Stem Cell Clinic

Fine-tuning adoptive cell therapy for advanced cancers – Newswise

By Stem Cell Medical Center

FINDINGS

Newswise Adoptive cell transfer immunotherapy is one of the most promising new treatments for people with hard-to-treat cancers. However, the process is complex and needs fine-tuning in order to develop more treatment strategies that will work for more people.

In a new study looking at adoptive cell transfer products bearing a transgenic T-cell receptor (TCR), researchers at the UCLA Jonsson Comprehensive Cancer Center have identified a discordant phenomenon in which a subset of patients displayed profoundly decreased expression of the transgenic TCR over time, despite the transgenic TCR being present at the DNA level. This gave rise to the observation that structural changes to the DNA via DNA methylation make it inaccessible for transcription and translation, which is an influential step in the flow of genetic information from DNA to RNA. This can be one clue into why some patients stop responding to this type of immunotherapy.

The issue is this phenomenon happens over time, said lead author Theodore Scott Nowicki, MD, PhD, clinical instructor of pediatrics and hematology/oncology at the David Geffen School of Medicine at UCLA. Were hoping this can help inform the design of future generations of these types of therapies and pinpoint different vectors that might be more or less vulnerable to this phenomenon.

JOURNAL

The study waspublished onlinein Cancer Discovery, a journal of the American Association for Cancer Research.

BACKGROUND

Adoptive cell transfer immunotherapy works by taking a patients own T cells, which are one of the components of the immune system, and genetically modifying them in the laboratory to target tumor-specific antigens on the surface of the tumor. The new army of tumor-specific T cells are then reinfused back into the patient to help attack the cancer.

A key component of adoptive cell transfer therapy requires genetically modifying T cells to target cancer cells. This is often done with viral transduction agents with either lentivirus- or retrovirus-based products to express either a cancer antigen-specific TCR or chimeric antigen receptor (CAR).

In order to develop more efficient cell therapies, Nowicki and colleagues are studying the genetic mutations of T cells to understand the structural changes to DNA over time. This could reveal why adoptive cell transfer therapy is more likely to work in some patients versus others and help inform the future design of next-generations of the therapy.

METHOD

The team analyzed 16 clinical transgenic adoptive cell therapy samples collected before and during treatment from patients with melanoma and sarcoma. This allowed the team to look at the expression of the transgenic TCR at the DNA and protein level. It gave them insight into what proportion of the cells displayed impaired expression of the transgenic TCR. They were then able to assess the degree of DNA methylation present in the retroviral vectors promoter region over time, and correlate this degree of DNA methylation with repression of the transgenic TCR.

IMPACT

The study can help researchers in the design of future generations of cellular immunotherapies to help treat people with advanced cancers.

AUTHORS

The studys lead and senior author is Dr. Nowicki. The study was conducted under the mentorship of Dr. Antoni Ribas, professor of medicine and director of the tumor immunology program at the UCLA Jonsson Comprehensive Cancer Center. Both Dr. Nowicki and Dr. Ribas are members of the Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research. Other authors include Colin Farrell, Marco Morselli, Liudmilla Rubbi, Katie Campbell, Mignonette Macabali, Beata Berent-Maoz, Begona Comin-Anduix and Matteo Pellegrini, all of UCLA.

FUNDING

The research was funded in part by grants from the National Institutes of Health, the Tower Cancer Research Foundation, the Hyundai Hope on Wheels foundation, the Parker Institute for Cancer Immunotherapy and the Ressler Family Fund.

***

The UCLA Jonsson Comprehensive Cancer Center has more than 500 researchers and clinicians engaged in cancer research, prevention, detection, control, treatment and education. One of the nation's largest comprehensive cancer centers, the UCLA Jonsson Comprehensive Cancer Center is dedicated to promoting research and translating basic science into leading-edge clinical studies.

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Fine-tuning adoptive cell therapy for advanced cancers - Newswise

Ascentage Pharma Announces First Patient Dosed in the Phase Ib Study of MDM2-p53 Inhibitor APG-115 as Single Agent and in Combinations for the…

By Stem Cell Treatment

SUZHOU, China and ROCKVILLE, Md., July 22, 2020 /PRNewswire/ -- Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the Phase Ib study of the company's novel MDM2-p53 inhibitor candidate APG-115 as a single agent or in combinations for the treatment of Chinese patients with relapsed/refractory acute myeloid leukemia (r/r AML), or relapsed/progressed high/very high risk myelodysplastic syndrome (MDS) has dosed its first patient in China. As the first MDM2-p53 inhibitor entering clinical studies for the treatment of solid tumors in China, this is the first study of APG-115 in patients with hematologic malignancies.

This multicenter Phase Ib clinical study in China is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of APG-115 as a single agent or in combination with azacitidine or cytarabine in patients with hematologic malignancies, including r/r AML and relapsed/progressed high/very high risk MDS.

AML is a clonal proliferative disease of the bone marrow, of which the incidence rate increases with age. AML is the most common type of leukemia in China, with an incidence rate of 1.62-2.32 cases per 100,000[1]. The standard induction therapy for AML comprises the "7+3" regimen (7 days of cytarabine plus 3 days of anthracycline drugs), but up to 40% of newly diagnosed AML patients do not achieve complete response (CR) during initial induction therapy, which is considered as refractory, or relapse within 6 months after achieving CR[2].

MDS is a heterogeneous hematopoietic disease caused by abnormal pluripotent stem cells, and the condition is characterized by poor hematopoietic function, bone marrow failure, reduction in peripheral blood cells, and reduced survival rates. The incidence rate of MDS in China is approximately 5 cases per 100,000. Although hypomethylating agents can produce a high response rate in patients with MDS, many patients eventually develop drug resistance to hypomethylating agents. Patients who have developed the acquired drug resistance commonly face a very poor prognosis. In patients with high-risk MDS, treatment failure with hypomethylating agents is associated with an average survival of less than 6 months[3]. As a result, both refractory/progressed AML and MDS represent an urgent medical need for more effective therapies.

APG-115 is an orally administered, selective, small-molecule inhibitor of the MDM2-p53 protein-protein interaction (PPI). APG-115 has strong binding affinity to MDM2 and is designed to activate tumor suppression activity of p53 by blocking the MDM2-p53 PPI. APG-115 is the first MDM2-p53 inhibitor entering clinical development in China, with multiple ongoing clinical studies in solid tumors in China and the US. At present, APG-115 is being investigated in a range of hematologic malignancies globally.

"Currently, there remains to be significant unmet medical needs in the treatment of hematologic malignancies, including AML and MDS," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We have also noticed that drug development targeting the MDM2-p53 pathway has received growing interest. As the first MDM2-p53 inhibitor entering clinical study in China, APG-115 has already demonstrated favorable safety profiles and preliminary efficacy in solid tumors. We will actively explore APG-115's therapeutic potential in hematologic malignancies, to hopefully provide more options of AML and MDS treatment to patients in China and around the world."

References:

1.Chang R, Wu S, Chen W, et al. Analysis on epidemiological characteristics of leukemia in Gansu Province from 2003 to 2012 [Article in Chinese]. Modern Preventive Med. 2014;41(21):3841-04.

2.Thol F, Schlenk RF, Heuser M, Ganser A. 2015. How I treat refractory and early relapsed acute myeloid leukemia. Blood 126: 319-27

3.Prebet T, Gore SD, Esterni B, Gardin C, Itzykson R, et al. 2011. Outcome of high-risk myelodysplastic syndrome after Azacitidine treatment failure. J Clin Oncol 29: 3322-7

About APG-115

APG-115 is an orally administered, selective, small-molecule inhibitor of the MDM2-p53 PPI. APG-115 has strong binding affinity to MDM2 and is designed to activate p53 tumor suppression activity by blocking the MDM2-p53 PPI. Ascentage Pharma has previously commenced three clinical trials of APG-115 in the US, including a Phase I study as single agent, a Phase Ib/II study in combination with pembrolizumab for treatment of metastatic melanoma and other advanced solid tumors, and a Phase I/II study as a single agent or in combination with chemotherapy for treatment of salivary gland cancer. APG-115 is the first MDM2-p53 inhibitor to enter clinical studies in China. A Phase I study as a single agent, and a Phase Ib study as a single agent or in combination with chemotherapy for treatment of AML (acute myeloid leukemia) or MDS (myelodysplastic syndrome) are ongoing in China.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and senesce diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 6855.HK.

Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 30 Phase I/II clinical trials in the US, Australia, and China. The company's core drug candidate HQP1351 was recently granted orphan drug and fast-track designations by the US Food and Drug Administration (FDA), and a New Drug Application for HQP1351 has been submitted in China. APG-2575, another key drug candidate of the company, was recently granted orphan drug designation by the FDA.

Forward-Looking Statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

SOURCE Ascentage Pharma

http://www.healthquearma.com

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Ascentage Pharma Announces First Patient Dosed in the Phase Ib Study of MDM2-p53 Inhibitor APG-115 as Single Agent and in Combinations for the...

Latest News On the Covid-19 impact on Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market Trade Overview, Industry Demand and…

By Stem Cell Treatment

The global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market is carefully researched in the report while largely concentrating on top players and their business tactics, geographical expansion, market segments, competitive landscape, manufacturing, and pricing and cost structures. Each section of the research study is specially prepared to explore key aspects of the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market. For instance, the market dynamics section digs deep into the drivers, restraints, trends, and opportunities of the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market. With qualitative and quantitative analysis, we help you with thorough and comprehensive research on the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market. We have also focused on SWOT, PESTLE, and Porters Five Forces analyses of the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market.

Leading players of the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market are analyzed taking into account their market share, recent developments, new product launches, partnerships, mergers or acquisitions, and markets served. We also provide an exhaustive analysis of their product portfolios to explore the products and applications they concentrate on when operating in the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market. Furthermore, the report offers two separate market forecasts one for the production side and another for the consumption side of the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market. It also provides useful recommendations for new as well as established players of the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market.

Final Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Report will add the analysis of the impact of COVID-19 on this Market.

Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market competition by top manufacturers/Key player Profiled: Janssen, Qiagen, Advanced Cell Diagnostics, ApoCell, Biofluidica, Clearbridge Biomedics, CytoTrack, Celsee, Fluxion, Gilupi, Cynvenio, On-chip, YZY Bio, BioView, Fluidigm, Ikonisys, AdnaGen, IVDiagnostics, Miltenyi Biotec, ScreenCell, Silicon Biosystems

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The global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) market was valued at $XX million in 2019, and Research analysts predict the global market size will reach $XX million by the end of 2029, growing at a CAGR of XX% between 2019 and 2029.

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 210 countries and territories around the world and 2 international conveyances. The global impacts of COVID-19 are already starting to be felt, and will significantly affect this industry in 2020.

This report analyses the impact of COVID-19 on this industry. COVID-19 can affect the global market in 3 ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on enterprises and financial markets.

This report provides detailed historical analysis of global market for Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) from 2014-2019, and provides extensive market forecasts from 2020-2029 by region/country and subsectors. It covers the sales volume, price, revenue, gross margin, historical growth and future perspectives in the Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) market.

Segmentation by Product:

CellSearch Others

Segmentation by Application:

Breast Cancer Diagnosis and Treatment Prostate Cancer Diagnosis and Treatment Colorectal Cancer Diagnosis and Treatment Lung Cancer Diagnosis and Treatment Other Cancers Diagnosis and Treatment

Competitive Analysis:

Global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Scope of the Report: The all-encompassing research weighs up on various aspects including but not limited to important industry definition, product applications, and product types. The pro-active approach towards analysis of investment feasibility, significant return on investment, supply chain management, import and export status, consumption volume and end-use offers more value to the overall statistics on the Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market. All factors that help business owners identify the next leg for growth are presented through self-explanatory resources such as charts, tables, and graphic images.

The report offers in-depth assessment of the growth and other aspects of the Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) market in important countries (regions), including:

North America(United States, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia)

South America (Brazil, Argentina, Colombia)

Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Our industry professionals are working reluctantly to understand, assemble and timely deliver assessment on impact of COVID-19 disaster on many corporations and their clients to help them in taking excellent business decisions. We acknowledge everyone who is doing their part in this financial and healthcare crisis.

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Table of Contents

Report Overview:It includes major players of the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market covered in the research study, research scope, and Market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends:This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market are discussed.

Market Share by Manufacturers:Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type:This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application:Besides an overview of the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market by application, it gives a study on the consumption in the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market by application.

Production by Region:Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region:This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles:Almost all leading players of the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market are profiled in this section. The analysts have provided information about their recent developments in the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market, products, revenue, production, business, and company.

Market Forecast by Production:The production and production value forecasts included in this section are for the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market as well as for key regional markets.

Market Forecast by Consumption:The consumption and consumption value forecasts included in this section are for the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market as well as for key regional markets.

Value Chain and Sales Analysis:It deeply analyzes customers, distributors, sales channels, and value chain of the global Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market.

Key Findings: This section gives a quick look at important findings of the research study.

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Latest News On the Covid-19 impact on Circulating Tumor Cells (CTCs) and Cancer Stem Cells (CSCs) Market Trade Overview, Industry Demand and...

The global cell expansion market size is estimated to be USD 14.9 billion in 2020 and projected to reach USD 30.1 billion by 2025, at a CAGR of 15.1%…

By Adult Stem Cells

Increasing incidence of chronic diseases, and government investments for cell-based research are set to drive the cell expansion market.

NEW YORK, July 22, 2020 /PRNewswire/ --

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The global cell expansion market size is estimated to be USD 14.9 billion in 2020 and projected to reach USD 30.1 billion by 2025, at a CAGR of 15.1%. Growth in this market is largely driven by the increasing incidence of chronic diseases, government investments for cell-based research, growing focus on personalized medicine, increasing focus on R&D for cell-based therapies, and increasing GMP certifications for cell therapy production facilities. On the other hand, ethical concerns regarding research in cell biology are expected to limit market growth to a certain extent in the coming years.

By instruments type, the cell expansion supporting equipment accounted for the fasted growing product segment of the cell expansion market The instruments segment includes cell expansion supporting equipment, bioreactors, and automated cell expansion systems.The cell expansion supporting equipment market includes flow cytometers, cell counters and hemocytometers, centrifuges, and other supporting equipment.

They are used in cell culture processes for isolating, culturing, scaling-up, and extracting biological products. These instruments are essential in laboratories and institutes for conducting research and analyzing the cell structure and function for cell therapy research. By cell type, the human cells segment accounted for the largest share of the cell expansion market

Based on cell type, the cell expansion market is segmented into human cells and animal cells.The human cells segment includes stem cells and differentiated cells.

The stem cells segment is further classified into adult stem cells, ESCs, and iPSCs. The human cells segment accounted for the larger share of the cell expansion market majorly due to the increasing investments by public and private organizations for research on human cells, growing application areas of human stem cells, and the growing incidence of diseases such as cancer.

Asia Pacific: The fastest-growing region in the cell expansion market. The Asia Pacific market is projected to grow at the highest CAGR during the forecast period, mainly due to the increasing focus of players on emerging Asian markets, increasing incidence of chronic and infectious diseases, rising geriatric population, and government initiatives for infrastructural improvements of healthcare facilities are driving the growth of the cell expansion market in this region.

North America: the largest share of the cell expansion market North America accounted for the largest share of the cell expansion market. The large share of this segment can primarily be attributed to the rising incidence of cancer, increasing government funding, rising research activates on stem cell therapies, growing awareness regarding advanced treatment methods, growing geriatric population, and the strong presence of industry players in the region.

Breakdown of primaries The study contains insights from various industry experts, ranging from component suppliers to Tier 1 companies and OEMs. The break-up of the primaries is as follows: By Company Type Tier 1- 70%, Tier 2- 20% and Tier 3 - 10% By Designation C level Executives- 30%, Directors- 20%, Others - 50% By Region North America - 35%, Europe - 24%, APAC 25%, RoW- 16%

The cell expansion market is dominated by a few globally established players such as Thermo Fisher Scientific, Inc. (US), Danaher (US), Becton, Dickinson and Company (US), Lonza (Switzerland), Corning, Inc. (US), Merck KGaA (Germany), Sartorius Stedim Biotech (France), Getinge AB (Sweden) Terumo Corporation (Japan), Miltenyi Biotec (Germany), PromoCell GmbH (Germany), Takara Bio Inc. (Japan), Solida Biotech GmBH (Germany), HiMedia Laboratories (India), Getinge AB, REPROCELL Inc. (Japan), Kohjin-Bio (Japan), Pierre Gurin (France), Cellexus Ltd.(UK), Eppendorf AG (Germany), CellGenix GmbH (Germany), iXCells Biotechnologies (US), Neuromics (US), Celltainer Biotech B.V. (Netherlands), and G&G Technologies (US).

Research Coverage: The report segments the cell expansion market based on region (Asia Pacific, Europe, North America, and RoW), product (consumables and instruments), cell type (human cells and animal cells), application (regenerative medicine and stem cell research, cancer and cell-based research and other applications), and end user (research institutes, biotechnology and biopharmaceutical companies, cell banks, and other end users). The report also provides a comprehensive review of market drivers, restraints, and opportunities in the cell expansion market.

Key Benefits of Buying the Report: The report will help the leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall market and the sub-segments.This report will help stakeholders understand the competitive landscape and gain more insights to better position their businesses and plan suitable go-to-market strategies.

The report also helps stakeholders understand the pulse of the cell expansion market and provides them information on key market drivers, restraints, challenges, and opportunities.

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The global cell expansion market size is estimated to be USD 14.9 billion in 2020 and projected to reach USD 30.1 billion by 2025, at a CAGR of 15.1%...

Global Induced Pluripotent Stem Cells (iPSCs) Market Evenly Poised To Reach A Market Value of USD 2610.10 million By Share, Size and Leading Players…

By Induced Pluripotent Stem Cells

Few of the major competitors currently working in global induced pluripotent stem cells market areFUJIFILM Holdings Corporation, Astellas Pharma Inc, Fate Therapeutics, Bristol-Myers Squibb Company, ViaCyte, Inc., CELGENE CORPORATION, Vericel Corporation, KCI Licensing, Inc, STEMCELL Technologies Inc., Japan Tissue Engineering Co., Ltd., Organogenesis Holdings Inc, Lonza, Takara Bio Inc., Horizon Discovery Group plc, Thermo Fisher Scientific.

How does this market Insights help?

Key Developments in the Market:

In March 2018, Kaneka Corporation announced that they have acquired a patent in the Japan for the creation of the method to mass-culture pluripotent stem cells including iPS cells and ES cells. This will help the company to use the technology to produce high quality pluripotent stem cells which can be used in the drug and cell therapy.

In March 2015, Fujifilm announced that they have acquired Cellular Dynamics International. The main aim of the acquisition is to expand their business in the iPS cell-based drug discovery support service with the use of CDS technology. It will help them to product high- quality automatic human cells with the help of the induced pluripotent stem cells. This will help the company to be more competitive in the drug discovery and regenerative medicine.

Key questions answered in the Global Induced Pluripotent Stem Cells (iPSCs) Market report include:

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Breakdown Of Global Induced Pluripotent Stem Cells (iPSCs) Market

By Cell Type

Hepatocytes

Fibroblasts

Keratinocytes

Amniotic Cells

Neurons

Others

By Application

Drug Development

Regenerative Medicine

Toxicity Testing

Academic Research

By End-User

Academic and Research Institutes

Biotechnology Companies

Others

By Geography

North America

South America

Europe

Asia-Pacific

Middle East & Africa

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Global Induced Pluripotent Stem Cells (iPSCs) Market Evenly Poised To Reach A Market Value of USD 2610.10 million By Share, Size and Leading Players...

Global Induced Pluripotent Stem Cells Market 2020 Segmentation Trend, CAGR Status, Growth, Analysis and Forecast to 2026 – Cole of Duty

By Induced Pluripotent Stem Cells

Induced Pluripotent Stem Cells Market Production by Regions:

The analyzed data on the Induced Pluripotent Stem Cells market help you put up a brand within the industry while competing with the giants. This report provides insights into a dynamic competitive environment. It also offers a progressive viewpoint on different factors driving or restricting market growth.

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In this study, the years considered to estimate the market size of Induced Pluripotent Stem Cells Market:

Questions Answered in the Induced Pluripotent Stem Cells Market Report:

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Detailed TOC of Global Induced Pluripotent Stem Cells Market Trends, Status and Forecast 2020-2026

1 Induced Pluripotent Stem Cells Market Overview

1.1 Product Overview and Scope of Induced Pluripotent Stem Cells

1.2 Covid-19 Impact on Induced Pluripotent Stem Cells Market Production Growth Rate Segment by Type

1.3 Covid-19 Impact on Induced Pluripotent Stem Cells Segment by Application

1.4 Covid-19 Impact on Global Induced Pluripotent Stem Cells Market Size Estimates and Forecast by Region

1.5 Covid-19 Impact on Global Induced Pluripotent Stem Cells Market Growth Prospects

1.5.1 Global Induced Pluripotent Stem Cells Revenue Estimates and Forecasts (2015-2026)

1.5.2 Global Induced Pluripotent Stem Cells Production Capacity Estimates and Forecasts (2015-2026)

1.5.3 Global Induced Pluripotent Stem Cells Production Estimates and Forecasts (2015-2026)

1.6 Coronavirus Disease 2019 (Covid-19) Impact Will Have a Severe Impact on Global Growth

1.6.1 Covid-19 Impact: Global GDP Growth, 2019, 2020 and 2021 Projections

1.6.2 Covid-19 Impact: Commodity Prices Indices

1.6.3 Covid-19 Impact: Global Major Government Policy

1.7 The Covid-19 Impact on Induced Pluripotent Stem Cells Industry

1.8 COVID-19 Impact: Induced Pluripotent Stem Cells Market Trends

2 Covid-19 Impact on Market Competition by Manufacturers

2.1 Global Induced Pluripotent Stem Cells Market Share by Manufacturers (2015-2020)

2.2 Global Induced Pluripotent Stem Cells Revenue Share by Manufacturers (2015-2020)

2.3 Market Share by Company Type (Tier 1, Tier 2 and Tier 3)

2.4 Global Induced Pluripotent Stem Cells Average Price by Manufacturers (2015-2020)

2.5 Manufacturers Induced Pluripotent Stem Cells Production Sites, Area Served, Product Types

2.6 Induced Pluripotent Stem Cells Market Competitive Situation and Trends

2.6.1 Induced Pluripotent Stem Cells Market Concentration Rate

2.6.2 Global Top 3 and Top 5 Players Market Share by Revenue

2.6.3 Mergers & Acquisitions, Expansion

3 Covid-19 Impact on Production and Capacity by Region

3.1 Global Induced Pluripotent Stem Cells Market Share by Regions (2015-2020)

3.2 Global Induced Pluripotent Stem Cells Revenue Market Share by Regions (2015-2020)

3.3 Global Induced Pluripotent Stem Cells Production Capacity, Revenue, Price and Gross Margin (2015-2020)

3.4 North America Induced Pluripotent Stem Cells Production

3.4.1 North America Induced Pluripotent Stem Cells Production Growth Rate (2015-2020)

3.4.2 North America Induced Pluripotent Stem Cells Production Capacity, Revenue, Price and Gross Margin (2015-2020)

3.5 Europe Induced Pluripotent Stem Cells Production

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Global Induced Pluripotent Stem Cells Market 2020 Segmentation Trend, CAGR Status, Growth, Analysis and Forecast to 2026 - Cole of Duty

Fate Therapeutics Receives FDA Clearance of IND for FT819 in B-Cell Malignancies – OncLive

By Induced Pluripotent Stem Cells

The FDA has cleared an investigational new drug application (IND) for the first-of-its-kind, off-the-shelf CAR T-cell product FT819, which targets CD19-positive malignancies, according to an announcement from Fate Therapeutics, the drugs co-developer.1

The biopharmaceutical company plans to evaluate the product as a treatment for patients with relapsed/refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), and non-Hodgkin lymphoma (NHL).

"The clearance of our IND application for FT819 is a ground-breaking milestone in the field of cell-based cancer immunotherapy. Our unique ability to produce CAR T cells from a clonal master engineered iPSC line creates a pathway for more patients to gain timely access to therapies with curative potential, Scott Wolchko, president and chief executive officer of Fate Therapeutics, stated in a recent press release.

As the first CAR-T cell therapy created from cell clonal master-induced pluripotent stem cell (iPSC) line, FT819 can be mass-produced and delivered off the shelf to offer broader access to the treatment. This CAR T-cell product was also developed to improve the safety and efficacy of this modality, and address limitations linked with the patient- and donor-derived products that are currently available, according to Fate Therapeutics.

The treatment is the result of a collaborative effort between a group of investigators led by Michael Sadelain, MD, PhD, the director of the Center for Cell Engineering and head of Gene Expression and Gene Transfer Laboratory at from Memorial Sloan Kettering Cancer Center and Fate Therapeutics.

Four years ago, we first set out under our partnership with Memorial Sloan Kettering led by Dr. Michel Sadelain to improve on the revolutionary success of patient-derived CAR T-cell therapy and bring an off-the-shelf paradigm to patients, and we are very excited to advance FT819 into clinical development, Wolchko added.

In the development of the product, investigators incorporated 1XX CAR signaling domain in an effort to extend T-cell effector function without inducing exhaustion. Additionally, CAR transgene was inserted directly into the T-cell receptor alpha constant (TRAC) locus, which is believed to encourage uniform CAR expression and amplify T-cell potency. Notably, the therapy was also designed to result in the complete bi-allelic disruption of T-cell receptor expression to prevent graft-versus-host disease (GVHD), a notable complication that is known to occur with allogeneic T-cell therapy.

Preclinical data presented during the 2020 AACR Virtual Meeting II showed that FT819 possessed a uniform product profile of 95% CAR+, TCR-, CD45+, CD7+, and CD3+ with most of the CD8 T cells expressing CD8.2 The global gene expression profile of the product showcased high similarity to primary CD19-targeted CAR T cells, thus solidifying its identity as a T lymphocyte, according to the study authors.

Functional assessment revealed strong antigen-specific cytolytic activity against leukemia and lymphoma cell lines (P = .0004) with the product. On-target, off-tumor cytolysis of CD19-positive B cells were confirmed in mixed lymphocyte reaction assay. Moreover, FT819 proved to be unable to produce a GVH response in a co-culture assay with anti-TCR crosslinking antibodies. Furthermore, FT819 was shown to control tumor growth (P = .0003 at day 21) in disseminated leukemia xenograft mouse studies. The product also showed sustained bone marrow localization for 45 days following treatment in a systemic administered leukemia model.

Collectively, these studies demonstrate that FT819 is a potent, homogenous CAR19 T-cell product candidate and can be potentially effectively used off-the-shelf in the treatment of B-cell malignancies, the investigators concluded.

In a planned multicenter phase 1 trial, investigators will identify the maximum-tolerated dose of FT819, as well as the clinical activity and safety of the product in 297 patients with B-cell malignancies, including CLL, ALL, and NHL. Notably, each indication will enroll independently and 3 doses of FT819 will be examined: a single dose of the product (regimen A), a single dose of FT819 in combination with IL-2 cytokine support (regimen 2), and 3 fractionated doses of FT819 (regimen C). Dose-expansion cohorts comprised of up to 15 patients for each indication and regimen can be used to further examine the clinical activity of the CAR T-cell product.

Originally posted here:
Fate Therapeutics Receives FDA Clearance of IND for FT819 in B-Cell Malignancies - OncLive

‘Missing link’: Bayer, Morningside help catapult a new kind of delivery tech to cell and gene therapy – Endpoints News

By Stem Cell Clinic

Robert Millman co-founded and led Semma Therapeutics as CEO while also a managing director of MPM Capital. By the time he left the stem cell therapy pioneer two years before it would be sold to Vertex he had left VC life behind.

Instead, he went around scouting new technologies, visiting with tech transfer offices and academics in the Boston/Cambridge area to find worthy ideas that could benefit from his IP expertise.

And he found quite a few.

One of them is Vesigen Therapeutics, which is launching with $28.5 million to turn a new class of extracellular vesicles into packaging and delivery tools for a variety of cargos mRNA, Cas9, base editors, PROTACs, you name it.

The barrier to being a drug company right now is not technology or targets, he told Endpoints News. Theres plenty of targets, theres plenty of technology, but theres no way of getting the two of those into a patient.

Vesigens platform stems from scientific co-founder and Harvard professor Quan Lus work on ARMMs, or arrestin domain-containing protein 1 [ARRDC1]-mediated microvesicles. As he wrote in Nature Communications in March 2018, ARMMs are distinct from exosomes, in that they lend themselves to more controlled production and cargos that can be recruited into the vesicle during the process of manufacturing rather than put together after the fact.

I dont understand really why a whole lot of venture firms didnt jump on it at the time, Millman said. I think its because most were focused on exosomes and just thought that this was another exosome company, and there was already Codiak and Evox.

But Lu showed in his paper delivery of function p53 protein to an p53 deficient animal and restoring p53 activity: To me it was revolutionary.

And compared to the current workhorses of genetic medicines such as viral vectors and lipid nanoparticles, ARMMs promise to package bigger and more varied payloads, get into more organs, and stay in circulation longer without triggering toxicity.

Faced with the Willy Wonka-like range of possibilities, Millman said the top order right now for his team of seven is to figure out a manufacturing setup that would load the cargos efficiently and be cleared by regulators.

In the three years that it will likely take to get to the cusp of the clinic, Vesigen is also collaborating with researchers to show how ARMMs can get into tissues that no one can go to with implications in ocular and neurological diseases as well as cancer.

The Series A, co-led by Leaps by Bayer and Morningside Ventures and joined by Linden Lake Ventures and Alexandria Venture Investments, should fund the company until 2025, when Millman expects to have built out the team to 30.

Its exactly the kind of projects that his group likes to invest in early, Leaps by Bayer head Jrgen Eckhardt said, especially as big believers in the cell and gene therapy space who see delivery as the missing link. For Vesigen, it also opens up opportunities to find partners within the pharma giants network down the road.

While Millman is keen not to lose focus, he also isnt hiding ambitions to make this the next big one.

I saw all of the problems Alnylam I was there for three years, we couldnt get delivery. I worked very early at Celera and established collaborations with Ionis and again delivery was limited. I was helping set up Verve Therapeutics and again delivery of Cas9 was a problem, he said. And here was an eloquent solution. I was just pleased to be at the right place at the right time.

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'Missing link': Bayer, Morningside help catapult a new kind of delivery tech to cell and gene therapy - Endpoints News

Two Cases Of West Nile Virus Confirmed In Greece Greek City Times – GreekCityTimes.com

By Stem Cell Doctors

Greeces National Organisation of Public Health (EODY) has announced the first two laboratory confirmed cases of the West Nile virus infection for the 2020 transmission period, one in the Peripheral Unit of Xanthi (Municipality of Topeiros) and the other in the western Thessaly (Municipality of Karditsa).

As mentioned in an announcement from the EODY:

Cases of the West Nile virus infection occur in many countries worldwide, as well as in many European countries, on an annual basis. From 2010 onwards, cases occur almost every year (and) in our country, in various areas, during the summer and autumn months. Therefore, the recurrence of incidents during the current broadcast period was considered possible and expected. In May 2020, EODY informed health professionals nationwide about the need to be vigilant about the early diagnosis of cases.

As the epidemiology of the virus is determined by many factors, the areas where the virus will circulate cannot be safely predicted. Therefore, EODY recommends that you observe the individual protection measures against mosquitoes throughout Greece.

Recall that the West Nile virus is transmitted mainly by the bite of infected common mosquitoes, which are infected by infected birds (some species mainly wild birds). Infected people are not considered to transmit the virus to other mosquitoes.

The majority of people infected with the virus do not get sick at all or have only a mild illness, while very few people (<1% of those infected) develop a serious disease that affects the nervous system (mainly encephalitis or meningitis). Older people (over 50) are at greater risk of becoming seriously ill, as well as people with immunosuppression and chronic underlying diseases.

In order to timely implement targeted response and prevention measures, EODY -in each transmission period- conducts enhanced epidemiological surveillance of the disease, investigates cases immediately and is in constant communication and cooperation with the competent national, regional and local authorities.

More information about the West Nile virus and mosquito protection measures can be found on the EODY website, while also every Thursday a report with the current epidemiological data will be posted on the EODY website.

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Two Cases Of West Nile Virus Confirmed In Greece Greek City Times - GreekCityTimes.com

Citius Pharmaceuticals Forms Scientific Advisory Board for the Planned Development of its Proprietary Treatment for Acute Respiratory Disease…

By Stem Cell Medicine

CRANFORD, N.J., July 22, 2020 /PRNewswire/ --Citius Pharmaceuticals, Inc. ("CITIUS") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical companyfocused on developing and commercializing critical care drug products, announced today the formation of the Citius ARDS (Acute Respiratory Distress Syndrome) Scientific Advisory Board to provide the company expert guidance on its planned development of induced mesenchymal stem cells (iMSCs) under option from Novellus, Inc. to treat and reduce the severity of acute respiratory distress syndrome (ARDS) associated with COVID -19.

The ARDS Advisory Board consultants are: Michael A. Matthay, MD, Professor of Medicine and Anesthesia at the University of California at San Francisco (UCSF), a Senior Associate at the Cardiovascular Research Institute, and Associate Director of the Critical Care Medicine at UCSF. Dr. Matthay's basic research has focused on the pathogenesis and resolution of the acute respiratory distress syndrome (ARDS), with an emphasis on translational work and patient-based research, including clinical trials. Dr. Matthay's recent research has focused on the biology and potential clinical use of allogeneic bone marrow derived mesenchymal stromal cells (MSCs) for ARDS. He is currently leading the "Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT)," a United States Department of Defense supported study of MSCs for ARDS.

Mitchell M. Levy, MD, Chief, Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, The Warren Alpert Medical School of Brown University, where he is Professor of Medicine. Dr. Levy also serves as Medical Director of the Medical ICU at Rhode Island Hospital. He has been an investigator on numerous pharmacologic and biologic trials intended to treat sepsis, cardiovascular and pulmonary pathology. He has expertise in trial design, clinical trial execution and trial management and is one of the three founding members of the Surviving Sepsis Campaign (SSC). Dr. Levy is Past-President of the Society of Critical Care Medicine (2009).

Lorraine B. Ware, MD, Professor of Medicine and Ralph and Lulu Owen Endowed Chair,Professor of Pathology, Microbiology and Immunology, Vanderbilt University;Director, Vanderbilt Medical Scholars Program. Dr. Lorraine Ware's comprehensive bench-to-bedside research program centers on the pathogenesis and treatment of sepsis and acute lung injury with a current focus on mechanisms of lung epithelial and endothelial oxidative injury by cell-free hemoglobin. Dr. Ware is also a lead investigator for the "Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT)" study.

"We are extremely pleased to have been able to attract such a prestigious group of experts to advise and guide us in the Company's planned development of iMSC's for the treatment of ARDS" said Mr. Myron Holubiak, CEO of Citius. "These individuals are recognized opinion leaders and expert in the planning and execution of clinical trials in this therapeutic area. We will be seeking their advice in all phases of our clinical trial design."

About Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

About Citius iMSCCitius's planned induced mesenchymal stem cell (iMSC) product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary non-immunogenic and non-viral mRNA-based (non-viral) reprogramming process. Unlike the MSCs derived from bone marrow, placenta, umbilical cord, or adipose tissue these proprietary iMSCs are based on a clonal process and therefore are genetically homogeneous and exhibit superior potency and higher cell viability. The Citius iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from an iMSC master cell bank. The master cell bank produces "off-the-shelf" iMSCs that are uniform as compared to MSCs using donor-sourced cells, which is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. In vitro studies demonstrate that iMSCs are shown to secrete higher levels of immunomodulatory proteins than donor-derived cells, and may reduce or prevent pulmonary injury associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19.

About Acute Respiratory Distress Syndrome (ARDS)ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

Safe HarborThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.

Factors that could cause actual results to differ materially from those currently anticipated are: the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned iMSCs therapy for ARDS; our need for substantial additional funds; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:Andrew Scott Vice President, Corporate Development (O) 908-967-6677 x105 [emailprotected]

SOURCE Citius Pharmaceuticals, Inc.

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