Archive for December, 2020

Janssen is seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

This morning, the company submitted a Biologics License Application to the U.S. Food and Drug Administration for this indication. Amivantamab is an investigational fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody that targets both adriver mutation as well as a resistance mechanism. Exon 20 insertion mutations account for at least 9% of EGFR mutations. However, there are no FDA-approved targeted therapies for patients with these mutations, which means chemotherapy remains the standard of care, Janssen said this morning.

EGFR mutations, can lead to uncontrolled cancer cell growth and division. Those mutations are some of the most common mutations in NSCLC.EGFR exon 20 insertion mutations are the third most prevalent primary EGFR mutation, but often go undetected, the company said.

The BLA submission for amivantamab is based on data from the monotherapy arm of the Phase I CHRYSALIS study, a multi-center, open-label, multi-cohort study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib, a novel third-generation EGFR tyrosine kinase inhibitor (TKI), in adult patients with advanced NSCLC. The BLA for amivantamab marks the first regulatory submission for patients with exon 20 insertion mutations and also marks Janssens first filing for the treatment of patients with lung cancer, the company said.

Elsewhere today:

Taysha Gene Therapies Texas-based Taysha Gene Therapies, Inc. secured both Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration for TSHA-103, an AAV-9-based gene therapy in development for SLC6A1-related epilepsy, the company announced this morning.

RA Session II, founder and chief executive officer of Taysha, said the company is pleased with the designations awarded by the FDA and encouraged by the results of the ongoing research.

SLC6A1 epilepsy is an autosomal dominant genetic disorder characterized by the loss of function of one copy of theSLC6A1gene, with clinical manifestations of seizures, epilepsy, language impairment and intellectual disability. Steven Gray, chief scientific advisor to the company and an associate professor in the Department of Pediatrics at UT Southwestern, said haploinsufficiency in theSLC6A1gene has been identified as a cause of genetic epilepsy. However, as of yet, there are no approved disease-modifying therapies for this indication, he said. Gray touted the FDA designations and said they highlight the importance of developing a treatment for patients.

BioAge Labs California-based BioAge Labs raised $90 million in an oversubscribed Series C financing found. Funds will be used to support the development of BioAges platform that maps key pathways that drive human aging, as well as its pipeline of treatments that targets those pathways, BioAge CEO Kristen Fortney said in a statement. BioAge anticipates taking its first platform-derived therapies, BGE-117 and BGE-175 into clinical trials in the first half of 2021.

The financing round was co-led by Andreessen Horowitz and serial entrepreneur, Elad Gil. New investors include Kaiser Foundation Hospitals, AARP Foundation and Phi-X Capital. Current investors in the company, including Caffeinated Capital, Redpoint Ventures, PEAR Ventures, AME Cloud Ventures and Felicis Ventures, also participated.

Kinnate Biopharma Bay Area-based Kinnate Biopharma announced the pricing of a $20 per share price for its initial public offering of 12,000,000 shares of common stock. Gross proceeds are expected to be $240 million. The stock will be available for trading starting today on the Nasdaq exchange under the ticker symbol KNTE. Kinnate Biopharma is focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers. Proceeds from the IPO will be used to fund clinical trials, for R&D and other general corporate purposes, the company said.

Valneva Frances Valneva SE said it will accelerate pediatric development of its Lyme vaccine candidate, VLA15, in collaboration with Pfizer. The company intends to begin dosing in the first quarter of 2021. The Phase II VLA15-221 study will include approximately 600 healthy participants between the ages of 5 and 65. If greenlit by health authorities, the study will be the first clinical trial of VLA15 to enroll a pediatric population aged 5-17 years and will compare the three-dose vaccination schedule Month 0-2-6 with a reduced two-dose schedule of Month 0-6. This study will complement the two ongoing Phase II studies VLA15-201 and VLA15-202, both of which posted positive data earlier this year. All three Phase II trials are anticipated to support a Phase III pivotal efficacy trial including all main target populations for the Lyme vaccine candidate starting in 2022.

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Daily Rundown: Who's Gunning For and Gaining Approval and Other Industry News - BioSpace

SEATTLE--(BUSINESS WIRE)--Shape Therapeutics, Inc. (ShapeTX), a next-generation gene therapy company with an industry-leading RNA targeting technology platform, announces today the unveiling of the AAVidTM capsid discovery platform and results from its first AAV5 variant library in a non-human primate selection campaign.

The AAVidTM capsid discovery platform uses non-random mutational fitness to create massive capsid libraries of billions of unique AAV variants for direct-to-NHP in vivo biological selection. By combining cutting-edge DNA synthesis, advanced synthetic biology, next-generation sequence barcoding and machine learning algorithms, ShapeTX generates industry-leading library size and diversity to enable the development of best-in-class human therapeutics.

Wildtype first-generation AAVs are enabling the recent advances in gene therapy, but they have been plagued by toxicities in the clinic due in part to a lack of tissue specificity, resulting in the need for high doses. Our AAVidTM platform solves the issue by creating novel capsid variants with specific tissue-tropism, said Francois Vigneault Ph.D., President and CEO at ShapeTX. Weve stayed quiet for the past three years while developing a superior AAV platform technology and are excited to announce that we have best-in-class AAV variants in hand. Today, we are announcing our novel liver-tropic AAV5 variants stay tuned for more to come.

David J. Huss, Ph.D., Vice President and Head of Research added, The vast structural space for exploration at the AAV capsid/target cell interface necessitates enormous library size and diversity, which until now, has only been probed with capsid library sizes in the tens of thousands to millions. At ShapeTX, we set out to create a superior AAV capsid discovery platform with library sizes in the billions of unique variants, thereby maximizing the opportunity for novel virus/target cell interactions. Dr. Huss presented the details of the platform at the 2nd RNA Editing Summit on Dec. 2, 2020.

About Shape Therapeutics, Inc

Shape Therapeutics is a biotechnology company developing next-generation RNA-targeted therapies to treat the worlds most challenging diseases. The ShapeTX technology platform includes RNAskip, a proprietary suppressor tRNA technology that enables premature stop codon readthrough; RNAfixTM, a precision RNA editing technology using endogenous Adenosine Deaminase Acting on RNA (ADAR); and AAVidTM, a next-generation engineered adeno-associated virus (AAV) platform producing highly specific, tissue-tropic AAVs. The power of the ShapeTX platforms resides in redirecting the cellular machinery already present in our cells, thereby bypassing the risks of immunogenicity and DNA damage seen with other contemporary editing technologies. ShapeTX is committed to data-driven scientific advancement, passionate people and a mission of providing life-long cures to patients. Shape Life!

Originally posted here:
Shape Therapeutics Unveils AAVid Capsid Discovery Platform and Identification of Novel Tissue-Specific AAV Variants, Solving a Fundamental Delivery...

Fort Collins, Colorado Global Cancer Gene Therapy Market report on in-depth research, sales estimates, and growth forecast details by segments, regions and research scope, historical data, key players, and growth value.

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Cancer Gene Therapy Market Size, Opportunities, Dynamic, Outlook and Forecast To 2027 - Cheshire Media

Professor Laurence D Hurst explains why understanding the nucleotide mutations in viruses, including SARS-CoV-2, can have significant implications for vaccine design.

With 61 codons specifying 20 amino acids, some can be encoded by more than one codon and it is often presumed that it does not matter which one a gene uses. When I first studied genetics, some books I read taught that mutations between such alternative codons (eg, GGA->GGC, both giving glycine) were called synonymous mutations, while others referred to them as silent mutations. However, are synonymous mutations really silent meaning they are identical in terms of fitness and function? Although they may specify the same amino acid, does that mean they are all the same?

Figure 1: Intronless GFP transgene expression is higher for variants of GFP with higher GC content at synonymous sites5

Perhaps one of the biggest surprises over recent years has been the discovery that versions of the same gene, differing only at synonymous sites, can not only have different properties, but effects that are not modest.1-5 For example, two versions of green fluorescent protein (GFP) differing only at synonymous sites can have orders of magnitude differences in their expression level.4 We similarly recently discovered that for an intronless transgene to express in human cell lines it needs to be GC rich, which can be achieved by altering the synonymous sites,5 as seen in Figure 1. It is no accident, we suggest, that the well-expressed endogenous intronless genes in humans (such as histones) are all GC rich and that our functional retrogenes tend to be richer in GC content than their parental genes.

The realisation that synonymous sites matter has clear relevance to the design of transgenes or other artificial genes, be these for experiments, gene therapy, protein production (eg, in bacteria) or for vaccine design. In the case of vaccines, we might wish to modulate a viral protein to be effectively expressed in human cells to illicit a strong and robust immune response.6 Conversely to the design of attenuated vaccines, we seek to produce a tuned down version of the virus that can function but is weak.7

The challenge is knowing not just which synonymous sites can be altered but knowing how they should be altered. One approach is mass randomisation try many alternatives and see what works.4,8,9 In principle this is fine, but this approach requires many randomisations, which is still technically difficult for long attenuated viruses. An alternative strategy that we have been exploring is to let nature tell us; we can apply tools and ideas from population genetics to better understand what natural selection favours and disfavours and in turn to estimate the strength of selection.

it will be interesting to see if we can learn a lesson from nature as to how to weaken a virus

Estimation of the strength of selection is possible from knowledge of the site frequency spectrum, (ie, how common variants are) from which we can infer the distribution of fitness effects (DFE). If a site is under strong purifying selection, then mutations may occur in the population but these are rapidly eliminated, so variants are always rare. By contrast, if they are selectively neutral, we expect some variants to be quite common. We recently applied this methodology to show that synonymous mutations in human genes that disrupt exonic splice enhancer motifs are often under strong selection and affect many synonymous sites in our genes.10 This has implications for both diagnostics and for transgene design for gene therapy, as we often remove introns in heterologous genes, so freeing up these residues from their role in specifying exons ceases.11

The same DFE methodology cannot easily be applied to viruses, as the methods assume free recombination (ie, we assume one mutation does not impact the fate of others in the same genome). However, other population genetical tools can still be applied. Recently, we examined SARS-CoV-2 and identified the profile of mutations that we see at four-fold degenerate sites.12 From this profile we could estimate what the synonymous site composition would be, assuming that the only forces are mutational biases and neutral evolution (ie, no selection). We observed that in this genome there is a strikingly strong C->U mutation bias and a G->U one. In the raw data this is not so obvious as G and C are quite rare. However, the mutability of the sites per occurrence of the site reveals the underlying patterns.

Figure 2: The rate of mutational flux from one dinucleotide to another in the coding sequence of SARS-CoV-2. The direction of flux is indicated by the indentation of the connecting links: the inner layer represents flux out while the outermost layer represents flux into the node. The frequency of the flux exchange is represented by the width of any given link where it meets the outer axis. Dinucleotide nodes are coloured according to their GC-content. Hence, it is evident that there is high flux away from GC-rich dinucleotides whereas AU-rich dinucleotides are largely conserved.12

With knowledge of the mutational bias we then asked what the equilibrium frequency of the four nucleotides would be using four simultaneous equations. This is the nucleotide content at which for every mutation changing a particular base there is an equal and opposite one creating the same base somewhere else in the genome, ensuring overall unchanged nucleotide content. Given the strong C->U and G->U mutational biases, it is no surprise that the equilibrium content is very U rich (we estimate equilibrium U content should be about 65 percent). However, while the four-fold sites are indeed U rich, they are not that U rich, being closer to 50 percent. A clue as to why the mutation bias is so skewed to generating U comes from analysis of equilibrium UU content: UU residues are predicted to be very common, with CU residues being particularly mutable generating UU (Figure 2) this is expected due to human APOBEC proteins attacking and mutating/editing the virus.13

One probable explanation for this difference between predicted and observed nucleotide content is selection against U content. There may be many U residues appearing in the population, but many are pushed out of the population owing to purification selection, ie, because of the deleterious effects of the mutations. That such selection is happening in the SARS-CoV-2 genome is also clear from the sequence data. We estimate that for every 10 mutations that appear in the sequence databases, another six are lost because of selection prior to genome sequencing. Indeed, UU content is about a quarter of that predicted (Figure 3).

Figure 3: The predicted (under neutral mutational equilibrium) and observed dinucleotide content of SARS-CoV-2. Note the very high predicted levels of UU given the strong mutational flux to UU residues (see Figure 2) and the net underrepresentation in actual sequence.9

This leaves two problems: why is selection operating on SARS-CoV-2 and what can we do with this information? In some cases, we have a good idea as to why: many mutations to U at codon sites generate stop codons. However, we have observed that U destabilises the transcripts and is associated with lower-reported transcript levels;12 a full explanation of the causes of selection on nucleotide content therefore requires manipulation of the sequences.

The second question, what to do with this information, is perhaps more urgent. It has previously been noted that nucleotide content manipulation is a viable means to attenuate viruses.7 Currently there are three groups investigating this route to make a vaccine for SARS-CoV-2: Indian Immunologicals Ltd/Griffith University, Codagenix/Serum Institute of India and Acbadem Labmed Health Services/Mehmet Ali Aydinlar University. In prior attempts, attention has been paid to CpG levels and UpA levels (which we find to be correlated between SARS genes and between different viruses).12 CpGs attract the attention of zinc antiviral protein (ZAP) and UpA attracts an RNAase L. Not surprisingly, some viruses, including SARS-CoV-2, therefore have low levels of both dinucleotide pairs given the levels of the underlying nucleotides.

The challenge is knowing not just which synonymous sites can be altered but knowing how they should be altered

In the past, attenuation strategies have focused on modulating synonymous sites to increase CpG and UpA, making the virus more visible to antiviral proteins.14 We in turn suggest a general strategy to utilise this method and to increase U content as well.12 Given the evidence that selection on the virus is to reduce U content, while our antiviral proteins are mutating it to increase U content, it will be interesting to see if we can learn a lesson from nature as to how to weaken a virus. This is an unusual circumstance in which we predict that we should build in more of the already most common synonymous site nucleotides (U in this case) to degrade the virus. More generally, it is assumed that the most used codons are those that tend to increase the fitness of the organism. In the face of such a severe mutation bias, however, this simpler logic no longer holds.

Laurence D Hurst is Professor of Evolutionary Genetics and Director of the Milner Centre for Evolution at the University of Bath. He is currently also the President of the Genetics Society. He completed his D.Phil in Oxford, after which he won a research fellowship and then moved to Cambridge University as a Royal Society Research Fellow. While on the fellowship he assumed his current Chair at Bath University. In 2015 he was elected a Fellow of the Academy of Medical Sciences and a Fellow of the Royal Society. He is a recipient of the Genetics Society Medal and the Scientific Medal of the Zoological Society of London.

Related topicsDisease research, DNA, Gene Therapy, Genetic analysis, Genomics, Protein, Proteogenomics, Proteomics, Research & Development, RNAs, Vaccine

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Tweaking synonymous sites for gene therapy and vaccines - Drug Target Review

FREDERICK, Md., Dec. 02, 2020 (GLOBE NEWSWIRE) -- RoosterBio, Inc, a leading supplier of innovative cellular therapy bioprocess tools and scalable manufacturing solutions for regenerative medicine, today announced it entered into an exclusive agency agreement with Sartorius Korea Biotech, a subsidiary of the Sartorius Group, a leading international partner of the biopharmaceutical and life science research sectors. This strategic partnership combines Sartorius proven expertise in providing high-caliber bioprocess testing, technical and customer services to the local SouthKorean market, as well as its global reach, and RoosterBios advanced platform of RUO and cGMP-grade human mesenchymal stem/stromal cell (hMSC) working cell banks, optimized paired media, and hMSC bioprocess systems. This winning combination sets the stage for accelerating the development of new, effective medical treatments and expands RoosterBios footprint into Asia, especially in South Korea.

South Korea is a preeminent innovator in hMSCs, and the South Korean biotech ecosystem has been flourishing according to every measure of growth. One of the first MSC therapies was developed in Korea, clearing an entirely new path to treat previously incurable diseases, said RoosterBio CEO Margot Connor. We are delighted to be working with Sartorius Korea Biotech in our global effort to industrialize the supply chain for next-gen treatments, and we are committed to accelerating the commercialization of cell- and gene-based therapies. We believe the talented team at Sartorius is uniquely suited to provide our mutual customers with scalable hMSC systems to expedite their cell-based therapeutic programs.

Under the terms of the agreement, Sartorius Korea Biotech will engage with its customers as an exclusive agent for RoosterBio to facilitate sales operations and increase the market potential for RoosterBio products on an exclusive basis in South Korea.

RoosterBios commercialized product systems standardize hMSC manufacturing to remove years of time and millions of dollars from the timeline of traditional mesenchymal cell therapeutic product development and clinical translation efforts, said Duck Sang Kim, Managing Director of Sartorius Korea Biotech. We look forward to introducing this synergistic biotechnology relationship to South Korea.

About RoosterBio, Inc

RoosterBio, Inc. is a privately held cell manufacturing platform technology company focused on accelerating the development of a sustainable Regenerative Medicine industry, one customer at a time. RoosterBio's products are high-volume, affordable, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems. RoosterBio has simplified and standardized how living cells are purchased, expanded, and used in development, leading to marked time and costs savings for customers. RoosterBio's innovative products are ushering in a new era of productivity and standardization into the field. Visit http://www.roosterbio.com.

About Sartorius Korea Biotech, Ltd.

Sartorius Korea Biotech based in Pangyo, South Korea, addresses the evolving needs of the biomanufacturing industry to produce biotech medications and vaccines safely and efficiently. The company is a subsidiary of the Sartorius Group, a leading international partner of life science research and the biopharmaceutical industry, and offers a diversified business portfolio reflecting the products and services of the two Group divisions, Bioprocess Solutions and Lab Products & Services. Sartorius Korea Biotech provides pharmaceutical and laboratory equipment, validation service, training, engineering and consulting, and KOLAS calibration, among other products and services.

Visit http://www.sartorius.com

Contact: Carrie Zhang, Director of Marketing, RoosterBioczhang@roosterbio.comAndre Hofmann, Head of Public Relations, Corporate Communications, Sartoriusandre.hofmann@sartorius.com

See the article here:
RoosterBio Collaborates with Sartorius to Expand Cell and Gene Therapy Manufacturing Platform Technology into South Korea - GlobeNewswire

Blood vessels are supposed to act like trees, pumping in oxygen tissues need to grow and immune cells required to clear out pathogens. But in tumors, the forest can go a bit haywire. Vessels grow prodigiously and bulge and twist at abrupt points, making it difficult to even tell whats a vein and whats an artery. It starts to look less like a forest and more like a gnarled root floor. A disorganized labyrinth, one oncologist has called it.

For cancer, chaos is a virtue. That gnarled root floor insulates solid tumors from immune cells and, in recent years, has flustered drug developers best attempts at developing therapies meant to rev up the immune system and direct it toward the tumors.

Researchers at the University of Pennsylvania, however, think they may have stumbled onto a solution, a way of whipping the blood vessels back into proper shape. If it works, experts say, it could pave the way for CAR-T treatments that attack solid tumors and potentially improve the effectiveness for more traditional approaches, such as radiation and chemotherapy.

Its a really novel and potentially important approach, Patrick Wen, a neuro-oncologist at Dana-Farber who was not involved in the work, told Endpoints News. They really did good work. This is a very different way of improving immunotherapy.

Yi Fan, a radiation oncologist and neurosurgeon at Penns School of Medicine, has been working for the last few years to understand why the labyrinth appears in the first place. Researchers had previously circled in on the so-called growth factors that stimulate blood vessel formation. Attempts to block these factors, though, disappointed; Avastin, an antibody against the factor VEGF, became a blockbuster but has continually failed to improve survival on a range of malignancies.

Scientists would have to go more fundamental. In a pair of 2018 papers, Fan showed that part of the problem is a process called endothelial cell transformation. Cells lining the blood vessels around the tumor acquire stem cell-like properties that allow them to reproduce and expand rapidly, as stem cells do.

Theres a genetic reprogramming, Fan told Endpoints. Theyll become really aggressive.

But how did that reprogramming happen? If Fan could pin down the pathway, he figured he could then devise a way to block it. He started knocking out kinases the cellular engines that can drive epigenetic change, or reprogramming one by one in endothelial cells isolated from patients with an aggressive brain cancer called glioblastoma. Out of 518, 35 prevented transformation and one did so particularly well: PAK4.

Then they injected tumors into mice, some who had PAK4 and some who had the kinase genetically removed: Eighty percent of the mice who had PAK4 removed lived for 60 days, while all of the wild-type mice died within 40. Fans team also showed that T cells infiltrated the tumors more easily in the PAK4-less mice.

It was a fortuitous finding: Drug companies had developed several PAK inhibitors a decade ago, when kinase inhibitors were the flashiest thing in pharma. Many had been abandoned, but Karyopharm had recently brought a PAK4 blocker into Phase I.

To see whether drug developers could exploit this finding, Fan and his team removed T cells from mice and developed a CAR-T therapy to attack the tumors.

They gave mice three different regimens. The CAR-T therapy on its own failed to reduce tumor size, apparently unable to reach through the vessels. The Karyopharm drug also had little effect on its own. But combined, they managed to reduce tumor size by 80% after five days. They published the results in Nature Cancer this week.

It is a really eye-opening result, Fan said. I think we see something really dramatic.

That, of course, is just in mice, but Fan already has strong supporting evidence for PAK4s role in cancer. Last December, while Fan was still completing his experiment, Nature Cancer published a paper from Antoni Ribas UCLA lab suggesting that PAK4 inhibitors can help T cells infiltrate around various solid tumors. They showed that the same Karyopharm inhibitor could boost the effects of PD-1 inhibitors in mice, allowing activated T cells to better reach tumors.

That work has already translated into the clinic; weeks after it came out, Karyopharm added an arm to their Phase I study of the drug that will look at the PAK4 inhibitor in combination with the PD-1 blocker Opdivo.

Ribas said that Fans work is compelling and helps confirm the role of PAK4, but he said a CAR-T therapy would face a much longer path to the clinic. Its simply much easier to combine an approved drug with an experimental one than to devise a new CAR-T therapy, mix it with the unapproved inhibitor (and all the other things, such as bone marrow-clearing chemotherapy, CAR-T recipients receive) and then deduce what effect each is having.

It will a take a while, Ribas told Endpoints. But I hope this is right and its developed clinically.

There are also other unresolved obstacles for CAR-T in solid tumors, Wen said. Developers still struggle to find targets that wont also send the super-charged T cells after healthy tissue. And tangled blood vessels are just one of several mechanisms tumors have of defending themselves. They can, for example, turn tumor-eating immune cells into tumor-defending ones.

Still, Wen said, in the short term, the approach offered a path toward boosting the efficacy of radiation, chemotherapy and other small molecule drugs. Although Fan focused on glioblastoma, researchers agreed PAK4 likely plays the same vessel-warping role in many other solid tumors.

Theres a lot of things you could look at, he said.

In a January review, Jessica Fessler and Thomas Gajewski at the University of Chicago said Ribas paper pointed towards a path for improving PD-1 and overcoming resistance in some tumors. But they also raised questions about the Karyopharm drug, noting that it hits other proteins besides PAK4. That could mean other mechanisms are also at play and that the drug could affect other tissues in humans.

Ribas agreed that Karyopharms drug might not be the perfect molecule but said others could be on their way. He serves as a scientific advisor to Arcus, the Terry Rosen startup that is now working on developing its own PAK4 inhibitor.

If they can develop a very selective PAK4 inhibitor, he said, it may be a more direct way of testing the role of PAK4.

Tests with that drug, in turn, could help clear up a biological mystery that emerged out of Fans and Ribas papers. Although both investigators zeroed in on PAK4, each of them suggested very different mechanisms by which PAK4 kept immune cells out of the tumor. Ribas suggested it directly suppresses T cells, while Fan found it led to those transformations inside the blood vessels near the tumor.

Kinases are versatile proteins and both researchers said its possible that PAK4 is doing both. Its also possible, they said, that one is more important than the other, or simply that one of them is just wrong.

When you start with completely new biology, its hard to get it right the first time, Ribas said.

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Penn researchers find a way through the labyrinth keeping CAR-T from solid tumors - Endpoints News

A little more than 2 years after Mercks Roger Perlmutter signed off on a deal that would pay Dragonfly up to $695 million for each drug program it picked off for solid tumors, the pharma giant is stepping up with their first opt-in.

We dont know exactly how much this deal costs Merck in the upfront, or which immunotherapy theyre getting, but its a major step forward for Bill Haneys Waltham, MA-based biotech, which built its TriNKET technology platform with the help of Tyler Jacks, an MIT professor, HHMI investigator and director of the David H. Koch Institute for Integrative Cancer Research as well as Berkeleys David Raulet, whose background as an expert in NK cells and tumor immunology helped spotlight some of the big ideas Dragonfly is pursuing.

This latest pact marks the latest in a flurry of BD deals for the pharma giant, just one last step before Perlmutter hangs it up as head of R&D and passes the reins to Dean Li. John Carroll

A little over a year since announcing its Series A, gene therapy biotech ViGeneron has entered into a new deal.

The German company is partnering with WuXi Advanced Therapies, a contract testing, development and manufacturing organization under WuXi AppTec based out of Philadelphia, to ramp up production of ViGenerons lead candidate VG901 for ophthalmic disorders. VG901s current target is for retinitis pigmentosa, also known as rod cone dystrophy, a degenerative eye disease that causes severe vision impairment as early as childhood.

Manufacturing for the candidate should begin before the year is out, ViGeneron said in a statement. The company added that the program came out of its proprietary vgAAV vector platform, which allows for better transduction of retinal cells as well as a less invasive treatment administration.

There is currently no cure for the disease, though there are some methods that can help manage symptoms like the use of low vision aids and portable lighting. Patients often experience worsening peripheral vision and trouble seeing at night. Max Gelman

Lentiviral vector manufacturer iVexSol has raised $13 million in Series A financing, bringing the total haul to $15.2 million from Casdin Capital and BioLife Solutions and a third undisclosed lead investor.

Founded on the promise to change the way this critical raw material is made using next-generation manufacturing tech, the company said it can produce LVVs at significantly greater quantities than traditional transient transfection processes. The companys name is short for intelligent vector solutions.

Much like adeno-associated viral vectors, or AAV, these delivery vehicles are crucial for cell and gene therapies such as CAR-T, iVexSol added, and their shortage means developers often have to wait 12 to 18 months for production slots.

Details on exactly how it plans to revolutionize the space are scant, but CEO Rod Rietze and CSO Mike Greene both bring technical experience from shops like Novartis and Pfizer.

Its new funding will help establish a facility in Lexington, MA housing stable LVV producer cell line master banks and commercial-grade LVV. Amber Tong

Continue reading here:
News briefing: Merck's Roger Perlmutter buys his first solid tumor TriNKET from Dragonfly; ViGeneron to expand production of eye gene therapy -...

Gene therapy has shown promise for the first time to help treatbowelcancerthat has spread to the liver.

Adelaide researchers showed the novel approach, which uses a modified virus to infect the liver, was able to shrink tumours in mice.

"We're very excited by these results," Dr Susan Woods, one of the investigators in the study that was published in the Gastroenterology journal, said.

Further testing will be carried out to see whether the therapy could work for othercancers that travel to the liver such as tumours of the breast, lung and pancreas.

The modified virus exclusively targets the liver and introduces a copy of a gene that instructs the organ to make more cells called fibroblasts which are known to be good and slowcancergrowth.

The team from SAHMRI and the University of Adelaide have been investigating why normal cells that surround thecancerare good while others are corrupted and promote tumour growth.

"Inbowelcancer, we know that patients with the poorest prognosis have a lot of these corrupted or bad tumour supporting fibroblasts," Dr Susan Woods said.

This type of gene therapy that uses a modified virus to enter the liver is currently being used on patients with blood disorders.

"This is the first sign that we could use this to treatcancerthat has spread to the liver," Dr Woods said.

Bowelcancersurvivor Hannah Devereux is heartened by the research and said there needs to be more treatment options for people who are diagnosed with the disease late, when it has already spread.

Hannah was only 34 when she was diagnosed withbowelcancer, soon after her second child was born.

"Had the baby, he was 10 days old, and they found two tumours. My world came crashing down," she said.

Hannah had complained about digestive symptoms during the pregnancy.

"The doctor just thought it was pregnancy related," she said.

Hannah required intensive treatment for a year including six months of chemotherapy, radiotherapy and two major surgeries.

She has now reached the five-yearcancer-free milestone and is the ambassador of the Jodi Lee Foundation to preventbowelcancer.

Bowelcanceraffects more than 15,000 Australians each year and fewer than 50 per cent of cases are detected early.

More than 100 Australians each week die frombowelcancer.

More:
New gene therapy could help treat bowel cancer that reaches the liver - 9News

~ Strong Presence at ASH Featuring Five Presentations, Including Late-BreakingOral Presentation on HOPE-B Pivotal Trial ~

~ uniQure to Host Investor Webcast Tuesday, December 8, 2020 at 5:00 p.m. ET ~

LEXINGTON, Mass. and AMSTERDAM, Nov. 30, 2020 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs,today announced that Steven Pipe, M.D., professor of pediatrics and pathology and pediatric medical director of the hemophilia and coagulation disorders program at the University of Michigan, will present clinical data from the HOPE-B pivotal trial of etranacogene dezaparvovec in hemophilia B at the virtual 62nd American Society of Hematology (ASH) Annual Meeting.

uniQure management along with Dr. Pipe will host an investor webcast on Tuesday, December 8, 2020, at 5:00 p.m. ET. To access the live webcast with presentation slides, please visit the Investor Relations section of uniQures website at http://www.uniQure.com. The webcast will be archived for 90 days. The event also may be accessed by dialing (877) 870 9135 for domestic callers and +44 020 719 283 38 for international callers. The passcode is 3164585. Please specify to the operator that you would like to join the uniQure Conference Call.

The conference abstracts are available and can be accessed through this link: ASH abstracts.

About uniQure

uniQure is delivering on the promise of gene therapy single treatments with potentially curative results. We are leveraging our modular and validated technology platform to rapidly advance a pipeline of proprietary gene therapies to treat patients with hemophilia B, Huntington's disease, Fabry disease, spinocerebellar ataxia Type 3 and other diseases.www.uniQure.com

uniQure Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to,whether we will present long-term follow-up data from our hemophilia B gene therapy studies, including two years of follow-up on the Phase IIb clinical trial of etranacogene dezaparvovec (AMT-061) and up to five years of follow-up from the Phase I/II clinical trial of AMT-060, and whether we will announce top-line data from the pivotal HOPE-B study of etranacogene dezaparvovec before the end of this year. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our and our collaborators clinical development activities, clinical results, collaboration arrangements, corporate reorganizations and strategic shifts, regulatory oversight, product commercialization and intellectual property claims, as well as the risks, uncertainties and other factors described under the heading "Risk Factors" in uniQures Quarterly Report on Form 10-Q filed onOctober 27, 2020. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

uniQure Contacts:

Link:
uniQure Announces Multiple Presentations and Investor Webcast on Hemophilia B Gene Therapy Program at the 62nd American Society of Hematology (ASH)...

Since 1901, Nobel Prizes have honored the worlds best and brightest and showcased the work of brilliant and creative minds, thanks to Swedish businessman Alfred Nobel, who made his fortune with the invention of dynamite.

The Prize in Physiology or Medicine often honors those whose discoveries led to medical breakthroughs, new drug treatments, or a better understanding of the human body that benefit us all.

The Prize in Literature celebrates those skilled in telling stories, creating poetry, and translating the human experience into words. The Prizes in Chemistry and Physics remind most of us how little we understand of genetics, atomic structures, or the universe around us, celebrating the scientists who further knowledge. A later addition to the award roster, the Nobel Memorial Prize in Economic Sciences is not an original Prize, but was established by the Central Bank of Sweden in 1968 as a memorial to Alfred Nobel. It applauds those who can unravel the mysteries of markets, trade, and money.

The Peace Prize celebrates, in Nobels words, the person who shall have done the most or the best work for fraternity between nations, the abolition or reduction of standing armies and for the holding and promotion of peace congresses, sometimes risking their lives to do so.

So precious are the awards that the medals of German physicists Max von Laue and James Franck, stored away for safekeeping in Copenhagen during World War II, were dissolved in acid to keep them away from approaching Nazi troops. After the war, the gold was reconstituted from the acid and recast into new medals.

But Nobel history has not been entirely noble. In 1939, British Prime Minister Neville Chamberlain, known for his policy of appeasement toward Nazi Germany, was nominated for the Peace Prize. In an act of irony and protest, members of the Swedish Parliament nominated Adolf Hitler. That nomination was withdrawn. Some recipients have ordered oppressive crackdowns on their own people or ignored genocides, either before or after receiving the Prize. The 1918 Nobel Prize in Chemistry was given to Germanys Fritz Haber, who invented a method of producing ammonia on a large scale, which was helpful in making fertilizer. But the same chemist helped develop the chlorine gas that was used as a chemical weapon in World War I.

Stacker looked at facts and events related to the Nobel Prizes each year from 1931 to 2020, drawing from the Nobel Committees recollections and announcements, news stories, and historical accounts.

Take a look, and see what was happening with the Nobel Prizes the year you were born.

You may also like: 100 years of military history

Originally posted here:
Nobel Prize history from the year you were born - Kenosha News

Aquaculture the farming of fish and shellfish, is the worlds fastest growing primary industry. It provides a healthy source of protein, oil and minerals for our rapidy expanding human population.

But viral and parasitic diseases remain a key challenge for aquaculture industries around the world.

Our global experience this year with COVID-19 has highlighted that biosecurity is expensive and often limited in its protection against the spread of contagious disease.

Developing effective treatments like vaccines can be challenging, take many years and can be difficult to manufacture and deploy in order to effectively protect large populations.

The same is true for disease in aquaculture.

We know, however, that there is natural genetic variation in resistance for aquacultures most problematic viral and parasitic diseases.

Read more

So our research, some of which is published in the journal Scientific Reports, explores how this knowledge could be used in combination with the latest DNA technology advances, like genomic selection and CRISPR, to protect animals against disease.

White spot syndrome virus (WSSV) is a contagious and lethal disease in penaeid prawns that causes billions of dollars of losses globally. It can decimate whole prawn farms within a few days of infection and preventative measures have proven ineffective.

In late 2016, biosecurity efforts failed and WSSV disease was detected for the first time in Australia. The disease spread quickly from the initial farm to other farms and neighbouring wild populations in Queensland.

The outbreak prompted the largest aquatic animal disease emergency response ever undertaken in Queensland, costing $A4.4 million and depleting Australias supply of chlorine around 3.8 million litres was used to clean ponds and water channels. It also resulted in temporary closure of the entire prawn farm industry, costing around $A400 million.

In April this year the disease resurfaced, re-infecting two farms. Like the rest of the world, Australia needs solutions that will help prawn farmers live with this virus.

Prawns and other crustaceans lack immunological memory, so vaccination for boosting the immune response has limited potential for protection against the virus.

Read more

Some animals are inherently better able to resist or tolerate the virus than others however, we dont really understand the specific mechanisms underlying these differences.

It is possible to breed animals with higher resistance to WSSV through conventional family selection, but progress has been slow. The industry desperately needs better, quicker solutions.

Our team of breeding and genetic scientists at the Norwegian Institute of Food, Fisheries and Aquaculture Research (Nofima) are working with a commercial partner, Benchmark Genetics, with funding from the Research Council of Norway, to boost the resistance of whiteleg shrimp (L. vannamei) against WSSV using genomic selection.

Instead of relying on pedigree relationships (family trees) to estimate the breeding value of individuals, our GenomResist project uses DNA sequence data to estimate the genomic relationships between individuals at tens-of-thousands of positions throughout the genome.

Some of the animals that are sequenced are challenged with WSSV, and response of these animals to infection, along with the genomic relationship data, can then be used to give us a much more precise way of predicting the disease resistance of potential breeding stock.

This is known as genomic selection.

A major advantage of genomic selection over traditional selective breeding for a trait like viral disease resistance is that it allows us to more accurately predict which breeders have the best overall resistance genotype without exposing the candidate breeders themselves to the disease.

Read more

In an experiment using two shrimp populations developed by Benchmark Genetics Colombia, animals were randomly separated into two groups, one a test population which was challenged with the virus and the other a breeding population that was kept under high biosecurity.

By analysing variation across the genome in both populations, we could predict the genetic value of potential breeders.

We then selected and mated broodstock to produce two different populations of shrimp one with high and the other with low genomic estimated breeding values. The survival of these two populations, and offspring from randomly mated parent stock, was compared in a virus challenge test.

We found that the average survival of shrimp families increased from 38 percent to 51 percent after only one generation of genomic selection for high white spot syndrome virus (WSSV) resistance.

Like the effect of vaccinating members of a population, high levels of immunity in the best populations can have a herd immunity effect because these highly resistant animals will no longer infect other animals.

Benchmark Genetics now uses this tool to offer shrimp populations that can survive and produce in the presence of WSSV.

Read more

Sea lice pose one of the biggest challenges facing the aquaculture industry worldwide. Sea lice wound and stress the fish. On top of this, the most effective methods of treatment (such as mechanical de-lousing) are also very stressful for the fish.

The cost to the Norwegian industry alone is more than US$550 million each year. Atlantic salmon are particularly susceptible to sea lice, while some species of Pacific salmon have very low susceptibility.

In a world-first project funded by the Norwegian Seafood Research Fund, our team from the University of Melbourne and Nofima, in collaboration with scientists from the UK, Canada and the USA, will work with large salmon breeding and production companies in Norway, using gene editing to find out which genes make salmon attractive as a host.

We are using the process for gene editing called CRISPR/Cas9 genetic scissors that won Emmanuelle Charpentier and Jennifer Doudna this years Nobel Prize in Chemistry.

If we can find the differences in the genetic code that cause lice to be attracted to Atlantic salmon, or that makes the skin of Pacific salmon unpleasant for sea lice to settle and develop, then we may be able to use that information to make Atlantic salmon resistant to sea lice.

Read more

Professor Tim Dempster and Associate Professor Ben Phillips at the University of Melbourne are also investigating the risk of sea lice adapting to the changes in the salmon, and how this would be best prevented.

The project will not make genetically edited fish available to the industry, but provide a thorough assessment of the potential for using this technology to improve the genetics of the fish, including possible effects on wild salmon populations.

Advances in our genetic knowledge and technologies are greatly increasing the accuracy and power of genetic improvement. But these new technologies also pose ethical issues for society that need to be openly debated and discussed.

Through these and other projects our team is working closely with industry and other researchers around the world to assess the potential for applying the latest sequencing and gene editing technologies to improve sustainability and welfare in aquaculture globally.

Banner: Getty Images

Read more:
Genomics, gene-editing and the Blue Revolution - Pursuit

Growing emphasis on the food safety and longer shelf life has played an important role in the development of ingredients that aid in food preservation. These ingredients vary from simple water content to salt or sugar to chemicals like antioxidants and are used to prevent growth of microorganisms, thereby delaying the spoilage process. In terms of origin, food safety and shelf life extension ingredients can be synthetic or natural in nature.

Food preserving ingredients have been an integral part of kitchen aisles in the form of lemon, ginger, vinegar, spices, salt and sugar. Their traditional utilization was replaced by synthetic ingredients with increasing commercialization of the food industry in past decades. However, with the dissemination of knowledge related to harmful effects of synthetic ingredients, currently, the industry is witnessing a prominent shift toward natural ingredients for food safety and shelf life extension.

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Shelf Life Extension Ingredients Market Notable Developments

Shelf Life Extension Ingredients Market Dynamics

Clean-Label Trend Fuels Synthetic to Natural Transition in Food Ingredient Landscape

Naturally sourced ingredients have gained significant traction as consumer preference for natural products continues to surge. In terms of effectiveness, natural preservatives are superior in delivering greater protection and longer shelf life. As they work with equivalent efficiency and are healthful in nature, adoption of naturally sourced ingredients is increasing consistently as compared to the synthetic options.

Natural ingredients such as antimicrobials or antioxidants have additional potential health benefits also. Well aware of the increasing consumer demand for natural food products that are without artificial ingredients, manufacturers in the food ingredient market are introducing bio-based or naturally sourced food safety ingredients.

Frozen Foods Drive Demand for Specialized Food Safety Ingredients

Ranging from salads to sauces or ready meals to rice, a plethora of food products are available in frozen forms. As the demand for fresh and frozen foods increase across the globe, food manufacturers are seeking innovative ways to introduce novel food safety ingredients to extend the shelf life of frozen foods.

Manufacturers in the food safety and shelf life extension ingredient market are introducing ingredients specific to refrigerated products. Along with providing safety, these ingredients are label friendly and help in reducing sodium content while enhancing consumers sensory experience.

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Shelf Life Extension Ingredients Market Regional Outlook

North America presents lucrative opportunities for the Shelf Life Extension Ingredients Market on the back of buoyancy in regions the food and beverage industry and presence of leading F&B companies.

The market is likely to witness increasing opportunities in the developing countries of Asia pacific. These countries are witnessing huge demand for frozen foods, RTD food and beverages and processed food, thereby presenting higher potential for the market in the future.

Shelf Life Extension Ingredients Market Segmentation

The Shelf Life Extension Ingredients Market is segmented into following,

Based on type, Shelf Life Extension Ingredients Market can be segmented in,

Based in function, Shelf Life Extension Ingredients Market can be segmented in,

Based on application, Shelf Life Extension Ingredients Market can be segmented in,

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Shelf Life Extension Ingredients Market Analysis of Key Players, End User, Demand and Consumption By 2028 - The Haitian-Caribbean News Network

Different families of lumpfish show marked differences in lice grazing, cataract prevalence and size, pointing to the possibility of breeding fish that are more effective at the removal of sea lice from farmed salmon, according to the results of a new study.

GIFAS

A study with 10 different half-sib lumpfish was performed in the small-scale R&D facilities at the Gildeskl Forskningsstasjon (GIFAS) in Norway to explore the potential genetic influence on the performance of key traits affecting lumpfish stocked in salmon farms.

This trial was part of a series of studies under a research programme on the selective breeding of lumpfish. Each study further explores the potential paternal influence and provides key information on specific behavioural, growth and health traits of great interest for the breeding programme.

Increasing resistance to chemotherapeutic agents by sea lice is driving the search for alternative approaches that can effectively minimise the impact caused by this group of ectoparasites. One of the most promising alternatives is the use of cleanerfish. In fact, the use of lumpfish as biological delousing agent has seen a remarkable growth in the past few years, with studies reporting up to 97 percent fewer adult female sea lice in salmon pens, found in a recent study between GIFAS and Akvaplan-Niva, where a link between lice-grazing preference and genetic composition was found. Parental influence on lumpfish behaviour regarding preference for natural food-sources such as sea lice has also been documented in previous studies.

Concerns over lumpfish welfare in salmon farms have been widely reported, as this species undergoes several stressful events during its life in aquaculture operations. Strategies such as supplementary health-boosting feeds, production of robust fish and optimised handling procedures can help to improve the welfare of lumpfish.

Expanding knowledge on the influence of genetics on the preference of lumpfish for sea lice and their health status opens the potential to design strategies such as breeding programmes that maximise the full sea lice grazing potential in salmon pens while safeguarding health.

The main objective of this study was to assess the grazing of different lumpfish families on sea lice found on Atlantic salmon in cages and investigate possible differences in growth, cataract prevalence and health of lumpfish with different parental backgrounds.

GIFAS

Ten different lumpfish families with a 54.8g mean weight were distributed among ten sea cages (5 5 5 m), stocked with 400 Atlantic salmon each (621.4g mean weight). Each of the ten cages was stocked with 48 lumpfish a 12 percent stocking density.

During the study, growth performance, health score, behaviour and stomach contents were recorded, as well as the sea lice infestation levels on the salmon stocked in each of the ten cages.

At the start of the trial, families 2; 6 and 10 were the smallest. These differences were only due to genetic influence, as hatching occurred in the same period for all the families, and the rearing conditions were equal for all families.

Growth performance trended positively and was similar for all lumpfish families, though families 2; 6 and 10 remained the smallest groups, while families 4 and 7 had the highest mean weights, both at the start and the end of the trial (figure 1).

Previous studies have shown that smaller lumpfish exhibit a greater inclination for natural food sources, including sea lice therefore a smaller average size is a desirable trait for selective breeding programmes.

Figure 1: mean weight calculated for each of the ten families at day 1, 14, 28, 42, 55 and 69. Values represent means S.D.

In this study, the incidence of cataracts increased throughout the study, with differences between families. Families 2; 6; 7 and 10 had the lowest prevalence (10 percent), while lumpfish from family 3 had the highest levels (21 percent; figure 2). Severity of cataracts was also different, being lowest in families 6 and 7. This gives a solid signal of genetic influence on cataract development of farmed lumpfish. This allows for the selection of lumpfish for breeding programmes with potentially lower cataract incidence.

Figure 2: occurrence of lumpfish with cataracts (percentage prevalence) calculated for each of the ten families at day 1, 14, 28, 42 and 69. Values represent means S.D.

The results of the gastric lavages performed during the study have shown that lumpfish from families 2, 6 and 10 showed a continual consumption of pre-adult and adult L. salmonis sea lice, where family 10 had the highest consumption levels (figure 3A). This indicates that sea lice grazing preference may be genetically influenced to a certain degree.

Gastric lavages showed a high consumption of Caligus elongatus throughout the study, with 56 percent of the family 10 member having been found with ingested C. elongatus (figure 3B). This may indicate that consumption of this sea louse species can be genetically influenced, and the breeding of lumpfish with higher grazing preference of this particular species could be of interest for deployment in farms historically affected by it.

Figure 3 (A): percentage values of L. salmonisconsumption of lumpfish of the ten lumpfish families sampled at each sampling time point and (B) percentage values of C. elongatus consumption for lumpfish of the ten lumpfish families sampled at each sampling time point. Values are presented as means S.D. A: sea lice (L. salmonis).

Operational welfare indicators were developed for the fish used in this study, to follow the health status during the study, for all the ten families.

There was a general trend towards a slight deterioration in health as the study progressed. Fish from family 2 displayed the best health conditions by the end of the trial, indicating a potential genetic influence on health status.

The potential for a breeding programme with this particular species was shown by the clear differences found in terms of mean weight, cataract prevalence, feeding preferences and lice grazing between the ten families, indicating genetic influences.

Lumpfish from families 2, 6 and 10 had the lowest mean weights, higher sea lice grazing and exhibited natural feeding behaviour more frequently. In addition, the members of these three families revealed significantly lower levels of cataract prevalence compared to the other remaining families.

The study results point to a strong potential genetic influence on key desirable traits, with evident aquaculture applications that can benefit salmon farmers as well as safeguarding the health and welfare of these animals on salmon farms.

Tiago Lopes is a marine biologist from Portugal, working in Gildeskal Forskningstasjon (GIFAS), Norway. There he will begin his industrial PhD involving Skretting, Akvaplan Niva and Nord University, with the ultimate goal of improving lumpfish welfare through nutrition.

Continue reading here:
How breeding can improve lice-eating efficacy of lumpfish in salmon farms - The Fish Site

5G Makes the World Safe for Consumerism

There seems to be no questioning the technological imperative. 5G will, when it is fully operative, increase download speeds such that general mobile phone internet activity will be 20 to 100 times faster, thus, for example, greatly enhancing watching Series TV on the go. 5G will also, its promoters claim, fulfill the promise of both Artificial Intelligence and the internet of things: interconnected smart homes, smart cars, and consumers served by smart farms and operated on by smart machines. Likewise, in genetics, the cracking of DNA and RNA codeswhich may enable current COVID-19 stimulators to allow the body to suppress the virus without a dangerous ingestion of COVIDmay eventually lead to promoting a generalized immunity from many diseases.

What could go wrong? Plenty, say 5G critics in France. Likewise, in the realm of genetic algorithms, the German series Biohackers equally sounds the alarm.

In the U.S. and across Asia, in particular, in China and South Korea, the answer to what can go wrong is Nothing. In the U.S. the debate over 5G is only about how fast and efficient the service is. The criticism is that the Verizon-Apple iPhone 12 and the AT&T-Galaxy 5G rollout, even in the large cities, is only partial, four times rather than 20 times faster. China, meanwhile, leads the world in 5G patents and sees the technology as its way to climb out of the stigma of the worlds low-end manufacturer, throwing off the Made in China labeling to be replaced by the Huawei branding of assembled technology, this time Made in Vietnam. In South Korea, the debate is on how soon 6G will arrive.

Europe is behind in the race to 5G, though one of its two telecom companies, Ericsson, has now announced its ready for a rollout. But not so fast. Across the continent questions are being raised about the safety, the consumerist changes, planned obsolescence and inequality the technology will effectuate, and about how 5G is part of the capitalist profit-driven productivist imperative that has so ravaged the planet. In Germany and Britain, angry citizens have pulled down towers. In France, especially with the rise of a progressive Green Party called EELV, the entire ethos of 5G is being questioned.

The opening salvo against the technology was fired by the Green Party Mayor of Grenoble, Eric Piolle, who questioned its supposed benefits. With 5G I can watch porn in HD in my elevator and know if I still have yogurt in the refrigerator is the way he described the new promised land that proponents claim the network will usher in. In return, the Rothschild banker-turned-President Emmanuel Macron, a prime promoter of neoliberal technology as the savior of French society, labeled the Greens Amish who wanted to return to the era of the oil lamp. His fellow right-wing confrres warned of a Green Peril, using the Cold War overlay of Red Peril, and branded those questioning this imperative as Khmer Green, likening them in the digital realm to Cambodias murderous Khmer Rouge.

There is little doubt that the primary reason 5G, the star of the Christmas consumer push, is being so thoroughly trumpeted is the profits it will reap, forecast to account for 668 billion dollars globally in six years and predicted, with the gain in the sale of mobile phones, with an enhanced gaming experience and with more widespread virtual reality headsets, to account for 5 percent of global GDP this year.

Elements of the French left, though, including Franois Ruffin, a legislator and director of the film Merci, Patron, or Thanks, Boss, a kind of French Roger and Me about Frances richest bosses mercilessly closing factories, have suggested that this technological bounty is being asked to fill the void in lives that are increasingly despairing. Ruffin notes also how this techno-totalitarianism, what media critic Evgeny Morozov calls solutionism, will amplify already existing inequalities. The technology may widen the gaps between the increasingly more plugged-in cities with 5G, the periphery around those cities with 4G, and the countrys rural areas with no G, thus in France exacerbating what is termed the territorial fracture and what in the U.S. might be called the Red/Blue dichotomy.

Echoing Morozov, Ruffin points out this kind of thinking leads not to, for example, regulating agribusiness to produce healthier and more eco-friendly food, but to supplying more intelligent forks. In Catholic France 5G is breathlessly talked about, Ruffin says, as the second coming of the Holy Spirit, illuminating our smartphones in the way the first coming descended on the apostles at Pentecost. In the holy light of such a miracle, the telecom industry shakes off the shackles of any sense of being a public good, and instead regulation becomes only about how market competition can be promoted.

France has always been suspicious of consumer miracles which its leading thinkers have often seen as foisted on it by American capitalism in its drive for global hegemony. Witness Godards Two or Three Things I Know About Her and Weekend and the films of Jacques Tati (Playtime, Mr. Hulots Holiday) in their unfolding of a critique of a French society being remade from without.

The debate here is raising important questions that are given short shrift in the rest of the world. Europe is simply being asked to conform and told that if it does not it will be left out of a mainspring of the global economy, with its devices unable to catch up or be plugged into the global flow.

Studies indicate that the digital economy emits 4 percent of greenhouse gas, a number that is predicted to double in five years and which 5 and 6G will accelerate. The Green Party labels 5G an enevore, that is, energy gorging, noting that mobile phone use already accounts for 2 percent of electric use in France.

The introduction of this speedier technology is designed to increase costs, not only of a monthly mobile bill as more data is accessed and downloaded, but also necessitating replacing existing mobile phones with 5G-ready equipment, phones which are now already on the average replaced every 18 months to 2 years. Eventually, the technology with increased pixilation for faster and clearer viewing will be a part of computers and televisions and, like the changeover in television sets from analog to digital, will require a wholescale worldwide replacement.

The ecological question also involves not only the global waste in disposing of the used devices which is estimated to reach 2 million tons, but also in their creation with 70 kilos or 154 pounds of raw materials, including rare metals, necessary for the assembling of one of these super devices. These rare metals, which emit radiation, are strip-mined in the south of China where production is still largely private and loosely regulated. Elsewhere, 80 percent of the cobalt and tantalum needed for assembly comes from the east of the Republic of Congo, a war-torn area where 40,000 children work in the mining zones.

Consumer enhancement, of course, with the tech companies goes hand in hand with consumer surveillance, and 5G increases the drive to a global data center where billions of data packages will be available to publicity and advertising agencies for use in instantaneously molding and soliciting user taste depending on the content of individual cell phones and the store any consumer passes or, more creepily, any impulses they have. By 2025 it is predicted that 75 billion objects will be interconnected, all transmitting user data so that the refrigerator that is telling you to buy more yogurt is also spying on you. The internet highway becomes a spy way.

The implementation of 5G is also wasteful. Huawei is clearly the global leader in cheap and efficient 5G construction. A mobile phone is made up of a complex of 250,000 inventions and patents. In 2020 the Chinese lead the world with 34 cell phone patents, followed by South Korea and Europe with the U.S. a distant fourth. Yet, in labeling the Chinese company a security riskwhen in fact the real threat is that it is a more skillful competitorand forcing its allies to boycott the company as well, installation of 5G will be more costly with companies required to duplicate already established efforts.

Finally, there is the question of safety. There has been no comprehensive government study on the effects of the increased sonic waves on the human body. Private corporate studies, which are not required to be made public, all negate this possibility, while public studies suggest there may be some danger. The U.S. National Toxicology Program found evidence of cancer tumors in rats exposed to high frequencies, and in Italy, the Ramazzini Institute warned there were potential carcinogens in radio frequencies. The French government has commissioned a thoroughgoing study, the results to be reported in Spring 2021. The newspaper of record Le Monde and 70 legislators have asked for a moratorium until the findings are revealed, but Macrons Minister of Finance Bruno Le Maire wants to hasten 5G installation, warning that a delay would contribute to France losing its digital sovereignty.

The corporate sector sees 5G as simply an economic issue with the question being when and how, not why. The Greens and the French left see 5G, in the way it will change French life, perhaps increasing what the French philosopher Gilles Deleuze called societies of control, as a social and ecological issue and a place where the overwhelming drive to more and faster which has so devastated the planet must be questioned. On the continental, national and individual level, to not have 5G means to drop out of the digital flow, with capital arguing, as Theodor Adorno warned in the mid-20th century, that the worst of all conditions is to be left behind. What a bleak future indeed without porn on our elevators and without knowing if we need another yogurt in our refrigerator!

Are you ready for more genetic engineering?

A series which similarly questions how technological prowess is being implemented and controlled, this time in the area of genomes and the human body, is the German show Biohackers. The series is financed by German government and Bavarian Television funds and shot in the same studio as another German series, Dark, both available on Netflix. The simplicity of Biohackers, which begins with a highly dramatic bio attack on a train and then flashes back to explain how the young female student Mia got there and why she is not susceptible to the attack, works in its favor, as opposed to the labored three-era, almost impenetrable flashbacks of Dark.

The action takes place on the Bavarian campus of the University of Freiburg, the German center of all kinds of genetic engineering experimentation. The students at the school, a band of renegades working on their own socially uplifting mutations, are part of a do-it-yourself biology known as the biotechnological social movement or as bio- or wetware hacking, similar to the early rough and tumble cyberpunks of the internet. Mias roommatesbotanist Chen Lu, monied beauty queen Lotta, and nerd seed experimenter Oleform an international group of scientific Scooby Doos who comes to her rescue as she is first taken under the wing of the universitys star biologist Dr. Tanya Lorenz and then threatened by her, as Mia and her friends expose the ruthlessness of their professors experiments to perfect a subject immune to disease.

Mias futon and her rumpled student quarters are contrasted to the corporate-funded Dr. Lorenzs elaborate multi-storied, impeccably furnished and ordered home in the Bavarian forest, complete with a lab in the basement. As with 5G, Dr. Lorenz issues a warning that Germany, which has lost out and is behind in digital mastery, must conquer the realm of biotechnology to compensate.

Dr. Lorenz, though, is revealed to be experimenting on human subjects, leaving a murderous trail behind her and recalling earlier experiments by the Nazis who also claimed to be benefiting humanity. She is Dr. Mengele in a pants suit. This contemporary version of the former ethos features Lorenz, as Mia points out, marking her subjects with a bar code, as the Nazis burnt prison numbers into their subjects flesh.

We are reminded that the Bavarian countryside and its dark forests hatched Hitler in his first coup attempt and that Freiburg University was the place the philosopher Martin Heidegger, in his moment of embracing National Socialism, accepted an appointment as head of the university until his gradual disgust with the movement resulted in his resignation.

Biohackers, renewed for a second season when the conspiracy to hide the experimentation reaches a national level, does not shy away from the subject of chemical and biological warfare. However, instead of the hackneyed usual and usually insane terrorist, the terror here is far better organized and financed not by rogue fanatics but by a corporate-medical ethos which values profit above human life.

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5G and 'Biohackers': Technology rules! (Is that a good thing?) - People's World