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What’s Happening In Biotech? 01.04-08.04

The past week in biotech has been largely about the AstraZeneca vaccine discussions and the EU and UK regulators advising to keep using the vaccine despite more blood clot cases that have emerged in the past week. At the same time, many countries that have earlier suspended the vaccine now try to give an alternative for people under 30, as their risk of hospitalization is significantly slower. There were also several non-Covid19 related outbreaks in biotech and among biotech startups. Some of the main stories we will cover will include Johnson & Johnson contact lenses that slow down the progression of childhood myopia, Philips’ 3D imaging software receiving FDA clearance, and Nanox, an Israeli biotech startup, with an ambitious plan to deploy thousands of its innovative digital X-ray beds.

Johnson & Johnson Will Produce Contact Lenses That Slow Down Childhood Myopia 

Johnson & Johnson has partnered with Menicon, a Japanese contact lenses manufacturer to produce contact lenses that will slow down the progression of nearsightedness in children ages 12 and under. The lenses will be distributed globally. 

Johnson & Johnson has been focusing on the treatment of myopia for quite some time now. Back in 2018, the company started to cooperate with the Singapore National Eye Centre and the Singapore Eye Research Institute, in a $26.35 million research partnership aiming at prevention and treatment of myopia. 

“For decades, Johnson & Johnson Vision has invested in research collaborations with academic centers, research institutes, and leading global health organizations who share our vision of leading with science to reshape the future of myopia and eye health,” Peter Menziuso, global president of Johnson & Johnson Vision Care, said in a statement. “Our collaboration with Menicon marks another step forward to bring a portfolio of differentiated products to help manage the progression of myopia in children, as we work towards our vision of helping the world see better, connect better, live better.” 

Biotech Startup Icosavax With $100 Million To Study VLP Covid-19 Vaccines

Icosavax announced that it has raised $100 million in funding to test their viruslike particle (VLP) technology vaccines against a series of diseases including respiratory syncytial virus (RSV) and Covid-19. 

The company will use the funding to move the RSV vaccine into clinical trials and the Covid-19 vaccine into human testing. The company said that the data from clinical trials will, “inform potential development paths in the rapidly evolving COVID vaccine landscape.” 

The round was led by RA Capital Management and included investors such as Janus Henderson Investors, Perceptive Advisors, and Sanofi Ventures.

Icosavax is built on a computationally designed VLP technology. The platform helps the biotech to overcome the biggest challenges with VLP vaccines – at-scale manufacturing. The platform supports the design of proteins that self-assemble into VLPs, which can lead to strong, durable protection without safety issues. 

Philips’ 3D Imaging Software With FDA Clearance 

The FDA has recently granted Philips a clearance regarding their three-dimensional imaging software. The software was announced by Philips just a few months ago, back in September 2020. 

The SmartCT imaging software works together with the company’s Azurion image-guided therapy platform. Together, the systems guide clinicians through the process of acquiring and analyzing 3D image data collected through angiography, neurology, soft-tissue imaging, and guidewire navigation.

The CT-like scans can be manipulated and measured on touchscreen tablets. The tablet can be connected to a larger monitor allowing for more effective treatment in case of interventional radiology procedures. 

“A key part of our image-guided therapy strategy is to combine high-quality, low X-ray dose imaging with a superior user experience that allows interventional radiologists to diagnose and treat patients as part of smoother, safer and less interrupted workflows,” Ronald Tabaksblat, Philips’ general manager of image-guided therapy systems, said in a release. “Philips SmartCT is a major step forward in 3D imaging, enhancing confidence in the interventional suite and supporting key elements of the quadruple aim of better patient outcomes, enhanced patient and staff experiences, and lower cost of care.”

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Biotech Startup Nanox With A FDA Clearance Of Its Digital X-Rays Beds 

The Israeli startup Nanox has just received an FDA 510(k) clearance of its digital X-rays beds. 

The X-ray beds created by Nanox can quickly be associated with Star Trek, as they are modeled after the sci-fi series “biobed” and repace the heated metal filament used in traditional imaging with an innovative “cold cathode” hardware. The lower costs that come with it could make digital X-rays more accessible around the globe. 

The clearance has been long-awaited since it has been more than a year since Nanox submitted their Nanox.ARC technology to FDA. Since then, Nanox raised more than $100 million from investors and closed a $190 million IPO on the Nasdaq Global Market. 

In the U.S., Nanox has penned a deal with USARAD to deploy an initial order of 3,000 systems across the country once it receives the go-ahead from the FDA, said the CEO of the company, Ran Poliakine. 

“We believe we are well-positioned to achieve our goal of democratizing medical imaging and expanding the market to the roughly two-thirds of the world’s population who currently have limited or no meaningful access to imaging or the preventative screening that it offers,” Poliakine said.

Apart from the U.S., Nanox has already ambitious plans to deploy the X-ray beds around the globe. So far, the company made arrangements regarding deploying 2,500 Nanox.ARC systems in South Korea and Vietnam, another 1,000 across Australia, New Zealand and Norway, and 500 more in Italy, all pending local regulatory approval. Poliakine said the first 15,000 Nanox.ARC systems are expected to be shipped out by the end of 2024.

EU And UK Regulators Continue To Recommend AstraZeneca Vaccine 

On Wednesday, the EU and UK regulators said that there are possible links between the AstraZeneca vaccine and rare cases of blood clots but urged the countries to continue using the vaccine as the benefits strongly outweigh the risks. 

After the first reports about the possible blood clots, more than a dozen countries suspended the rollout of the vaccine. Now, it has resumed in the most, however, many countries decided to set a minimum age. 

The European Medicines Agency (EMA) received reports of 169 cases of the rare brain blood clot by early April, after 34 million doses had been administered in the European Economic Area, according to Sabine Straus, chair of the EMA’s safety committee. 

EMA did issue a statement in which it reminds health professionals and patients of 

“the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination”.

“So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination,” it added. However, it did not issue any new guidelines and the EU is still urging people to take the AstraZeneca vaccine as they consider the risk to be minuscule, as compared to the risk of Covid. 

Professor Frederic Adnet, head of emergency services at Avicenne Hospital in Bobigny, France, said the statement would nevertheless have a negative effect in countries where skepticism towards the AstraZeneca vaccine is growing. “The EMA’s communication today will undoubtedly affect confidence further in AstraZeneca’s vaccine,” he said.

“The risk of mortality from COVID is much greater than the risk of mortality from these rare side-effects,” EMA’s executive director Emer Cooke said.

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Britain Will Give Alternative To The AstraZeneca Vaccine

On Wednesday, it was announced by the Britain’s vaccine advisory committee that the people under 30 should be offered an alternative to the Oxford/AstraZeneca vaccine due to its connection to rare blood clots. 

Officials said the benefits of the shot continued to outweigh its risks for the majority of people. However, for the young people with smaller risk of hospitalization, the vaccine advisory committee said other vaccines are recommended. 

Wei Shen Lim, chair of Britain’s Joint Committee on Vaccination and Immunisation (JCVI), said, 

“We are advising a preference for one vaccine over another vaccine for a particular age group, really out of the utmost caution, rather than because we have any serious safety concerns.”

Over 20 million AstraZeneca vaccine doses have been given until March 31 in the UK, with 79 side effects and 19 deaths. 

 “This is a vanishingly rare, but sadly quite serious, adverse event…, and you can’t pick these kind of things up until you have literally deployed tens of millions of doses of vaccine,” Deputy Chief Medical Officer Jonathan Van-Tam said.

“As the regulators have said, this vaccine is safe, effective and has already saved thousands of lives – and the vast majority of people should continue to take it when offered,” Boris Johnson said. 

Munir Pirmohamed, chair of the Commission on Human Medicines, said the link between cerebral blood clots, lower platelets and the AstraZeneca vaccine was “getting firmer”.

“Early evidence suggests that this constellation of symptoms is caused by an immune response against platelets which allows the platelets to then lead to clotting in different parts of the body,” he told a news conference. “But what we don’t have clearly is the link between the vaccine and how the immune response becomes activated against the platelets, and that’s where the scientific work needs to go on to identify what that link is.”

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