New vaccine candidates come one step closer to the emergency approval in the European Union, with the German CureVac’s candidate filing for approval this month and the Chinese Sinovac officially under real-time review by the European Medicines Agency (EMA). Meanwhile, Harvard Scientists have discovered two lung-on-a-chip models that show promising results in Covid-19 drug discovery. Apart from biotech news related to Covid-19, there were several breakthroughs in Medtech. Medtronic launched a virtual spinal cord stimulation treatment. MIT scientists found a new way to eliminate cancer cells by squeezing them out of the tissue lining. Mitotech found a novel way to fight eye disorders and the first wireless device that can monitor the brain activity of Parkinson’s patients has been developed. To find out more about these and other stories, take a look at our latest biotech weekly.
MedTech News: New Lung-On-A-Chip Models Developed By Harvard Scientists Can Advance Covid-19 Drug Discovery
Two teams from Harvard University have made a great discovery while developing the newest lung-on-a-chip models that could help to combat Covid-19. One of the models has already uncovered an existing drug that may be effectively used in tackling the virus.
The team led by Harvard’s Wyss Institute for Biologically Inspired Engineering found out that an antimalarial drug, amodiaquine, prevented the SARS-CoV-2 virus from getting into the lung cells. The results have already been validated in the journal Nature Biomedical Engineering.
The model created by the Harvard teams is called Lung Airway Chip and includes two channels, one of which is filled with air while the other containing human blood vessel cells and liquid that mimics the blood flow. In the model device that is as small as a memory stick, the traits are extremely similar to the real human lung.
“We designed a SARS-CoV-2 pseudovirus that expresses the SARS-CoV-2 spike protein so that we could identify drugs that interfere with the spike protein’s ability to bind to human lung cells’ ACE2 receptors,” explained co-author Haiqing Bai, Ph.D.
While under the studies, the lung model showed no efficiency in the antimalarial drugs such as hydroxychloroquine and chloroquine (both of them were seen as potential Covid-19 cure at the beginning of the pandemic). However, instead, it pointed at amodiaquine. In the trials, the drug was able to reduce the infection by 60% in the chips.
“In terms of COVID-19, we’ve had very minimal timelines for developing therapies. In the future, if we have these models ready in hand, we can easily use them to study and test therapeutics in urgent situations where clinical trials are limited,” said co-author Y. Shrike Zhang, Ph.D.
BioTech Weekly News: Sanofi Starts New Immunology Drug R&D In Partnership With Stanford Medical
Sanofi is starting a new immunology drug discovery journey, together with Stanford Medical.
“The journey of a drug is typically over 10 to 12 years. It’s a very long journey,” Frank Nestle, Sanofi’s global head of research and Chief Scientific Officer, said in an interview.
The scientific exchange collaboration between Sanofi and Stanford will allow the latter to receive funding for the discovery of up to three programs and host an annual research event to explore the complexities of autoimmune and inflammatory diseases.
The three programs will focus on type 2 inflammation, type 1 diabetes, and immune-related adverse effects of cancer.
MedTech News: Medtronic Is Launching A Virtual Spinal Cord Stimulation Treatment
Medtronic is about to launch its first virtual treatment for spinal cord stimulation, to assist patients with controlling their chronic pain in the time of the pandemic that limits the on-site therapy possibilities.
The clinical data released by Medtronic last year showed that their adaptive treatment could decrease chronic pain by at least half among 85% of the study participants.
The company has also developed a website and a mobile app together with the digital health provider Higgs Boson Health and the platforms are supposed to serve as a guide for patients at the beginning of their therapy, as well as a place where the patients can communicate with the caregivers and health professionals.
Medtronic is planning to personalize and improve the therapy by collecting real-time feedback from patients who will be able to give it from the comfort of their own homes, saving a trip to the clinic.
Medtronic’s CareGuidePro includes several features that can facilitate the therapy for the patients, including procedure-specific FAQs, task lists, or reminders.
Currently, Medtech is enrolling patients for a limited commercial release. The expanded launch is expected this summer.
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Biotech Weekly News: MIT Scientists Find A Way To Expel Cancer By Squeezing The Cells Out Of The Tissue Lining
The joint scientific collaboration between the Massachusetts Institute of Technology (MIT) and King’s College London, led by the Nobel laureate H. Robert Horvitz, Ph.D., has shown an unprecedented process that can fight cancer.
In a process called cell extrusion, the cancer cells are squeezed out of the lining of tissues. The extrusion could serve as a basic mechanism to eliminate cancer cells based on the subsequent replication stress.
“The discovery that extrusion is driven by a failure in DNA replication was unexpected and offers a new way to think about and possibly intervene in certain diseases, particularly cancer,” Horvitz said in a statement.
“Replication stress is one of the characteristic features of cells that are precancerous or cancerous,” Vivek Dwivedi, Ph.D., a post-doc at MIT and the study’s first author, said in the statement. “And what this finding suggests is that the extrusion of cells that are experiencing replication stress is potentially a tumor suppressor mechanism.”
MedTech News: Mitotech With A New Approach To Treating Eye Diseases
Mitotech is approaching Phase 3 clinical trials with its dry eye disease drug, after very promising results from the first two rounds of trials.
With 16 million people being diagnosed with dry eye disease only in America and the increasingly prevalent home office only expected to raise that amount, the demand for an effective drug that can tackle the condition is growing.
The company’s lead compound SkQ1 targets a biological process that has not been extensively addressed by the ophthalmic treatments before mitochondria-specific oxidative stress. Except for the dry eye syndrome, the mitochondria-specific oxidative stress can be applied in several other eye disorders such as dry AMD and glaucoma.
The studies have shown that oxidative stress may be crucial for patients suffering from glaucoma as the progress influences both the elevation of intraocular pressure (IOP) and the neurological damage that may follow.
“We have seen many new IOP-lowering interventions, both pharmacologic and surgical, emerge for our glaucoma patients, but in my opinion, there is still ample room for versatile topical medications targeting both IOP and ocular surface disease,” Dr. John Sheppard, the president at Virginia Eye Consultant, says. “Dry eye is ubiquitous in the aging glaucoma population, where efficacious prescription glaucoma drops nevertheless also create somewhat tolerable but truly undesirable dryness, redness, and irritation. A novel pharmaceutical intervention simultaneously effectively controlling both glaucoma and dry eye addresses a highly prevalent problem. An even more essential and lofty target is neuroprotection of the glaucomatous optic nerve. No proven treatment currently exists to prevent or repair damage to the optic nerve, the actual cause of permanent vision loss in glaucoma patients. Such a treatment could transform the field entirely.”
“We think that properly addressing oxidative stress in mitochondria is a critical missing piece in the treatment of many eye disorders,” said Natalia Perekhvatova, CEO of Mitotech. “That includes indications with markets from stable to high growth rates, as well as orphan indications. We believe that mitochondria-targeted therapies offer a unique approach that has the potential to benefit millions of patients and we are working hard on our parallel development programs.”
MedTech News: First Device Offering Long-Term Wireless Monitoring For The Brians Of The Parkinson’s Patients
Researchers have developed a device that can be a milestone in understanding the impact of Parkinson’s disease on brain activity.
Through a neurostimulation device that is implanted on the patient’s chest, the device can be connected to electrodes in the brain through thin wires. The electrodes can subsequently track all of the brain’s activity and transmit all of the data to a pocket-sized device.
Then the neurologists can analyze the data and gain better insights into brain activity among patients struggling with Parkinson’s disease. Several deep brain stimulation devices can manage Parkinson’s symptoms and be cleared by the FDA shows that they provide effects. However, so far all the devices have been limited to clinical settings and short-time use
“This is the first device that allows for continuous and direct wireless recording of the entire brain signal over many hours,” Philip Starr said in a release, whose University of California, San Francisco lab helped develop the device. “That means we are able to perform whole-brain recording over a long period of time while people are going about their daily lives.”
“Although we are not at the point where we can distinguish specific normal behaviors from brain activity recording, it is an absolutely legitimate concern,” Starr said. “We have told patients to feel free to remove their wearable devices and to turn off their brain recordings whenever they engage in activities they would like to keep private.”
CureVac Plans To Get Their Vaccine Approved By The EU
The German CureVac’s Covid-19 vaccine candidate is close to filing for emergency approval in the European Union. The filing is expected already this month.
The vaccine uses the mRNA approach that is also used by several other coronavirus vaccines such as Pfizer/BioNTech and Moderna.
The late-stage trial of the vaccine involved almost 40 000 participants in Europe and Latin America. CureVac has not yet announced when the results from the latest study will be published.
However, the company did state they expect to file for early authorization in Europe in late May or early June.
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EU Drug Regulator Starts Real-Time Review Of Sinovac’s Covid-19 Vaccine
On Tuesday, Europe’s drug regulator announced it has begun the real-time review of the Covid-19 vaccine developed by Sinovac. The review is based on both animal and human trials.
This is the first Chinese vaccine that the European Medicines Agency (EMA) is reviewing in real-time and the fourth Covid-19 vaccine undergoing such a review, following CureVac, Novavax, and Sputnik V.
Sinovac has not shown consistent efficacy rates, ranging between 50% and 90% depending on the study. So far, the vaccine is only authorized in China, Indonesia, Brazil, and Turkey.
As opposed to the mRNA vaccine that was made by Pfizer/BioNTech and Moderna, the Sinovac’s candidate contains inactivated or dead versions of the SARS-CoV-2, aiming at helping the immune system in producing antibodies.
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