Category Archives: Cell Therapy

NKGen Biotech, Inc.

SANTA ANA, Calif., June 21, 2022 (GLOBE NEWSWIRE) -- NKGen Biotech, a biotechnology company harnessing the power of the bodys immune system through the development of Natural Killer (NK) cell therapies, today announced that senior management will be hosting one-on-one meetings at the Truist Securities Cell Therapy Symposium - symposia-cel being held in person in New York City on Tuesday, June 28, 2022. Details on the symposium can be found below.

Truist Securities Cell Therapy Symposium - symposia-cel (in person)Format: Symposium and 1 x 1 meetingsDate: Tuesday, June 28, 2022Meeting Times: 12:30 pm 5:00 pm EDTLocation: New York, NYRegistration: Event website

If you are interested in arranging a 1 x1 meeting with NKGen Biotech, please contact your Truist representative.

About NKGen Biotech

NKGen Biotech, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK Natural Killer (NK) cell therapeutics. Leveraging our proprietary cell expansion and activation technology and cutting-edge cell manufacturing expertise, we have the ability to infinitely expand natural killer cells while significantly enhancing cytotoxicity across our peripheral blood-derived products. NKGen Biotechs lead product candidate, SNK01, is currently in clinical trials for the treatment of advanced refractory solid tumors both as a monotherapy and in combination with other agents, including checkpoint inhibitors and cell engagers. NKGen Biotech is committed to the vision of executing on our clinical strategies with the goal of commercializing our NK cell therapies to help save and sustain patients lives worldwide. The company and its commercially licensed cGMP facility are headquartered in Santa Ana, California, USA. For more information, please visit http://www.nkgenbiotech.com.

Contact:Denise Chua, MBA, CLS, MT (ASCP)Vice President, Investor Relations and Corporate Communications949-396-6830dchua@nkgenbiotech.com

Read more:
NKGen Biotech to Participate in Truist Securities Cell Therapy Symposium - Yahoo Finance

Major advances in cell therapies have been achieved since the first successful cell therapy was conducted in 1956 in the treatment of leukaemia, and they are now a regular, although highly specialised, treatment for a select few conditions. With the emergence of new cell therapy techniques in recent years, increasingly researchers have focused on the identification of new therapeutic targets to broaden the possible use of cell therapies.

First published in our Biotech Review of the year issue 9.

What are cell therapies?

In the simplest of terms, one can think of cell therapies as living medicines. Traditional medicines work by directing and inducing a patients own cells, whereas cell therapy uses live cells that are injected or grafted into a patient where the cells work locally or systemically to restore the function of tissues or organs. Cell therapies can be used where a patients cells are compromised, or insufficient in numbers, and may bring significant improvement to a patients life or even be curative, depending on the condition being treated. Cell therapies can therefore be life-changing, but as a specialised treatment, every step of their development and use is expensive. However, because cell therapies are often used as a last resort in select patient populations after all other treatments have failed or where none are available to begin with, the cost-benefit ratio may be favourable.

How do cell therapies work?

The basic concept of cell therapies is to take healthy cells and implant them into a patient to cure or alleviate symptoms of a disease. In principle this is simple, however, getting to a stage of having suitable cells in sufficient amounts and of sufficient quality is extremely challenging. It may help to think about what the point of the therapy is: to make the transplanted cells do something that cures (or treats) an illness or condition. Cell therapies are powerful tools, but there are also significant risks. Cells used in cell therapies have the potential to transform into malignant cells, migrate to sites outside of the target area or tissue and can generate unwanted immunogenicity. Unsurprisingly, the mitigation of such risks is a core element in the applicable regulatory environment.

Sources of cells for cell therapies

There are two sources of cells for cell therapy; autologous and allogeneic cells. Autologous cells are harvested from a patient, stored, and treated before being re-implanted into the same patient, whereas allogeneic cells are harvested from a healthy donor before processing and implantation into a patient. A third form of cell therapy, xenogeneic, is possible where the cells to be grafted come from a different animal species. Currently, xenografts are limited to research settings in which human cells are transplanted into other species, but with the hope that, if problems such as rejection and endogenous retroviruses can be overcome, this methodology can be reversed and animal cells be used safely and effectively in the treatment of humans.

One of the benefits of autologous cell therapies is that the immunogenic response is minimal as the patient is being administered their own cells. This form of therapy is therefore particularly suitable for immunocompromised patients. However, unless the cells can be procured and re-implanted within the same surgical procedure, autologous therapy is by no means straightforward, because the therapy must be customised for each patient. The cells must be collected, processed to achieve the desired population, and then re-implanted. Following harvest, the cells may require weeks of isolation in culture and expansion before there are enough that are suitable for treatment, with each step between procurement and implantation conducted under strict quality and safety conditions.

This is time-consuming and there is no guarantee that a sufficient amount of cell product will be produced, nor that it will be available in time to treat a patient with an aggressive form of disease. Another drawback of autologous cell therapies arises from the fact that they are personalised for each patient so that the time and cost cannot be shared between patients by scaling the operation. Traditional quality and effectiveness testing is always applicable, but the relevant question is whether they make sense for all personalised cell therapy medicinal products. Despite this, there have been major advances in autologous therapies in the last few years, most excitingly CAR-T therapy, the first approved genetically modified cell therapy.

In contrast to autologous therapies, allogeneic cell therapies use cells harvested from a healthy donor, after which the cells are cultured and scaled to produce large amounts of cells over time. This can result in an off-the-shelf product that can be used for multiple patients. The drawback of using cells that are not the patients own is that a patient who receives allogeneic cells will need to undergo immunosuppressive therapy to prevent serious immunological complications such as graft versus host disease. Some of the benefits associated with the use of allogeneic cell therapies are the immediate availability of cultured cells and the availability of having multiple donors on file to match patients as well as possible. If allogeneic cell therapies can be sufficiently refined to be effective, and their manufacturing scaled appropriately, there might be a shift from using autologous to allogeneic cells in therapies. Although scaling may be done in theory and large batches of cells cultured, new issues arise such as the functional heterogeneity inherent in cells which introduces variability between batches of cells, and which will likely affect functional responses in patients.

Manufacturing

The manufacturing process for cell therapies is complex and highly specialised. Cell cultures are temperamental and can currently only be produced manually and in small batches, although there are attempts to automate the production. There is also a major manufacturing bottleneck around talent: a shortage of people qualified in cell therapies at all levels, from technical staff manufacturing the cells to scientists and clinicians. Another issue is around the facilities for the production of cells which are highly regulated environments to ensure microbiological purity of the cell-drug product.

This brings logistical issues. As an example, for patients in the EU who are to receive Novartiss therapy Kymriah, the process involves harvesting autologous cells from patients in the EU, flying them to the USA for transformation into treatment cell therapy product, and then flying them back to be re-infused to patients as treatment. Due to the specialised facilities required, manufacture of cells is only done in a select few places. Manufacturers have been trying to address some of the bottlenecks. As an example, Novartis recently invested $90 million in a cell and gene therapy factory in Switzerland to establish an EU facility.

As with most areas of life, COVID-19 also touched upon cell therapies. The viral vectors used in their production are also used in vaccine production, as is explored elsewhere in this years Biotech Review. Viral vector manufacturing is already at capacity, and demand is unlikely to decrease in the next few years. There is therefore an urgent need to implement scaling of viral vector production to increase their yield as soon as possible to enable increased cell culture manufacturing capacity.

The regulatory environment of cell therapies

The regulatory landscape for cell therapies varies from country to country, which in and of itself is problematic for the development of therapies, standards, and clinical trialsIn the EU, cell therapies the manufacture of which involve substantial manipulation are regulated as Advanced Therapy Medicinal Products (ATMPs) for purposes of medicines law. There are three types of ATMPs: gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products. In addition to needing to meet the donation, procurement and testing requirements of the EUs blood cell and tissue regulations,they are also regulated by the ATMP Regulation. Before being brought to market, all medicines (including cell therapies) must be authorised by the relevant regulator: getting a marketing authorisation is demanding, especially when it comes to ATMPs. In the UK the licensing authority is the MHRA; in the EU, applications are addressed centrally, to the European Medicines Agency (EMA).

Are cell therapies correctly classified as ATMPs?

The problem is that although the ATMP Regulation accommodates cellular and genetic medicinal products within the European medicines regime, they do not quite fit a framework designed around mass-market pharmaceutical products. For example, when the Regulation was proposed in the early 2000s, embryo-derived cell products and other allogeneic products were expected to dominate. Things have, however, turned out quite differently. Most therapies are not derived from embryonic cells, and the vast majority of them are based on the patients own cells.

The awkwardness of the ATMP Regulation becomes apparent as soon as one thinks of autologous cell therapies: products designed and manufactured solely for one person. As the ATMP Regulation is intended to govern products placed on the market, can it truly be said that a product like cell therapy intended for one person is truly placed on a market? Despite this, autologous therapies do get authorised, but is the process fit for purpose? With the development of more accessible cell therapies, there seems to be a gradual acceptance that the current framework needs to be reconsidered. After MEPs approved, in November 2021, a new EU medicines strategy which expressly refers to the position of new and innovative medicines, we anticipate that the European Commission will publish proposals in due course. Whether these address such issues remains to be seen. There are no plans for Great Britain.

The EUs blood cell and tissue regulationsalready address quality and safety frameworks for cells, so is it legitimate to argue that the autologous cell therapy market would be better regulated as a service than based on a framework for mass-market products? Some of the fundamental questions asked during market authorisation preparation for mainstream small molecule medicines are questions such as, what is the mechanism of action? and what is the dose? But questions such as these do not fit products like cell therapies where the mechanism of action is the cells themselves. The European Commission is undertaking a review of the blood cell and tissue regulations, although as above, there are no plans for Great Britain.

Trends in the coming years

With the scientific advances made in recent years, we are likely to see increased use of personalised medicine and cell therapies in the coming years. There are currently over 1,300 active cell therapy clinical trials globally, with the majority of trials being CAR-T cell therapies. Although increased use and development of these therapies will require manufacturers to address the manufacturing bottlenecks to meet growing demand, one can be positive about future developments. In parallel, regulatory authorities will need to address the inappropriate classification of cell therapies to enable their use. As therapies for more conditions become available, the cost of therapies and how health systems cover them (or not) will likely be a heated subject.

More here:
Cell therapies: An introduction - Lexology

Full TitlePhase 1 Trial of Autologous HER2-specific CAR T cells in Pediatric Patients with Refractory or Recurrent Ependymoma (PBTC-059) (CIRB)Purpose

CAR T-cell therapy is a type of immunotherapy. With CAR T-cell therapy, white blood cells called T cells are removed from the patient, altered in the laboratory to recognize a protein on the patients cancer cells, multiplied to larger numbers, and returned to the patient to find and destroy cancer cells. The treatment is made from the modified T cells.

In this study, researchers are evaluating a CAR T-cell therapy directed toward a protein on cancer cells called HER2. They are assessing this treatment in children, adolescents, and young adults with a brain tumor called an ependymoma that has come back or continued to grow despite prior treatment.

Before patients receive the CAR T cells, they will have conditioning chemotherapy with fludarabine and cyclophosphamide chemotherapy to suppress the immune system and help prepare the body for receiving the CAR T cells. The treatments in this study are given intravenously (by vein).

To be eligible for this study, patients must meet several requirements, including:

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

See the original post:
A Phase I Study of HER2-Directed CAR T-Cell Therapy for People with Recurrent or Persistent Ependymoma - On Cancer - Memorial Sloan Kettering

Innovation in cell processing is much needed to improve process development and GMP manufacturing performance and ensure a high enough yield for a viable therapy. Developers can now speed up clinical development, efficiently scale-out and be poised to be first to market with Invetech's new Korus system.

"To fast-track the commercialization of cell and gene therapies, our industry needs efficient and scalable manufacturing technologies that can deliver high quality therapies cost-effectively," says Andreas Knaack, Invetech's President. "Invetech's new technology offering, as demonstrated by our new Korus system, represents our continued commitment to helping make life-saving therapies accessible to more patients."

Invetech's Korus system uses a gentle elutriation process to provide a cleaner cell population for cell therapy production. Study results show a transformative change to processing starting materials compared to current industry standards that will set manufacturers up for downstream success.

Compared to standard washing protocols, the Korus can resulti in:

- 31% purer lymphocyte population- 49% improvement in T cell recovery after selection- 70% more T cells during expansion- 2.5X improvement in manufacturing yield

Integrating Korus technology into a cell therapy manufacturing process can lead to better downstream performance including significantly higher target cell recovery during selection and significantly higher cell growth during expansion. The 2.5X improvement in manufacturing yield means that cell therapy developers can expect to more consistently grow enough cells for a viable final cell therapy product.

During testing in the above internal study, similar lymphocyte recovery performance was seen in both Korus and CS5+ (wash) control armsdespite the increase in purity in the Korus arm due to elutriation. Relative Korus T cell selection recovery and fold expansion were considerably higher leading to over 70% more cells cultured in the Korus arm.

Jon Ellis, who leads Invetech's Cell Therapy Science & Application team explains the results of Korus's testing program. "Manufacturing efficiency of cell therapies needs improvement and innovation if the cell therapy industry is going to reach its commercialization goals. Our data shows that whilst achieving similar apheresis lymphocyte cell recovery to the control wash process, Korus eluted lymphocytes to high purity which resulted in improvements in downstream performance including greater Dynabead cell selection recovery and fold expansion."

"Overall, this innovation in cell processing will reduce the impact of starting material variability, contribute to higher manufacturing yield and reduced risk of batch failure; and potentially reduce the cost of goods for future therapies."

The Korus system is for research, laboratory or further manufacturing use only. It is not intended as a medical device in therapeutic or diagnostic procedures. Customers are responsible for validating the use of Korus within their process or therapy.

About Invetech

Invetechhelps cell and gene therapy developers to visualize, strategize and manage the future. Throughready-to-run systems, custom solutions and full-spectrum services, we swiftly accelerate vital, emerging therapies from the clinic to commercial-scale manufacturing. Together with our partners, we expand the reach of next-generation medical advances that are revolutionizing healthcare.

Further Press Information

Paul Dal PozzoSenior Product ManagerInvetechPaul.DalPozzo@invetechgroup.com+ 1 720 822 3709

Eeva RoutioMarketing Manager, Brand and Thought LeadershipInvetecheeva.routio@invetechgroup.com+ 1 858 688 7136

Related Links: invetechgroup.com/korus

i The full comparison study can be accessed here.

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SOURCE Invetech

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New Korus Technology Set to Transform Industry Standards in Elutriation and Cell Wash - PR Newswire UK

The European Medicines Agency (EMA) has validated the type II variation application for extension of the indication for Breyanzi (lisocabtagene maraleucel) to treat adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who are refractory or have relapsed within 12 months of initial therapy and are candidates for hematopoietic

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EMA validates application for CAR-T cell therapy Breyanzi from BMS - The Pharma Letter

ACE1831 is a potential antibodyarmed allogeneic gamma delta T cell therapy developed using Acepodia's unique antibody-cell conjugation (ACC) technology as an optimized T cell engager platform to treat patients with non-Hodgkin's lymphoma

ALAMEDA, Calif. and TAIPEI, Taiwan, June 20, 2022 /PRNewswire/ -- Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care, today announced that it has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate a Phase 1, first-in-human, multi-center clinical study of its ACE1831 in patients with non-Hodgkin's lymphoma.

"The FDA clearance of our IND application for ACE1831 is a significant milestone for Acepodia as we move into the clinic with a first antibody armed allogeneic gamma delta T cell product candidate through our unique ACC platform. Based on ACE1831's encouraging preclinical data, we believe that our antibody armed gamma delta T cell therapy has the potential to provide additional treatment options for patients with NHL," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "The ACC approach allows us to circumvent the limitations of current T cell engager therapies. Meanwhile, we can also significantly reduce manufacturing costs and has the potential to generate a cost-effective cancer treatment for patients. We look forward to advancing ACE1831 into its first clinical trial," said the chief executive officer.

About Gamma-Delta () T CellsAcepodia's gamma delta T cell program harnesses the unique properties of gamma delta T cells to develop a new class of allogeneic cell therapies for the treatment of cancer. Gamma delta T cells have characteristics of both the innate and adaptive immune systems that make them an ideal chassis for the development of cell therapies. This cell type can recognize and attack cancerous cells as well as coordinate a broad antitumor immune response by recruiting other immune factors and cells to the site of disease. Gamma delta T cells have also been shown to preferentially traffic to distinct tissues and could be ideally suited for more targeted treatment of certain types of cancers.

About AcepodiaAcepodia is a clinical-stage biotechnology company developingfirst-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care. Leveraging its ACC technology, the company links tumor-targeting antibodies to its proprietary immune cells, such as gamma deltaT cells to create novel antibody cell effector (ACE) therapies, which have increased binding strength against tumors that express low levels of tumor antigens.

Acepodia is made up of seasoned leadership and scientific experts dedicated to advancing its robust pipeline of ACE therapies with the potential to bring innovative, effective and affordable cell therapies to a broad population of patients across a variety of solid tumors and hematologic cancers. For more information, visithttps://www.acepodia.comand follow Acepodia onTwitterandLinkedIn.

About non-Hodgkin's lymphomaNHL is the most common cancer of the lymphatic system that develops in white blood cells called lymphocytes. Because lymph tissue is found all through the body, lymphoma can begin almost anywhere. The most common type of NHL in adults is diffuse large B-cell lymphoma, which is usually aggressive, accounting for about 30% of NHL diagnoses. Most types of NHL are incurable with available therapies, and more than 500,000 new cases of NHL are diagnosed each year worldwide.

Investor ContactAcepodiair@acepodiabio.com

Media Contactpr@acepodiabio.com

Gina LeeDirector of Communications and Public AffairsT. +886-2-2697-6100 ext.131M. +886-919-259-599E. gina@acepodiabio.com

View original content:https://www.prnewswire.com/news-releases/acepodia-announces-fda-clearance-of-ind-application-for-ace1831-an-anti-cd20-armed-allogeneic-gamma-delta-t-cell-therapy-candidate-to-treat-patients-with-non-hodgkins-lymphoma-301570711.html

SOURCE Acepodia Biotech, Inc.

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Acepodia Announces FDA Clearance of IND Application for ACE1831, an Anti-CD20 Armed Allogeneic gamma delta T-cell Therapy Candidate to Treat Patients...

Dublin, June 16, 2022 (GLOBE NEWSWIRE) -- The "Global CAR T Cell Therapy Market Opportunity & Clinical Pipeline Insight 2028" drug pipelines has been added to ResearchAndMarkets.com's offering.

Global CAR T cell therapy market opportunity is expected to surpass US$ 15 Billion by 2028

The development of CAR T cell therapy will gather momentum from the increasing number of investors, designers, and analysts in the guide therapy.

Rising frequencies of cancer across the globe together with the relentless technological advancement for dependable and effective cancer treatment is expected to support the growth of the worldwide CAR-T cell therapy market. Furthermore, heavy investments in clinical research and development in cell therapy are estimated to boost the market for CAR-T cell therapy in the years to come.

The report provides information on the globally approved CAR T cell therapies along with their price, dosage, and sales analysis. The report analyzes and forecasts the size of the global CAR-T cell therapy market.

The report delivers a full-scale exploration of market dynamics and factors that are manipulating the growth of the global CAR-T cell therapy market. The report also gives a competitive analysis of major market players that will give a competitive advantage to customers in their respective businesses.

Chimeric antigen receptor (CAR) T cell therapy is a novel immunotherapeutic approach that is indicated for the management of cancer. CAR T-cell therapy is a type of therapy in which the T-cells are taken from the blood of the patient, which is then modified in a lab by the addition of a gene for a man-made receptor (chimeric antigen receptor).

This aids in better recognizing of specific cancer cell antigens. The CAR T-cells are then given back to the patient. To date, 6 CAR T-cell therapy products including Kymriah (tisagenlecleucel), yescarta (axicabtagene), Tecartus (brexucabtagene autoleucel), Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), and Abecma (idecabtagene vicleucel) have been approved by FDA for the management of wide range of cancers. In addition to this, Relmacabtagene autoleucel have been approved in China.

The introduction of CAR T cell therapies has shown high adoption rates in a short span of time has propelled further research and development activities in this domain. Apart from hematological malignancies, the researchers are also expanding the role of CAR T cell therapies in solid tumors which will propel the growth of the market.

For instance, a recent research study demonstrated that infusing immune cells into patients has shown early promise by shrinking tumors in digestive system. The interim results demonstrated that tumors in nearly 50% of the 37 patients so far reduced in size after the therapy.

The global CAR T cell therapy market is highly consolidated with several key players. The pharmaceutical giants in the market are increasingly partnering or collaborating with technology companies to integrate advanced technologies for the betterment of CAR-T therapy or to expand their geographical presence.

For instance, Bayer and Atara Biotherapeutics entered into a worldwide license agreement for the development of next-generation ATA3271 which is mesothelin-directed CAR-T cell therapy. The agreement also aims to develop ATA2271, for the management of high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer.

Among drug types, Yescarta is currently dominating the market. Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma.

Recently in 2022, regulatory bodies expanded the approval of drugs for the management of large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within a year of first-line chemotherapy. The wide range of therapeutic indications as well as the global availability of the drug is the major factors which are the major factors aiding in the dominance of these factors.

Report Highlights:

Key Topics Covered:

1. Research Methodology

2. Chimeric Antigen Receptor (CAR) T Cell Therapy - Next Era in Immuno Oncology

3. Evolution of Chimeric Antigen Receptor (CAR) T-Cell Design3.1 Structure of CAR-T Cell3.2 1st Generation Chimeric Antigen Receptor3.3 2nd & 3rd Generation CAR-T Cell3.4 Principle of Chimeric Antigen Receptor Design

4. Approaches to Improve the Efficiency of CAR-T Cell Therapy

5. CAR T Cell Therapy Manufacturing Cost Analysis

6. Emerging In-Vivo Induced CAR T Cell Therapies6.1 Need of In-Vivo CAR T Cell Therapy6.2 In-Vivo CAR T Cell Platform; VivoVec, TumorTag, & RACR/CAR6.3 Key Drug in Research & Development

7. Global CAR T Cell Therapy Market Outlook 2022 - 20287.1 Market Overview7.2 Future Market Opportunity

8. Globally Approved CAR T Cell Therapies - Pricing, Dosage & Sales Analysis 20288.1 Tisagenlecleucel (Kymriah)8.2 Axicabtagene Ciloleuce (Yescarta)8.3 Brexucabtagene Autoleucel (Tecartus)8.4 Lisocabtagene maraleucel (Breyanzi)8.5 Idecabtagene Vicleucel (Abecma)8.6 Relmacabtagene autoleucel (Carteyva)8.7 Ciltacabtagene autoleucel (Carvykti)

9. US CAR T Cell Therapy Market Outlook9.1 Approved & Key CAR T Cell Therapy Products in US9.2 Market Overview9.3 Current Reimbursement Scenario

10. Europe CAR T Cell Therapy Market Outlook10.1 Approved & Key CAR T Cell Therapy Products in Europe10.2 UK10.3 Germany10.4 Spain10.5 France10.6 Rest of Europe10.7 Current Reimbursement Scenario

11. China CAR T Cell Therapy Market Outlook11.1 Approved & Key CAR T Cell Therapy Products in China11.2 Current Market Size & Forecast

12. Japan CAR T Cell Therapy Market Outlook12.1 Approved & Key CAR T Cell Therapy Products in Japan12.2 Market Overview12.3 Current Reimbursement Scenario

13. South Korea CAR T Cell Therapy Market Outlook13.1 Approved & Key CAR T Cell Therapies in South Korea13.2 Future Market Opportunity

14. Australia CAR T Cell Therapy Market Outlook14.1 Approved & Key CAR T Cell Products in Australia14.2 Australia CAR T Cell Therapy Market14.3 Current Reimbursement Scenario

15. Taiwan CAR T Cell Therapy Market Outlook

16. Global CAR T Cells Clinical Pipeline Overview16.1 By Company16.2 By County16.3 By Indication16.4 By Phase

17. Global CAR T Cells Clinical Pipeline By Company, Indication & Phase17.1 Research17.2 Preclinical17.3 Clinical17.4 Phase-I17.5 Phase-I/II17.6 Phase-II17.7 Phase-III17.8 Registered

18. Marketed CAR T Cell Therapy Clinical insight18.1 Breyanzi18.2 CARVYKTI18.3 Yescarta18.4 Kymriah18.5 Abecma18.6 Tecartus

19. Global CAR-T Cell Therapy Market Dynamics19.1 Favorable Parameters19.2 Market Challenges

20. Competitive Landscape20.1 Autolus20.2 Bellicum20.3 Bluebird20.4 Celgene20.5 Cellectis20.6 Celyad20.7 Eureka Therapeutics20.8 Fortress Biotech20.9 Immune Therapeutics20.10 Juno Therapeutics20.11 Kite Pharma20.12 Novartis20.13 Sorrento therapeutics20.14 TILT Biotherapeutics20.15 Ziopharm

For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/4xxf5g

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Global CAR T Cell Therapy Market Research 2022: Opportunity & Clinical Pipeline Insights to 2028 - Insight On More Than 600 CAR T Cell Therapies...

JERSEY CITY, N.J., June 15, 2022 /PRNewswire/ --InsightAce Analytic Pvt. Ltd. announces the release of market assessment report on "Global Cell Therapy Packaging Products and Services Market (Therapy (T-cell Therapies, Dendritic Cell Vaccines, Stem Cell Therapies, NK Cell Therapies, and Other ATMPs), Package Engineering Design (Primary Packaging and Secondary Packaging), Scale of Operation (Clinical and Commercial)) By Trends, Industry Competition Analysis, Revenue and Forecast Till 2030"

According to the latest research by InsightAce Analytic, the global cell therapy packaging products and services market is expected to reach US$ 1,252.14 Million in 2030, recording a promising CAGR of 20.32% during the period of 2022-2030.

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Cell therapy aims to modify genetic material to treat different chronic diseases. Cell and gene therapy is the most significant medical advance in recent history. The increasing investments by key players in the development of promising therapies and advanced packaging technologies are anticipated to fuel the market growth over the forecast period.

Biopharmaceutical companies are investing in developing and manufacturing new customizable "patient-centered medicine" and modernizing their supply chains. Although biopharmaceutical firms' primary focus is on the drug product (DP) research and production and delivery methods (e.g., syringes), packaging and labelling are crucial to ensuring product quality and efficacy. The packaging of cell and gene therapy products must maintain closure integrity and product stability and allow simple access to the product while remaining functional during heat and mechanical loads experienced. The packaging must be designed to endure cryogenic temperatures without compromising the quality of the biological material or its longevity. For instance, In February 2022, Sharp, a leading provider in contract packaging and clinical supply services, has designed new purpose-built production suites to fulfil the rising demand from producers of gene treatments for dedicated and specialized packaging capacity. The innovative secondary packaging by Sharp aims to give an appropriate environment for tackling the challenges of gene treatments, notably at low temperatures and distribution in cold and ultra-cold supply chains. In summary, packaging technology and engineering, graphics, and labelling design are vital components of the development and marketing of gene and cell therapy programs.

Major driving factors of the cell therapy packaging products and services market are the increasing need for cell therapies, advancements in packaging and labelling, high prevalence of cancer diseases. Furthermore, advanced medical technologies, the rising trend of outsourcing in the healthcare industry, and the ongoing efforts of service providers to further improve their portfolios are enhancing the growth of the cell therapy packaging products and services market. However, the high cost of manufacturing systems, lack of standard therapy protocols, and complex procedures are restraining the growth of this market.

Geographically, the North America region is the primary revenue holder of this market due to rising awareness about cell and gene therapies, increasing government investments in the research and development of cell therapies, stringent regulations and an increasing number of human chronic diseases. On the other hand, Europe will also dominate the market during the forecast period due to advancements in the biopharmaceutical field and stringent regulations. The Asia-Pacific market is expected to grow faster in the future due to the growing cell therapy manufacturing industries and the adoption of new technologies.

Major key players in the cell therapy packaging products and services market areAlmac, Catalent Pharma Solutions, Cryoport Systems, Core Cryolab Inc., Yourway, Lufthansa Cargo, Saint-Gobain Life Sciences, Thermo Fisher Scientific, Sharp, West Pharmaceutical Services, Chart Industries Inc., and Other Prominent Players. Leading manufacturers in this field focus on novel therapy innovations, partnerships, collaborations, mergers, and agreements. These strategies will help to boost their growth opportunities in this market.

Key Developments:

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Market Segments

Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2022 to 2030 based on Therapy

Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2022 to 2030 based on Package Engineering Design

Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2022 to 2030 based on Scale of Operation

Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2022 to 2030 based on Region

North America cell therapy packaging products and services market revenue (US$ Million) by Country, 2022 to 2030

Europe cell therapy packaging products and services market revenue (US$ Million) by Country, 2022 to 2030

Asia Pacific cell therapy packaging products and services market revenue (US$ Million) by Country,2022 to 2030

Latin Americacell therapy packaging products and services market revenue (US$ Million) by Country, 2022 to 2030

Middle East & Africa cell therapy packaging products and services market revenue (US$ Million) by Country, 2022 to 2030

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Cell Therapy Packaging Products and Services Market worth $1.25 Billion by 2030 - Exclusive Report by InsightAce Analytic - PR Newswire

We all love to reminisce about the good old days! Memories are part of our life and everyone reflects upon the good and bad times spent. Unfortunately, with a steadily increasing incidence of Alzheimers disease globally, many are losing their memoriesin fact even losing the ability to remember basic activities that do not as such require conscious thought.What is Alzheimers disease?Alzheimers disease (AD) is one of the major causes of dementia, and as of the last decade, there are approximately 3.7 million Indians with the condition. The lack of awareness regarding the early symptoms of the disease and knowledge about the associated risks poses challenges in early diagnosis and prompt interventions. Moreover, one cannot prevent or reverse the disease process.AD begins in individuals around the age of 40-50 years when certain unwanted proteins accumulate in the brain. These protein deposits interfere with the connections in the brain and disrupt the transmission of informationconsider them roadblocks that cannot be crossed.Thus, with time and depending on the extent of protein accumulation, a patient begins to forget things and gradually fails to form a link between the sensory information gained and the required action. For example, in advanced stages, apart from being unable to recognise people (including family members) a patient might not know what to do with a toothbrush or how the lock on a door should be fastened, although these are things he/she would have been doing for years together. It is a sad sight to watch a family member deteriorate in this manner. Since such episodes affect the overall quality of life of the patient, caregivers also tend to face the burden.How can this be treated?Unfortunately, there are no medications to treat the disease. Thus, the least we can do is try to slow down the progression of the condition. To begin with, annual health check-ups must be advised to everyone over the age of 45 years, adding brain imaging where required. By this we might be able to identify AD early and initiate activities and treatment that can slow the progression, says Dr Pradeep Mahajan, Regenerative Medicine Researcher.We have stem cells and growth factors in our body, which function to control inflammation, enhance the functions of other cells, and provide a constant pool of healthy cells to regenerate lost tissues. Through cell-based therapy, we are only providing these molecules at the required location in the appropriate quantity, explains Dr Mahajan.He continues, There are several other molecules, for example, chaperones (helper proteins) and exosomes (cell-associated packets of genetic material, proteins, immune cells, etc.) that act as messenger molecules, and also help in de-tangling nerve fibres and protein deposits in the brain. These can be utilised to create a healthier environment in the brain and restore internal balance (homeostasis).With more targeted therapies being researched, it might be possible to reverse AD in the future. For now, though, regenerative medicine can be a beacon of hope for patients to help lead an independent life for as long as possible in a natural, minimally invasive manner, concludes Dr Mahajan.

Originally posted here:
How stem cell therapy can help with Alzheimer's disease - Times of India

BOSTON & SEATTLE & EMERYVILLE, Calif.--(BUSINESS WIRE)--Affini-T Therapeutics, Inc., a biotechnology company unlocking the power of T cells against oncogenic driver mutations, and Metagenomi, Inc., a genetic medicines company with a versatile portfolio of next-generation, wholly-owned gene editing tools, today announced a partnership to enable Affini-Ts next generation ex vivo T cell receptor (TCR) cell therapies for solid tumor patients using Metagenomis novel proprietary gene editing systems.

We are delighted to announce our partnership with Metagenomi and to apply their next-generation gene editing systems to our cell therapies targeting oncogenic and viral driver genes, including KRAS and p53, to provide the greatest impact for patients across a variety of hard-to-treat solid tumor types, said Jak Knowles, M.D., Co-founder, President and Chief Executive Officer, Affini-T Therapeutics. By working with Metagenomi, we will gain access to powerful, novel gene editing tools to make precise and multiplex edits to immune cells, thereby optimizing the effector function of our cell-based therapeutics.

With this collaboration, Metagenomi is executing on its ex vivo therapeutics partnering strategy in the immuno-oncology space. We are especially excited to partner with the outstanding team at Affini-T and its scientific founder Dr. Phil Greenberg, who has fundamentally advanced this field. We believe that cell therapy, combined with our powerful gene editing tools, is the future of immuno-oncology, treating patients with the highest unmet medical need, said Brian C. Thomas, Ph.D., Founder and Chief Executive Officer of Metagenomi. Our strategy in cell therapy strives to create a broad pipeline of licensed, partnered and in-house development programs with leading scientific teams.

The partnership will leverage Metagenomis proprietary gene editing systems to complement Affini-Ts state-of-the-art TCR discovery and synthetic biology platforms to generate groundbreaking cell therapy products. Affini-T will have the option to exclusively license Metagenomis technology to make gene edits in autologous TCR T cell therapies for specific tumor targets, with the option to expand non-exclusively to editing certain allogeneic approaches. In the future the parties will discuss further targets for co-development and co-commercialization.

Under the terms of the agreement, Metagenomi will be entitled to receive tiered payments for each optioned cancer target plus additional milestone and royalty payments.

About Metagenomi

Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful gene editing systems that are ultra-small, extremely efficient, highly specific and have a decreased risk of immune response. These systems fuel our pipeline of novel medicines and can be leveraged by partners. Our goal is to revolutionize gene editing for the benefit of patients around the world. For more information, please visit https://metagenomi.co/.

About Affini-T Therapeutics

Affini-T is unlocking the power of T cells and targeting core oncogenic drivers to develop potentially curative therapies for solid tumor cancers. Our differentiated cell therapy platform harnesses state-of-the-art engineering and synthetic biology capabilities to target even the most devastating cancer-driving mutations, beginning with KRAS. We leverage these tools to optimize T cell functions and rewrite the rules of the solid tumor microenvironment, enabling the potential for sustained clinical outcomes in patients. Building on the world-class innovation inherent in our leadership team, founders and technologies, we are powered to develop transformational medicines that last. Follow us on LinkedIn and Twitter.

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Affini-T Therapeutics & Metagenomi Announce Next-Generation Gene Editing Partnership to Advance Cell Therapies for Solid Tumor Patients - Business...