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Virtual Clinical Trials, Covid-19 Antibody Cocktail Effective, And New Radiotherapy Cleared By FDA – Biotech Weekly

What can we expect from the collaboration between Luman and Novo Nordisk? How can the discovery of a new Glial Cell improve brain repairs? Can the new Covid-19 vaccines target more than just the B cells? What radiotherapy treatment was just approved by the FDA and why is it so important? Will Exscientia become a leader in AI-powered drug development after it acquires the promising startup Allcyte? Regeneron Antibody Treatment shows brilliant effects. 

Lumen And Novo Nordisk To Collaborate On Oral Biologics For Cardiometabolic Disease

The clinical-stage biopharma company, Lumen Bioscience, has just announced it is partnering with Novo Nordisk. The collaboration aims at evaluating the use of Lumen’s unique drug development and manufacturing platform in Novo Nordisk’s R&D development activities. 

“Novo Nordisk is a world-leading metabolic disease company, and we are thrilled that they share our enthusiasm for new strategies for delivering oral biologics,” said Brian Finrow, Lumen’s CEO. “This collaboration brings the best of two worlds together: Lumen’s expertise in large-scale, affordable manufacturing of orally delivered biologic drugs and Novo Nordisk’s expertise in the clinical development and commercialization of treatments for cardiometabolic disease.”

The first stages of the collaboration will occur in the next year. No financial details were announced by either of the companies. 

Discovery Of A New Cell Can Result In Improved Brain Repairs  

Glial cells can be found in the central nervous system and protect & maintain the brain’s neurons. They have a variety of functions such as supplying oxygen to the neurons, cleaning up brain debris, and working on holding the neurons in their places. 

In the journal Science paper “Release of stem cells from quiescence reveals gliogenic domains in the adult mouse brain”, the researchers from the University of Basel report the existence of two new types of glial cells that may play an instrumental role in brain repair and neuroplasticity. 

“Quiescent neural stem cells (NSCs) in the adult mouse ventricular-subventricular zone (V-SVZ) undergo activation to generate neurons and some glia,” wrote the researchers. “Here we show that platelet-derived growth factor receptor beta (PDGFRβ) is expressed by adult V-SVZ NSCs that generate olfactory bulb interneurons and glia. Selective deletion of PDGFRβ in adult V-SVZ NSCs leads to their release from quiescence, uncovering gliogenic domains for different glial cell types.”

The research was led by Fiona Doetsch, PhD, professor at the Biozentrum of the University of Basel.

“We found an activation switch for quiescent stem cells,” Doetsch explained. “It is a receptor that maintains the stem cells in their resting state. We were able to turn off this switch and thus activate the stem cells.”

“Some of the stem cells did not develop into neurons, but into two different novel types of glial cells,” Doetsch added. 

Developers Of Covid-19 Vaccine May Reach Out To More Than Just B Cells 

According to a new study, the new Covid-19 vaccines can do more than reach out to the B cells and help them recognize and respond to SARS-CoV2. Recently, other bits have come to light. Although their functions are not widely known, they can activate T cells. 

The new study comes from Boston University’s National Emerging Infectious Diseases Laboratories (NEIDL) and the Broad Institute of MIT and Harvard. The researchers from these institutions have been focusing on all the possible “red flags” that are appearing when an individual has contracted Covid-19, as well as the responses from T cells. 

The results of this work appeared June 16 in the journal Cell, in an article titled, “Profiling SARS-CoV-2 HLA-I peptidome reveals T cell epitopes from out-of-frame ORFs.”

“We found HLA-I peptides derived not only from canonical ORFs but also from internal out-of-frame ORFs in Spike and Nucleocapsid not captured by current vaccines,” the article’s authors wrote. “Some peptides from out-of-frame ORFs elicited T cell responses in a humanized mouse model and COVID-19 patients that exceeded responses to canonical peptides including some of the strongest epitopes reported to date. Whole proteome analysis of infected cells revealed that early expressed viral proteins contribute more to HLA-I presentation and immunogenicity.”

Based on the new information, “companies should reevaluate their vaccine designs,” said Mohsan Saeed, Ph.D., a NEIDL virologist and the co-corresponding author of the paper.

“It’s quite remarkable that such a strong immune signature of the virus is coming from regions [of the virus’ genetic sequence] that we were blind to,” said Weingarten-Gabby, the paper’s lead author and postdoctoral fellow in the Sabeti lab. “This is a striking reminder that curiosity-driven research stands at the basis of discoveries that can transform the development of vaccines and therapies.”

“Our discovery … can assist in the development of new vaccines that will mimic more accurately the response of our immune system to the virus,” Sabeti added.

US Patients Can Now Use Radiotherapy System Changing Cancer Landscape 

Today, Elekta Harmony linear accelerator was cleared by the U.S. Food and Drug Administration. The radiation therapy system can pave the way for a range of treatments tackling some of the most complex and serious diseases using radiotherapy techniques. 

“The cancer burden in the United States and worldwide is increasing significantly, arising not just from an aging population, but also from delayed diagnoses and treatments due to Covid-19,” notes Larry Biscotti, Elekta’s Executive Vice President Region North & Central America. “Harmony was designed not only to enable the latest advanced radiotherapy techniques but also to simplify and streamline the radiotherapy process, with guided workflows and a user interface that facilitates a short learning curve. The interface gives the treatment staff all the information they need where they need it. The results are shorter treatment times, greater productivity, and more patients treated.”

“Research results are pointing to the clinical value of hypofractionation for a variety of malignancies, including prostate, breast, and lung cancers,” adds John Christodouleas, MD, MPH, SVP of Medical Affairs & Clinical Research Linac-Based RT. “The trends in patterns of care data suggest that hypofractionation – enabled through systems capable of stereotactic body radiotherapy [SBRT] – is going to be routine at all radiotherapy centers,” he says. “If only 10 percent of metastatic carcinoma patients are treated with SBRT once or twice throughout their treatment course, SBRT will be in considerable demand. When we designed Harmony, SBRT indications were a priority.”

“In cancer care, we’re seeing a shift in which networks are siting many machines to cover large geographic areas to bring treatment closer to where people live,” he observes. “These networks need delivery systems that can handle both technically demanding treatments like SBRT and also more conventional IGRT regimens. Harmony was built as an efficient, versatile linear accelerator allowing clinicians to treat more patients with high-quality precision radiation therapy.”

Exscientia Acquires Allcyte To Speed Up Its AI-Powered Drug Discovery Goals

Exscientia has just announced they will acquire an Austrian AI startup that leverages AI to predict how cancer treatments will work in individual patients. The unique technology of Allcyte will be combined with Exscientia’s software that also utilizes AI, both to identify potential new drugs but also build them and get them through the clinical trials. 

Exscientia will pay €50 million, or about $60.6 million U.S., in cash and ordinary shares to acquire Allcyte. 

The deal helps Exscientia tremendously in leveraging the precision medicine approach in drug molecules design. “Allcyte is able to demonstrate what therapy actually works in the individual patient with the most disease-relevant screening platform we have seen,” Exscientia CEO Andrew Hopkins said in a statement. “Combining Allcyte’s platform with Exscientia’s technologies can redefine how drugs are developed, enabling integrated discovery and patient selection.”

Medidata Bets On Virtual Clinical Trials And Rolls Out Decentralized Technology Platform 

Medidata, the company whose cloud platform stands behind the clinical trial life cycle of Moderna’s Covid-19 vaccine now rolls out a decentralized technology platform. The company is betting big on the virtualization of clinical trials and wants to combine technology and workflows to allow for remote patient participation. 

“The life science industry has seen accelerating interest and adoption of decentralized trial technology in the wake of the COVID-19 pandemic. Sponsors and CROs are increasingly turning to decentralized trial models in an effort to bring increased efficiency, security, and accessibility to the clinical research process,” said Anthony Costello, president of the patient cloud at Medidata, in a statement.

The platform can be used across a variety of clinical trials and the company ensures that its platform will reduce the chance of data discrepancies and transfer lags. 

“The mission-critical nature of our platform has been most visible in Life Sciences, where a majority of the COVID-19 clinical trials were conducted with our MEDIDATA software solutions during 2020. The health crisis has very clearly revealed the game-changing nature of our virtual twin experience, from research to patient care,” said Bernard Charles, Dassault CEO and vice-chairman, in the company’s fourth-quarter 2020 results. Medidata expanded its customer base by 16% in 2020.

Regeneron Antibody Cocktail Reduces Deaths Among Hospitalized Patients 

Yesterday, a large British study found that the Covid-19 antibody treatment by Regeneron and Roche reduced deaths in hospitalized patients. 

The experimental Covid-19 antibody cocktail has been provided with emergency approval in the United States. The results from the large-scale trial that was just completed confirms that the therapy has high effectiveness among hospitalized patients. According to the study, it will reduce the 28-day mortality of people admitted to the hospital Covid-19 and whose immune system has not been able to produce an antibody response by 20%.

“People have been very, very skeptical, that any treatment against this particular virus would work by the time people get in a hospital,” Martin Landray, the joint chief investigator on the trial, told reporters.

“If you haven’t raised antibodies of your own, you really would benefit from getting some,” he said.

Many other companies are currently also working on developing seminal treatments. So far, two additional treatments for mild-to-moderate Covid-19 cases have been approved in the United States: antibody treatments developed by Eli Lilly and Co (LLY.N) as well as by Vir Biotechnology Inc (VIR.O) with GlaxoSmithKline Plc (GSK.L). .

“This opens up the possibility for many, many others,” Landrey said commenting on the successful results. “People see a few negative trials and they say ‘well that’ll never work’ and they opt-out and go off and do something else. (But) this is very, very clear, the picture that we’ve got from this trial.”

“The absolute magnitude of benefit in mortality is not large, and it means that a large (possibly 20) number of people have to be treated with the extremely expensive drug for a single death to be prevented,” said Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine.

“If (patients) can be readily identified and treated it will have some benefit in practice, but its benefits should not be overstated.”


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