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Thinking About Risk Early on Is Key for Cell Therapy Success – Labiotech.eu

Posted: October 16, 2021 at 3:00 am

For cell therapy to become mainstream, important issues such as management of risk and quality control need to be addressed, argues Duncan Borthwick, Global Marketing Manager at cell therapy manufacturing firm Solentim.

Research and development of cell therapies, along with other advanced medicines like gene therapies, has increased exponentially over the last few years.

According to the Alliance for Regenerative Medicine,as of June this year there were over 2,000 ongoing clinical trials of cell therapies around the world. Of these, 541 were at phase III.

Its absolutely boom time for cell therapy, Borthwick told me, adding that the field has changed enormously in recent years. Its just unimaginably different. And not only its applications, but also the robustness of the methodologies. You speak to some of the researchers and they say two years ago, we couldnt get these cells to grow.

With an increased presence in medicine comes increased scrutiny. Following the appearance of adverts for cell therapies to treat or cure serious diseases in early 2020, the EMA released a statement warning patients against using unregulated cell therapies due to safety concerns.

Similar warnings have also been distributed in the US. Cell therapy developers and clinics offering such therapies were given a break by the FDA in 2017 and told to collect evidence to see if they needed to submit an investigational new drug or marketing application. That period of grace ran out in May this year and the FDA is now enforcing stricter regulations on people offering such therapies.

Unregulated cell-based therapies are a great concern to everybody, says Borthwick. In this context, tighter regulatory control of cell therapies can be beneficial for the industry.

Being able to designate gene therapies and somatic cell therapies in tissue-engineered products under a category is really, really helpful. It sets a new kind of cornerstone for that regulatory framework and also a mechanism by which companies can approach the regulator in terms of clinical trials, says Borthwick.

Although many cell therapies do go through a rigorous development process, it is still a relatively new field. Risk management and quality control can be difficult to navigate for new startups looking to take a cell therapy to market.

One of the many challenges of cell therapy is to make robust control mechanisms by which young and old companies can build a path to develop clinical products, which are going to help peoples lives, explains Borthwick.

A problem with any therapy based on live components is that controlling variation between different batches can be a problem.

If youre trying to control the risk to humans, you control the risk in production, whats called a control strategy, says Borthwick. One of the key ways you can do that is to say, instead of starting with a big pool of cells that are all different, lets take it down into individual cells, pick a good one and make that into a master cell bank.

This has historically been a challenge, as the technology was not advanced enough, says Borthwick. Researchers reduced the volume of cells, carefully pipetted it out, and hoped that some contained single cells that could be the parent of a new cell line.

To address this problem, Solentims founders created imaging processes that could take away the doubt around whether or not a single cell was present when starting a new cell line. The company now covers the whole cell line production process and has expanded into seeding and growth methods.

Solentim has been working closely with researchers and therapy developers across the industry, as well as regulators such as the EMA and FDA, on getting the different steps right.

When you put in a proposal for human treatments, an IND submission, you dont pass the IND submission, you just dont get negative comments at that time. Theres an ongoing review process, explains Borthwick.

Its a very risk-averse community. Rightly so, because if you get it wrong, youre going to get a nasty letter from the FDA. But moreover, you might be developing this for five years. If you dont get this bit right, the regulator is going to come back and say thats too much of a risk to bring to human trials. So, its really important to get it right.

Once a good quality cell line has been created, Borthwick says another important point to consider for cell therapy developers is the scalability and continuity of the process.

You cant wait until you find yourself in production before scrambling to put together a quality process. And theres so much to be gained from starting to think early about that proportional approach to quality.

For instance, how many other providers are involved in the process and how well do you understand their processes? Theres a massive thing about single vendor use going on. If I can understand one vendor really well, then thats so much easier to manage than 20.

The important thing is to find methods that work and then are scalable in terms of throughput. Once youre moving from research to production, can you scale that whole story of risk analysis, paperwork, and regulation? Ultimately, it makes the whole thing so much easier.

Borthwick encourages young startups or academic spinouts that are trying to move from an academic laboratory set up to a large-scale therapy production line to think seriously about this and to question all their initial processes. For example, some cell growth reagents are fine to use in the lab on a small scale, but wont work when scaled up.

Theres many which have animal products in them, which then present massive challenges as you approach clinical trials. There are others which cannot have GMP certification, and theres others that just wont work on high-throughput automation, for instance, he says.

Sometimes you need to stop and think a little bit. Put in place good practices now That might be staff or processes, get people involved at an early stage, because it is going to give you massive time savings later on. Dont be terrified by the world of regulation and risk. Theres a lot of good people out there.

Having an industrial scale-up process that maintains quality and reduces therapy variation will only become more important for companies to succeed in the long run.

We are contacted every week by some company we havent heard of that are moving into the space, says Borthwick, who adds that neighbouring markets, such as cultured meat producers, are also carefully observing cell therapy developers to try and learn from their processes and methodology about how to maintain quality and reduce risks.

Both the FDA and EMA have been learning about advanced therapies and developing the best ways to regulate them over the last few years, but are now becoming more familiar with the area. Borthwick advocates good communication and discussion with the local regulatory agencies when trying to bring a product to market.

One of our collaborators said that their greatest fear is that the regulator will never OK their products, because they wont be able to see if theyve managed risk appropriately. Its up to us to communicate that approach effectively from an early stage to the regulator, because we all want this to work.

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The Benefit of CAR T-Cell Therapy in Indolent Lymphoma – Cancer Network

Posted: October 16, 2021 at 3:00 am

Caron A. Jacobson, MD, MMSC, highlights data supporting the use of CAR T-cell therapy in patients with indolent lymphoma.

Those with B-cell histology have derived positive clinical benefit from treatment with CD19-targeted chimeric antigen receptor (CAR) T-cell therapy, with those with indolent B-cell non-Hodgkin lymphoma achieving a high rate of durable remission. Although early data from first-in-human research indicated that this treatment appears promising, longer follow up is necessary in order to confirm whether the responses translate to cures in patients with these indolent, difficult-to-treat diseases.1

Caron A. Jacobson, MD, MMSC, medical director, Immune Effector Cell Therapy Program and senior physician at Dana-Farber Cancer Institute in Boston, Massachusetts, discussed results from the ZUMA-5 trial (NCT03105336), provided a comparison between ZUMA-5 and the SCHOLAR-5 trials,2 and interim results from the ELARA study (NCT03568461) in a presentation at the Society of Hematologic Oncology 2021 Annual Meeting on September 10, 2021.

ZUMA-5 evaluated axicabtagene ciloleucel (axi-cel; Yescarta) in 124 patients with follicular lymphoma (FL) and 22 patients with marginal zone lymphoma (MZL) who had undergone 3 lines of prior therapy. The primary end point was overall response rate (ORR), and key secondary end points were complete response (CR) rate, duration of response (DOR), progression-free survival (PFS), overall survival (OS), and incidence of adverse events (AEs).

These were a group of patients at high-risk, with the majority [46.5%] having FLIPI scores greater than 3, Jacobson, an assistant professor of medicine at Harvard Medical School, said. In addition, many patients (54.1%) were classified as POD24, ie, having progression of disease within 24 months of receiving their first anti-CD20 monoclonal antibodycontaining therapy.

In ZUMA-5, ORR was 92% with a CR rate of 76%. For patients with FL, after 12 months of follow up, the ORR was 94% (n = 84) with a CR of 80%. For patients with MZL, the ORR was 85% (n = 20) with a CR rate of 60% (n = 12). It is notable that 52% of patients who had had an initial partial response at first tumor restaging, went on to have a CR after a median of 2.2 months of follow-up, Jacobson said in her presentation.

In patients with FL, median DFS, PFS, and OS have not been reached; among patients who had responded at a median follow-up of 18 months, 78% were maintaining their response. Jacobson said the MZL survival curves were quite immature because patients only needed one month of follow-up to be included in the efficacy analysis. We are awaiting longer-term follow-up for this cohort, Jacobson noted.

When outcomes by POD24 were reviewed, patients with FL and MZL with POD24 had a lower CR rate and a shorter DOR and PFS than those without POD24. This was most notable in the MZL cohort, where only 58% of patients had a CR in the POD24 group compared with 75% and the median DOR was 11.1 months. Median PFS was 9.2 months for patients with POD24 compared with not reached for both end points for patients with MZL without POD24, Jacobson explained.

The safety profile appeared more favorable than that observed with axi-cel in patients with diffuse large B-cell lymphoma (DLBCL) with only 7% of patients having grade 3 or greater cytokine release syndrome (CRS) and 19% of patients with grade 3 or greater neurologic events. Also, the median time to onset of CRS was later in FL and MZL at 4 days, compared with DLBCL at 2 days, according to findings from the ZUMA-1 study (NCT02348216).

Results from the SCHOLAR-5 study were presented at the 2021 European Hematology Association Meeting (EHA2021).2 This was a retrospective meta-analysis comparing clinical outcomes from the updated 18-month ZUMA-5 study to a matched sample from the SCHOLAR-5 study. Data from the pivotal DELTA trial (NCT01282424) evaluating idelalisib (Zydelig) was included in the SCHOLAR-5 cohort. Eighty-five patients in the SCHOLAR-5 study and 86 patients in ZUMA-5 were evaluable after propensity score weighing was applied to the cohorts.

In third-line or higher, the ORR was 49.9% in SCHOLAR-5 compared with 94.2% for an OR of 16.2 (95% CI, 5.6-46.9). The median PFS and OS were not reached in ZUMA-5 and in SCHOLAR-5 were 12.7 months and 59.8 months, respectively. The analysis revealed a statistically significant improvement in both overall response rate from 49.9% to 94.2%, and a complete response rate from 29.9% to 79.2%, Jacobson said. This translates to an improvement in PFS, time-to-next treatment, and a statistically significant improvement in overall survival that was seen even within the first 3 years of follow-up.

Another study that evaluates CD19-directed CAR T cell therapy in follicular therapy is the ELARA study.3 The study evaluated tisagenlecleucel (Kymriah) in relapsed FL in patients who are in the third line setting and beyond. Investigators reported a complete response rate of 66%, with an ORR of 86% and a median follow-up of 11 months. Jacobson noted that a high proportion of patients maintained their response and that the PFS and OS curves were like those presented in ZUMA-5.

Regarding safety, Jacobson said the toxicity profile for tisagenlecleucel in FL was improved over the toxicity for the agent in patients with DLBCL and was better than the safety profile of axicabtagene ciloleucel. Investigators reported that 48.5% of patients had any grade CRS and no patients had grade 3 or higher CRS. In terms of immune cellassociated neurologic syndrome (ICANS), 9.3% of patients had any grade ICANS and 1% of patients had grade 3 or higher ICANS.3

According to Jacobson, other ongoing studies include ZUMA-5, explores axi-cel in patients with marginal zone lymphoma, the ongoing ELARA study, and the TRANSCEND study (NCT02631044), which evaluates lisocabtagene maraleucel (Breyanzi) in follicular lymphoma. Further, phase 1/2 studies that explore new agents include both allogeneic and natural killer CAR T-cells, as well as dual antigen targeting CARs that involve patients with indolent lymphomas.

We are hopeful that these emerging therapies will change the course of these cancers and provide curative therapy for our patients, concluded Jacobson.

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New CAR T-Cell Therapy Appears Safe in B-Cell Malignancies – Targeted Oncology

Posted: October 16, 2021 at 3:00 am

The CAR T-cell therapy may provide another therapy option for patients with large B-cell lymphoma.

CTX110, an allogeneic chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed or refractory CD19-positive B-cell malignancies, is well tolerated across a variety of dosing levels, according to results of the phase 1 CARBON (NCT04035434) released by CRISPR Therapeutics.1

We are excited to share positive data from our CARBON trial, which show that CTX110 could offer patients with large B-cell lymphomas an immediately available off-the-shelf therapy with efficacy similar to autologous CAR T and a differentiated safety profile, said Samarth Kulkarni, PhD, chief executive officer of CRISPR Therapeutics, in a press release. Furthermore, we have the potential to improve upon already observed efficacy with a consolidation dosing strategy. Based on these encouraging results, we are planning to expand CARBON into a potentially registrational trial in the first quarter of 2022.

The phase 1 CARBON study has an estimated enrollment of 143 participants and an estimated study completion date of August 2026. The primary end point of the dose escalation portion is the rate of adverse events (AEs). The primary end point of the dose expansion cohort is objective response rate (ORR). Secondary end points include duration of response, duration of clinical benefit, and progression-free survival.2

1

During the study, patients received a single transfusion of CTX110 following 3 days of a standard lymphodepletion regimen. The regimen contained fludarabine 30mg/m2 a day and cyclophosphamide 500mg/m2 a day. At disease progression, patients were eligible for redosing.

At the August 26, 2021 data cutoff, 30 patients with large B-cell lymphoma (LBCL) had been enrolled, 26 of which had received the agent with at least 28 days of follow-up. Only patients with at least 28 days of follow-up were included in the analysis.

The ORR was 58% and the complete response rate (CR) was 38% in LBCL with a single dose of the agent at dose level 2 and above. The 6-month CR rate was 21%, and the longest response was still ongoing at 18 months after initial infusion.

In terms of safety, no cases of graft versus host disease and no infusion reactions were reported. Only grade 1 or 2 cytokine release syndrome was observed. Other AEs included infections such as 1 case of pseudomonal sepsis and one case of grade 3 or higher immune effector cell-associated neurotoxicity syndrome. However, this was reported in a patient with concurrent HHV-6 encephalitis.

In order to participate, patients must be at least 18 years of age, a confirmed B-cell malignancy, an ECOG score of 0 or 1, adequate renal, liver, cardiac, and pulmonary organ function, and agree to use acceptable methods of contraception. Patients who received previous CAR T-cell therapy, a history of central nervous system involvement, a seizure disorder, active HIV, a previous or concurrent malignancy, or a primary immunodeficiency disorder are not eligible to participate.

The study is currently recruiting in California, Florida, Georgia, Illinois, Kansas, Massachusetts, Minnesota, Missouri, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, and Washington.

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New CAR T-Cell Therapy Appears Safe in B-Cell Malignancies - Targeted Oncology

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Global Cell Therapy Consumables Market (2021 to 2031) – by Type of Consumable, Type of Cell Therapy, Scale of Operation, Type of End-User and Key…

Posted: October 16, 2021 at 3:00 am

DUBLIN--(BUSINESS WIRE)--The "Cell Therapy Consumables Market by Type of Consumable, Type of Cell Therapy, Scale of Operation, Type of End-User and Key Geographical Regions: Industry Trends and Global Forecasts, 2021 - 2031" report has been added to ResearchAndMarkets.com's offering.

This report features an extensive study on the consumable providers within the cell therapy industry. The study also includes an elaborate discussion on the future potential of this evolving market.

According to the US Food and Drug Administration (FDA), there has been an evident increase in the number of cell and gene therapy products being evaluated in early phases of development. This can further be validated by the observed upsurge in the number of investigational new drug (IND) applications. In fact, more than 800 IND applications have been filed for ongoing clinical studies, indicating remarkable scientific progress and therapeutic promise of these breakthrough drug candidates. However, manufacturing of cell therapies is a complex and capital-intensive process fraught with a wide range of challenges. Some of the key concerns of contemporary innovators include raw material supply constraints, current facility limitations, high cost of ancillary materials (buffers, growth factors and media) used in upstream processes, regulatory and compliance-related issues, and inconsistencies related to quality attributes of the final product. Further, the onset of recent COVID-19 pandemic has created additional challenges for therapy developers, in terms of procuring the required raw materials, by disrupting well-established supply chains.

Recent reports indicate that the global demand for human serum albumin (a key component of cell culture media for use in a multitude of therapeutic and emerging biotech areas) has increased at an annual rate of 10%-15%. On the contrary, the use of animal components is highly disregarded by the US FDA, European Medicines Agency (EMA), and other regulatory bodies on the grounds that they pose an undesirable risk of transmitting infectious agents, such as prions (mad cow disease) and virus (HIV), as well as enable high batch-to-batch variation. Consequently, serum-free and xeno-free media have proven to be a promising alternative to serum derived components. In order to produce quality cellular therapies, several drug developers prefer to rely on third-party service providers for the supply of raw materials, such as cell culture medium, cell isolation kits and cell separation reagents.

Presently, over 60 service providers are actively engaged in providing consumable/raw material products for the production of cell therapies. The current consolidated market landscape is primarily dominated by the presence of large players, capturing a substantial proportion of the market share. In the recent past, many of the aforementioned service providers have also forged strategic alliances and/or acquired other players, in order to further enhance their respective service offerings. Given that the demand for cell therapies is indubitably rising, the corresponding opportunity for cell therapy consumable service providers is expected to witness steady growth, over the next decade.

Key Questions Answered

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION

4. MARKET LANDSCAPE

5. COMPANY COMPETITIVENESS ANALYSIS

6. BRAND POSITIONING OF KEY INDUSTRY PLAYERS

7. COMPANY PROFILES

7.1. Chapter Overview

7.2. Miltenyi Biotec

7.2.1. Company Overview

7.2.2. Product Portfolio

7.2.3. Recent Developments and Future Outlook

7.3. STEMCELL Technologies

7.4. Bio-Techne

7.5. Irvine Scientific

7.6. Thermo Fisher Scientific

7.7. Sartorius

7.8. BD Biosciences

7.9. Lonza

7.10. CellGenix

7.11. Corning

8. RECENT DEVELOPMENTS AND INITIATIVES

9. LIKELY PARTNER ANALYSIS FOR CELL THERAPY CONSUMABLE PROVIDERS

10. DEMAND ANALYSIS

11. MARKET FORECAST AND OPPORTUNITY ANALYSIS

12. UPCOMING TRENDS AND FUTURE GROWTH OPPORTUNITIES

13. IMPACT OF COVID-19 ON CELL THERAPY CONSUMABLES MARKET

14. CONCLUDING REMARKS

15. INTERVIEW TRANSCRIPTS

16. APPENDIX I: TABULATED DATA

17. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/17t5mu

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Global Cell Therapy Consumables Market (2021 to 2031) - by Type of Consumable, Type of Cell Therapy, Scale of Operation, Type of End-User and Key...

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LogicBio Therapeutics to Present New GeneRide Data at the European Society of Gene and Cell Therapy Virtual Congress 2021 – WIBW

Posted: October 16, 2021 at 3:00 am

- Oral and poster presentations to highlight preclinical GeneRide platform data in new indications demonstrating strong evidence of selective advantage of the corrected hepatocytes

Published: Oct. 12, 2021 at 3:05 PM CDT

LEXINGTON, Mass., Oct. 12, 2021 /PRNewswire/ --LogicBio Therapeutics, Inc.(Nasdaq:LOGC), a clinical-stage genetic medicine company pioneering gene editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood, today announced that it was selected to present new data from the company's GeneRide platform in a plenary oral presentation and three poster presentations at the upcoming European Society of Gene and Cell Therapy (ESGCT) Virtual Congress 2021, to be held from October 19-22, 2021.

The oral presentation will include new preclinical GeneRide data showing delivery of corrective genes in three different indications with intrinsic liver damage demonstrating strong evidence of selective advantage of the corrected hepatocytes. Poster presentations will highlight GeneRide expression data in preclinical models of tyrosinemia type 1, as well as the company's optimized adeno-associated virus (AAV) process development.

Oral Presentation Details:

Title: Nuclease-free, promoterless recombinant AAV-mediated genome editing restores function of hepatocytes leading to selective advantage and repopulation in mouse models with liver disease (OR40)Presenter:Shengwen Zhang, Director, Pharmacology, LogicBio TherapeuticsSession: 5b: Gene Editing IIISession date/time:October 21, 2021,17:00-17:15 p.m. CEST (11:00-11:15 a.m. ET)

Poster Presentations Details:

Title: A novel endonuclease-free genome editing technology to edit hepatocytes in vivo led to a full molecular liver transplant and cured mice in preclinical models of Tyrosinemia Type 1 (P253)Q. Qiang Xiong, Director, Head of Preclinical Pharmacology, LogicBio Therapeutics

Title: Development of an Anion Exchange Chromatography Method to Assess Percent Full Capsids for Chimeric Capsid AAV-LK03 (P268)William Lee, Research Associate, LogicBio Therapeutics

Title: Modified plasmid and transfection optimization in suspension HEK293 cells lead to scalable high-yield process for AAV manufacturing (P278)Hans Reuter, Upstream Engineer, Process Development, LogicBio Therapeutics

Additional information on the meeting can be found on the ESGCT website.

The presentation and posters will be available shortly after being presented on the LogicBio Therapeutics website at Presentations | LogicBio Therapeutics, Inc.

AboutLogicBio Therapeutics

LogicBio Therapeuticsis a clinical-stage genetic medicine company pioneering gene editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood. The Company's gene editing platform, GeneRide, is a new approach to precise gene insertion harnessing a cell's natural DNA repair process potentially leading to durable therapeutic protein expression levels. The Company's gene delivery platform, sAAVy, is an adeno-associated virus (AAV) capsid engineering platform designed to optimize gene delivery for treatments in a broad range of indications and tissues. The Company is based inLexington, MA.For more information, visitwww.logicbio.com, which does not form a part of this release.

Investor Contacts: Laurence WattsGilmartin Group(619) 916-7620laurence@gilmartinir.com

Stephen JasperGilmartin Group(858) 525-2047stephen@gilmartinir.com

Media Contacts:Adam DaleyBerry & Company Public RelationsW:212-253-8881C: 614-580-2048adaley@berrypr.com

Jenna UrbanBerry & Company Public RelationsW: 212-253-8881C: 203-218-9180jurban@berrypr.com

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SOURCE LogicBio Therapeutics, Inc.

The above press release was provided courtesy of PRNewswire. The views, opinions and statements in the press release are not endorsed by Gray Media Group nor do they necessarily state or reflect those of Gray Media Group, Inc.

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LogicBio Therapeutics to Present New GeneRide Data at the European Society of Gene and Cell Therapy Virtual Congress 2021 - WIBW

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Achilles Therapeutics joins Northern Alliance for Advanced Therapies Treatment Centre – EPM Magazine

Posted: October 16, 2021 at 3:00 am

Biopharmaceutical companyAchilles Therapeutics has joined the NorthernAlliance for Advanced Therapies Treatment Centre (NA-ATTC) consortium to help expand the centre's cell therapy expertise.

Funded by Innovate UK, the NA-ATTC consortium is a government innovation agency that was created to address the challenges in bringing advanced therapy medicinal products to patients.Specifically, the consortium focuses on all elements of the clinical delivery pathway from procurement of starting materials, through to delivery of clinical trials, and adoption and reimbursement across a range of advanced therapies and indications. Currently, it is one of only threeAdvanced Therapy Treatment Centres in the UK.

"We are delighted to join the Northern Alliance,part of the Advanced Therapy Treatment Centre network,and contribute to this great initiative focusing on multiple aspects of operational delivery," commentedDr Shree Patel, SVP, Clinical Operations at Achilles."We look forward to collaborating and contributing our learnings to the consortium as we work together for the benefit of patients to overcome some of the challenges of cell therapy."

As an industry partner, Achilles will contribute its knowledge and expertise in supply chain and operations for cell therapies that has been developed with its precision clonal neoantigen-reactive T cell therapy (cNeT). Achilles will help the consortium understand the operational gaps in current pathways and practices to be bridged to improve delivery of this type of cell therapy product to patients.

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A bispecific CAR-T cell therapy targeting BCMA and CD38 in relapsed or refractory multiple myeloma – DocWire News

Posted: October 16, 2021 at 3:00 am

This article was originally published here

J Hematol Oncol. 2021 Oct 9;14(1):161. doi: 10.1186/s13045-021-01170-7.

ABSTRACT

BACKGROUND: BCMA-specific chimeric antigen receptor-T cells (CAR-Ts) have exhibited remarkable efficacy in refractory or relapsed multiple myeloma (RRMM); however, primary resistance and relapse exist with single-target immunotherapy. Bispecific CARs are proposed to mitigate these limitations.

METHODS: We constructed a humanized bispecific BM38 CAR targeting BCMA and CD38 and tested the antimyeloma activity of BM38 CAR-Ts in vitro and in vivo. Twenty-three patients with RRMM received infusions of BM38 CAR-Ts in a phase I trial.

RESULTS: BM38 CAR-Ts showed stronger in vitro cytotoxicity to heterogeneous MM cells than did T cells expressing an individual BCMA or CD38 CAR. BM38 CAR-Ts also exhibited potent antimyeloma activity in xenograft mouse models. In the phase I trial, cytokine release syndrome occurred in 20 patients (87%) and was mostly grade 1-2 (65%). Neurotoxicity was not observed. Hematologic toxicities were common, including neutropenia in 96% of the patients, leukopenia in 87%, anemia in 43% and thrombocytopenia in 61%. At a median follow-up of 9.0 months (range 0.5 to 18.5), 20 patients (87%) attained a clinical response and minimal residual disease-negativity ( 10-4 nucleated cells), with 12 (52%) achieving a stringent complete response. Extramedullary plasmacytoma was eliminated completely in 56% and partially in 33% and of 9 patients. The median progression-free survival was 17.2 months. Two relapsed patients maintained BCMA and CD38 expression on MM cells. Notably, BM38 CAR-Ts cells were detectable in 77.8% of evaluable patients at 9 months and 62.2% at 12 months.

CONCLUSION: Bispecific BM38 CAR-Ts were feasible, safe and significantly effective in patient with RRMM.

TRIAL REGISTRATION: Chictr.org.cn ChiCTR1800018143.

PMID:34627333 | DOI:10.1186/s13045-021-01170-7

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A bispecific CAR-T cell therapy targeting BCMA and CD38 in relapsed or refractory multiple myeloma - DocWire News

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What is Transhumanism?

Posted: October 16, 2021 at 2:59 am

The human desire to acquire posthuman attributes is as ancient as the human species itself. Humans have always sought to expand the boundaries of their existence, be it ecologically, geographically, or mentally. There is a tendency in at least some individuals always to try to find a way around every limitation and obstacle.

Ceremonial burial and preserved fragments of religious writings show that prehistoric humans were deeply disturbed by the death of their loved ones and sought to reduce the cognitive dissonance by postulating an afterlife. Yet, despite the idea of an afterlife, people still endeavored to extend life. In the Sumerian Epic of Gilgamesh (approx. 2000 B.C.), a king embarks on a quest to find an herb that can make him immortal. Its worth noting that it was assumed both that mortality was not inescapable in principle, and that there existed (at least mythological) means of overcoming it. That people really strove to live longer and richer lives can also be seen in the development of systems of magic and alchemy; lacking scientific means of producing an elixir of life, one resorted to magical means. This strategy was adopted, for example, by the various schools of esoteric Taoism in China, which sought physical immortality and control over or harmony with the forces of nature.

The Greeks were ambivalent about humans transgressing our natural confines. On the one hand, they were fascinated by the idea. We see it in the myth of Prometheus, who stole the fire from Zeus and gave it to the humans, thereby permanently improving the human condition. And in the myth of Daedalus, the gods are repeatedly challenged, quite successfully, by a clever engineer and artist, who uses non-magical means to extend human capabilities. On the other hand, there is also the concept of hubris: that some ambitions are off-limit and would backfire if pursued. In the end, Daedalus enterprise ends in disaster (not, however, because it was punished by the gods but owing entirely to natural causes).

Greek philosophers made the first, stumbling attempts to create systems of thought that were based not purely on faith but on logical reasoning. Socrates and the sophists extended the application of critical thinking from metaphysics and cosmology to include the study of ethics and questions about human society and human psychology. Out of this inquiry arose cultural humanism, a very important current throughout the history of Western science, political theory, ethics, and law.

In the Renaissance, human thinking was awoken from medieval otherworldliness and the scholastic modes of reasoning that had predominated for a millennium, and the human being and the natural world again became legitimate objects of study. Renaissance humanism encouraged people to rely on their own observations and their own judgment rather than to defer in every matter to religious authorities. Renaissance humanism also created the ideal of the well-rounded personality, one that is highly developed scientifically, morally, culturally, and spiritually. A milestone is Giovanni Pico della Mirandolas Oration on the Dignity of Man (1486), which states that man does not have a ready form but that it is mans task to form himself. And crucially, modern science began to take form then, through the works of Copernicus, Kepler, and Galileo.

The Age of Enlightenment can be said to have started with the publication of Francis Bacons Novum Organum, the new tool (1620), in which he proposes a scientific methodology based on empirical investigation rather than a priori reasoning. Bacon advocates the project of effecting all things possible, by which he meant the achievement of mastery over nature in order to improve the condition of human beings. The heritage from the Renaissance combines with the influences of Isaac Newton, Thomas Hobbes, John Locke, Immanuel Kant, Marquis de Condorcet, and others to form the basis for rational humanism, which emphasizes science and critical reasoning rather than revelation and religious authority as ways of learning about the natural world and the destiny and nature of man and of providing a grounding for morality. Transhumanism traces its roots to this rational humanism.

In the 18th and 19th centuries we begin to see glimpses of the idea that even humans themselves can be developed through the appliance of science. Benjamin Franklin and Voltaire speculated about extending human life span through medical science. Especially after Darwins theory of evolution, atheism or agnosticism came to be seen as increasingly attractive alternatives. However, the optimism of the late 19th century often degenerated into narrow-minded positivism and the belief that progress was automatic. When this view collided with reality, some people reacted by turning to irrationalism, concluding that since reason was not sufficient, it was worthless. This resulted in the anti-technological, anti-intellectual sentiments whose sequelae we can still witness today in some postmodernist writers, in the New Age movement, and among the neo-Luddite wing of the anti-globalization agitators.

A significant stimulus in the formation of transhumanism was the essay Daedalus: Science and the Future (1923) by the British biochemist J. B. S. Haldane, in which he discusses how scientific and technological findings may come to affect society and improve the human condition. This essay set off a chain reaction of future-oriented discussions, including The World, the Flesh and the Devil by J. D. Bernal (1929), which speculates about space colonization and bionic implants as well as mental improvements through advanced social science and psychology; the works of Olaf Stapledon; and the essay Icarus: the Future of Science (1924) by Bertrand Russell, who took a more pessimistic view, arguing that without more kindliness in the world, technological power will mainly serve to increase mens ability to inflict harm on one another. Science fiction authors such as H. G. Wells and Olaf Stapledon also got many people thinking about the future evolution of the human race. One frequently cited work is Aldous Huxleys Brave New World (1932), a dystopia where psychological conditioning, promiscuous sexuality, biotechnology, and opiate drugs are used to keep the population placid and contented in a static, totalitarian society ruled by an elite consisting of ten world controllers. Huxleys novel warns of the dehumanizing potential of technology being used to arrest growth and to diminish the scope of human nature rather than enhance it.

The Second World War changed the direction of some of those currents that result in todays transhumanism. The eugenics movement, which had previously found advocates not only among racists on the extreme right but also among socialists and progressivist social democrats, was thoroughly discredited. The goal of creating a new and better world through a centrally imposed vision became taboo and pass; and the horrors of the Stalinist Soviet Union again underscored the dangers of such an approach. Mindful of these historical lessons, transhumanists are often deeply suspicious of collectively orchestrated change, arguing instead for the right of individuals to redesign themselves and their own descendants.

In the postwar era, optimistic futurists tended to direct their attention more toward technological progress, such as space travel, medicine, and computers. Science began to catch up with speculation. Transhumanist ideas during this period were discussed and analyzed chiefly in the literary genre of science fiction. Authors such as Arthur C. Clarke, Isaac Asimov, Robert Heinlein, Stanislaw Lem, and later Bruce Sterling, Greg Egan, and Vernor Vinge have explored various aspects of transhumanism in their writings and contributed to its proliferation.

Robert Ettinger played an important role in giving transhumanism its modern form. The publication of his book The Prospect of Immortality in 1964 led to the creation of the cryonics movement. Ettinger argued that since medical technology seems to be constantly progressing, and since chemical activity comes to a complete halt at low temperatures, it should be possible to freeze a person today and preserve the body until such a time when technology is advanced enough to repair the freezing damage and reverse the original cause of deanimation. In a later work, Man into Superman (1972), he discussed a number of conceivable improvements to the human being, continuing the tradition started by Haldane and Bernal.

Another influential early transhumanist was F. M. Esfandiary, who later changed his name to FM-2030. One of the first professors of future studies, FM taught at the New School for Social Research in New York in the 1960s and formed a school of optimistic futurists known as the UpWingers. In his book Are you a transhuman? (1989), he described what he saw as the signs of the emergence of the transhuman person, in his terminology indicating an evolutionary link towards posthumanity. (A terminological aside: an early use of the word transhuman was in the 1972-book of Ettinger, who doesnt now remember where he first encountered the term. The word transhumanism may have been coined by Julian Huxley in New Bottles for New Wine (1957); the sense in which he used it, however, was not quite the contemporary one.) Further, its use is evidenced in T.S. Elliots writing around the same time. And it is known that Dante Alighieri referred to the notion of the transhuman in historical writings.

In the 1970s and 1980s, several organizations sprung up for life extension, cryonics, space colonization, science fiction, media arts, and futurism. They were often isolated from one another, and while they shared similar views and values, they did not yet amount to any unified coherent worldview. One prominent voice from a standpoint with strong transhumanist elements during this era came from Marvin Minsky, an eminent artificial intelligence researcher.

In 1986, Eric Drexler published Engines of Creation, the first book-length exposition of molecular manufacturing. (The possibility of nanotechnology had been anticipated by Nobel Laureate physicist Richard Feynman in a now-famous after-dinner address in 1959 entitled There is Plenty of Room at the Bottom.) In this groundbreaking work, Drexler not only argued for the feasibility of assembler-based nanotechnology but also explored its consequences and began charting the strategic challenges posed by its development. Drexlers later writings supplied more technical analyses that confirmed his initial conclusions. To prepare the world for nanotechnology and work towards it safe implementation, he founded the Foresight Institute together with his then wife Christine Peterson in 1986.

Ed Regiss Great Mambo Chicken and the Transhuman Condition (1990) took a humorous look at transhumanisms hubristic scientists and philosophers. Another couple of influential books were roboticist Hans Moravecs seminal Mind Children (1988) about the future development of machine intelligence, and more recently Ray Kurzweils bestselling Age of Spiritual Machines (1999), which presented ideas similar to Moravecs. Frank Tiplers Physics of Immortality (1994), inspired by the writings of Pierre Teilhard de Chardin (a paleontologist and Jesuit theologian who saw an evolutionary telos in the development of an encompassing noosphere, a global consciousness) argued that advanced civilizations might come to have a shaping influence on the future evolution of the cosmos, although some were put off by Tiplers attempt to blend science with religion. Many science advocates, such as Carl Sagan, Richard Dawkins, Steven Pinker, and Douglas Hofstadter, have also helped pave the way for public understanding of transhumanist ideas.

In 1988, the first issue of the Extropy Magazine was published by Max More and Tom Morrow, and in 1992 they founded the Extropy Institute (the term extropy being coined as an informal opposite of entropy). The magazine and the institute served as catalysts, bringing together disparate groups of people with futuristic ideas. More wrote the first definition of transhumanism in its modern sense, and created his own distinctive brand of transhumanism, which emphasized individualism, dynamic optimism, and the market mechanism in addition to technology. The transhumanist arts genre became more self-aware through the works of the artist Natasha Vita-More. During this time, an intense exploration of ideas also took place on various Internet mailing lists. Influential early contributors included Anders Sandberg (then a neuroscience doctoral student) and Robin Hanson (an economist and polymath) among many others.

The World Transhumanist Association was founded in 1998 by Nick Bostrom and David Pearce to act as a coordinating international nonprofit organization for all transhumanist-related groups and interests, across the political spectrum. The WTA focused on supporting transhumanism as a serious academic discipline and on promoting public awareness of transhumanist thinking. The WTA began publishing the Journal of Evolution and Technology, the first scholarly peer-reviewed journal for transhumanist studies in 1999 (which is also the year when the first version of this FAQ was published). In 2001, the WTA adopted its current constitution and is now governed by an executive board that is democratically elected by its full membership. James Hughes especially (a former WTA Secretary) among others helped lift the WTA to its current more mature stage, and a strong team of volunteers has been building up the organization to what it is today.

Humanity+ developed after to rebrand transhumanism informing Humanity+ as a cooperative organization, seeking to pull together the leaders of transhumanism: from the early 1990s: Max More, Natasha Vita-More, Anders Sandberg; the late 1990s: Nick Bostrom, David Pearce, James Hughes; the 2000s: James Clement, Ben Goertzel, Giulio Prisco and many others. In short, it is based on the early work of Extropy Institute and WTA.

In the past couple of years, the transhumanist movement has been growing fast and furiously. Local groups are mushrooming in all parts of the world. Awareness of transhumanist ideas is spreading. Transhumanism is undergoing the transition from being the preoccupation of a fringe group of intellectual pioneers to becoming a mainstream approach to understanding the prospects for technological transformation of the human condition. That technological advances will help us overcome many of our current human limitations is no longer an insight confined to a few handfuls of techno-savvy visionaries. Yet understanding the consequences of these anticipated possibilities and the ethical choices we will face is a momentous challenge that humanity will be grappling with over the coming decades. The transhumanist tradition has produced a (still evolving) body of thinking to illuminate these complex issues that is unparalleled in its scope and depth of foresight.

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Transhumanism: Expert exposes liberal billionaire elitists …

Posted: October 16, 2021 at 2:59 am

Tue Nov 10, 2020 - 7:07 pm ESTFri Jun 18, 2021 - 5:25 pm EDT

November 10, 2020 (LifeSiteNews) The COVID-19 pandemic was manufactured by the worlds elites as part of a plan to globally advance transhumanism literally, the fusion of human beings with technology in an attempt to alter human nature itself and create a superhuman being and an earthly paradise, according to a Peruvian academic and expert in technology.

This dystopian nightmare scenario is no longer the stuff of science fiction, but an integral part of the proposed post-pandemic Great Reset, Dr. Miklos Lukacs de Pereny said at a recent summit on COVID-19.

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Indeed, to the extent that implementing the transhumanist agenda is possible, it requires the concentration of political and economic power in the hands of a global elite and the dependence of people on the state, said Lukacs.

Thats precisely the aim of the Great Reset, promoted by German economist Klaus Schwab, CEO and founder of World Economic Forum, along with billionaire philanthropists George Soros and Bill Gates and other owners, managers, and shareholders of Big Tech, Big Pharma, and Big Finance who meet at the WEF retreats at Davos, Switzerland, contended Lukacs.

Transhumanism is far from a benign doctrine. Rather, it is at complete enmity with Christianity, Lukacs pointed out during the virtual in Truth Over Fear Summit organized by California-based Catholic writer and broadcaster Patrick Coffin.

Transhumanists take science as their religion and believe in a philosophy of absolute relativism that claims that individuals can change reality at will, and they seek to relativize the human being and turn it into a putty that can be modified or molded to our taste and our desire and by rejecting those limits nature or God have placed on us.

Transhumanism therefore requires the destruction of the Judeo-Christian morality, which is based on absolute principles and values.

Those raising alarm about the Great Reset often overlook the crucial role of technology in the plans of the meta-capitalists, contended Lukacs, who has Ph.D. in management from the Manchester Institute of Innovation Research (MIoIR) from the University of Manchester.

The COVID-19 pandemic was just another social engineering project deliberately planned and implemented by predatory meta capitalism to achieve the ultimate end: redefining and reconfiguring the human nature and condition, he argued in a presentation in Spanish.

I have the firm conviction that this pandemic has been manufactured and its purpose is none other than to initiate, as they say, or implement the Great Reset, which will open the door to the advancement of the transhumanist agenda, he said.

Indeed, WEFs Schwab has been promoting the Great Reset as a way to harness the Fourth Industrial Revolution, a term he coined, which, he declared in January 2016, will affect the very essence of our human experience.

Schwab described the Fourth Industrial Revolution then as a fusion of technologies that is blurring the lines among the physical, digital and biological spheres, Lukacs said.

Those technologies include genetic engineering such as CRISPR genetic editing, artificial intelligence (A.I.), robotics, the Internet of Things (IoT), 3D printing, and quantum computing.

The Fourth Industrial Revolution is nothing other than the implementation of transhumanism on a global level, emphasized Lukacs.

Transhumanism as a political ideology and cultural movement was defined in 1998 by Swedish economist Nick Bostrom, then a professor at Oxford, and David Pearce, a British philosopher, who that year founded the World Transhumanist Association.

More recently, Yuval Noah Harari, the Israeli historian and author of Homo Deus, who is regarded as a great visionary, has been promoting transhumanism.

Transhumanists propose to use technology to alter human nature to produce human beings with super longevity, super intelligence, super well-being, Lukacs said.

They reject the Christian belief in absolute truth, and that God created human person in His image and likeness, and see absolute values as a brake for their pretensions of transhumanist and globalist progressivism.

Thats why the approval of abortion is key to understanding why we are entering fully into this transhumanist agenda of the Fourth Industrial Revolution, Lukacs said.

When abortion was approved, the political, economic order and moral values on which Western civilization is based collapsed.

Abortion means nothing other than the transition of the human being from a subject of rights to an object of commercialization, to an object of experimentation, he said.

Life ceases to have an inherent value, an inherent dignity. It becomes an object of consumption, an object of production, and this aligns perfectly with the goal of transhumanists to experiment with the human being.

Transhumanism is a struggle against those propositions of absolute values, said Lukacs, and what it embodies in progressivism is absolute relativism.

Evidence that absolute relativism has caught hold in the Western world is the rapid and widespread rise in trangenderism.

Lukacs also noted cases of transspecisim, transageism, transableism, and transracism.

Examples of these attempts to reshape ones reality at will include the American known as Lizard Man, the Canadian man living as a six-year-old, the British woman who blinded herself because she wanted to be disabled, and the German woman who injected herself with melatonin to darken her skin to identify as black.

These are previous states of transhumanism, a kind of accustoming, especially of the new generations, to accept this diversity, Lukacs said.

While many transhumanist proposals are rooted in science fiction, Lukacs pointed out they now have the technology to attempt to realize their mad aspirations.

Transhumanists propose to increase longevity by using CRISPR genetic editing, which has been used to triple the lifespan of mice. Thus, using this technique on human beings, it is conceivable that people could live to the age of 200 or 300 years old, he said.

They propose to increase human intelligence by planting chips in people that have greater processing capacity than the human brain.

An example is Elon Musks NeuraLink, which is an interface that is applied to the cerebral cortex and which Musk says will help people with Alzheimers or epilepsy, but which Lukacs speculates could open the door to neuro-hackers.

There is also the post-humanist school of transhumanism, of which economist Bostrom is a proponent.

Bostrom proposes that at some point it will not even be necessary to have a physical body, but we will be a set of information, that we will be able to upload our thoughts to the Cloud, that we will be able to form a great collective intelligence with other human beings, Lukac said.

As for the promise of super wellbeing, philosopher Pearce said it was the hedonist imperative to genetically modify us to aspire to super well-being.

What Pearce is saying is that through genetic modification, were going to be virtuous human beings, and that we have to forget about pain and suffering, we have to get rid of those genes that make us aggressive, violent, jealous, that force us to fight and kill each other, said Lukacs.

When you put all these things into the balance, what you are realizing is what you are looking at is literally the destruction of human beings, of Homo sapiens, and their conversion to Homo deus.

But as with the Great Reset, the elites twist the language and disguise their transhumanist agenda behind vaguely benign phrases, so Schwabs Fourth Industrial Revolution is sold to us as an idea thats not necessarily going to affect us, or that it is progress that will benefit humanity, he said.

However, just as ordinary people will suffer in the Great Reset under the architecture of oppression, as Edward Snowden phrased it, so they will bear the brunt of the experimentation by transhumanists.

Its very worrying because for achieving that kind of dream, many, many mistakes will happen for sure. The burden will be carried by the people that get affected by this in their health, in their lives, in their economic situation and in their psychological or mental state, said Lukacs.

Its a very, very costly experiment. And [the elites] are not going to bear any responsibility for this. Trust me, he told Coffin.

For them, its wonderful. For the rest, this is just dystopian.

Lukacs also contended that the global elites encountered an unexpected roadblock to their plans in U.S. president Donald Trump.

Actually, the structure of power is not that complicated, he told Coffin in an online Q&A session.

At the top are the meta-capitalists or capitalists that have so much financial muscle that they can play beyond the rules of capitalism; actually, they make the rules of capitalism or remake them, he said.

And you have those guys on Big Tech, Big Pharma, Big Finance, Big Construction, everything big, the big corporate transnational world. Those are the billionaires who through their philanthropies, their billion-dollar pledges and all this kind of stuff, they funnel money downwards to all the politicians, who are basically rented politicians, they rent them, they run the world for them, he said.

Its really the privatization of power through philanthropy, added Lukacs.

And then, of course, you will have a layer of middle ground or middle level institutions, NGOs, universities, foundations, and then youll go down to grassroots local government. Its a pyramidal structure.

But Trump is one key public figure who could evidently not be rented.

It is so obvious that in the States right now for the past, what, four, five months, a state coup has been in the making. As simple as that. I have no problem in saying it openly, Lukacs told Coffin.

Thats the situation. They have tried to oust a president that was democratically elected because they are desperate. China is still progressing. And their partners in the West, theyre just not catching up. So, they are a little bit desperate. China is not going to wait.

For more information on Truth Over Fear Summit, go here. Premium passes are still available.

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Transhumanism: Expert exposes liberal billionaire elitists ...

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TRANSHUMANISM / HUMAN 2.0 End Time Talks

Posted: October 16, 2021 at 2:59 am

STORY AT-A-GLANCE

Two years ago, in October 2018, Forbes contributor Neil Sahota, a United Nations artificial intelligence adviser and UC Irvine professor, warned that transhumanism is fast approaching likely faster than you think.1

In the past few years, there has been considerable discussion around the idea we are slowly merging with our technology, that we are becoming transhuman, with updated abilities, including enhanced intelligence, strength, and awareness,Sahota writes.

The goal of the transhumanist movement, or Human 2.0, is to transcend biology into technology. Or, as Dr. Carrie Madej explains in the video above, to meld human biology with technology and artificial intelligence.

Two visible proponents of transhumanism are Ray Kurzweil (director of engineering at Google since 2012) and Elon Musk (founder of SpaceX, Tesla and Neuralink).

According to Madej, right now, today, we may be standing at the literal crossroads of transhumanism, thanks to the fast approaching release of one or more mRNA COVID-19 vaccines.

Many of theCOVID-19 vaccines currently being fast-trackedare not conventional vaccines. Their design is aimed at manipulating your very biology, and therefore have the potential to alter the biology of the entire human race.

Conventional vaccines train your body to recognize and respond to the proteins of a particular virus by injecting a small amount of the actual viral protein into your body, thereby triggering an immune response and the development of antibodies.

This is not what happens with an mRNA vaccine. The theory behind these vaccines is that when you inject the mRNA into your cells, it will stimulate your cells to manufacture their own viral protein.2The mRNA COVID-19 vaccine will be the first of its kind. No mRNA vaccine has ever been licensed before. And, to add insult to injury, theyre forgoing all animal safety testing.

Madej reviews some of the background of certain individuals participating in the race for a COVID-19 vaccine, which include Moderna co-founder Derrick Rossi, a Harvard researcher who successfully reprogrammed stem cells using modified RNA, thus changing the function of the stem cells. Moderna was founded on this concept of being able to modify human biological function through genetic engineering, Madej says.

As mentioned, the mRNA vaccines are designed to instruct your cells to make the SARS-CoV-2 spike protein, the glycoprotein that attaches to the ACE2 receptor of the cell. This is the first stage of the two-stage process viruses use to gain entry into cells.

The idea is that by creating the SARS-CoV-2 spike protein, your immune system will mount a response to it and begin producing antibodies to the virus. However, as reported by The Vaccine Reaction, researchers have pointed out potential weaknesses:3

According to researchers at University of Pennsylvania and Duke University, mRNA vaccines have potential safety issues, including local and systemic inflammation and stimulation of auto-reactive antibodies and autoimmunity, as well as development of edema (swelling) and blood clots.4

Systemic inflammation, auto-reactive antibodies and autoimmune problems are not insignificant concerns. In fact, these are in large part why previous attempts to create a coronavirus vaccine have ALL failed.

Over the past 20 years, coronavirus vaccine research has been plagued by one consistent adverse outcome in particular, namely paradoxical immune enhancement. This is caused by the fact that coronaviruses produce two different types of antibodies neutralizing antibodies5that fight the infection, and binding antibodies6(also known as nonneutralizing antibodies) that cannot prevent viral infection.

Incapable of preventing viral infection, binding antibodies can instead trigger paradoxical immune enhancement. What that means is that it looks good until you get the disease, and then it makes the disease far worse than it would have been otherwise. As detailed in myinterview with Robert F. Kennedy Jr., in one coronavirus vaccine trial using ferrets, all the vaccinated animals died when exposed to the actual virus.

According to Madej, animal studies have also found the type of mRNA technology introduced with this vaccine can increase the risk of cancer and mutagenesis (gene mutations).

Madej goes on to discuss how this mRNA vaccine is going to be administered. Rather than a conventional injection, the vaccine will be administered using a microneedle platform. Not only can it be mass produced quickly, but it can also be administered by anyone. Its as simple at attaching an adhesive bandage to your arm.

The adhesive side of the bandage has rows of tiny microneedles and a hydrogel base that contains luciferase enzyme and the vaccine itself. Because of their tiny size, the microneedles are said to be nearly painless when pressed into the skin.

The idea is that the microneedles will puncture the skin, delivering the modified synthetic RNA into the nucleus of your cells. RNA is essentially coding material that your body uses. In this case, as mentioned, the instructions are to produce the SARS-CoV-2 viral protein.

Synthetic genes can be patented. If inserting a synthetic RNA ends up creating permanent changes in the genome, humans will contain patentable genes. What will that mean for us, seeing how patents have owners, and owners have patent rights?

The problem with all of this, Madej notes, is that theyre using a process called transfection a process used to create genetically modified organisms. She points out that research has confirmedGMO foodsare not as healthy as conventional unmodified foods. The question is, might we also become less healthy?

Vaccine manufacturers have stated that this will not alter our DNA, our genome,Madej says. I say that is not true. Because if we use this process to make a genetically modified organism, why would it not do the same thing to a human? I dont know why theyre saying that.

If you look at the definition of transfection, it will tell you that it can be a temporary change in the cell. And I think that is what the vaccine manufacturers are banking on.

Or, its a possibility for it to become stable, to be taken up into the genome, and to be so stable that it will start replicating when the genome replicates. Meaning it is now a permanent part of your genome. Thats a chance that were taking. It could be temporary, or it could be permanent.

Naturally, we wont find out the truth about whether the vaccine causes a temporary or permanent change for many years after the experimental vaccine is introduced, and thats an important piece of information.

Why? Because synthetic genes can be patented. So, if inserting a synthetic RNA ends up creating permanent changes in the genome, humans will contain patentable genes. What will that mean for us, seeing how patents have owners, and owners have patent rights?

Another part of the delivery system that raises its own set of questions is the use of the enzyme luciferase, which has bioluminescent qualities. While invisible under normal conditions, using a cellphone app or special device, you will be able to see a glowing vaccination mark.

As described in the journal RSC Advances7in 2015, luciferase gene-loaded quantum dots can efficiently deliver genes into cells. The abstract discusses their use as self-illuminating probes for hepatoma imaging, but the fact that quantum dots can deliver genetic material is interesting in itself.

The hydrogel, meanwhile, is a DARPA invention that involves nanotechnology and nanobots. This bioelectronic interface is part of how the vaccination mark will be able to connect to your smartphone, Madej says, providing information about blood sugar, heart rate and any number of other biological data.

It has the potential to see almost anything that goes on in your body, Madej says. This will have immediate ramifications for our privacy, yet no one has yet addressed where this information will be going. Who will collect and have access to all this data? Who will be responsible for protecting it? How will it be used?

Also, if your cellphone can receive information from your body, what information can your body receive from it, or other sources? Could transmissions affect our mood? Our behavior? Our physical function? Our thoughts or memories?

In his Forbes article,8Sahota quotes Kurzweils book The Singularity Is Near: When Humans Transcend Biology, in which Kurzweil states:

The Singularity will represent the culmination of the merger of our biological thinking and existence with our technology, resulting in a world that is still human but that transcends our biological roots.

If Madej turns out to be correct, and the mRNA vaccine ushers in the ability to alter not only our genes but also opens the door for nanotechnology-driven interfacing between our bodies and programmable technology, arent we in fact stepping over the line into transhuman territory?

The Truthstream Media video above discusses the larger issues of transhumanism and the race to merge man with machine and artificial intelligence. There are even ongoing attempts to upload the human mind into the cloud, ultimately creating a form of digital hive mind where everyone communicates via Wi-Fi telepathy. This, despite the fact we still do not fully understand what the mind actually is, or where its located.

Another transhumanist that has recently brought us to a brand-new precipice is Elon Musk, with his latest venture, Neuralink, described in the video presentation given in late August, above. Neuralink is a transcranial implant that uses direct current stimulation. For now, the device is aimed at helping people with brain or spinal injuries.

Ultimately, the goal is to merge the human brain with computers. I have strong reservations about this. Theres tremendous room for unintended psychological and psychiatric consequences. In an interview that I did with psychiatrist Dr. Peter Breggin that has not yet been published, he discussed his concerns with this technology, saying:

Whats interesting to me is that while Musk is so brilliant, hes stupid about the brain. Thats probably because the neurosurgeons and psychiatrists he consults are stupid about the brain. I mean theyre just stupid.

He wants to put in multiple threadlike electrodes into the brain, into webs of neurons, and put in low voltage stimulation. This is insane. The brain cant tolerate this. He hopes to [be able to] communicate but theres not going to be any communication.

The brain isnt going to talk to these electrodes. Thats not how the brain works. The brain talks to itself. Its not going to talk to Elon Musk [or anyone else] and hes going to disrupt the brain talking to itself. Its a terrible thing to do.

I wish somebody who knows Elon Musk would say, You ought to talk to Peter Breggin. He says your consultants are stupid. Hes already planning to try to get FDA approval for some neurological disorders and thatll be the beginning of the onslaught.

Getting back to the mRNA vaccines, time will tell just how hazardous they end up being. Clearly, if the changes end up being permanent, the chance of long-term side effects is much greater than if they end up being temporary.

In a worst-case scenario, whatever changes occur could even be generational. The problem is these issues wont be readily apparent any time soon. In my view, this vaccine could easily turn into a global catastrophe the likes of which weve never experienced before.

We really should not be quick to dismiss the idea that these vaccines may cause permanent genetic changes, because we now have proof that even conventional vaccines have the ability to do that, and they dont involve the insertion of synthetic RNA.

After the H1N1 swine flu of 2009, the ASO3-adjuvanted swine flu vaccine Pandemrix (a fast-tracked vaccine used in Europe but not in the U.S. during 2009-2010) was causally linked9to childhood narcolepsy, which abruptly skyrocketed in several countries.10,11

Children and teens in Finland,12the U.K.13and Sweden14were among the hardest hit. Further analyses discerned a rise in narcolepsy among adults who received the vaccine as well, although the link wasnt as obvious as that in children and adolescents.15

A 2019 study16reported finding a novel association between Pandemrix-associated narcolepsy and the non-coding RNA gene GDNF-AS1 a gene thought to regulate the production of glial cell line-derived neurotrophic factor or GDNF, a protein that plays an important role in neuronal survival.

They also confirmed a strong association between vaccine-induced narcolepsy and a certain haplotype, suggesting variation in genes related to immunity and neuronal survival may interact to increase the susceptibility to Pandemrix-induced narcolepsy in certain individuals.

In addition to that, theres the research17showing that the H1N1 swine flu vaccine was one of five inactivated vaccines that increased overall mortality, especially among girls. A swine flu article Iwrote 11 years ago, in 2009, turned out to have a rather prophetic warning at the end:

The swine flu vaccine has not been tested for safety or efficacy, but we DO know it will contain harmful additives. The choice, to me, is obvious. And in the future, anytime a new pandemic appears and officials urge you to rush out and get a shot, please remember this article and ask yourself if its really you who stands to benefit from their advice.

We can also learn from the swine flu fiasco of 1976, detailed in this 1979 60 Minutes episode. Fearing a repeat of the 1918 Spanish flu pandemic, the government propaganda machine cranked into action, 60 Minutes says, telling all Americans to get vaccinated.

According to 60 Minutes, 46 million Americans were vaccinated against the swine flu at that time. Over the next few years, thousands of Americans filed vaccine damage claims with the federal government.18As reported by Smithsonian Magazine in 2017:19

In the spring of 1976, it looked like that years flu was the real thing. Spoiler alert: it wasnt, and rushed response led to a medical debacle that hasnt gone away.

Some of the American publics hesitance to embrace vaccines the flu vaccine in particular can be attributed to the long-lasting effects of a failed 1976 campaign to mass-vaccinate the public against a strain of the swine flu virus, writes Rebecca Kreston for Discover.

This government-led campaign was widely viewed as a debacle and put an irreparable dent in future public health initiative, as well as negatively influenced the publics perception of both the flu and the flu shot in this country.

A 1981 report by the U.S. General Accounting Office to Sen. John Durkin, D-N.H., reads, in part:20

Before the swine flu program there were comparatively few vaccine-related claims made against the Government. Since 1963, Public Health Service records showed that only 27 non-swine flu claims were filed.

However, as of December 31, 1979, we found that 3,839 claims and 988 lawsuits had been filed against the Government alleging injury, death, or other damage resulting from the 45 million swine flu immunizations given under the program.

A Justice official told us that as of October 2, 1980, 3,965 claims and 1,384 lawsuits had been filed. Of the 3,965 claims filed, the Justice official said 316 claims had been settled for about $12.3 million

The devastating side effects of the Pandemrix vaccine should be instructive. No one anticipated a flu vaccine to have genetic consequences, yet it did. Now theyre proposing injecting mRNA to make every single cell in your body produce the SARS-CoV-2 spike protein.

It seems outright foolish not to assume there will be significant consequences. Perhaps even transhumanistic ones? The 1976 swine flu hoax is equally instructive, in that it demonstrates the long history of mass vaccination campaigns causing far more harm than good.

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TRANSHUMANISM / HUMAN 2.0 End Time Talks

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