Monthly Archives: June 2020

Atara Biotherapeutics cell-based therapy ATA188 is safe and well-tolerated in people with progressive forms of multiple sclerosis (MS), and induces a sustained reduction in disability in a dose-dependent manner, findings from the first part of a Phase 1 clinical trial show.

ATA188 had an acceptable safety and tolerability profile across all four doses tested. But more people on higher doses experienced sustained decreases in disability, and researchers chose the 20 million dose (the second highest dose) for further testing in this trials second part.

Patient enrollmentfor this randomized, placebo-controlled part two is again underway at sites in the U.S. and Australia after atemporary pause inresponse to theCOVID-19 pandemic, the company said in a press release.

The new data were presented at the2020 European Academy of Neurology (EAN) Congress which was held virtually due to the pandemic in the poster Phase 1 study of the safety and efficacy of ATA188, an off-the-shelf, allogeneic Epstein-Barr virus-targeted T-cell immunotherapy to treat progressive forms of multiple sclerosis (EAN registration is needed to access the presentations).

Infection with theEpstein-Barr virus (EBV, a common form of the herpes virus) is increasingly seen as a possible cause of MS, leadingB-cellsto go rogue and produce antibodies that wrongly attack the protective myelin coating of nerve cells.

ATA188 is designed to help patients get rid of these damaging B-cells, by providing them with T-cells (immune cells with the ability to fight threats) that have been modified to eliminate EBV-infected cells.

The ongoing Phase 1a/1b trial (NCT03283826) is assessing the safety and effectiveness of ATA188 in a near equal mix of patients with either primary progressive MS (PPMS) or secondary progressive disease (SPMS).

It is being conducted in two parts. First, 25 patients were given one of four ATA188 doses 5 million (5 x 106), 10 million (1 x 107), 20 million (2 x 107), or 40 million (4 x 107) cells to determine the safest and most effective dose for future testing. The first three dose groups had six patients; in the fourth group, seven patients received the 40 million dose.

Treatment was administered in two cycles, with three ATA188 injections each, with patients evaluated after treatment initiation at three, six, and 12 months. These people could then enter an extension part of the trial, and receive once-a-year ATA188 intravenous (IV) injections for up to four years.

Part ones main goal was to assess treatment safety and tolerability. Secondary measures include changes in disability scores, assessed with the expanded disability status scale (EDSS) and timed 25 foot walk (T25FW; time taken to safely walk 25 feet).

Results here showed that the treatment was safe and well-tolerated across all four dose groups, with runny nose being the only treatment-related side effect reported in more than one person.

There was no evidence of cytokine release syndrome(a systemic inflammatory response),graft versus host disease (a complication in which healthy cells are attacked by transplanted T-cells), or dose-limiting toxicities.

Potential treatment efficacy was assessed using a composite measure of sustained disability improvement (SDI), defined as clinically significant improvements in either EDSS or T25FW scores. These improvements had to be sustained, meaning that patients needed to show improvements at two consecutive time points.

In other words, a patient had SDI at six months if improvement in disability scores was seen at three months and confirmed at six months. For SDI at one year, patients had to show improvements at month six and confirm them at the 12-month evaluation.

Researchers found that one patient on the 5 million dose, one on the 10 million dose, and two patients on the 20 million dose group achieved SDI at six months, and that all maintained those improvements at one year. A third patient on the 20 million cells per dose also achieved SDI at 12 months.

Two patients on the highest 40 million dose also reached SDI at six months, but 12-month assessments are not yet complete in this group.

Most patients achieved SDI due to clinical improvements in EDSS, researchers reported.

An additional outcome measure, based on several validated MS scales, was used to help categorize outcomes on a range from clinical decline to clinical improvement. Those patients who achieved durable clinical improvements on SDI measures also experienced a clinical improvement using this outcome measure.

With dose increases, more patients again showed clinical improvements on this scale, and fewer of them experienced clinical decline.

The approach of targeting EBV-infected B cells has led to very encouraging preliminary results, as ATA188 proved to be safe and well-tolerated across all four dose cohorts in this Phase 1a study, Lawrence Steinman, MD, a professor at Stanford University, said in the release.

These results, along with the observed trend in sustained disability improvements seen at six months and maintained at 12 months, highlight the opportunity to advance into the randomized placebo-controlled study of ATA188 for the treatment of patients with progressive MS, Steinman added.

Researchers are now testing the recommended20 million dose in the trials second part, which will randomly assign a new group of adults with progressive MS to ATA188 or a placebo.

Treatment goals here are to continue studying safety and effectiveness, and to establish ATA188s superiority over a placebo in a number of measures, including disability progression, cognition, fatigue, changes on MRI scans, and biological factors.

If these data are confirmed in a double-blind, placebo-controlled, randomized study, we could see an evolution in the treatment paradigm for progressive MS and other forms of this debilitating disease, Steinman said.

We look forward to the continued study of ATA188 in progressive MS, and believe our novel therapeutic approach targeting the EBV-infected B cell as a propagator of autoimmunity may help patients with other forms of MS, said AJ Joshi, MD, senior vice president and chief medical officer of Atara Biotherapeutics.

Among other disorders being also considered are autoimmune conditions where EBV has been implicated, including lupus, rheumatoid arthritis, and Sjgrens syndrome, Joshi added.

Total Posts: 1,053

Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

Original post:
Progressive MS Cell Therapy, ATA188, Safe and Lessens Disability, Trial Reports - Multiple Sclerosis News Today

NEW YORK, June 03, 2020 (GLOBE NEWSWIRE) -- Cytovia Therapeutics, Inc (Cytovia), an emerging biopharmaceutical company developing Natural Killer (NK) immunotherapies for cancer, today announces the appointment of Dr. Wei Li as acting Chief Scientific Officer (CSO), effective June 1, 2020.

During her biotech career, Dr. Li co-founded two companies and built up extensive expertise in all aspects of drug research and development, including preclinical development and pharmacology, clinical development and operations, regulatory affairs, biomarker development and biomanufacturing.

Most recently, Dr. Li was Chief Development Officer at OliX Pharmaceuticals, a leading public South Korean biotech company developing siRNA therapeutics for multiple indications. She also served as Executive Vice President, Product Development at Boston Biomedical, Inc (BBI) from 2007-2018, playing a key role in growing it from a start-up in 2007 to an industry leader in cancer stem cell research, including through the acquisition by Sumitomo Dainippon in 2012. Dr. Li led the development of napabucasin (BBI608), a first-in-class drug selected as one of the worlds top ten cancer drugs in late stage clinical development by Fierce Biotech. Dr. Li started her career at ArQule, a public biotech company developing targeted therapies for hematological malignancies and acquired by Merck &Co in 2019.

Wei Li holds a PhD in Molecular Virology from Georgia State University and completed her Postdoctoral Training at Harvard Medical School.

Dr. Wei Li said: I am thrilled to be joining the great team of scientists and entrepreneurs at Cytovia Therapeutics. NK-cell based therapeutics are at an inflection point. Initial clinical trials have shown promising safety and efficacy. Off-the-shelf manufacturing promises broader and faster patient access. Cytovia Therapeutics has an excellent iPSC CAR-NK platform and a strong pipeline in both hematological and solid tumors. It is tremendously exciting to be involved in this stage of the companys development.

Dr Daniel Teper, co-founder, Chairman and CEO of Cytovia Therapeutics, Inc said: We are delighted to welcome Dr. Wei Li to Cytovia Therapeutics as Chief Scientific Officer. Wei has a stellar track record of bringing innovative oncology drugs from discovery to clinical development. Her operational excellence and entrepreneurial drive will be critical to help bring multiple iPSC CAR NK therapeutics to initial clinical trials starting in 2021.

ABOUT CYTOVIA THERAPEUTICS, INCCytovia Therapeutics is an emerging biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem and Macromoltek.

Learn more at http://www.cytoviatx.com

Contact for media enquiries at Cytovia Therapeutics, IncSophie BadrVP corporate AffairsSophie.badre@cytoviatx.com1(929) 317 1565

Read the original here:
Cytovia Therapeutics, Inc appoints Dr. Wei Li as Chief Scientific Officer to accelerate the development of iPSC CAR-NK Cell Therapy for Cancer -...

Patients with relapsed or refractory indolent non-Hodgkin lymphoma who were treated with the chimeric antigen receptor (CAR) T-cell therapy of axicabtagene ciloleucel (axi-cel; Yescarta) had high rates of complete response (CR) and demonstrated the agent's manageable safety profile, according to an interim analysis of the phase 2 ZUMA-5 study (NCT03105336) presented as part of the 2020 American Society of Clinical Oncology Virtual Scientific Program.1

Axi-cel yields high rates of response in indolent B-cell non-Hodgkin lymphoma, Caron A. Jacobson, MD, of the Dana-Farber Cancer Institute, said during a presentation of the data. Although longer follow-up is needed, these responses appear to be durable amongst follicular lymphoma patients.

Adults with relapsed or refractory follicular lymphoma (FL; grades 1-3a) and marginal zone lymphoma (MZL; nodal or extranodal) after 2 lines of therapy (including an anti-CD20 monoclonal antibody [mAb] with an alkylating agent), and an ECOG status of 0 or 1 were eligible for the study. Participants were leukapheresed and received conditioning chemotherapy followed by axi-cel infusion at 2 106 CAR T-cells/kg.

Of the 96 patients evaluable for efficacy, the objective response rate (ORR) was 93% (95% CI, 86%-97%) and the CR rate was 80% (95% CI, 71%-88%). The median time to first response was 1 month (range, 0.8-3.1). More specifically, patients with FL (n = 80) had an ORR of 95%, with an 81% CR rate, and those with MZL (n = 16) had an ORR of 81% with a 75% CR rate.

With a median follow-up of 15.3 months, the estimated duration of response (DOR) in all patients was 20.8 months, and 68% of patients with FL had an ongoing response as of the data cut-off. Moreover, the median PFS was 23.5 months (95% CI, 22.8 - not evaluable) in all patients, and the median overall survival (OS) was not reached. However, the 12-months OS rate was 94.3% (95% CI, 86.8-97.6) for all patients.

These interim results suggest that axi-cel may be a promising approach for treating this patient population.

The primary endpoint of the study was ORR by central review. Key secondary endpoints included DOR, progression-free survival (PFS), OS, safety, and blood levels of cytokines and CAR T-cells.

As of December 16, 2019, 140 patients (FL, n = 124; MZL, n = 16) had received axi-cel with a median follow-up of 15.3 months (range, 1.9-28.8). The median age of the participants was 63 years of age (range, 34-79), 49% of patients were male, 52% had stage IV disease, 51% had 3 FLIPI, and 49% had high tumor bulk (GELF). Moreover, patients had a median 3 prior lines of therapy, 66% progressed < 2 years after initial anti-CD20 mAb-containing therapy (POD24), and 73% were refractory to the last prior treatment.

All of the study participants were evaluable for safety, and 119 patients (85%) experienced grade 3 adverse events (AEs). The most commonly observed AEs were neutropenia (34%) and anemia (22%). Additionally, grade 3 cytokine release syndrome (CRS) and neurologic events (NEs) occurred in 8% and 17% of patients, respectively. There were only 2 grade 5 AEs, including multisystem organ failure in the context of CRS (related to axi-cel) and aortic dissection (unrelated to axi-cel).

Given the long natural history of these diseases, safety is of paramount importance, Jacobson said. The safety profile was manageable and reversible, and appeared to be at least similar to that of axi-cel in aggressive lymphomas.

The median time to peak of anti-CD19 CAR T-cell levels after axi-cel infusion was 8 days (range, 8 - 371). Furthermore, anti-CD19 CAR T-cells were detectable at 18 months in most patients with evaluable samples (13/15 [87%]).

Notably, in patients with FL, peak CAR T-cell expansion was associated with both grade 3 CRS (P = 0.0088) and neurologic events (P = 0.0076). In addition, peak serum analyses across multiple immune programs were associated with grade 3 CRS, grade 3 neurologic events, or both in patients with FL.

This may have implications for the possibility of outpatient therapy for this disease in the future, said Jacobson.

Axi-cel appears to be a promising therapeutic approach for patients with relapsed and refractory indolent B-cell non-Hodgkin lymphoma.

Axi-cel is currently approved by the FDA as a treatment for adult patients with relapsed or refractory large B-cell lymphoma based on findings from the phase II ZUMA-1 trial.2 The agent is indicated specifically following 2 prior therapies for those with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma (TFL).

References

<< View more of Targeted Oncology's coverage from the 2020 ASCO Virtual Annual Meeting

Continued here:
CAR T-Cell Therapy With Axi-Cel Holds Promise in R/R Indolent NHL - Targeted Oncology

This detailed market study covers Cart Cell Therapy Market growth potentials which can assist the stakeholders to understand key trends and prospects in Cart cell therapy market identifying the growth opportunities and competitive scenarios. The report also focuses on data from different primary and secondary sources, and is analyzed using various tools. It helps to gain insights into the markets growth potential, which can help investors identify scope and opportunities. The analysis also provides details of each segment in the global Cart cell therapy market.

Get Sample Copy of This Report @https://www.quincemarketinsights.com/request-sample-61563?utm_source=Radhika/AZ

According to the report, Cart cell therapy market report highlights market opportunities and competitive scenarios for Cart cell therapy on a regional and global basis. Market size estimation and forecasts have been provided based on a unique research design customized to the dynamics of the Cart cell therapy market. The Cart cell therapy market has been segmented by target antigen (cd19, cd22 and others), application (acute lymphoblastic leukemia, diffuse large b-cell lymphoma and others), end user (hospital, pharmaceuticals, clinic and others). Historic back-drop for the Cart cell therapy market has been analyzed according to organic and inorganic developments to provide precise market size estimations. Also, key factors impacting the growth of the Cart cell therapy market have been identified with potential gravity.

Regional segmentation and analysis to understand growth patterns:The market has been segmented in major regions to understand the global development and demand patterns of this market.

North America, Western Europe, Eastern Europe, Asia Pacific, Middle East, & Rest of the World segmented the Cart cell therapy market on a regional basis. Some of the major markets in North America and Western Europe are also typical suppliers of chemicals such as specialty chemicals, bulk chemicals, and so on. The major companies in this market have their headquarters in North and Western Europe.

The Asia Pacific and the Middle East are expected to register substantial growth in the Cart cell therapy market during the forecast period. This demand is with regard to the growth of major end-use industries such as marine, oil & gas, industrial, construction & infrastructure, energy & power, automotive & transportation. Major countries in the Asia Pacific region include China, South Korea, Japan, India, Australia, and so on. Middle East includes the UAE, Saudi Arabia, Iran, Israel, Egypt, and so on.

Eastern Europe has been largely dominated by Russia and Turkey with operations of major chemical giants in the region. Rest the World that includes South America and Africa has a strong potential for the Cart cell therapy market. There have been an increasing number of investments by global companies in these regions to strengthen their presence and tap the potential market. Major economies in these regions for the Cart cell therapy market include Brazil, South Africa, Nigeria, Argentina, Colombia, and others.

This report provides:1) An overview of the global market for Cart cell therapy market and related technologies.2) Analysis of global market trends, yearly estimates and annual growth rate projections for compounds (CAGRs).3) Identification of new market opportunities and targeted consumer marketing strategies for global Cart cell therapy market.4) Analysis of R&D and demand for new technologies and new applications5) Extensive company profiles of key players in industry.

The researchers have studied the market in depth and have developed important segments such as product type, application and region. Each and every segment and its sub-segments are analyzed based on their market share, growth prospects and CAGR. Each market segment offers in-depth, both qualitative and quantitative information on market outlook.

Company profiled in this report based on Business overview, Financial data, Product landscape, Strategic outlook & SWOT analysis:1. Novartis AG2. Kite Pharma3. Mustang Bio4. Sorrento Therapeutics5. CARsgen Therapeutics6. Autolus Therapeutics7. Pfizer Inc.8. Cellectis, Legend Biotech9. Bellicum Pharmaceuticals10. and others.

Get ToC for the overview of the premium report @https://www.quincemarketinsights.com/request-toc-61563?utm_source=Radhika/AZ

Market Segmentation:By Target Antigeno CD19o CD22o Others

By Applicationo Acute Lymphoblastic Leukemiao Diffuse Large B-Cell Lymphomao Others

By End-Usero Pharmaceuticals Companieso Hospitalo Clinico Other

By Region:North Americao By Country (US, Canada, Mexico)o By Target Antigeno By Applicationo By End User

Western Europeo By Country (Germany, UK, France, Italy, Spain, Rest of Western Europe)o By Target Antigeno By Applicationo By End User

Eastern Europeo By Country (Russia, Turkey, Rest of Eastern Europe)o By Target Antigeno By Applicationo By End User

Asia Pacifico By Country (China, Japan, India, South Korea, Australia, Rest of Asia Pacific)o By Target Antigeno By Applicationo By End User

Middle Easto By Country (UAE, Saudi Arabia, Qatar, Iran, Rest of Middle East)o By Target Antigeno By Applicationo By End User

Rest of the Worldo By Region (South America, Africa)o By Target Antigeno By Applicationo By End User

Reasons to Buy This Report:o Market size estimation of the cart cell therapy market on a regional and global basiso Unique research usage for market size estimation and forecast

o Profiling of major companies operating in the market with key developmentso Broad scope to cover all the possible segments helping every stakeholder in the market

Customization:We provide customization of the study to meet specific requirements:o By Segmento By Sub-segmento By Region/Country

Contact:

Quince Market Insights

Ajay D. (Knowledge Partner)

Office No- A109,

Pune, Maharashtra 411028

Phone: IN +91 706 672 5858

US +1 208 405 2835

UK +44 121 364 6144

APAC +91 706 672 4848

Email: sales@quincemarketinsights.com

Web:www.quincemarketinsights.com

ABOUT US:

QMI has the most comprehensive collection of market research products and services available on the web. We deliver reports from virtually all major publications and refresh our list regularly to provide you with immediate online access to the worlds most extensive and up-to-date archive of professional insights into global markets, companies, goods, and patterns.

Continued here:
Cart Cell Therapy Market 2020 Global Outlook, Research, Trends and Forecast to 2028| Novartis AG, Kite... - Azizsalon News

A perfect mix of quantitative & qualitative Cell Therapy Technologiesmarket information highlighting developments, industry challenges that competitors are facing along with gaps and opportunities available and would trend in Cell Therapy Technologiesmarket. The study bridges the historical data from 2014 to 2019 and estimated until 2025.

The Cell Therapy TechnologiesMarket report also provides the market impact and new opportunities created due to the COVID19/CORONA Virus Catastrophe The total market is further divided by company, by country, and by application/types for the competitive landscape analysis. The report then estimates 2020-2025 market development trends of Cell Therapy TechnologiesIndustry.

Downlaod Sample ToC to understand the CORONA Virus/COVID19 impact and be smart in redefining business strategies. https://inforgrowth.com/CovidImpact-Request/6321133/cell-therapy-technologies-market

The Top players are Danaher, Thermo Fisher Scientific, Merck, Terumo, BD, Lonza Group, GE Healthcare, Sartorius, Stemcell Technologies, Miltenyi Biotec, .

Market Segmentation:

Cell Therapy Technologies Market is analyzed by types like Equipment, Consumables, Others

On the basis of the end users/applications, Human, Animal

Download Free Sample PDF along with few company profileshttps://inforgrowth.com/sample-request/6321133/cell-therapy-technologies-market

Be the first to knock the door showing the potential that Cell Therapy Technologiesmarket is holding in it. Uncover the Gaps and Opportunities to derive the most relevant insights from our research document to gain market size.

A major chunk of this Global Cell Therapy TechnologiesMarket research report is talking about some significant approaches for enhancing the performance of the companies. Marketing strategies and different channels have been listed here. Collectively, it gives more focus on changing rules, regulations, and policies of governments. It will help to both established and new startups of the market.

The study objectives of this report are:To analyze global Cell Therapy Technologiesstatus, future forecast, growth opportunity, key market, and key players.To present the Cell Therapy Technologiesdevelopment in the United States, Europe, and China.To strategically profile the key players and comprehensively analyze their development plan and strategies.To define, describe and forecast the market by product type, market, and key regions.

Get Special Discount Up To 50%, https://inforgrowth.com/discount/6321133/cell-therapy-technologies-market

Major Points from Table of Contents

1 Cell Therapy Technologies Cell Therapy Technologies Market Overview2 Cell Therapy Technologies Market Competition by Manufacturers3 Production Capacity by Region4 Global Cell Therapy Technologies Market by Regions5 Production, Revenue, Price Trend by Type6 Global Cell Therapy Technologies Market Analysis by Application7 Company Profiles and Key Figures in Cell Therapy Technologies Business8 Cell Therapy Technologies Manufacturing Cost Analysis9 Marketing Channel, Distributors and Customers10 Market Dynamics11 Production and Supply Forecast12 Consumption and Demand Forecast13 Forecast by Type and by Application (2021-2026)14 Research Finding and Conclusion15 Methodology and Data Source.

ENQUIRE MORE ABOUT THIS REPORT AT https://inforgrowth.com/enquiry/6321133/cell-therapy-technologies-market

FOR ALL YOUR RESEARCH NEEDS, REACH OUT TO US AT:Address: 6400 Village Pkwy suite # 104, Dublin, CA 94568, USAContact Name: Rohan S.Email:[emailprotected]Phone: +1-909-329-2808UK: +44 (203) 743 1898Website: http://www.inforgrowth.com

Read the rest here:
Latest Update 2020: Cell Therapy Technologies Market by COVID19 Impact Analysis And Top Manufacturers: Danaher, Thermo Fisher Scientific, Merck,...

Basel, June 2, 2020 Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory action is now expected in September 2020.

Novartis will continue to work with the FDA to complete the review as soon as possible, said Marie-France Tschudin, President, Novartis Pharmaceuticals. We are well prepared and ready to launch ofatumumab upon approval. We are committed to the MS community and look forward to bringing this important advancement to patients with MS.

Additional regulatory filings are currently underway and regulatory approval for ofatumumab in Europe is expected by Q2 2021.

About ofatumumabOfatumumab (OMB 157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-adminstered by a once-monthly injection, delivered subcutaneously1,2,7. As shown in preclinical studies, ofatumumab is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion3. The selective mechanism of action and subcutaneous administration of ofatumumab allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and may preserve the B-cells in the spleen, as shown in preclinical studies4. Once-monthly dosing of ofatumumab also allows fast repletion of B-cells and offers more flexibility5. Ofatumumab was originated by Genmab and licensed to GlaxoSmithKline; Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 20156.

DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 145 nationalities work at Novartis around the world. Find out more athttps://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnewsFor Novartis multimedia content, please visit https://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact media.relations@novartis.com

References1. Hauser S.Efficacy and safety of ofatumumab versus teriflunomide in relapsing multiple sclerosis: results of the phase 3 ASCLEPIOS I and II trials. Presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Conference; September 1113, 2019; Stockholm, Sweden.2. Bar-Or A, Fox E, Goodyear A, et al.Onset of B-cell Depletion with Subcutaneous Administration of Ofatumumab in Relapsing Multiple Sclerosis: Results from the APLIOS Bioequivalence Study. Presented at Americas Committee for Treatment and Research in Multiple Sclerosis Forum; February 2729, 2020.3. Smith P, Kakarieka A, Wallstroem E.Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. Poster presented at ECTRIMS; September 2016; London, UK.4. Smith P, Huck C, Wegert V, et al.Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presented at ECTRIMS; September 1417, 2016; London, UK.5. Savelieva M, Kahn J, Bagger M, et al.Comparison of the B-Cell Recovery Time Following Discontinuation of Anti-CD20 Therapies. ePoster presented at ECTRIMS; October 2528, 2017; Paris, France.6. GSK press release.GSK completes divestment of rights to ofatumumab for auto-immune indications to Novartis. December 21, 2015. Available from:https://www.gsk.com/en-gb/media/press-releases/gsk-completes-divestment-of-rights-to-ofatumumab-for-auto-immune-indications-to-novartis/%5BLast accessed: June 2020].7. Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS I & II clinical trials), data on file, Novartis. https://clinicaltrials.gov/ct2/show/NCT02792218; https://clinicaltrials.gov/ct2/show/NCT02792231.

# # #

Novartis Media RelationsE-mail: media.relations@novartis.com

Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com

Originally posted here:
Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis -...

The world isnt just battling a health pandemic yet in addition a economic one, as the Novel Coronavirus (COVID-19) throws its long shadow over economies around the world. The whole lockdown circumstance in a few nations has legitimately or indirectly affected numerous ventures causing a move in activities like gracefully chain operations, seller tasks, product commercialization, and so forth. The Report on Adoptive Cell Therapy For Cancer Treatment Market which give detailed investigation of impact of the novel Coronavirus (COVID-19) pandemic on the historical and present/future market information.

Ask For Sample Copy of Adoptive Cell Therapy For Cancer Treatment Report here:https://www.globalmarketers.biz/report/life-sciences/global-adoptive-cell-therapy-for-cancer-treatment-industry-market-research-report/577#request_sample

GlobalAdoptive Cell Therapy For Cancer Treatment market research reportprovides the latest manufacturing data and business coming trends, providing you to recognize the outcomes and end-users offering Revenue growth and profitability. The Adoptive Cell Therapy For Cancer Treatment industry report lists the leading competitors and provides the game-changing strategic analysis of the key factors driving the market. The report includes the forecasts by 2026, analysis by 2019, and discussion of significant trade, market volume, market share evaluations and outlines of the top Adoptive Cell Therapy For Cancer Treatment industry players.

Major Players in Adoptive Cell Therapy For Cancer Treatment market are:GlaxoSmithKlineGenentechMerckRocheAmgenEli LillyJanssenBristol-Myers Squibb

Make an Inquiry About This Report @ https://www.globalmarketers.biz/report/life-sciences/global-adoptive-cell-therapy-for-cancer-treatment-industry-market-research-report/577#inquiry_before_buying

Market Segmentation:

Market Segmentation by Type:

SurgeryChemotherapyRadiotherapy

Market Segmentation by Application:

Autologous adoptive T cell therapyAllogeneic Adoptive T cell therapy

Any query? Enquire Here For Discount :https://www.globalmarketers.biz/discount_inquiry/discount/577

Below is a comprehensive list of the Key Questions to be explained for each element in the Global Adoptive Cell Therapy For Cancer Treatment Industry, which can help organizations to survive and develop their self. So, here arekey questions answeredin the report to guide the industry.

1. Market size

What is the Adoptive Cell Therapy For Cancer Treatment industry market size?

And, what will be the market size in the next five years?

2. Global Adoptive Cell Therapy For Cancer Treatment Market: CAGR

What is the growth rate of the Adoptive Cell Therapy For Cancer Treatment industry in the next 5 years?

Take a look at

Which segments are growing the fastest?

3. Key Geographies

The biggest contributor to Adoptive Cell Therapy For Cancer Treatment industry?

Find amongNorth America, Asia-Pacific, Europe, Africa, South America.

Which countries to watch out for the coming years?

Find amongU.S., Canada, U.K., France, Germany, China, India, Russia, The Middle Eastand so on.

4. Market Opportunities

Which factors are contributing to the positive growth of the market?

Applications in

What factors are proving to be opportunities for the Adoptive Cell Therapy For Cancer Treatment industry?

Want to customize this report? Enquire Here (To get higher priority use company email ID)

5. Key Vendors

Who are the major players in the Adoptive Cell Therapy For Cancer Treatment business?

What growth strategies are major giantsadopting?

Also, what share do they control?

What developments have they undertaken?

6. Business Challenges

Which factors are contributing to the negative growth of the market?

What factors are proving to be hurdles for the Global Adoptive Cell Therapy For Cancer Treatment market?

Why buy from us

Custom research service:

Speak to the Adoptive Cell Therapy For Cancer Treatment report authors to design a premium study to complete your analysis needs.

Quality assurance:

Information security:

Your personal and confidential information is safe and secure with us.

Do you know?

Our library has thousands of reports on hundreds of topics.

Thousands of people come to us for insights every month

Request for more detailed information (TOC and Sample): https://www.globalmarketers.biz/report/life-sciences/global-adoptive-cell-therapy-for-cancer-treatment-industry-market-research-report/577#table_of_contents

See the original post here:
The COVID-19 Shuffle: Adoptive Cell Therapy For Cancer Treatment Market Size, Share, Applications, Regions, Top Companies, Trends, Market Drivers and...

The dying patient just needed to hold on a little while longer.

Within a few hours, she would receive the new treatment. The placenta cells a therapy that showed promise in boosting the immune system were on their way to Holy Name Medical Center from another state.

It was April, and the coronavirus crisis was intensifying. The patient, an unidentified woman, lay dying of COVID-19 at the Teaneck facility, one of New Jerseys hardest-hit hospitals.

Everyone was anxious and was excited that we would treat her, said Dr. Ravit Barkama, a clinical researcher at the hospital. And the cells were basically on the way to Holy Name from Maryland.

It was an example of the hope and heartache doctors and nurses faced in the early days of the unfolding medical crisis. They rushed to treat a crush of patients flooding the emergency room, while clinical researchers studied the latest data and searched for anything in their arsenals to keep the infected alive.

While the first phase of the COVID-19 crisis is winding down, the pandemic and the health care establishments work are far from over. Holy Name is taking a hard look at everything its medical personnel learned in enduring those treacherous first three months.

The clinical researchers recently shared a report with NJ Advance Media outlining a series of medical takeaways: Everything theyve learned after treating hundreds of coronavirus patients since the crisis began.

Its an orderly account with dense detail and precise explanations a dramatic contrast to March and April, when more than 200 patients were dying on ventilators, one after the other. When the intensive care units were filled.

When there seemed to be no clear answers.

The researchers learned the ways COVID-19 affects the body, the various stages in which it manifests and consumes patients, the medications and therapies that show promise and the treatments that proved ineffective.

Like every hospital in the state, Holy Name was desperately looking for ways to combat the disease after the pandemic hit New Jersey.

Treatment was trial and error. It was a scramble, often necessitating learning on the fly.

The first few weeks, basically, almost every night was ... working with a lot of frustration, Barkama said.

She and her counterpart, Dr. Thomas Birch, have been working as a research duo of sorts, investigating possible therapies for a deluge of COVID-19 patients.

"How are we going to treat the patients? What can we give them? How can we make this better? How can we keep people from dying? How can we keep people off of the ventilator?" Birch said.

It was an exhausting sprint of confusion and dashed hopes.

Barkama and Birch recalled late nights poring over research and data. Barkama called counterparts in Israel and Europe asking what was working.

They found insights, if not epiphanies.

One of the hard-won lessons was COVID-19 is a disease of stages.

It follows a largely defined progression in the human body, from exposure and incubation (phase 1), to the showing of symptoms (phase 2), to the virus impact on the lungs (phase 3) to the decrease of lung inflammation (phase 4).

We basically realized certain interventions might be effective in certain phases and not effective in others. And so thats the key, said Dr. Suraj Saggar, infectious disease specialist at Holy Name.

Early intervention is crucial. Antiviral drugs likely work best during the first phase when used as a pre-emptive therapy, the report said.

The antiviral drug, remdesivir, seems most effective during phase 2, the stage when the initial symptoms emerge. Convalescent plasma may also have some benefit during this stage.

The third phase is what makes COVID-19 different, the report said. This is when symptoms like shortness of breath, persistent fever and pneumonia develop. Severe inflammation begins to batter the lungs, blood vessels and organs.

The bodys overreactive immune system not the virus does most of the damage. It is why inflammatory drugs and immunosuppressive appear to help during this period.

The final stage, or the convalescent phase, is when the inflammation begins to subside and the lungs and other tissues clear the debris from inflammation, injured tissues and fluid, the report said. The stage can span three to six weeks, delaying the time when the patient can be weaned from the ventilator.

It is possible placenta-derived cells may further reduce inflammation, according to the report.

It was a tremendous amount of reading, a tremendous amount of reviewing patient cases and seeing what was going on with them clinically, their symptoms, their physical exam findings, the laboratory and imaging, said Birch, who is also an infectious disease specialist. How they responded to some of the therapies that were being used, and how we might use them more rationally.

When potential treatments emerged, such as placenta cell therapy or remdesivir, it offered hope after weeks of anguish at Holy Name.

It was no different in April as they tried to help the dying woman.

The doctors and researchers waited April 11.

The cells would arrive in just a few more hours, they were told.

The findings on placenta cell therapy were still preliminary, but the treatment championed by a company in Israel was showing promise. Six critically ill coronavirus patients in Israel had shown signs of improvement after taking it.

Some saw it as a possible dream treatment.

But then an alarm blared over Holy Names loudspeakers. It was a Code Blue, an emergency calling for the CPR team.

"It goes 'Code Blue ICU,' and then, of course, I knew that something was very wrong," Barkama said.

Her heart dropped. She rushed to see who it was.

It was the dying woman.

"A few hours before we were supposed to give the treatment, she desaturated and passed away," Barkama said.

The loss devastated her.

"When I saw it was her I must say that it was emotionally very difficult to lose a patient a few hours before the so-called 'dream treatment,'" Barkama said.

While the researchers remain hopeful about placenta-derived cell therapy, only four patients have been treated at the hospital thus far. Its too early to assess the results.

Remdesivir has also shown promise, but research remains ongoing. The National Institutes of Health has found positive results, and Gilead, the maker of the drug, said in a statement earlier this week that it found encouraging data from a recent trial, especially if used as an intervention therapy.

Holy Names staff hope the lessons pay dividends for New Jersey hospitals in case they again encounter chaos like they did in March.

Looming in the back of everyones mind is the possible resurgence of the virus in the fall, after already claiming 11,880 lives and causing 162,068 infections in New Jersey.

There is, of course, a good chance that there will be [another phase], and were not looking at this as a historical episode, Barkama said.

The research continues. Hospitals were caught flat-footed, often forced to learn and sift out new techniques on the fly, revamp old ones and apply them in new ways.

We obviously hope, just like everyone else, that it will never hit us so hard again, Barkama said. But were going to be prepared in case it does.

Spencer Kent may be reached at skent@njadvancemedia.com. Follow him on Twitter @SpencerMKent. Find NJ.com on Facebook.

Have a tip? Tell us. nj.com/tips.

Get the latest updates right in your inbox. Subscribe to NJ.coms newsletters.

See more here:
Lessons from the epicenter: How one N.J. hospital endured the worst of the pandemic and learned from it - nj.com