Global Cell Therapies & Oncolytic Virus Markets, 2016-2019 & 2026 – Stimulation of the Intrinsic Vascular Cell to Provide Ample Industry…

DUBLIN--(BUSINESS WIRE)--The "Global Cell Therapies & Oncolytic Virus Market Analysis 2019" report has been added to ResearchAndMarkets.com's offering.

The Global Cell Therapies & Oncolytic Virus market is growing at a CAGR of 17.32% from 2018 to 2026.

Factors such as rise in technological advancements and increase in usage of combination therapies are driving the market growth. Though, occurrence of immune reaction to the virus-based treatments caused by repeated administration of therapeutics to treat cancer and Staggering expense related to oncolytic virus therapy are projected to inhibit the growth of the market. Moreover, stimulation of the intrinsic vascular cell may provide ample opportunities for the market growth.

By application, melanoma segment acquired significant growth in the market because most of the cancer therapies are developed for melanoma cancers. Increasing prostate cancer cases are also leading to the strong growth rate in prostate cancer therapies in recent years which is driving the market growth.

The key vendors mentioned are PsiOxus Therapeutics, Cold Genesys, TILT Biotherapeutics, SillaJen Biotherapeutics, Genelux Corporation, Vyriad, Lokon Pharma, TILT Biotherapeutics and Sorrento Therapeutics.

Key Questions Answered in this Report

Key Topics Covered

1 Market Synopsis

2 Research Outline

3 Market Dynamics

3.1 Drivers

3.2 Restraints

4 Market Environment

4.1 Bargaining power of suppliers

4.2 Bargaining power of buyers

4.3 Threat of substitutes

4.4 Threat of new entrants

4.5 Competitive rivalry

5 Global Cell Therapies & Oncolytic Virus Market, By Type

5.1 Introduction

5.2 Adenoviruses-Based Oncolytic viruses

5.3 HSV-Based Oncolytic Viruses

5.4 Newcastle Disease Virus-Based Oncolytic Viruses

5.5 Vaccinia Virus-Based Oncolytic Viruses

5.6 Vesicular Stomatitis Virus-Based Oncolytic Viruses

6 Global Cell Therapies & Oncolytic Virus Market, By Application

6.1 Introduction

6.2 Breast Cancer

6.3 Melanoma

6.4 Ovarian Cancer

6.5 Prostate cancer

7 Global Cell Therapies & Oncolytic Virus Market, By Geography

7.1 Introduction

7.2 North America

7.3 Europe

7.4 Asia-Pacific

7.5 South America

7.6 Middle East & Africa

8 Strategic Benchmarking

9 Vendors Landscape

9.1 PsiOxus Therapeutics

9.2 Cold Genesys

9.3 TILT Biotherapeutics

9.4 SillaJen Biotherapeutics

9.5 Genelux Corporation

9.6 Vyriad

9.7 Lokon Pharma

9.8 TILT Biotherapeutics

9.9 Sorrento Therapeutics

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

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Global Cell Therapies & Oncolytic Virus Markets, 2016-2019 & 2026 - Stimulation of the Intrinsic Vascular Cell to Provide Ample Industry...

Leading from the front in cell therapy – – pharmaphorum

In these videos, senior stakeholders from Kite, a Gilead Company, describe how a culture of innovation and partnership help it lead from the front in the team sport of cell therapy.

Dick Sundh, Anne Kerber, and Bethany Dudek reflect on the leadership focus of the company and outline how Kite aims to become the cell therapy leader of Europe.

Embodying leadership in cell therapy

On my very first day at Kite one of my colleagues said to me Dick, theres only one thing you need to remember; cell therapy is a team sport, says Dick Sundh, Head of Europe for Kite, a Gilead Company, as he describes the process of building the organisations cell therapy business in Europe.

Kite has been at the forefront of cell therapy development and, since the first European approvals of CAR T cell therapies in 2018, the company has been establishing the necessary European infrastructures to deliver cell therapies in the region, and manufacture at scale.

According to pharma veteran Sundh, the job has proven to be an interesting challenge and Kite has broken new ground in establishing the foundations required to enable access to cell therapies. We are learning every day along with our partners and medical institutions across Europe.

And its not only about the science, but about embodying leadership qualities by demonstrating the companys core values on a daily basis. When healthcare professionals and employees feel you truly care about patients you have a real opportunity to become a true leader.

Sundh explains that Kites situation is unique; operating as a separate business unit within one of the worlds largest pharma companies, Gilead Sciences.

Its about expanding the footprint for cell therapy in Europe. We have the best of both worlds because we have a big pharma company in the background with resources where we need it. Otherwise were independent and allowed to go as fast and as innovatively as we want to. Teamwork is at the heart of everything we do.

I feel very passionate and privileged about being part of redefining not only how we understand oncology, but how we treat it.

Delivering the potential of cell therapies

Anne Kerber, Vice President, Head of Clinical Development in Europe at Kite, a Gilead Company, describes the clinical process the company is undertaking to deliver on the potential of individualised cell therapies for patients with rare forms of blood cancer, who face ongoing unmet needs.

In her role, Kerber draws on her experience as a qualified haematologist/oncologist to inform her work with a diverse range of research partners across Europe, in the clinical development of cell therapies. We work closely with many healthcare professionals and see a high level of commitment from physicians to enrol in clinical trials; we understand that, for them, partnership, education and learning is key.

Having followed the development journey of cell therapies for several years, Kerber has gone on to work with healthcare professionals to build their knowledge of cell therapies for use in their own clinical research.

Kerber stresses the importance of teamwork in developing cell therapies, particularly in light of their complex manufacturing processes when compared to more conventional treatments.

Becoming closely involved with the experiences of patients on their treatment journey is another important part of Kerbers remit these are specialist therapies and as such the company has a much closer relationship with their stakeholders than would be the case with a conventional medicine.

In cell therapy, collaboration is very important and each person in the chain has a critical role to play in ensuring patients receive these therapies at the right time.

Translating innovation in quality systems into clinical delivery

Bethany Dudek, Executive Director, Head of Quality at Kite, a Gilead Company, describes the complex quality control processes that are required to deliver cell therapies to the exacting standards required.

Dudek and her team oversees everything from inspection of incoming apheresis white blood cells collected from patients using a specialised process to obtain vital T-cells to testing and releasing the final product once it has been manufactured.

Cell therapies are bespoke treatments derived from a persons own T-cells, genetically modified to recognise tumour cells, then returned to the individual patient to trigger their immune system to target certain cancers.

Once we receive the apheresis, its a continuous process until we get to the final product and its important that the quality organisation and manufacturing supply chain work closely as a team to get the product back to the hospital and to the patient.

The remit of the quality team also includes overseeing how the cell therapy product is delivered to patients, which requires the qualification of treating hospitals to undertake this process. This particular step is unique to cell therapies and ensures that treating hospitals understand how to receive and store the product at each stage, as well as maintaining the vital chain of custody throughout.

Its exciting because it allows us to collaborate more closely with our European colleagues at Gilead and Kite as well as healthcare professionals in the clinic. It helps us get the treatment to the patient, ensuring optimal quality.

According to Dudek, the leadership of Kites parent company Gilead has been central to allowing these highly specialised cancer therapies to reach patients in Europe.

The support from Gilead has been very important for our support to healthcare providers and to the centres that provide our product to patients.

We learn alongside colleagues, healthcare professionals and other stakeholders how to bring these innovative therapies to the people who need them.

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Leading from the front in cell therapy - - pharmaphorum

Neon Therapeutics Announces New Strategic Focus on Novel T Cell Programs – GlobeNewswire

Lead program, NEO-PTC-01, is a personalized neoantigen adoptive T cell therapy candidate to address refractory solid tumors

Corporate restructuring effected to focus resources while exploring strategic options

CAMBRIDGE, Mass., Nov. 20, 2019 (GLOBE NEWSWIRE) -- Neon Therapeutics, Inc. (Nasdaq: NTGN)today announced its new strategic focus on the development of its novel neoantigen-based T cell programs, in conjunction with a corporate restructuring. Neon will focus its efforts on the advancement of both personal and precision neoantigen-targeted T cell therapy candidates. Neons most advanced program is NEO-PTC-01, its personal neoantigen-targeted T cell therapy candidate consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patients tumor. Neon expects to file a Clinical Trial Application (CTA) in Europe by the end of 2019 to evaluate NEO-PTC-01 in patients with metastatic melanoma who are refractory to checkpoint inhibitors.

Prioritizing development of novel T cell therapies will leverage our years of expertise and learnings in pioneering neoantigen science, while positioning Neon to best deliver new therapies that could potentially improve patient outcomes and bring value to shareholders. The strategic restructuring will enable us to focus resources to execute on this vision. We acknowledge this decision impacts many talented employees who helped build Neon into a leader in neoantigen-based-therapies and we are grateful for their many contributions, said Hugh ODowd, Neons Chief Executive Officer.

NEO-PTC-01 leverages Neons neoantigen platforms, including RECON, its machine-learning bioinformatics platform, and NEO-STIM, its proprietary process to directly prime, activate and expand neoantigen-targeting T cells ex vivo. Neon believes that this approach will allow NEO-PTC-01, a non-engineered product that leverages peripheral blood mononuclear cells (PBMCs) as starting material, to specifically target each patient's individual tumor with T cells that can drive a robust and persistent anti-tumor response.

The initial clinical development of NEO-PTC-01 will be focused on demonstrating monotherapy activity targeting metastatic solid tumors that are refractory to checkpoint inhibitor therapy. Following the planned submission of a CTA by the end of 2019, the company plans to initiate a Phase 1 dose escalation clinical trial in second-line metastatic melanoma in collaboration with the Netherlands Cancer Institute. The second planned indication for NEO-PTC-01 is second-line metastatic ovarian cancer, with potential to expand to other solid tumor types and potential development in the United States.

NEO-PTC-01 has the potential to unlock the potency of cell therapy in solid tumors with several key advantages that overcome the challenges of other cell therapy approaches. In pre-clinical development and in several patient samples, we have demonstrated the ability to produce multiple enriched neoantigen-specific CD8+ and CD4+ T cell populations, including both memory and de novo T cell responses, that killed patient-specific tumors by targeting their tumor neoantigens. We believe that neoantigen targets will provide the tumor specificity required to develop safe, effective and durable T cell therapies for the treatment of solid tumors, said Richard Gaynor, M.D., Neons President of Research and Development.

Neon is also advancing a precision T cell therapy program targeting shared neoantigens in genetically defined patient populations. This process utilizes off-the-shelf targets with a patients own PBMCs to develop a novel cell-based immunotherapy enabling rapid deployment for each patient. The lead program from this approach, NEO-STC-01, is a T cell therapy candidate targeting shared RAS neoantigens initially in pancreatic cancer and is currently in preclinical development.

Corporate Restructuring

As part of this new strategic focus, Neon is reducing its workforce by approximately 24% of its current headcount. At this time, Neon will cease undertaking new additional spending commitments related to its cancer vaccine programs, NEO-PV-01 and NEO-SV-01. The company will continue to conduct follow-up from its NT-002 clinical trial of NEO-PV-01 in first-line patients with untreated advanced or metastatic non-small cell lung cancer, with plans to report clinical data from this trial in the third quarter of 2020. Neon also plans to cease future enrollment in its NT-003 trial in metastatic melanoma. Neon believes these actions will improve its potential to bring value to patients, employees and shareholders. As part of these cost reduction efforts, Neon intends to explore strategic options.

Neon expects that the restructuring and other cost-saving efforts will result in approximately $35 million in annualized cost savings. Neon estimates that it will incur approximately $1.5 million of pre-tax charges for severance and other costs related to the restructuring in 2019. With this restructuring, Neon now expects that its cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2020.

There can be no assurance that Neons restructuring and other cost-saving efforts will be sufficient to continue the development of NEO-PTC-01 or its other programs through completion of the planned or ongoing clinical trials, nor that Neons exploration of strategic alternatives will result in any transaction being entered into or consummated. Neon has not set a timetable for completion of this strategic review process and Neon does not intend to comment further unless or until its board of directors has approved a definitive course of action, the review process is concluded, or it determines that disclosure is required or appropriate.

About Neon Therapeutics

Neon Therapeuticsis a biotechnology company developing novel neoantigen-targeted T cell therapies, dedicated to transforming the treatment of cancer by directing the immune system towards neoantigens. Neon is using its neoantigen platform to develop both personal and precision neoantigen-targeted T cell therapy candidates. Neons most advanced program is NEO-PTC-01, its personal neoantigen-targeted T cell therapy candidate consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patients tumor. Neon expects to file a Clinical Trial Application (CTA) in Europe by the end of 2019 to evaluate NEO-PTC-01 in patients with metastatic melanoma who are refractory to checkpoint inhibitors.

For more information, please visitneontherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements ofNeon Therapeutics, Inc.within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to obtain and maintain regulatory approval of our product candidates; the potential timing and advancement of our clinical trials; the potential timing and manner of data readouts from our ongoing and planned clinical trials; the design and potential efficacy of our therapeutic approaches; our plans to explore strategic alternatives; financial plans and projections, including its restructuring and other cost-saving efforts and impact on cash runway; and our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials. Any forward-looking statements in this press release are based on managements current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing and conduct of studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will not be successfully developed and commercialized; the risk that the results of preclinical studies and clinical trials may not be predictive of future results in connection with future studies or trials; the risk that Neons collaborations will not continue or will not be successful; risks related to our ability to protect and maintain our intellectual property position; risks related to our capital requirements, use of capital and unexpected expenditures, including our ability to manage operating expenses or obtain funding to support planned business activities or to explore and establish strategic alternative transactions; risks related to our ability to attract and retain personnel; and risks related to the ability of our licensors to protect and maintain their intellectual property position. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Neons actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in Neons most recent Quarterly Report on Form 10-Q, as filed with theSecurities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Neons other filings with theSecurities and Exchange Commission. All information in this press release is as of the date of the release, and Neon undertakes no duty to update this information unless required by law.

Investor Contact:Will OConnor, Stern Investor Relationswill@sternir.com212-362-1200

Media Contact:Stephanie Simon,Ten Bridge Communicationsstephanie@tenbridgecommunications.com617-581-9333

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Neon Therapeutics Announces New Strategic Focus on Novel T Cell Programs - GlobeNewswire

New cell therapy player launches with $57M from marquee investors to go after ‘definitive’ tumor targets – Endpoints News

A crew of Amgen and Kite vets is publicly throwing their new startup into the cell therapy hat though they are saying little outside of the basics and $57 million in Series A cash.

The Column Group, Vida Ventures, Samsara BioCapital and Nextech Invest are backing A2 Biotherapeutics quest to find new ways of engaging immune cells in selectively attacking cancer. To do so, the biotech is working with two target classes: peptide MHC targets and targets that are irreversibly lost in tumor cells. The former builds on an increasingly popular strategy of locating neoantigens for T cells to home in on, while the latter is inspired by a mechanism used by natural killer cells.

A2 Biotherapeutics has potent, highly selective binders that we combine into molecular constructs to integrate multiple signals and potentially provide a large therapeutic window, said CSO Alexander Kamb, who co-founded the biotech after a stint as SVP of research at Amgen. They could be antibody and T-cell receptor fragments, according to its statement.

Scott Foraker, his former colleague at the Big Biotech, recently signed on as president and CEO.

Working out of Agoura Hills, California, their team of 40 expects to usher the first product candidate into the clinic next year. Its four programs in development span cancer testis antigen for solid tumors; targets lost antigens for solid tumors; neoantigens for head and neck cancer; and neoantigens for pancreatic, colorectal and lung cancer.

It also plans on constructing a manufacturing facility arguably the most important core competency that differentiates one cell therapy player from another in 2020 with the mindset of ultimately producing its own commercial supply. The site would support an autologous approach, though A2 Bio didnt specify what kind of cells it would use as the source.

Their lead in technical ops is Michelle Kreke, who was credited for leading chemistry, manufacturing and controls for the pioneering CAR-T Yescarta.

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New cell therapy player launches with $57M from marquee investors to go after 'definitive' tumor targets - Endpoints News

Zelluna Immunotherapy and Glycostem Therapeutics announce partnership to develop allogeneic TCR-NK therapies – BioSpace

Oslo and Oss, Norway and the Netherlands, November 19, 2019 - Zelluna Immunotherapy, a biopharma company developing T-cell receptor (TCR) guided adoptive cell therapy products for the treatment of multiple solid cancers, and Glycostem Therapeutics BV, a clinical stage and leading Natural Killer (NK) cell manufacturing company, today announce that they have entered into a development, license and supply agreement. This collaboration will focus on the development and manufacture of allogeneic TCR guided NK-cell therapies (TCR-NKs) for the treatment of patients with cancer.

This partnership between Zelluna and Glycostem represents a critical milestone in Zellunas aim to transform cell therapy treatments by enabling more patients to be treated effectively, rapidly and safely. It is the industrys first commercial development partnership of TCR-NK cells for treating cancer aiming at the rapid translation of our proprietary TCR-NK approach, said Miguel Forte, CEO, Zelluna. Zelluna selected Glycostem as a partner for the delivery of TCR-NK therapies for their expertise in NK-cell science, GMP manufacturing and clinical testing of NK-cell products. The development of TCR-NK programs will run in parallel to Zellunas autologous TCR-T development programs, including its lead autologous T-cell product entering the clinic next year. Zellunas vision of cell therapies continues to be autologous and allogeneic products delivering much needed patient benefit.

Currently, NK-cell based therapies such as CAR-NKs are receiving considerable interest from the wider cell therapy community. Through the partnership with Glycostem, Zelluna is enabling its proprietary TCR-NK approach with the potential to target a broader repertoire of tumor associated antigens by targeting NK-cells with TCRs for treatment of patients with solid cancers.

Zelluna will lead the development and commercialization of TCR-NK products with its TCRs and TCR development competence. Glycostem will contribute by manufacturing clinical grade umbilical cord derived NK-cells, NK-cell expertise, product process development, and clinical and commercial supply. Zelluna and Glycostem will be able to manufacture upfront a large number of patient doses to store and ship to clinical sites upon demand in an off-the-shelf manner.

We are very proud to be collaborating with Zelluna, a transformative TCR cell therapy company to jointly develop allogeneic TCR-NK products for the benefit of hard to treat patients. This partnership will enable Glycostems NK-cells to deliver increased efficacy against solid tumors in a TCR-NK product using Zellunas TCR targeting mechanism, said Troels Jordansen, CEO, Glycostem. This is further confirmation of the significant interest in NK-cell products and an external validation of Glycostems abilities which supports our commercial and scientific ambitions; taking cellular immunotherapy to the next level.

About Zelluna Immunotherapy

Zelluna Immunotherapy is a company developing transformative T cell receptor (TCR) based cellular immunotherapies for the treatment of solid cancers. The company is developing a unique portfolio of tumor specific TCRs that target the MHC class II pathway to broadly engage the host immune system to provide a safe, efficient and durable clinical response. The company is developing therapies based on the effector functions of autologous T cells (TCR-T) and allogeneic NK cells (TCR-NK). Both of these platforms have their unique advantages and provides the opportunity to attack cancers from multiple angles and improve access to these advanced therapies to a large patient population. For more information, please visit http://www.zelluna.com.

About Glycostem

Netherlands-based Glycostem Therapeutics BV, a clinical stage biotech company, develops allogeneic cellular immunotherapy to treat several types of cancer. By harnessing the power of stem cell-derived Natural Killer (NK) cells, Glycostems products are a safe alternative to CAR-T-cells. Glycostems lead product, oNKord(R), is manufactured from allogeneic raw material and is available off-the shelf. Thanks to its nine patent families, longstanding technical expertise and resources, as well as Orphan Drug Designation, Glycostem has secured a leadership position in the global NK-cell market. oNKord(R) is produced in a closed system in Glycostems state-of-the-art and GMP (Good Manufacturing Practice) licensed production facility in the Netherlands, from which it can be distributed globally. The production technology includes ex vivo generation of high numbers of NK-cells with a high degree of purity for clinical applications. oNKord(R) successfully passed phase I clinical trial (elderly and frail AML - Acute Myeloid Leukemia - patients), providing solid safety data and strong indication of clinical activity, including response on MRD (Minimal Residual Disease). Results indicate that oNKord(R) may be safely infused in AML patients. Glycostem is furthermore developing a range of CAR-NK products in-house and in cooperation with amongst other global partners MolMed SPA (BIT:MLM).

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Zelluna Immunotherapy and Glycostem Therapeutics announce partnership to develop allogeneic TCR-NK therapies - BioSpace

Latest Research : Personalized Cell Therapy Market Size, CAGR Status, Market Trends, Analysis and Forecast 2019-2028 – Daily Criticism

A New Business Strategy report released byMarketresearch.biz, titled- Global Personalized Cell Therapy Market Robust Growth, Revenue Estimation During forthcoming years. This Global Personalized Cell Therapy market report brings data for the estimated year 2019 and forecasted till 2028 in terms of both, value (US$ MN) and volume (MT). The report also consists of forecast factors, macroeconomic factors, and a market outlook of the Personalized Cell Therapy market. The study is conducted using top-down and bottom-up approaches and further analyzed using analytical tools such as porters five force analysis and uncover Opportunities, Challenges, restraints, and rising trends of the Global Personalized Cell Therapy market. This survey report also states import/export consumption, supply and demand Figures, cost, price, revenue, and gross margins.Some of the Major Companies Profiled in the reports with SWOT Analysis areCytori Therapeutics Inc, Bellicum Pharmaceuticals Inc, Saneron CCEL Therapeutics Inc, MolMed S.p.A., Vericel Corporation, Oxford Nanopore Technologies, Cell Medica, MediGene AG, TxCell.

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Global personalized cell therapy market segmentation, by technique:

Platelet TransfusionsBone Marrow TransplantationPacked Red Cell TransfusionsOrgan TransplantationGlobal personalized cell therapy market segmentation, by therapeutic area:

Cardiovascular DiseasesNeurological DisordersInflammatory DiseasesDiabetesCancer

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4.1 By Type [2013-2028]

4.2 By Application [2013-2028]

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5.2.2 Restraints

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5.3 Porters Five Force Model

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Latest Research : Personalized Cell Therapy Market Size, CAGR Status, Market Trends, Analysis and Forecast 2019-2028 - Daily Criticism

What Patients With Mantle Cell Lymphoma Should Know About the FDA’s Approval of Brukinsa – Curetoday.com

The Food and Drug Administration approved Brukinsa to treat relapsed and refractory mantle cell lymphoma, but what does this mean for patients?

MCL is a type of non-Hodgkin lymphoma (NHL) that represents about 3% to 10% of all NHL cases in the United States, affecting approximately 15,000 patients.

The issue with MCL is that it is an aggressive lymphoma, the five-year median overall survival is about five years, and it is regarded, as for most patients, incurable, Dr. Lee Greenberger, chief scientific officer of The Leukemia & Lymphoma Society (LLS), said in an interview with CURE. Therefore, most patients given initial therapy with MCL are expected to relapse and need additional therapy. Hence, new therapies are critically needed.

How Brukinsa WorksThe FDAs approval of Brukinsa is based on the results of two clinical trials. The first included 86 patients with MCL and examined how many patients had complete or partial shrinkage of their tumors after they received the therapy. The findings showed that 84% of patients had their tumors shrink and the time between the initial response to therapy and disease progression or relapse, also known as median duration of response, was 19.5 months. The second trial, which included 32 patients, also showed tumor shrinkage in 84% of patients and median duration of response was 18.5 months.

Brukinsa is an oral drug known as a Brutons tyrosine kinase (BTK) inhibitor. BTK inhibitors, such as Imbruvica (ibrutinib) and Calquence (acalabrutinib), block the BTK protein which may prevent malignant B cells from growing, and these types of medications have already proven to be effective in treating patients with MCL.

The efficacy of these three agents is roughly similar, although the overall response rate and complete response rate is numerically higher with Brukinsa ... it is not clear that these differences are statistically distinct, Greenberger said. (This approval) gives patients another option that might be useful if intolerance to ibrutinib or acalabrutinib occurs. It is possible that Brukinsa will have a superior safety profile compared to ibrutinib.

Side effects experienced while taking Brukinsa included decreased white blood cells that fight against infection, decreased platelet count, upper respiratory tract infection, decreased hemoglobin (oxygen-carrying protein in red blood cells), rash, bruising, diarrhea and cough.

While taking the medication, patients should use sun protection because there is risk of other malignancies including skin cancers, according to the FDA.

On the safety side, the frequency of serious atrial fibrillation (irregular heartbeat) is less common with Brukinsa (2%) versus ibrutinib (approximately 6%)versus acalabrutinib (1%), Greenberger said. (However), these comparisons need to be made with caution because no side-by-side comparison are available.

The Future of Mantle Cell LymphomaPatients with relapsed MCL tend to develop resistance to Imbruvica roughly 30% of patients in initial therapy and 20% to 50% of patients after responding to therapy. It is not clear why resistance to (Imbruvica) is so common (in MCL) compared to other diseases treated with (Imbruvica), such as chronic lymphocytic leukemia, Greenberger said.

Therefore, it is important to develop new therapies for patients to try once their disease becomes resistant, he explained. resistance mechanism could also be distinct and perhaps less frequent with Brukinsa, especially if a patient can tolerate the medicine better than other agents and do not reduce the dose of Brukinsa while on therapy.

Researchers working on current clinical trials are investigating combination therapies, including those that combine Imbruvica, Calquence and Brukinsa with chemotherapy agents, in several blood cancers. The LLS is funding some work on this in the MCL space and is conducting additional research with chimeric antigen receptor T cell therapy, a type of immunotherapy, in these patients. The goal is to further decrease cancer burden and increase the time patients are disease-free, Greenberger said.

Read CUREs original coverage of the FDAs approval of Brukinsa for patients with mantle cell lymphoma.

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What Patients With Mantle Cell Lymphoma Should Know About the FDA's Approval of Brukinsa - Curetoday.com