universal approach to eliminate the global scourge of malaria and other parasitic infections that have long thwarted the social and economic development of sub-Saharan Africa and many regions of South Asia,” he adds.
With a €49M ($60M) Series A, the French biotech startup eureKARE has announced its primary goal of priming the translational pump in the microbiome.
“There are many opportunities to extract this research and build new companies, but we definitely need new funds and new investment structures,” says Rodolphe Besserve, eureKARE’s CEO.
The Paris-based startup plans to use the Series A funding to expand the academic research and focus on novel areas such as microbiome and synthetic biology.
“We wanted to bridge a gap that we see in Europe between academia and where the actual research comes to light,” says Alexandre Mouradian, eureKARE’s founder, and chairman.
“There’s a lot of clinical proofs-of-concept that wasn’t there five years ago,” says Savita Bernal, CBO for Lyon-based MaaT Pharma, “and some companies will be entering the market extremely soon.”
CRISPR has been a frequent topic in our news. Since the technology has undergone a huge development, the researchers have been working nonstop to find new ways to leverage it. One of the important targets was the development of gene drives that will target the pathogen-spreading mosquitos that transmit several life-threatening diseases such as malaria or dengue.
However, so far not much attention has been given to the Culex genus mosquitos. This specific type of insect spread several diseases such as the West Nile virus, Japanese encephalitis virus, and the pathogen causing avian malaria.
Now, researchers from the University of California San Diego have developed gene-editing tools that can eventually stop the Culex mosquitoes from spreading the disease.
“My coauthors and I believe that our work will be impactful for scientists working on the biology of the Culex disease vector since new genetic tools are deeply needed in this field,” said Gantz, an assistant research scientist in the Division of Biological Sciences at UC San Diego. “We also believe the scientific community beyond the gene drive field will welcome these findings since they could be of broad interest.”
Culex mosquitoes do not constitute a huge problem in the United States but they are very much dangerous among the African and Asian nations.
“These modified gRNAs can increase gene drive performance in the fruit fly and could potentially offer better alternatives for future gene drive and gene-editing products in other species,” said Gantz.
On Tuesday, The World Health Organization (WHO) announced it has granted approval to the Covid-19 vaccine made by Sinovac Biotech. In a statement, the WHO’s independent panel of experts advised that the vaccine would be used in adults over 18. As the vaccine is shown to be protective among older people, there is no upper age limit.
The independent panel of experts has been working on their decision since May 5th and it has based its opinion on the latest clinical data proving the safety, efficacy and proper manufacturing practices of the vaccine.
“It’s now crucial to get these lifesaving tools to the people that need them quickly,” WHO Director-General Tedros Adhanom Ghebreyesus said.
Due to the low-maintenance storing requirements, the Sinovac vaccine is a perfect solution for low-income countries.
Yesterday, the U.S. Food and Drug Administration authorized the marketing of a device that helps diagnose autism disorder. The Cognoa ASD Diagnosis Aid is a software-based on machine learning and it helps to assess and detect ASD in children between 18 months to 5 years.
“Autism spectrum disorder can delay a child’s physical, cognitive and social development, including motor skill development, learning, communication and interacting with others. The earlier ASD can be diagnosed, the more quickly intervention strategies and appropriate therapies can begin,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Today’s marketing authorization provides a new tool for helping diagnose children with ASD.”
Autism Spectrum Disorder is estimated to affect roughly 2% of children. However, an accurate diagnosis still causes problems as ASD can contribute to a range of symptoms. Thus, many children are only diagnosed during school-age which prevents the early intervention.
The FDA reviewed Cognoa Diagnosis Aid through the De Novo premarket review which is meant for low-to moderate-risk devices.
The FDA reviewed the Cognoa ASD Diagnosis Aid through the De Novo premarket review
A study that was published yesterday in the journal JAMA found that the use of continuous glucose monitors in patients with insulin-treated type 2 diabetes will lead to better blood sugar. The study was conducted by Kaiser Permanente.
“The improvement in blood sugar control was comparable to what a patient might experience after starting a new diabetes medication,” said the study’s lead author Andrew J. Karter, PhD, a senior research scientist with the Kaiser Permanente Northern California Division of Research.
“Blood sugar levels that go too low can be dangerous,” said the study’s senior author Richard Dlott, MD, an endocrinologist and the medical director of population care for The Permanente Medical Group. “This study shows that continuous glucose monitors helped people stay close to their glucose targets without going too low.”
Now, the scientists say they must find out if there are other patients suffering from type 2 diabetes who could benefit from the continuous glucose monitors. “This study found that patients who used continuous glucose monitors had very good results compared to those who continued only with intermittent testing using finger sticks,” said Dr. Dlott. “We now need to determine whether there are other patients who might also benefit, even if they don’t meet all of the Medicare criteria. The newest technology isn’t always better for everybody. We need to identify the people who are most likely to benefit.”
Empirical Spine, the Medtech startup and maker of LimiFlex Paraspinous Tension Band has closed its Series B funding round led by HD (Scientific Health Development) led the round, with additional investment from GP&G (Green Park & Golf) and other syndicate members. The round closed at $10 million and the newest financial injection will be used to advance the company’s products.
“We are gratified by the confidence investors are showing in the LimiFlex device,” said Empirical Spine CEO Richard Treadwell. “As study data accumulate, we have more and more evidence that LimiFlex is on track to meet or exceed the clinical results we hoped for. The new funds will enable us to develop and submit a very strong PMA filing in the coming months.”
Dr. Reginald Davis of BioSpine Institute commented, “Results from the LimiFlex trial suggest the LimiFlex device may offer a motion-preserving, minimally invasive treatment option suitable for use in outpatient settings, such as the ambulatory surgery center (ASC). In my practice, I have seen increased interest in these benefits from both patients and physicians.”
As traditional ways to stabilize the spine after surgery are associated with time-consuming and invasive procedures, the LimiFlex device is revolutionizing the market as it offers a non-invasive way to stabilize the spine.