Category Archives: Human Genetic Engineering

SIOUX FALLS, S.D., Sept. 2, 2020 /PRNewswire/ -- Sanford Health, the largest provider of rural healthcare in the country, today announced it has initiated a Phase 1b trial of SAB-185, a first-of-its-kindhuman polyclonal antibodytherapeutic candidate developed by SAB Biotherapeutics (SAB), that would be used to treat patients with mild to moderate COVID-19 at an early stage of the disease. The trial will enroll a total of 21 adult patients across several clinical sites. Sanford Health is the first site in the country to open the study to patients.

"Today's milestone underscores our relentless commitment to advancing the science of medicine to ensure our patients benefit from new discoveries as quickly as possible," said David A. Pearce, PhD, president of innovation and research at Sanford Health. "Working with SAB Biotherapeutics on this clinical trial gives us an opportunity to deliver on our promise to patients."

"We are eager to participate in this clinical trial to investigate the safety of SAB-185, a human polyclonal antibody therapeutic candidate for COVID-19," said Dr. Susan Hoover, principal investigator and an infectious disease physician at Sanford Health. "Our goal is to advance the science around COVID-19 so physicians can be better prepared to treat this novel coronavirus in the future, especially for our populations most at-risk."

SAB's novel platform, which leverages genetically engineered cattle to produce fully human antibodies, enables scalable and reliable production of specifically targeted, high potency neutralizing antibody products. This approach has expedited the rapid development of this novel immunotherapy for COVID-19, deploying the same natural immune response to fight the disease as recovered patients, but with a much higher concentration of antibodies.

"SAB is pleased to advance SAB-185, one of the leading novel therapeutics for COVID-19, into human trials and leverage the rapid response capabilities of our first-of-its-kind technology during this pandemic, when its needed most," said Eddie Sullivan, founder, president and CEO of SAB Biotherapeutics.

SAB is a Sioux Falls-based biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies.Sanford Health is committed to taking research from the bench and bringing promising new treatments to our patients' bedside.New medical discoveries come out of hard work, innovation and research. SAB and Sanford Health are committed to developing and delivering novel solutions to overcome this global pandemic and improve people's lives.

About Sanford HealthSanford Health, one of the largest health systems inthe United States, is dedicated to the integrated delivery of health care, genomic medicine, senior care and services, global clinics, research and affordable insurance. Headquartered inSioux Falls, South Dakota, the organization includes 46 hospitals, 1,400 physicians and more than 200 Good Samaritan Society senior care locations in 26 states and 10 countries. Learn more about Sanford Health's transformative work to improve the human condition atsanfordhealth.orgorSanford Health News.

About SAB BiotherapeuticsSAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. Utilizing some of the most complex genetic engineering and antibody science in the world, SAB has developed the only platform that can rapidly produce natural, highly-targeted, high-potency, human polyclonal immunotherapies at commercial scale. The company is advancing programs in autoimmunity, infectious diseases, inflammation and oncology. SAB is rapidly progressing on a new therapeutic for COVID-19, SAB-185, fully human polyclonal antibodies targeted to SARS-CoV-2 without using human donors. For more information visitsabbiotherapeutics.comor follow @SABBantibody on Twitter.

Media Contacts:

Angela Dejene[emailprotected](218) 280-0148

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Sanford Health is first in nation to dose patient with promising novel therapeutic candidate for COVID-19, SAB-185 - PRNewswire

Johns Hopkins Medicine researchers have added to evidence that a gene responsible for turning off a cells natural suicide signals may also be the culprit in making breast cancer and melanoma cells resistant to therapies that use the immune system to fight cancer. A summary of the research, conducted with mice and human cells, appeared in Cell Reports.When the gene, called BIRC2, is sent into overdrive, it makes too much, or an overexpression, of protein levels. This occurs in about 40% of breast cancers, particularly the more lethal type called triple negative, and it is not known how often the gene is overexpressed in melanomas.

If further studies affirm and refine the new findings, the researchers say, BIRC2 overexpression could be a key marker for immunotherapy resistance, further advancing precision medicine efforts in this area of cancer treatment. A marker of this kind could alert clinicians to the potential need for using drugs that block the genes activity in combination with immunotherapy drugs to form a potent cocktail to kill cancer in some treatment-resistant patients. Cancer cells use many pathways to evade the immune system, so our goal is to find additional drugs in our toolbox to complement the immunotherapy drugs currently in use, says Gregg Semenza, M.D., Ph.D., the C. Michael Armstrong Professor of Genetic Medicine, Pediatrics, Oncology, Medicine, Radiation Oncology and Biological Chemistry at the Johns Hopkins University School of Medicine, and director of the Vascular Program at the Johns Hopkins Institute for Cell Engineering.

Semenza shared the 2019 Nobel Prize in Physiology or Medicine for the discovery of the gene that guides how cells adapt to low oxygen levels, a condition called hypoxia.

In 2018, Semenzas team showed that hypoxia essentially molds cancer cells into survival machines. Hypoxia prompts cancer cells to turn on three genes to help them evade the immune system by inactivating either the identification system or the eat me signal on immune cells. A cell surface protein called CD47 is the only dont eat me signal that blocks killing of cancer cells by immune cells called macrophages. Other cell surface proteins, PDL1 and CD73, block killing of cancer cells by immune cells called T lymphocytes.

These super-survivor cancer cells could explain, in part, Semenza says, why only 20% to 30% of cancer patients respond to drugs that boost the immune systems ability to target cancer cells.

For the current study, building on his basic science discoveries, Semenza and his team sorted through 325 human genes identified by researchers at the Dana Farber Cancer Institute in Boston whose protein products were overexpressed in melanoma cells and linked to processes that help cancer cells evade the immune system.

Semenzas team found that 38 of the genes are influenced by the transcription factor HIF-1, which regulates how cells adapt to hypoxia; among the 38 was BIRC2 (baculoviral IAP repeat-containing 2), already known to prevent cell suicide, or apoptosis, in essence a form of programmed cell death that is a brake on the kind of unchecked cell growth characteristic of cancer.

BIRC2 also blocks cells from secreting proteins that attract immune cells, such as T-cells and natural killer cells.

First, by studying the BIRC2 genome in human breast cancer cells, Semenzas team found that hypoxia proteins HIF1 and HIF2 bind directly to a portion of the BIRC2 gene under low oxygen conditions, identifying a direct mechanism for boosting the BIRC2 genes protein production.

Then, the research team examined how tumors developed in mice when they were injected with human breast cancer or melanoma cells genetically engineered to contain little or no BIRC2 gene expression. In mice injected with cancer cells lacking BIRC2 expression, tumors took longer to form, about three to four weeks, compared with the typical two weeks it takes to form tumors in mice.

The tumors formed by BIRC2-free cancer cells also had up to five times the level of a protein called CXCL9, the substance that attracts immune system T-cells and natural killer cells to the tumor location. The longer the tumor took to form, the more T-cells and natural killer cells were found inside the tumor.

Semenza notes that finding a plentiful number of immune cells within a tumor is a key indicator of immunotherapy success.

Next, to determine whether the immune system was critical to the stalled tumor growth they saw, Semenzas team injected the BIRC2-free melanoma and breast cancer cells into mice bred to have no functioning immune system. They found that tumors grew at the same rate, in about two weeks, as typical tumors. This suggests that the decreased tumor growth rate associated with loss of BIRC2 is dependent on recruiting T-cells and natural killer cells into the tumor, says Semenza.

Finally, Semenza and his team analyzed mice implanted with human breast cancer or melanoma tumors that either produced BIRC2 or were engineered to lack BIRC2. They gave the mice with melanoma tumors two types of immunotherapy FDA-approved for human use, and treated mice with breast tumors with one of the immunotherapy drugs. In both tumor types, the immunotherapy drugs were effective only against the tumors that lacked BIRC2.

Experimental drugs called SMAC mimetics that inactivate BIRC2 and other anti-cell suicide proteins are currently in clinical trials for certain types of cancers, but Semenza says that the drugs have not been very effective when used on their own.

These drugs might be very useful to improve the response to immunotherapy drugs in people with tumors that have high BIRC2 levels, says Semenza.Reference: Samanta D, Huang TYT, Shah R, Yang Y, Pan F, Semenza GL. BIRC2 Expression Impairs Anti-Cancer Immunity and Immunotherapy Efficacy. Cell Rep. 2020;32(8). doi:10.1016/j.celrep.2020.108073

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Cell Suicide Gene Further Linked to Immunotherapy Response - Technology Networks

New Rochelle, NY, September 2, 2020A meta-analysis of non-human primate (NHP) studies showed that adeno-associated virus (AAV) gene therapy often caused dorsal root ganglion (DRG) pathology. There were no clinical effects. The study is reported in the peer-reviewed journal Human Gene Therapy.Click here to read the full-text article free on the Human Gene Therapy website through October 2, 2020.

The dorsal root ganglion is a cluster of neurons in the dorsal root of a spinal nerve. DRG pathology was present in 83% of NHP given AAV through the cerebrospinal fluid and 32% of NHP that received an intravenous injection.

The data suggest that DRG pathology is almost universal after AAV vectors are delivered into the cerebral spinal fluid of nonhuman primates. However, none of the animals receiving a vector expressing a therapeutic transgene displayed any clinical signs, stated James M. Wilson, MD, PhD, a professor of Medicine and director of the Gene Therapy Program and the Orphan Disease Center, and coauthors from the Perelman School of Medicine at the University of Pennsylvania.

The DRG pathology associated with AAV has triggered an increase in the intensity of preclinical evaluation of AAV vectors prior to initiation of clinical trials of new vectors, according to Editor-in-Chief of Human Gene Therapy Terence R. Flotte, MD, Celia and Isaac Haidak Professor of Medical Education and Dean, Provost, and Executive Deputy Chancellor, University of Massachusetts Medical School. The insights offered by Dr. Wilsons paper provide an excellent summary perspective on this phenomenon, which could potentially eliminate the need for a number of redundant preclinical safety studies and thus shorten the path to the clinic for new vectors.

Individual studies utilized for data extraction were supported by REGENXBIO (all studies previously published), Biogen (some studies previously published), Passage Bio, Amicus Therapeutics, ODC MPS I pilot grant MPS-18-D010-01 and MPS-19-001-0, Janssen, Cure FA, Rett Syndrome Research Trust and Elaaj Bio. These entities funded the original studies whose samples were later run through the comparative meta-analysis covered in the manuscript. The studies, company sponsor, and transgenes representing each data point are not disclosed.

About the JournalHuman Gene Therapy ,the Official Journal of the European Society of Gene and Cell Therapy and eight other international gene therapy societies, was the first peer-reviewed journal in the field and provides all-inclusive access to the critical pillars of human gene therapy: research, methods, and clinical applications. The Journal is led by Editor-in-Chief Terence R. Flotte, MD, Celia and Isaac Haidak Professor of Medical Education and Dean, Provost, and Executive Deputy Chancellor, University of Massachusetts Medical School, and an esteemed international editorial board. Human Gene Therapy is available in print and online. Complete tables of contents and a sample issue are available on the Human Gene Therapy website.

About the PublisherMary Ann Liebert, Inc., publishers is known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research. Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industrys most widely read publication worldwide. A complete list of the firms 90 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.

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Toxicity of dorsal root ganglia is widely associated with CNS AAV gene therapy - Science Codex

Last week, Gilead Sciences said it would test its COVID-19 drug remdesivir against a related compound in its library called GS-441524 in animal trials, after facing scrutiny over the latter drug, which has been used for years to treat feline infectious peritonitis (FIP) despite not being licensed for that use.

Now, another California biotech, Anivive Lifesciences, is working on a COVID-19 antiviral drug thats inspired by cats, and it has new preclinical research findings to back up the project.

Scientists led by the University of Alberta reported that a drug developed to treat a coronavirus that can cause FIP inhibited the main protease of both SARS-CoV and SARS-CoV-2. That prevented the human coronaviruses from replicating in cell cultures, they reported in the journal Nature Communications.

Overcoming Scalability Challenges with Autologous Therapies

Catalent presents a clinical-to-commercial perspective on autologous therapies. Join experts Prof. Gerhard Bauer and Catalents Dr. James Crutchley as they discuss challenges and an innovative methodology to commercially scale autologous therapies.

Anivive originally licensed the drug, called GC376, from Kansas State University in 2018 and has been working since then to develop it as an antiviral to treat FIP, a progressive disease in cats thats often caused by a coronavirus and is fatal if left untreated. Last month, Anivive said it had started two preclinical studies to determine whether GC376 could also treat COVID-19.

RELATED: COVID-19: New animal data back up Gilead's remdesivir as other treatment candidates emerge

GC376 was designed to inhibit a protease called 3C, which promotes the replication of several coronaviruses that infect animals and people. They include feline coronavirus (FCoV), which usually causes mild symptoms in cats but can lead to FIP.

Two pilot studies of GC376 in pet cats infected with FIP showed that the drug was effective against the disease within two weeks and was well tolerated. Anivive is currently scaling up production of the drug for larger studies in cats.

For the new study, the University of Alberta team tested both GC376 and its parent drug, GC373, for their ability to inhibit the 3C protease. Both drugs blocked viral replication, they reported.

The authors acknowledged that vaccines against COVID-19 are advancing rapidly, but they suggested antiviral drugs are still necessary in the short term. SARS-CoV-2 is a virus with a significant mutation rate. Also, in some patients the virus has persisted longer than 2 months with some possibility of re-infection, they wrote in the study.

M. Joanne Lemieux, Ph.D., professor of structural biology at the University of Alberta, pointed out in an interview with Genetic Engineering & Biotechnology News that GC376 could be advanced rapidly into human trials, given its track record in veterinary medicine.

Because this drug has already been used to treat cats with coronavirus, and its effective with little to no toxicity, its already passed [preclinical] stages, and this allows us to move forward, Lemieux said.

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Cats point the way to potential COVID-19 remedies - FierceBiotech

It goes by many names: cultured, in vitro, cell-based, cultivated, lab-grown meat, etc. As the names imply, it is a meat alternative made in a lab via animal cells and a cultured medium, like fetal bovine serum or a proprietary mix of sugars and salts. Several companies around the world are promoting this new technique as a way to cultivate a meat alternative that is supposedly cleaner and safer than traditional meat.

(We are only looking at those products that culture cells taken from animals into a new meat-like formulation. There are many other products that culture plant, fungi, or algal cells into a meat substitute, but we are not reviewing them here.)

29 companies are planning to bring lab-cultured meat to market in the form of chicken, beef, pork, seafood, pet food, and beyond. These companies include Memphis Meats, Aleph Farms, Mosa Meat, Meatable, SuperMeat, and Finless Foods. These companies are backed by huge investments from meat industry corporations (Cargill and Tyson), venture capitalist firms (Blue Yard Capital, Union Square Ventures, S2G Ventures, and Emerald Technology Ventures), and billionaires (such as Bill Gates and Richard Branson).

While the hype is certainly there, is lab-cultured meat actually better? Its proponents tout it as an environmentally responsible, cruelty-free, and antibiotic-free alternative to current meat production. While the goal of producing sustainable meat without killing animals is admirable, lab-cultured meat is in its infancy and the science behind the production methods requires more scrutiny.

Of particular concern is the genetic engineering of cells and their potential cancer-promoting properties. To be able to better assess whether the products are being produced by methods that involve genetic engineering and use genetic constructs (called onco-genes, typically used to make stem cells keep growing; this is not a problem for lab experiments, but could be for food products) that might encourage cancer cells, we need more information on how the cells are engineered and kept growing. Many of the companies are claiming this information is confidential and a business secret. These companies are not yet patenting their production processes wherein this information would be more fully disclosed. Some suggest that the production will follow the FDA cell culture guidelines, but theFDAs cell culture guidelines do not apply to this because theyre not designed for food.

To produce lab-cultured meat, many producers extract animal cells from living animals. This is typically done via biopsy, a painful and uncomfortable procedure that uses large needles. If a company could scale up with this method, it would require a consistent supply of animals from which to acquire cells and innumerable painful extractions. To make the cell-based product more consistent, the producer may biopsy the same animal many times for the cells that growing meat requires.

Growing animal cells (typically muscle cells) also requires a growth medium. When lab-cultured meat production first began, companies depended on fetal bovine serum (FBS) as a growth medium. Producing FBS involves extracting blood from the fetus of a pregnant cow when the cow is slaughtered.

Given its high cost, it appears that FBS is usually only used during small-scale lab trials. Additionally, increasing production capacity using FBS comes with its own set of concerns. Even disregarding the high cost of FBS, non-genetically engineered animal muscle cells only proliferate or increase to a certain degree. In order to overcome this limitation, large companies such as Mosa Meats and Memphis Meats claim theyve found an FBS alternative that does not involve animals along with an effective way to expand production. For Memphis Meats, this process involves the utilization of abioreactor and the creation of immortal cell lines.

Curious about how we make our Memphis Meat? See below! #sogood pic.twitter.com/co5d7OY0bI

Memphis Meats (@MemphisMeats) May 8, 2018

These companies are using a bioreactor essentially a very large vessel for containing biological reactions and processes to implement a scaffold-based system to grow meat, which uses a specific structure for cells to grow on and around. The scaffolding helps the cells differentiate into a specific meat-like formation. Researchers cite using cornstarch fibers, plant skeletons, fungi, and gelatin as common scaffold materials. Instead of animal muscle cell precursors (otherwise known as myosatellites), researchers have been using cultured stem cells. This distinction is important because extracted muscle cells will only proliferate to a certain extent. Companies are trying cultured stem cells as an alternative type of cell(s) that could proliferate exponentially so that they could scale up production, and later differentiate the cells into the various cell types that make up animal meat (muscle, fat, and blood cells) in a bioreactor.

In this process, the stem cells still come from animals or animal embryos, but what differentiates the two methods is that in the scaffold-based system, the cells can be genetically engineered to proliferate indefinitely. These cells are otherwise known as pluripotent (which make many kinds of cells, like stem cells) or totipotent (which make every kind of cell, as do embryos). This would greatly expand a companys capacity to make lab-cultured meat, but the methods by which companies make these cells proliferate come with human health and food safety ramifications.

While the FDA has previously reviewed enzymes, oils, algal, fungal, and bacterial products grown in microorganisms, these new animal cell-cultured products are much more complicated in structure and require a more thorough review. The scale required for making lab-cultured meat feasible for mass consumption will be the largest form of tissue engineering to exist and could introduce new kinds of genetically engineered cells into our diets. Further research will also be needed to conrm or dispel uncertainties over various potential safety issues. Candidate topics for research include the safety of ingesting rapidly growing genetically-modied cell lines, as these lines exhibit the characteristics of a cancerous cell which include overgrowth of cells not attributed to the original characteristics of a population of cultured primary cells. If lab-cultured meat enters the market, there are several human health concerns associated with this new production method, specifically that these genetically-modified cell lines could exhibit the characteristics of a cancerous cell.

While these companies dont disclose much to the public about their processing methods, their public patents reveal the creation of oncogenic, or cancer-causing, cells.A Memphis Meats patent on the creation of modified pluripotent cell lines involves the activation or inactivation of various proteins responsible for tumor suppression. Another patent from JUST Inc. describes the utilization of growth factors as part of its growth medium. This process could promote the development of cancer-like cells in lab-cultured meat products. Additionally, it is possible certain growth factors can be absorbed in the bloodstream after digestion.

If they are using stem cells, cell-based meat companies need to pay attention to the risk of cancer cells emerging in their cultures. A research team from the Harvard Stem Cell Institute (HSCI), Harvard Medical School (HMS), and the Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard has found that as stem cell lines grow in a lab environment, they often acquire mutations in the TP53 (p53) gene, an important tumor suppressor responsible for controlling cell growth and division. Their research suggests that inexpensive genetic sequencing technologies should be used by cell-based meat companies to screen for mutated cells in stem cell cultures so that these cultures can be excluded.

Cancer-causing additives are prohibited in our food supply under the Delaney Clauses in the 1958 Food Additive Amendments and the 1960 Color Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA). These new rapidly growing cell lines might be considered color additives if they are being used to produce the color in the meat. The federal statutes regulating meat also prohibit the selling of animals with symptoms of illness, such as cancerous cells in meat. Regardless, all of these new ways of making cells that continue to grow or differentiate should require a safety assessment to determine if they contain cancerous cells before they can be sold.

In describing the scaffolding and growth media being used, lab-cultured meat companies need to be fully transparent about what ingredients theyre using. During the above-mentioned industry nonprofits presentation, the presenter suggested the growth media could be composed of a variety of different ingredients like proteins, amino acids, vitamins, and inorganic salts classified under the GRAS (Generally Recognized As Safe) process that allows companies to do their own testing and not submit to a new FDA food additive review. Since companies are not required to fully disclose the composition of their scaffolding or growth media, potentially exposing consumers to novel proteins and allergens, the new mixture of ingredients should be reviewed under a full FDA supervised food additive review, not GRAS.

Another major issue associated with processing methods using cell lines and/or culture medium is contamination. Unlike animals, cells do not have a fully functioning immune system, so there is a high likelihood of bacterial or fungal growth, mycoplasma, and other human pathogens growing in vats of cells. While lab-cultured meat companies emphasize that this type of meat production would be more sterile than traditional animal agriculture, its unknown how that is true without the use of antibiotics or some other pharmaceutical means of pathogenic control.

Based on commentary from various companies, antibiotic usage across the industry is still very unclear. While the industrys promoters have outlined many uses for antibiotics in lab-grown meat production in preventing contamination, they have not disclosed the amount of antibiotics being used in the various processes. Instead, they suggest that because mass production of lab-grown meat will be done in an industrial rather than lab setting, with bioreactors and tanks, there will be higher safety oversight than in medical labs. It is suggested that the many preventative measures in the industry will maintain a sterile boundary and deter antibiotic use in production. It remains a question of how a food production plant would be more sterile than a medical lab.

Some companies, such as Memphis Meats claim they are genetically engineering cell lines to be antibiotic-resistant, which would suggest they plan on using antibiotics, but dont want their meat cells to be affected. Problems with bacterial and viral contamination plague medical cell culture, so they generally use antimicrobials. Still, any large-scale production that requires antibiotic use even if just for a short-term duration should require such lab-cultured meat undergo even stricter USDA drug residue testing, pathogen testing, and FDA tolerance requirements than conventionally-produced meat. Many other companies claim they dont plan to use antibiotics in expanded production which begs the question, in addition to supposed sterile bioreactors, are they using other undisclosed processes to prevent contamination? For example, Future Meat Technologies describes the use of a special resin to remove toxins.

The companies have also not disclosed plans for how they will dispose of the toxins from bioreactors, scaffolding, and culture media like growth factors/hormones, differentiation factors, often including fetal calf serum or horse serum, and antimicrobials (commonly added to cultured cells to prevent bacterial and fungal contamination, particularly in long-term cultures). In conventionally-produced meat, animals dispose of these toxins in their urine and feces. If companies cant find a way for this meat to dispose of these toxins, they could potentially build up within the meat itself. Given the lack of clarity of these companies and their processes, there must be continuous monitoring of the cell lines and growth media/bioreactor for contaminants and some sort of standardization established across the industry to ensure safety.

The industry is new and the exact production process and inputs needed for large-scale, lab-cultured meat production are unknown (or not being disclosed by the companies). It is the responsibility of both FDA and USDA to ensure that all inputs used in production and the final product are safe for human and animal consumption. These agencies must ensure that lab-cultured meat is labeled appropriately, including if any of the product ingredients are genetically modified or if the ingredients are produced using unmodified cells from animals. These agencies must also ensure that this product doesnt introduce new allergens into the food supply, that any hormones or antibiotics used are not found at unsafe levels in the final product, and that the product doesnt contain any compounds or oncogenic (cancer-causing) cells that have not been approved for use in food.

Lab-cultured meat should not be allowed to use the Generally Recognized As Safe (GRAS) regulatory loophole wherein companies can hire their own experts to evaluate their products, often in secret without any notice to the public or FDA. GRAS is an inappropriate designation because the consensus among knowledgeable experts regarding the safety of lab-cultured meat does not yet exist. Instead, FDA should require that lab-cultured meat products be regulated more thoroughly as food additives. Meat companies should submit complete food additive petitions for each of the novel ingredients used to produce these meats as well as a final food approval petition for the entire product. The production facilities, like all meat processing plants, should then have USDA inspectors on-site monitoring the process and inspecting the meat. The USDA announced in August that it will start the process of developing regulations for these new kinds of meat. Adequate regulation will be necessary to address the concerns raised in this blog.

Overall, due to the novel nature of lab-cultured meat, the lack of transparency from the companies involved, and the myriad potential health risks to consumers, rigorous regulation of this product is vitally important. Join Center for Food Safetys mailing list to protect your right to safe food HERE >>

For those of you interested in eating more plant-based, we highly recommend downloading theFood Monster App with over 15,000 delicious recipes it is the largest plant-based recipe resource to help reduce your environmental footprint, save animals and get healthy! And, while you are at it, we encourage you to also learn about theenvironmentalandhealth benefitsof aplant-based diet.

Here are some great resources to get you started:

For more Animal, Earth, Life, Vegan Food, Health, and Recipe content published daily, subscribe to theOne Green Planet Newsletter! Lastly, being publicly-funded gives us a greater chance to continue providing you with high-quality content. Please considersupporting usby donating!

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Is Lab-Grown Meat Healthy and Safe to Consume? - One Green Planet

Celyad Oncology is at the forefront of cutting-edge immunotherapy and is hopeful of providing a new way forward for patients with relapsed/refractory multiple myeloma. After receiving FDA approval on July 14th to begin Phase I trials, they plan to be in the clinic with their first patient the end of 2020.

The Belgian clinical-stage biotechnology company is focused on the discovery and development of chimeric antigen receptor T cell (CAR-T) therapies for cancer. Celyad Oncology is also developing CYAD-101, an investigational non-gene edited, allogeneic NKG2D-based CAR-T therapy for metastatic colorectal cancer.

The two primary types of cell therapy are autologous and allogeneic. Autologous CAR-T therapy uses the transplantation and genetic editing of a patients own immune cells in a single batch, while an allogeneic transplant uses immune cells from a donor manufactured in large batches. Celyad Oncology is only the fourth company to proceed to Phase I with an allogeneic CAR-T working against a target known as B-cell maturationantigen (BCMA), which is highly expressed in multiple myeloma patients.

The Phase I objectives for CYAD-211 are to establish the viability, effectiveness and further possibilities opened up by the shRNA-based technology. Along with analyzing the merits of targeting BCMA with a CAR-T, Celyad Oncology Chief Executive Officer Filippo Petti shared that the companys first priority is to prove the premise that ShRNA bears out for allogeneic CAR-T.

The first level is to get into the clinic and evaluate the question, is shRNA a novel, non-gene edited allogeneic approach to CAR-T? Where the majority of our peers in the space work on genome using the gene editing technology, if we can show that another non-gene editing technology like ShRNA works, it would just open up the whole field in terms of allogeneic CAR-T. It would demonstrate that we have an unencumbered asset and technology platform for us to create next-generation CAR-T candidates with, Petti said. Well know very quickly, within the first few patients, if we are seeing an absence of graft-versus-host disease, and if ShRNA carries its weight in terms of being an allogeneic technology.

He expects to have a sense of how competitive the data is in terms of both safety and clinical efficacy by end of year 2021.

Dr. Laurence Cooper, Chief Executive Officer (CEO) of Ziopharm Oncology, who is also a veteran innovator in pairing genetic engineering with immunotherapies, explained that Graft-versus-Host Disease (GvHD) is one of biggest challenges facing companies who take the allogeneic approach.

When you put in third party cells, those cells get really confused right off the bat because now theyre somewhere new, and all of a sudden they perceive the patient as the threat. This can result in Graft-versus-Host Disease, an autoimmune disease triggered by the native biology in the T cell through its T cell receptor, Cooper said. The engineering that youre talking about is to eliminate that threat. Some cut out the genetic material coding for the endogenous T cell receptor so that now a T cell can go into another person, and it cant perceive the threat anymore because its lost its antennae. Another way is to prevent expression of the T cell receptor. Now the T cell can do something useful if you put in a CAR, it can go off and targetBCMA.

Frdric F. Lehmann, Head of the Oncology Franchise at Celyad Oncology, explained how the shRNA-based therapy is engineered to reign in the cells new rampant disregard for threat, and lessen the chances of an autoimmune response.

One of the innovations for CYAD-211 is incorporating in the vector a short hairpin RNA (shRNA) targeting the CD3 subunit of the T cell Receptor (TCR). This effectively downregulates the surface expression of the TCR thereby inhibiting the signaling that would lead to Graft-versus-Host Disease, Lehmann said.

A notable drawback with the autologous approach to CAR-T therapy is that it is costly and time-consuming. Petti explained how CYAD-211 not only has the potential to improve efficacy, but also make the treatment process more scalable and therefore economically expedient.

When it comes to commercialization, because we use an all-in-one-vector approach, we benefit from less manipulations during manufacturing, allowing us to enrich for the engineered cells we want, which eventually could help during potential commercialization of a product thats streamlined, Petti said.

He added that the all-in-one vector approach increases efficiency because, as opposed to the case with the gene editing process, they are able to accomplish everything in a single step.

Long term, Cooper is excited about the possibility that, whether autologous or allogeneic, immunotherapy may one day replace bone marrow transplants, or even chemotherapy, but emphasized that it must be made accessible.

If these immunotherapies can be advanced really to replace chemotherapy, not to replace transplantation for liquid tumors, but to replace chemotherapy, which is a huge goal if you can get it to do that, you have to bring the costs down to make it available for the masses, inside first world economies as well as less privileged societies, Cooper said.

In 2013, the overall five-year survival rate for multiple myeloma stood at 49.6%. Relapsed/refractory patients for whom currently available treatments have failed, are the intended beneficiaries of much of the biotechnology work being done in this area. And impressive steps have recently been made.

GlaxoSmithKlines BLENREP (BelantamabMafodotin) is the first in its class to work against BCMA, while Janssen Biotechs (Johnson & Johnson) DARZALEX (Daratumumab) is the first human Anti-CD38 monoclonal antibody in the space. After their 2019 acquisition of Celgene Corp., Bristol-Myers Squibb gained Revlimid (Lenalidomide), a hematology drug approved for multiple myeloma, and Amgen and Takeda have popular proteasome inhibitors on the market.

With Celyad Oncology moving the needle forward once again, the future looks a little brighter for multiple myeloma patients.

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Celyad's High Hopes for a Path Forward in Cancer Immunotherapy with CYAD-211 - BioSpace