Daily Archives: June 21, 2021

The lab leak hypothesis about the origin of Covid-19 has been getting a lot of attention lately, and deservedly so. This is the idea that the SARS-CoV-2 virus accidentally escaped from a laboratory in Wuhan, China, that conducts research on coronaviruses. Just a few weeks ago, a group of highly respected virologists and epidemiologists published a letter in the journal Sciencecalling for a more thorough investigation, stating that the lab leak hypothesis was not taken seriously enough in earlier investigations.

The coincidence of having a major virus research facility, the Wuhan Institute of Virology (WIV), just a short distance from the live animal food market that was originally believed to be the source of the outbreak is too great to ignore. Even more curious is that WIV was actively doing research on coronaviruses in bats, including the bats that carry a strain of SARS-CoV-2 that is the closest known relative to the Covid-19 virus itself.

From the beginning of the outbreak, attention was focused on WIV, and various conspiracy theorists suggested, without any evidence, that the Covid-19 virus was either intentionally engineered, intentionally released, or both. Let me just say right off the bat that I dont believe either of those claims.

However, I do think the lab leak hypothesis is credible, and its also possible that gain of function research (more about this below) might be responsible.

In arguing against (unsupported) claims that the Chinese released the virus on purpose, a group of virologists published a paper very early in the pandemic, in March 2020, which looked at the genome sequence of the virus and concluded that SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus. Other studies since then have come to similar conclusions: the virus is very similar to naturally-occurring coronaviruses, and it is possible that it simply evolved naturally in the wild, probably in bats.

Even so, the lab leak hypothesis remains highly credible, regardless of whether or not the virus was genetically engineered. Heres why. First, we know that lab accidents can happen and viruses can escape, even if these accidents are rare. We also know that the Wuhan Institute of Virology had thousands of viruses, including coronaviruses, in its facility. And despite claims that viruses couldnt possibly have escaped accidentally, a 2017Naturearticle describing the then-new Wuhan Institute reported, perhaps prophetically, that worries surround the [Wuhan Institute of Virology], too. The SARS virus has escaped from high-level containment facilities in Beijing multiple times.

The secrecy of the Chinese government, which has not yet allowed independent, outside scientists full access to WIV to investigate, hasnt helped matters. We need to know if any viruses in WIV are similar to the Covid-19 virus, and at this point we cant trust the Chinese governments assurances on this question. Of course, even if they allow outsiders to investigate now, we cannot know that they have preserved all the viruses that were present in the lab in the winter of 2019-2020.

Now lets talk about gain-of-function research. Gain of function, or GoF, refers to research that tries to make viruses or bacteria more harmful, by making them more infectious. This seems crazy, right? And yet its been going on for years, despite the efforts of many scientists to stop it. In the past, GoF research focused on the influenza virus, and in particular on a small number of scientists (highly irresponsible ones, in my view) who were trying to give avian influenzabird fluthe ability to jump from birds into humans. I wrote about this in 2013, and in 2017, and again in 2019, each time calling on the US government to stop funding this extremely dangerous work. The NIH did put a pause on gain-of-function research for a few years, but the work resumed in 2019.

Now, let me explain why GoF research does not require artificially engineering a virus. Viruses mutate very rapidly all by themselves, and RNA viruses like influenza and SARS-CoV-2 mutate even more rapidly than DNA viruses. So a GoF experiment doesnt need to engineer a virus to make it more infectious: instead, scientists can simply grow a few trillion viral particles, which is easy, and design experiments to select the ones that are more infectious. For example, some GoF research on bird flu simply sprays an aerosol mixture of viruses into a ferrets nose (influenza research often uses ferrets, since you cant ethically do this with people), and waits to see if the ferret comes down with the flu. If it does (and this has been done, successfully), the strain that succeeds now has a new function, because it can infect mammals. The viruses that are artificially selected (as opposed to natural selection) in these experiments will appear completely natural; no genetic engineering required.

We know that WIV was conducting gain-of-function experiments, and we know that its work included coronaviruses. Was the Wuhan Institute of Virology running GoF experiments on SARS-CoV-2 viruses from bats? Possibly. And if it was, these experiments could easily have produced a strain that infected humans. If a lab employee was accidentally infected with such a strain, that could have started the pandemic. And even if SARS-CoV-2 wasnt the subject of GoF experiments, a naturally-occurring strain being studied at WIV could still have infected one of their scientists and thereby leaked out into the population.

Im not saying that any of these events is likely. I am, however, agreeing with the scientists who, in their recent letter toScience, called for a deeper investigation into the cause of the Covid-19 pandemic.

Finally, let me echo a sentiment they expressed in their letter, which is best said by simply quoting them: in this time of unfortunate anti-Asian sentiment in some countries, we note that at the beginning of the pandemic, it was Chinese doctors, scientists, journalists, and citizens who shared with the world crucial information about the spread of the virusoften at great personal cost. Rather than seeking to cast blame, we need to uncover the origin of the Covid-19 pandemic, and any behaviors that led to it, as a means to help all societies prevent future pandemics.

Steven Salzberg is a Bloomberg Distinguished Professor in the Departments of Biomedical Engineering, Computer Science, and Biostatistics at Johns Hopkins University. He conducts research on genomics and computational biology. Find Steven on Twitter @StevenSalzberg1

A version of this article was originally posted at the Genomics, Medicine and Pseudoscience blog in the Field of Science Network and has been reposted here with permission. Find Field of Science on Twitter @fieldofscience

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Maybe both sides are right: If SARS-CoV-2 was leaked from a Wuhan lab, it doesn't mean the virus was necessarily engineered - Genetic Literacy Project

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Kytopen., a transformative biotechnology company offering non-viral delivery that links the discovery, development and manufacturing of engineered cell therapies, today announced it was awarded a SBIR Fast Track grant from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institute of Health (NIH). Kytopen is eligible for up to $2M over the course of the 3-year award as project milestones are successfully completed within the Phase I and Phase II portions of the grant.

Natural killer (NK) cells represent a high impact population for cell therapy, but due to limitations in current methodologies for gene delivery, NK cells remain a largely untapped resource. This SBIR grant will be used to demonstrate that non-viral delivery via Kytopens Flowfect platform can alleviate this limitation on NK cell gene editing at both research and manufacturing scale, which is needed for pre-clinical and clinical studies. Due to the major potential impact NK cells represent in a clinical setting, non-viral Cas Ribonucleoprotein (RNP) gene knockout will allow for novel therapeutic applications in infectious disease, autoimmune disorders, and immuno-oncology.

Paulo Garcia, Kytopens CEO and Co-Founder will serve as the Principal Investigator (PI) on the grant. Dr. Garcia explains that engineered NK cells have tremendous therapeutic promise including the potential to treat solid tumors in an allogeneic modality. The Flowfect platform will facilitate high-throughput target discovery while providing a clear path towards clinical manufacturing of next-generation cell products.

NK cells are a subset of innate immune cells that can respond to threat without antibody priming. This quick response to stimuli makes them an ideal immunotherapy candidate. Yet, genetic modification in NK cells has proven to be difficult using conventional viral and non-viral transfection methodologies. Alternative delivery methods are necessary in order to make genetic modifications at reproducible and efficient rates, while maintaining high cell viability and functionality.

The awarded study leverages continuous fluid flow coupled with low energy electric fields for transfection via a proprietary Flowfect platform (Figure 1). This platform represents a novel approach to non-viral delivery in historically hard-to-transfect human cells. The current research proposes to engineer non-activated NK cells with Cas RNPs for gene editing using the Flowfect platform. To achieve this goal, Kytopen has outlined a two-phase research strategy which focuses on stability and functionality of edited NK cells both in vitro and in vivo.

NIH sponsored grant programs are an integral source of capital for early-stage U.S. small businesses that are creating innovative technologies to improve human health. These programs help small businesses break into the federal research and development arena, create life-saving technologies, and stimulate economic growth. Kytopen is honored to be a recipient of this competitive award from the NIH/NIAID and looks forward to unlocking biological capabilities of engineered NK cells for improving patients lives during the performance of this project.

About the Flowfect Technology

Kytopens proprietary Flowfect platform eliminates the complexity of gene editing and integrates discovery, development and manufacturing in one flexible and scalable non-viral delivery solution. The Flowfect technology utilizes electro-mechanical energy to disrupt the cell membrane and introduce genetic material (such as RNA, DNA, or CRISPR/Cas RNP) to a wide variety of hard-to-transfect primary cells. During the Flowfect process, a solution containing cells and genetic payload suspended in a proprietary buffer flows continuously through a channel while the solution is exposed to a low energy electric field. Due to the continuous flow and low electrical energy required, cells engineered using Flowfect exhibit high viability while also exhibiting high transfection efficiency post-processing. The Flowfect technology utilizes relatively high flow rates enabling cell engineering in minutes for discovery and optimization (e.g. 96 well plate in <10 minutes) and direct scale up to manufacturing volumes of >10mL, engineering over 2 billion cells per minute in a single channel.

About Kytopen

Kytopen, an MIT spin-out, is a transformative biotechnology company that offers a customizable yet scalable multi-solution platform, which seamlessly links the discovery, development and manufacturing phases of cell engineering. Flowfect, a gentle, non-viral delivery method unlocks new therapeutic approaches, by engineering immune cells with minimal disruption, preserving the functionality and viability of human cells and enhancing the cells biology. The Flowfect platform accelerates therapies from the bench to clinical through flexibility and scalability, which drives higher cell yields, faster approvals, and better outcomes from potentially curative cell-based treatments. Kytopens goal is to enable simple and efficient non-viral manufacturing of cell therapies in days versus weeks to increase access to many more patients. For more information, visit: http://www.kytopen.com

Read more:
Kytopen Awarded NIH Grant of Up to $2M to Unlock the Power of Engineered Natural Killer (NK) Cells via Flowfect Platform - Business Wire

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Genome Editing or Genome Engineering Market Market: Latest Innovations, Drivers and Industry Key Events 2021 2027 The Courier - The Courier

Washington, June 20, 2021 Databridgemarketresearch.com announces the release of the report Global CRISPR Gene-Editing Market Size, Share & Trends Analysis Report By 2027. Market research report proves to be an ideal solution when it comes to a better understanding of the chemical and materials industry and lead the business growth. Market definitions, segmentation, applications, and value chain structure of this industry are all mentioned in the report. This report provides current as well as upcoming technical and financial details of the industry to 2026. According to this report, the market renovation will mainly take place due to the actions of key players or brands like developments, product launches, joint ventures, mergers, and acquisitions. The company profiles of all the key players and brands that are dominating this Report have been taken into consideration here.

Global CRISPR gene-editing market is rising gradually with a healthy CAGR of 23.35 % in the forecast period of 2019-2026. Growing prevalence of cancer worldwide and expanding the application of CRISPR technology by innovative research from the different academic organizations are the key factors for market growth.

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Few of the major competitors currently working in the global CRISPR gene-editing market are Applied StemCell, ACEA BIO, Synthego, Thermo Fisher Scientific Inc, GenScript, Addgene, Merck KGaA, Intellia Therapeutics, Inc, Cellectis, Precision Biosciences, Caribou Biosciences, Inc, Transposagen Biopharmaceuticals, Inc, OriGene Technologies, Inc, Novartis AG, New England Biolabs among others

Global CRISPR Gene-Editing Market By Therapeutic Application (Oncology, Autoimmune/Inflammatory), Application (Genome Engineering, Disease Models, Functional Genomics and Others), Technology (CRISPR/Cas9, Zinc Finger Nucleases and Others), Services (Design Tools, Plasmid and Vector, Cas9 and g-RNA, Delivery System Products and Others), Products (GenCrispr/Cas9 kits, GenCrispr Cas9 Antibodies, GenCrispr Cas9 Enzymes and Others), End-Users (Biotechnology & Pharmaceutical Companies, Academic & Government Research Institutes, Contract Research Organizations and Others), Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa) Industry Trends and Forecast to 2026

Global CRISPR Gene-Editing Research Methodology

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In April 2019, GenScript has launched Single-stranded DNA Service for CRISPR-based Gene Editing which help the key researchers to have access on the high quality, pure ssDNA for CRISPR-based gene insertion and hence can accelerate the development of gene as well as cell therapy for cancer immunotherapy

In February 2018, Cellectis has received two U.S. patents (US#9,855,297 and US#9,890,393) entiled as Methods for engineering T cells for immunotherapy by using RNA-guided CAS nuclease system for CRISPR Use in T-Cells. The U.S. grant of these patents, the company can generate revenue by out-licensing the products to the pharma companies that are ready to use CRISPR technologies in T-cells

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Global CRISPR Gene-Editing Market Recent Trends and Developments, Challenges, key drivers and Restraints and Forecast 2021-2028 The Manomet Current -...

Due to unanswered questions into the origins of the coronavirus pandemic, both the U.S. government and scientists have called for a deeper examination into the validity of claims that a virus could have escaped from a lab in Wuhan, China.

Much of the discussion surrounds gain-of-function research. So The Conversation asked David Gillum and Rebecca Moritz, who work closely with virologists on a day-to-day basis to ensure the safety and security of the research, and Sam Weiss Evans and Megan Palmer, who are science and technology policy experts, to explain what this term means and why this kind of research is important.

Any organism can acquire a new ability or property, or gain a function. This can happen through natural selection or a researchers experiments. In research, many different types of experiments generate functions, and some pose certain safety and security concerns.

Scientists use a variety of techniques to modify organisms depending on the properties of the organism itself and the end goal. Some of these methods involve directly making changes at the level of genetic code. Others may involve placing organisms in environments that select for functions linked to genetic changes.

Gain of function can occur in an organism in either nature or the laboratory. Some lab examples include creating more salt- and drought-resistant plants or modifying disease vectors to produce mosquitoes that are resistant to transmitting dengue fever. Gain of function can also be useful for environmental reasons, such as modifying E. coli so that it can convert plastic waste into a valuable commodity.

In the current debate around SARS-CoV-2, the virus that causes COVID-19, gain of function has a much narrower meaning related to a virus becoming easier to move between humans, or becoming more lethal in humans. It is important to remember, though, that the term gain of function by itself covers much more than this type of research.

Two researchers working in a high-containment laboratory hold cell cultures infected with the novel coronavirus.picture alliance via Getty provided by The Conversation,

Gain-of-function experiments may help researchers test scientific theories, develop new technologies and find treatments for infectious diseases. For example, in 2003, when the original SARS-CoV outbreak occurred, researchers developed a method to study the virus in the laboratory. One of the experiments was to grow the virus in mice so they could study it. This work led to a model for researching the virus and testing potential vaccines and treatments.

Gain-of-function research that focuses on potential pandemic pathogens has been supported on the premise that it will help researchers better understand the evolving pathogenic landscape, be better prepared for a pandemic response and develop treatments and countermeasures.

But critics argue that this research to anticipate potential pandemic pathogens does not lead to substantial benefit and is not worth the potential risks. And they say getting out ahead of such threats can be achieved through other means biological research and otherwise. For instance, the current pandemic has provided numerous lessons on the social and behavioral dynamics of disease prevention measures, which could lead to robust new research programs on the cultural aspects of pandemic preparedness. Understanding when the risks of gain-of-function research outweigh the potential benefits and alternatives, therefore, continues to be subject to debate.

Some potential outcomes of gain-of-function research may include the creation of organisms that are more transmissible or more virulent than the original organism or those that evade current detection methods and available treatments. Other examples include engineering organisms that can evade current detection methods and available treatments, or grow in another part of an organism, such as the ability to cross the blood-brain barrier.

There is no such thing as zero risk in conducting experiments. So the question is whether certain gain-of-function research can be performed at an acceptable level of safety and security by utilizing risk-mitigation measures. These strategies for reducing risk include the use of biocontainment facilities, exposure control plans, strict operating procedures and training, incident response planning and much more. These efforts involve dedication and meticulous attention to detail at multiple levels of an institution.

Lab incidents will still occur. A robust biosafety and biosecurity system, along with appropriate institutional response, helps to ensure that these incidents are inconsequential. The challenge is to make sure that any research conducted gain-of-function or otherwise doesnt pose unreasonable risks to researchers, the public and the environment.

Determining whether specific experiments with potential pathogens should be conducted remains a difficult and contentious topic.

There are multiple ways to answer this question. The first is if the research is intended to develop a biological weapon. The United Nations Biological Weapons Convention, which went into effect in 1975, forbids state parties from developing, producing, stockpiling, or otherwise acquiring or sharing biological agents, toxins and equipment that have no justification for peaceful or defensive purposes. There should be no research, then, whether gain-of-function or otherwise, that seeks to purposefully develop a biological weapon.

Another way to answer the question is by focusing on the content of the research, rather than its intent. Through experience, researchers and governments have developed lists of both experiments and organisms that need additional oversight because of their potential safety and security risks. One example of this arose when flu researchers placed a self-imposed pause on gain-of-function research involving the transmissibility of highly pathogenic avian influenza H5N1 viruses in 2012. The U.S. government subsequently imposed a moratorium on the work in 2014. Both moratoriums were lifted by the end of 2017 following a lengthy debate and study of the risks and the development of additional oversight and reporting requirements.

In the past decade, the United States has developed oversight for research that could be directly misused for nefarious purposes. This includes policies on dual-use research of concern (DURC) and policies on pathogens of pandemic potential enhanced to gain transmissibility or virulence.

The main point is that our understanding is constantly evolving. Just before the COVID-19 pandemic began, the U.S. government had started to review and update its policies. It is an open question what lessons will be learned from this pandemic, and how that will reshape our understanding of the value of gain-of-function research. One thing that is likely to happen, though, is that we will rethink the assumptions we have been making about the relationships between biological research, security and society. This may be an opportunity to review and enhance systems of biosecurity and biosafety governance.

David Gillum, Senior Director of Environmental Health and Safety and Chief Safety Officer, Arizona State University and Rebecca Moritz, Biosafety Director and Responsible Official, Colorado State University. This article is republished from The Conversation under a Creative Commons license. Read the original article. Disclosures: David Gillum is the past president of the American Biological Safety Association (ABSA) International. He is a past-judge and member of the safety and security committee for the International Genetically Engineered Machine Competition. Megan J. Palmer receives funding from the Open Philanthropy Project and the Nuclear Threat Initiative. She is on the Council of the Engineering Biology Research Consortium, co-chairs a World Economic Forum Global Future Council on Synthetic Biology, is an Advisor to the International Genetically Engineered Machine Competition, is a member of a World Health Organization Working Group on the Responsible Use of Life Sciences, and is a member of the Board of Directors of Revive and Restore. Sam Weiss Evans receives funding from the Schmidt Futures Foundation. He is a member of the Engineering Biology Research Consortiums Security Working Group, and an Advisor to the international Genetically Engineered Machines Competition. Rebecca Moritz does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Read more from the original source:
Gain Of Function Research And Why It Matters - Science 2.0