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Vor Biopharma and MaxCyte Announce Clinical and Commercial License Agreement for Engineered Hematopoietic Stem Cells (eHSCs) to Treat Cancer -…

By Stem Cell Treatment

CAMBRIDGE, Mass. & GAITHERSBURG, Md.--(BUSINESS WIRE)--Vor Biopharma, an oncology company pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, and MaxCyte, Inc., a global cell-based therapies and life sciences company, today announced a clinical and commercial license agreement under which Vor will use MaxCytes Flow Electroporation technology to produce eHSCs and initiate Investigational New Drug (IND)-enabling studies to accelerate its progress towards the clinic.

Under the terms of the agreement, Vor obtains non-exclusive clinical and commercial use rights to MaxCytes Flow Electroporation technology and ExPERT platform to develop up to five engineered cell therapies, including VOR33, Vors lead eHSC candidate, which is in development for acute myeloid leukemia (AML). In return, MaxCyte will receive undisclosed development and approval milestones and sales-based payments in addition to other licensing fees.

Vor will use MaxCytes cell engineering platform to deliver its gene editing machinery into hematopoietic stem cells to remove biologically redundant cell surface proteins that are also expressed on blood cancer cells. Once the eHSCs are transplanted into a cancer patient, these cells are effectively hidden from complementary targeted therapies that target the relevant protein, while diseased cells are left vulnerable to attack. Vors approach thereby could unleash the potential of targeted therapies by broadening the therapeutic window and improving the utility of complementary targeted therapies.

MaxCyte is a leader in GMP electroporation technology, and we are thrilled that this agreement provides us with long-term access to a platform technology applicable to a pipeline of eHSC programs used to treat AML and other blood cancers, said Sadik Kassim, Ph.D., Chief Technology Officer of Vor. As we build on promising in vivo data from our lead candidate VOR33, we can now expand our manufacturing capabilities to support later-stage studies, regulatory filings and commercialization of VOR33.

MaxCytes ExPERT instrument family represents the next generation of leading, clinically validated, electroporation technology for complex and scalable cellular engineering. By delivering high transfection efficiency with enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics.

We look forward to expanding our relationship with Vor Biopharma as the company pioneers a potential future standard of care in hematopoietic stem cell transplants for cancer patients in need, said Doug Doerfler, President & CEO of MaxCyte. This agreement represents another key business milestone for MaxCyte, emphasizing the value of our technology platform applied to next-generation engineered cell therapies that may make a true difference in patient outcomes.

About VOR33Vors lead product candidate, VOR33, consists of engineered hematopoietic stem cells (eHSCs) that lack the protein CD33. Once these cells are transplanted into a cancer patient, CD33 becomes a far more cancer-specific target, potentially avoiding toxicity to the normal blood and bone marrow associated with CD33-targeted therapies. In so doing, Vor aims to improve the therapeutic window and effectiveness of CD33-targeted therapies, thereby potentially broadening the clinical benefit to patients suffering from AML.

About Vor BiopharmaVor Biopharma aims to transform the lives of cancer patients by pioneering engineered hematopoietic stem cell (eHSC) therapies. By removing biologically redundant proteins from eHSCs, these cells become inherently invulnerable to complementary targeted therapies while tumor cells are left susceptible, thereby unleashing the potential of targeted therapies to benefit cancer patients in need.

Vors platform could be used to potentially change the treatment paradigm of both hematopoietic stem cell transplants and targeted therapies, such as antibody drug conjugates, bispecific antibodies and CAR-T cell treatments. A proof-of-concept study for Vors lead program has been published in Proceedings of the National Academy of Sciences.

Vor is based in Cambridge, Mass. and has a broad intellectual property base, including in-licenses from Columbia University, where foundational work was conducted by inventor and Vor Scientific Board Chair Siddhartha Mukherjee, MD, DPhil. Vor was founded by Dr. Mukherjee and PureTech Health and is supported by leading investors including 5AM Ventures and RA Capital Management, Johnson & Johnson Innovation JJDC, Inc. (JJDC), Novartis Institutes for BioMedical Research and Osage University Partners.

About MaxCyteMaxCyte is a clinical-stage global cell-based therapies and life sciences company applying its proprietary cell engineering platform to deliver the advances of cell-based medicine to patients with high unmet medical needs. MaxCyte is developing novel CARMA therapies for its own pipeline, with its first drug candidate in a Phase I clinical trial. CARMA is MaxCytes mRNA-based proprietary therapeutic platform for autologous cell therapy for the treatment of solid cancers. In addition, through its life sciences business, MaxCyte leverages its Flow Electroporation Technology to enable its biopharmaceutical partners to advance the development of innovative medicines, particularly in cell therapy. MaxCyte has placed its flow electroporation instruments worldwide, including with all of the top ten global biopharmaceutical companies. The Company now has more than 80 partnered programme licenses in cell therapy with more than 45 licensed for clinical use. With its robust delivery technology platform, MaxCyte helps its partners to unlock the full potential of their products. For more information, visit http://www.maxcyte.com.

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Vor Biopharma and MaxCyte Announce Clinical and Commercial License Agreement for Engineered Hematopoietic Stem Cells (eHSCs) to Treat Cancer -...

CALQUENCE Approved in the US for Adult Patients With Chronic Lymphocytic Leukemia – Business Wire

By Stem Cell Treatment

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved CALQUENCE (acalabrutinib) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The US approval was granted under the FDAs Real-Time Oncology Review and newly established Project Orbis programs.

The approval is based on positive results from the interim analyses of two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL. Together, the trials showed that CALQUENCE in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death versus the comparator arms in both 1st-line and relapsed or refractory CLL. Across both trials, the safety and tolerability of CALQUENCE were consistent with its established profile.

Dave Fredrickson, Executive Vice President, Oncology Business Unit said: With over 20,000 new cases anticipated this year in the US alone, todays approval of CALQUENCE provides new hope for patients with one of the most common types of adult leukemia, offering outstanding efficacy and a favorable tolerability profile. The chronic lymphocytic leukemia patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment.

Dr. Jeff Sharman, Director of Research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for The US Oncology Network, and a lead author of the ELEVATE-TN trial, said: Tolerability remains an issue in the current treatment landscape of chronic lymphocytic leukemia, which may require ongoing therapy for many years. In the ELEVATE-TN and ASCEND trials comparing CALQUENCE to commonly used treatment regimens, CALQUENCE demonstrated a clinically meaningful improvement in progression-free survival in patients across multiple settings, while maintaining its favorable tolerability and safety profile.

The results of the interim analysis of the ELEVATE-TN trial will be presented at the upcoming American Society of Hematology congress.

The trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with either CALQUENCE in combination with obinutuzumab or CALQUENCE monotherapy versus chlorambucil chemotherapy plus obinutuzumab, a current standard-of-care combination used in the control arm.

In the CALQUENCE combination arm, risk of disease progression or death was reduced by 90% (HR 0.10; 95% CI, 0.06-0.17, p<0.0001) and in the monotherapy arm it was reduced by 80% (HR 0.20; 95% CI, 0.13-0.30, p<0.0001).

The median time to disease progression for patients treated with CALQUENCE in combination with obinutuzumab or as a monotherapy has not yet been reached vs. 22.6 months (95% CI, 20-28) for chlorambucil plus obinutuzumab.

ELEVATE-TN safety overview (most common ARs*, 15%):

Adverse reaction

CALQUENCE plus obinutuzumab(n=178)

CALQUENCE monotherapy(n=179)

Chlorambucil plus obinutuzumab(n=169)

Any

Grade 3

Any

Grade 3

Any

Grade 3

Infection

69%

22%

65%

14%

46%

13%

Neutropenia

53%

37%

23%

13%

78%

50%

Anemia

52%

12%

53%

10%

54%

14%

Thrombocytopenia

51%

12%

32%

3.4%

61%

16%

Headache

40%

1.1%

39%

1.1%

12%

0

Diarrhea

39%

4.5%

35%

0.6%

21%

1.8%

Musculoskeletal pain

37%

2.2%

32%

1.1%

16%

2.4%

Fatigue

34%

2.2%

23%

1.1%

24%

1.2%

Bruising

31%

0

21%

0

5%

0

Rash

26%

2.2%

25%

0.6%

9%

0.6%

Arthralgia

22%

1.1%

16%

0.6%

4.7%

1.2%

Dizziness

20%

0

12%

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CALQUENCE Approved in the US for Adult Patients With Chronic Lymphocytic Leukemia - Business Wire

Full Alliance Group Announces New EBO2 Sites in Florida and the Caribbean – P&T Community

By Stem Cell Medicine

BEVERLY HILLS, California, Nov. 21, 2019 /PRNewswire/ -- Full Alliance Group, Inc. (OTCPK: FAGI) is pleased to announce the opening of two new EBO2 treatment offices.

Dr. Yu and his staff arrived in Boca Raton, Florida, and then the Cayman Islands earlier this week with two brand-new portable EBO2 units and are currently training Dr. Joseph Purita and his staff. Dr. Purita is well-known in the stem cell and regenerative medicine sector and is eager to implement our ozone technology within his thriving practice.He has offices in Boca Raton as well as in the Cayman Islands.

Dr. Purita's Pensum Regenerative Clinic in Grand Cayman already specializes in stem cell treatment and anti-aging.The addition of EBO2 technology is expected to work synergistically with the well-established stem cell protocols already in place at the clinic.

"Expanding our footprint to the East and South, as well as the Caribbean, has been a critical part of our strategic plan," said Dr. Brian Volpp, MD, CEO and President of Full Alliance Group, Inc. "We are grateful that Dr. Purita has committed to the Yu Method and that he has made the financial commitment for two of our new units.His reputation within the stem cell community should allow ozone therapy to become more mainstream as he gains more experience with integrating EBO2 into his existing protocols."

Also, we have been advised by our legal team that the third quarter financial filing must be made publicly available to all shareholders. Consequently, the filing has been posted on our website:https://FullAlliance.com

About Full Alliance Group Inc.

Full Alliance Group Inc. (OTCPK: FAGI) is a multi-faceted holding company with various interests in technology, healthcare, and nutraceuticals. Nutra Yu, Inc., a wholly owned subsidiary of Full Alliance Group, develops, markets, and distributes a proprietary line of nutraceutical products. EBO2, Inc., a wholly owned subsidiary of Full Alliance Group, is the provider of ''EBO2'', a modern high volume blood gas exchange unit for the treatment of 5-7 liters of blood with medical ozone. The unit allows extracorporeal blood and oxygenation, ozone exposure and blood filtration.The process filters blood in a unique way by using the integrated diffusing membranes within the filter fibers to trap lipids and proteins which are in excess in the venous blood supply. The EBO2 unit is considered the world's most advanced medical ozone therapy.

For additional information regarding Full Alliance Group, visit, http://www.fullalliance.com.

Paul Brian Volpp, MD, MPH, President / CEO The Full Alliance Group

Forward-Looking StatementsThis shareholder update may contain a number of forward-looking statements. Words and variations of words such as: "expect", "goals", "could", "plans", "believe", "continue", "may", "will", and similar expressions are intended to identify our forward-looking statements, including but not limited to: our expectation for growth, benefits from brand-building, cost savings and margins. These forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond our control, which could cause our actual results to differ materially from those indicated in our forward-looking statements. Such factors include, but are not limited to: continued volatility of, and sharp increase in: costs/pricing actions, increased competition, ability to raise sufficient operating capital, risks from operating internationally, consumer weakness, weakness in economic conditions and tax law changes.

Full Alliance Group Inc. Investor RelationsDave DonlinEmail: Info@TheCervelleGroup.comPhone: (407) 490-6635Web: http://www.StockInvestorDaily.comVisit: http://www.fullalliance.comContact: ir@fullalliance.com

View original content:http://www.prnewswire.com/news-releases/full-alliance-group-announces-new-ebo2-sites-in-florida-and-the-caribbean-300963216.html

SOURCE Full Alliance Group, Inc.

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Full Alliance Group Announces New EBO2 Sites in Florida and the Caribbean - P&T Community

Multiple Doses of Stem Cells Show Potential in Treating Severe Asthma – PR Web

By Stem Cell Medicine

Inflammatory and remodeling processes and immunosuppressive effects in house dust mite (HDM)-induced allergic asthma.

DURHAM, N.C. (PRWEB) November 20, 2019

A study released today in STEM CELLS Translational Medicine (SCTM) describes how multiple doses of a type of stem cell called mesenchymal stromal cells (MSCs) might offer a new way to treat people suffering from severe asthma.

An asthma attack is triggered by allergens entering the lungs and causing swelling of the airways. This sets off a domino effect that results in narrowing of the airways from the nose and mouth to the lungs. The most severe cases can lead to death. According to the Centers for Disease Control and Prevention, one in 13 people have asthma. There is no cure, but it can be managed in most cases with proper prevention and treatment.

The study in SCTM, conducted by researchers at the Federal University of Rio de Janeiro and the National Institute of Science and Technology for Regenerative Medicine, focused on a new treatment for asthma brought on by house dust mites (HDMs). Some estimate that these common microscopic creatures are the culprit behind nearly 85 percent of all asthma attacks.

Patricia Rieken Macedo Rocco, M.D., Ph.D., was lead investigator on the study. Previous experiments tell us that a single dose of adipose tissue-derived MSCs reduced lung inflammation in asthma brought on by HDMs, but it was unable to reverse lung remodeling, she said. We wanted to see how multiple doses of MSCs might perform.

Earlier studies using bone marrow-derived MSCs also demonstrated therapeutic effects in HDM-induced allergic asthma, but the availability of these cells is limited due to the invasive procedure needed to harvest the cells. We opted for MSCs collected from human adipose tissue instead, as they can be easily obtained by liposuction, Dr. Rocco explained. Furthermore, adipose tissue is estimated to contain a greater number of MSCs compared to bone marrow, and these cells appear to be expandable to a higher number of passages, thus providing attractive advantages for use in a multiple-dose regimen.

For their study, the team used a mouse model that had been developed to be sensitive to HDMs. One group of animals received two intravenous doses of MSCs (105 cells/day) beginning 24 hours after being exposed to the mites; a second group received three doses; and a third group was administered dexamethasone, a steroid often used to treat experimental asthma. A control group was given saline only.

After seven days, the animals treated with the two and three doses of MSCs showed reduced lung inflammation and remodeling, improved lung function and T-cell immunosuppression, with the three-dose regimen proving the most effective.

MSC-induced immunosuppression has been reported in models of autoimmune disorders and in early-stage clinical trials, with some promising results for the treatment of graft versus host disease, multiple sclerosis, systemic lupus erythematosus and other conditions. But this is the first study demonstrating that multiple doses of MSCs may induce immunosuppressive effects in experimental allergic asthma, Dr. Rocco said.

These findings should be borne in mind for future clinical trials in patients with severe asthma.

Outcomes from this study highlight the potential of mesenchymal stromal cells to reduce lung inflammation caused by asthma, which affects more than 25 million people in America alone, said Anthony Atala, M.D., Editor-in-Chief of SCTM and director of the Wake Forest Institute for Regenerative Medicine. Larger clinical studies will be welcomed to further verify the safety and efficacy of this treatment.

The full article, Multiple Doses of Adipose Tissue-Derived Mesenchymal Stromal Cells Induce Immunosuppression in Experimental Asthma, can be accessed at https://stemcellsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/sctm.19-0120.

About STEM CELLS Translational Medicine: STEM CELLS Translational Medicine (SCTM), co-published by AlphaMed Press and Wiley, is a monthly peer-reviewed publication dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices. SCTM is the official journal partner of Regenerative Medicine Foundation.

About AlphaMed Press: Established in 1983, AlphaMed Press with offices in Durham, NC, San Francisco, CA, and Belfast, Northern Ireland, publishes two other internationally renowned peer-reviewed journals: STEM CELLS, is the world's first journal devoted to this fast paced field of research. The Oncologist (http://www.TheOncologist.com), also a monthly peer-reviewed publication, is devoted to community and hospital-based oncologists and physicians entrusted with cancer patient care. All three journals are premier periodicals with globally recognized editorial boards dedicated to advancing knowledge and education in their focused disciplines.

About Wiley: Wiley, a global company, helps people and organizations develop the skills and knowledge they need to succeed. Our online scientific, technical, medical and scholarly journals, combined with our digital learning, assessment and certification solutions, help universities, learned societies, businesses, governments and individuals increase the academic and professional impact of their work. For more than 200 years, we have delivered consistent performance to our stakeholders. The company's website can be accessed at http://www.wiley.com.

About Regenerative Medicine Foundation (RMF): The non-profit Regenerative Medicine Foundation fosters strategic collaborations to accelerate the development of regenerative medicine to improve health and deliver cures. RMF pursues its mission by producing its flagship World Stem Cell Summit, honouring leaders through the Stem Cell and Regenerative Medicine Action Awards, and promoting educational initiatives.

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Multiple Doses of Stem Cells Show Potential in Treating Severe Asthma - PR Web

Vor Biopharma and MaxCyte Announce Clinical and Commercial License Agreement for Engineered Hematopoietic Stem Cells (eHSCs) to Treat Cancer | More…

By Stem Cell Medicine

DetailsCategory: More NewsPublished on Thursday, 21 November 2019 18:22Hits: 84

- Clinical and commercial agreement using MaxCytes recently launched ExPERT platform enables up to five of Vors engineered cell therapies and includes development and approval milestones and sales-based payments

- Takes MaxCytes total number of partnered commercial licenses to seven

CAMBRIDGE, MA & GAITHERSBURG, MD, USA I November 21, 2019 I Vor Biopharma, an oncology company pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, and MaxCyte, Inc., a global cell-based therapies and life sciences company, today announced a clinical and commercial license agreement under which Vor will use MaxCytes Flow Electroporation technology to produce eHSCs and initiate Investigational New Drug (IND)-enabling studies to accelerate its progress towards the clinic.

Under the terms of the agreement, Vor obtains non-exclusive clinical and commercial use rights to MaxCytes Flow Electroporation technology and ExPERT platform to develop up to five engineered cell therapies, including VOR33, Vors lead eHSC candidate, which is in development for acute myeloid leukemia (AML). In return, MaxCyte will receive undisclosed development and approval milestones and sales-based payments in addition to other licensing fees.

Vor will use MaxCytes cell engineering platform to deliver its gene editing machinery into hematopoietic stem cells to remove biologically redundant cell surface proteins that are also expressed on blood cancer cells. Once the eHSCs are transplanted into a cancer patient, these cells are effectively hidden from complementary targeted therapies that target the relevant protein, while diseased cells are left vulnerable to attack. Vors approach thereby could unleash the potential of targeted therapies by broadening the therapeutic window and improving the utility of complementary targeted therapies.

MaxCyte is a leader in GMP electroporation technology, and we are thrilled that this agreement provides us with long-term access to a platform technology applicable to a pipeline of eHSC programs used to treat AML and other blood cancers, said Sadik Kassim, Ph.D., Chief Technology Officer of Vor. As we build on promising in vivo data from our lead candidate VOR33, we can now expand our manufacturing capabilities to support later-stage studies, regulatory filings and commercialization of VOR33.

MaxCytes ExPERT instrument family represents the next generation of leading, clinically validated, electroporation technology for complex and scalable cellular engineering. By delivering high transfection efficiency with enhanced functionality, the ExPERT platform delivers the high-end performance essential to enable the next wave of biological and cellular therapeutics.

We look forward to expanding our relationship with Vor Biopharma as the company pioneers a potential future standard of care in hematopoietic stem cell transplants for cancer patients in need, said Doug Doerfler, President & CEO of MaxCyte. This agreement represents another key business milestone for MaxCyte, emphasizing the value of our technology platform applied to next-generation engineered cell therapies that may make a true difference in patient outcomes.

About VOR33 Vors lead product candidate, VOR33, consists of engineered hematopoietic stem cells (eHSCs) that lack the protein CD33. Once these cells are transplanted into a cancer patient, CD33 becomes a far more cancer-specific target, potentially avoiding toxicity to the normal blood and bone marrow associated with CD33-targeted therapies. In so doing, Vor aims to improve the therapeutic window and effectiveness of CD33-targeted therapies, thereby potentially broadening the clinical benefit to patients suffering from AML.

About Vor Biopharma Vor Biopharma aims to transform the lives of cancer patients by pioneering engineered hematopoietic stem cell (eHSC) therapies. By removing biologically redundant proteins from eHSCs, these cells become inherently invulnerable to complementary targeted therapies while tumor cells are left susceptible, thereby unleashing the potential of targeted therapies to benefit cancer patients in need.

Vors platform could be used to potentially change the treatment paradigm of both hematopoietic stem cell transplants and targeted therapies, such as antibody drug conjugates, bispecific antibodies and CAR-T cell treatments. A proof-of-concept study for Vors lead program has been published in Proceedings of the National Academy of Sciences.

Vor is based in Cambridge, Mass. and has a broad intellectual property base, including in-licenses from Columbia University, where foundational work was conducted by inventor and Vor Scientific Board Chair Siddhartha Mukherjee, MD, DPhil. Vor was founded by Dr. Mukherjee and PureTech Health and is supported by leading investors including 5AM Ventures and RA Capital Management, Johnson & Johnson Innovation JJDC, Inc. (JJDC), Novartis Institutes for BioMedical Research and Osage University Partners.

About MaxCyte MaxCyte is a clinical-stage global cell-based therapies and life sciences company applying its proprietary cell engineering platform to deliver the advances of cell-based medicine to patients with high unmet medical needs. MaxCyte is developing novel CARMA therapies for its own pipeline, with its first drug candidate in a Phase I clinical trial. CARMA is MaxCytes mRNA-based proprietary therapeutic platform for autologous cell therapy for the treatment of solid cancers. In addition, through its life sciences business, MaxCyte leverages its Flow Electroporation Technology to enable its biopharmaceutical partners to advance the development of innovative medicines, particularly in cell therapy. MaxCyte has placed its flow electroporation instruments worldwide, including with all of the top ten global biopharmaceutical companies. The Company now has more than 80 partnered programme licenses in cell therapy with more than 45 licensed for clinical use. With its robust delivery technology platform, MaxCyte helps its partners to unlock the full potential of their products. For more information, visit http://www.maxcyte.com.

SOURCE: MaxCyte

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Vor Biopharma and MaxCyte Announce Clinical and Commercial License Agreement for Engineered Hematopoietic Stem Cells (eHSCs) to Treat Cancer | More...

Growing at an Annualized Rate of Over 20%, The Cell Therapy Manufacturing Market is Estimated to Reach Close to USD 10 Billion by 2030, Claims Roots…

By Stem Cell Medicine

The approval of KYMRIAH, YESCARTA, Alofisel and Zyntelgo has increased the interest of pharma stakeholders in cell therapies; further, owing to the technical challenges in this field, outsourcing manufacturing operations has become a necessity

LONDON, Nov. 21, 2019 /PRNewswire/ -- Roots Analysishas announced the addition of "Cell Therapy Manufacturing Market (3rd Edition), 2019 - 2030" report to its list of offerings.

Owing to various reasons, the demand for cell therapies is anticipated to increase over the coming years. Therefore, both therapy developers and contract service providers may need to strengthen their capabilities and expand available capacity. In this context, automation is expected to be a key enabler within the cell therapy manufacturing and contract services industry.

To order this 500+ page report, which features 160+ figures and 250+ tables, please visit this link

Key Market Insights

More than 160 organizations claim to be engaged in cell therapy manufacturing

The market landscape is dominated by industry players, representing more than 60% of the total number of stakeholders. Amongst these, over 55 are large or mid-sized firms (having more than 50 employees).

100+ players focused on T-cell and stem cell therapies

Most of these players are focused on manufacturing T-cell therapies, including CART, TCR or TILs. It is worth highlighting that more than 35 organizations claim to have necessary capabilities for the manufacturing of both types of therapies.

Presently, 70+ companies have commercial scale capacity

As majority of the cell therapy products are in clinical trials, the demand is high at this scale. However, it is worth noting that several players (~50%) have already developed commercial scale capacity for cell therapies.

Europe is currently considered a current hub for cell therapy production

More than 220 manufacturing facilities have been established by various players, worldwide; of these, 35% are in Europe, followed by those based in North America. Other emerging regions include Australia, China, Japan, Singapore, South Korea and Israel.

50+ facility expansions reported between 2015-2019

More than 85% of the expansions are related to setting up of new facilities across different regions. Maximum expansion activity was observed in the US and in certain countries within the Asia Pacific regions.

20+ companies offer automated solutions to cell therapy developers

Players that claim to offer consultancy services related to automation include (in alphabetical order) Berkeley Lights, Cesca Therapeutics, Ferrologix, FluDesign Sonics, GE Healthcare and Terumo BCT. Further, we identified players,namely (in alphabetical order) Fraunhofer Institute for Manufacturing Engineering and Automation IPA, Invetech, KMC Systems, Mayo Clinic Center for Regenerative Medicine and RoosterBio, that offer consultancy solutions related to automation.

Partnership activity has grown at an annualized rate of 16%, between 2014 and 2018

More than 200 agreements have been inked in the last 5 years; majority of these were focused on the supply of cell-based therapy products for clinical trials. Other popular types of collaboration models include manufacturing process development agreements (16%), services agreements (12%) and acquisitions (10%).

By 2030, developed geographies will capture over 60% of the market share

Asia Pacific is anticipated to capture the major share (~36%) of the market by 2030. It is also important to highlight that financial resources, technical expertise and established infrastructure is likely to drive cell therapy manufacturing market in Europe, which is estimated to grow at a CAGR of ~26%.

To request a sample copy / brochure of this report, please visit this link

Key Questions Answered

The USD 10+ billion (by 2030) financial opportunity within the cell therapy manufacturing market has been analyzed across the following segments:

The report features inputs from eminent industry stakeholders, according to whom the manufacturing of cell therapies is largely being outsourced due to exorbitant costs associated with the setting-up of in-house expertise. The report includes detailed transcripts of discussions held with the following experts:

The research covers profiles of key players (industry and non-industry) that offer manufacturing services for cell-based therapies, featuring a company overview, information on manufacturing facilities, and recent collaborations.

For additional details, please visit

https://www.rootsanalysis.com/reports/view_document/cell-therapy-manufacturing/285.html or email sales@rootsanalysis.com

You may also be interested in the following titles:

Contact:

Gaurav Chaudhary+1(415)800-3415Gaurav.Chaudhary@rootsanalysis.com

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Growing at an Annualized Rate of Over 20%, The Cell Therapy Manufacturing Market is Estimated to Reach Close to USD 10 Billion by 2030, Claims Roots...

Global Cell Separation Market 2020-2024 | Evolving Opportunities with Akadeum Life Sciences and Becton, Dickinson and Co. | Technavio – Business Wire

By Stem Cell Medicine

LONDON--(BUSINESS WIRE)--The global cell separation market is poised to grow by USD 7.12 billion during 2020-2024, progressing at a CAGR of over 17% during the forecast period. Request Free Sample Pages

Read the 142-page research report with TOC on "Cell Separation Market Analysis Report by End-User (Academic institutions and research laboratories; Pharmaceutical and biotechnology companies; and Hospitals and clinical testing laboratories), by Geography (North America, Europe, Asia, and ROW), and Segment Forecasts, 2020 - 2024"

The market is driven by the increasing use of cell separation in cancer research. In addition, the rising focus on personalized medicine is anticipated to further boost the growth of the cell separation market.

The increasing use of cell separation in cancer research will be one of the major drivers in the global market. Over the last few years, cell separation has been used along with imaging, proteomics, and molecular biological methods to identify and characterize cancer stem cells. This helps in the early diagnosis of tumors, monitoring of circulating tumor cells, and evaluation of intratumor heterogeneity. Also, the incidence of cancer is increasing rapidly, especially amongst women. Cervical and breast cancers are the most common types in the world. The rising incidence of cancer is encouraging further research in the field. Moreover, advances in computer techniques, optics, and lasers introduced a new generation of cell separation techniques which are capable of high speed processing of single cell suspensions. These factors will boost the global cell separation market growth during the forecast period of 2020-2024.

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Major Five Cell Separation Market Companies:

Akadeum Life Sciences

Akadeum Life Sciences owns and operates the businesses under various segments such as T cell isolation kits, B cell isolation kits, red blood cell products, Streptavidin products, and CD45 products. The product offered by the company is human T Cell isolation kit. This product uses streptavidin-conjugated BACS microbubbles and biotinylated antibodies for cell separation.

Becton, Dickinson and Co.

Becton operates the business under three segments, which include BD medical, BD life sciences, and BD interventional. The companys key offering include the BD IMag cell separation magnet. This product is used to attract labeled cells to the adjacent walls of tubes, allowing the removal of the supernatant, which contains unlabeled cells.

Bio-Rad Laboratories Inc.

Bio-Rad Laboratories Inc. has business operations under various segments, namely life science and clinical diagnostics. The product offered by the company is the ddSEQ single-cell isolator. This product is offered as an automated device to process hundreds to tens of thousands of cells per day.

Cell Microsystems, Inc.

Cell Microsystems, Inc. operates the business under three segments, which include CellRaft AIR System, CytoSort Array, and CellRaft System for inverted microscopes. The companys key offerings include the CellRaft AIR System. This product is available with an automated precision X-Y stage and a microscope with three-channel fluorescence imaging capabilities. It is designed to reduce the time taken for cell separation.

Danaher Corp.

Danaher Corp. operates the business through the following segments: Life Sciences, Diagnostics, Dental, and Environmental & Applied Solutions. The companys key offering in the cell separation market include Avanti J-26S XP. This product is offered as a centrifuge, which includes the elutriation particle separation functionality.

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Cell Separation End-User Outlook (Revenue, USD Million, 2020 - 2024)

Cell Separation Regional Outlook (Revenue, USD Million, 2020 - 2024)

Technavios sample reports are free of charge and contain multiple sections of the report, such as the market size and forecast, drivers, challenges, trends, and more. Request a free sample report

Related Reports on HealthCare are:

Cell Isolation Market Global Cell Isolation Market by product (consumables and instruments), end-users (AR, PB, CRO, and others), and geography (Asia, Europe, North America, and ROW).

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Global Cell Separation Market 2020-2024 | Evolving Opportunities with Akadeum Life Sciences and Becton, Dickinson and Co. | Technavio - Business Wire

Attending This Year’s North American CF Conference Gave Me Hope – Cystic Fibrosis News Today

By Stem Cell Doctors

Two weeks ago, I watched a livestream of theNorth American Cystic Fibrosis Conference (NACFC) as I popped Trikafta (elexacaftor/tezacaftor/ivacaftor) tablets out of their blister pack. Francis Collins, one of the researchers who discovered the cystic fibrosis transmembrane conductance regulator (CFTR) gene, was singing to an audience of thousands. I teared up when he sang, Dare to dream till the story of CF is history.

It was a poignant moment. A researcher who dedicated his life to cystic fibrosis sang about persisting until we find a cure as I took a medication to slow the progression of my disease.

Francis didnt just reinforce the solidarity of the researchers, nurse coordinators, social workers, and doctors who work each day to improve our lives. He ignited the room through empathy. His serenade began with a song from Five Feet Apart that emphasizes the perspective of people who face the unknown every day: Im not givin up, even when Im down to my last breath, so dont give up on me.

That is our communitys plea.

This was my first time at NACFC, thanks to the U.S. Adult Cystic Fibrosis Association. My biggest takeaway from the conference is that we are a team. We arent stopping just because we have treatments available to us.

You may be wondering why I was watching the livestream. I realized that in order to conserve energy and optimize the hours between my daily breathing treatments, I couldnt attend every session. Instead, I spent a good amount of time in the exhibitor hall, chatting with people I had only interacted with through email. I was astounded by the incredible science on display and was especially fascinated by the living, breathing pig lungs that were inhaling air through a positive expiratory pressure device.

Despite the emphasis that has been placed on modulator therapies like Trikafta, patients still need anti-infectives. Bacteria wont just disappear from our lungs after decades of colonization. We also need regenerative medicine because many of us have underlying damage that modulators cannot treat. I was concerned that modulators might overshadow the importance of other research areas, but I was pleasantly surprised.

I saw hundreds of research posters on airway clearance devices, novel molecules as anti-infectives, and quorum sensing to eliminate bacterial communication, to name a few. I also met a researcher who knew me as patient EB. James Gurney heard of my case earlier this year when I was treated with the bacteriophage he was presenting at NACFC. The researcher-patient connection came full circle, and we were both amazed.

I stay up to date with research, but the results of a stem cell therapy in Phase 1 patient clinical trials gave me even more hope! I heard trial data on RNA therapy. Organoids are being utilized in theratyping procedures to deliver personalized medicine. Companies Ive never heard of are trying to outdo the success of Trikafta by researching new modulators. I also learned that in multiple labs around the world, gene editing has been successful in fixing the CFTR gene!

Future treatments are fueled by the CF Foundations Path to a Cure. The plan is to provide modulators for everyone, treat comorbidities like infections and cystic fibrosis-related diabetes, optimize medical systems, facilitate mutual learning between doctors and patients, and ultimately find a cure. People are excited to open doors for patients. Medical professionals are starting to recognize our value in facilitating the path toward care partnerships.

I encourage patients and caregivers to watch the NACFC sessions that are available online. More than ever, I encourage people with CF to be active and open to participating in new clinical trials. Be inquisitive, be bold in trying new treatments, and share your health journey with researchers and care teams who need your valuable input.

Without the opportunity to attend NACFC, I wouldnt have known that stem cell trials are happening in the CF community! I hope to attend NACFC again and remain an active part of the research community.

***

Note: Cystic Fibrosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Cystic Fibrosis News Today, or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to cystic fibrosis.

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Attending This Year's North American CF Conference Gave Me Hope - Cystic Fibrosis News Today

Scranton Police Officer Finds a Connection Through Cancer – WNEP Scranton/Wilkes-Barre

By Stem Cell Doctors

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SCRANTON, Pa. -- A Scranton police officer and a teacher in the Riverside School District found themselves connecting over something most people hope to never endure -- a cancer diagnosis.

As a Scranton Police officer and a member of the department's special operations group, Chris Hallock knew he had signed up for a dangerous job, one that might put his life at risk.

"Another interview I did, they asked if being a police officer prepared me for this. And I actually laughed at that question," Hallock said. "There's nothing that can prepare you for this."

"Shots fired, man down." Those were phrases on Hallock's radar. "You have cancer," wasn't one of them.

"You hear about it, and you know we would attend benefits, and I would run 5Ks for people, and you just never imagined it would be you that they'd be telling that you have cancer."

Chris was diagnosed with acute myeloid leukemia. A cop in his mid-30s, who works out for two hours a day, and runs 5Ks, was now having trouble simply walking up the stairs.

"Everyone looks at you like you're the wounded animal now. And, you know, that's a tough pill to swallow," he said.

That feeling is something Maria Voytko, a teacher in the Riverside School District, is all too familiar with.

"I still feel like I have this big C on my forehead, that's like, I have cancer, and everybody's kind of looking at me like, 'Is she OK now?' and it's, unfortunately, never going to go away, so it's something that you just have to deal with."

Maria was diagnosed with the same type of leukemia when she was just a senior in high school. She and Chris connected through a friend of Chris' wife, Angela.

Although they were diagnosed at vastly different stages of their lives, the pair found that cancer ignores circumstances.

"I'll never forget the first time that Maria broke through to me was she told me just ask me how the cancer stares were going. and, you know, I just, I go, 'OK, she gets it,'" Hallock said.

In February of last year, Hallock received a lifesaving stem cell transplant from his sister. He's now in recovery mode, which means countless doctors' appointments and treatments to make sure his immune system regenerates properly.

Even then, as Maria knows, recovery doesn't stop there.

"Remission does not end the chapter of cancer. It is a lifelong sentence, unfortunately."

A sentence that is much easier to live out with people by your side, especially people who understand what you're going through.

"It brought me hope, you know, seeing, Maria. You know, in talking to her and seeing how she beat it."

But the past two years weren't always full of hope and happiness for Hallock.

"People always say you're so strong, and sometimes I struggle with that because people didn't see behind the scenes."

Chris and Angela gave birth to their first son, Giovanni, now 2, one month before the diagnosis. Some might say that's bad timing, but Hallock calls it a blessing in disguise.

"He gave me something to fight for. You know, I knew I needed to be there, and I wanted to be there for him, and I wanted to set a good example for him that you know if times get tough, you just, you know, keep pushing forward. And, you know, I don't know if I would have been as strong as I was if it wasn't for him," Chris said.

For Chris and Maria, it's no longer about surviving life. It's about celebrating it.

"I am so proud of every single year in my life. I'm 41, and I made it here, and I'm going to make 42 and 82, you know, so I'm never going to lie about my age. People think I'm crazy," Maria said.

"It's living in the honor of people who, unfortunately, didn't make it. It's rubbing into cancer's face that, you know what? Yeah, I'm here. I'm here. You gave me your best shot, and I'm here," Chris said.

Now Chris wants to pay it forward and help others the same way Maria helped him giving public speeches, reaching out on social media, even just chatting with other cancer patients he sees at the hospital when he goes in for treatments. Most importantly, he wants to get his message out there

"Tomorrow's a new day with a new beginning, and you just have to remember that even if this is the worst day of your life, tomorrow could be the best day of your life, but if you don't fight to live till tomorrow, you'll never experience that."

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Scranton Police Officer Finds a Connection Through Cancer - WNEP Scranton/Wilkes-Barre

Major step taken in creating complex organs in the lab – Drug Target Review

By Embryonic Stem Cells

A major step has been taken towards developing functional miniature versions of human organs in a Petri dish which can be used to shed light on the processes involved in the genesis of diseases.

Scientists from the University of Wrzburg, Germany have taken a major step towards developing functional miniature versions of human organs, known as complex organoids.

Japanese researchers had previously developed a way of creating pluripotent stem cells through epigenetic reprogramming of connective tissue cells, which has yielded a highly valuable cell type that can be used to grow all cells of the human body in a Petri dish.

When culturing these so-called induced pluripotent stem cells (iPS cells) as three-dimensional (3D) cell aggregates, the organoids can be created by selectively adding growth factors.

Such organoid models are often similar to real embryonic tissues. However, most remained incomplete because they lacked stromal cells and structures, the supportive framework of an organ composed of connective tissue.

This new development was part of a project led by Dr Philipp Wrsdrfer and Professor Sleyman Ergn, the head of the Institute of Anatomy and Cell Biology, which has resulted in organoids that have complexity similar to that of normal tissue and are far superior to previous structures.

Organoid models are often surprisingly similar to real embryonic tissues. Shown here (from left): 3D reconstruction of the vascular network within an organoid, brain organoid with blood vessels (red) and brain stem cells (green) and a tumour organoid with blood vessels (red) and tumour cells (green) (credit: Institute for Anatomy and Cell Biology).

We used a trick to achieve our goal, explained Philipp Wrsdrfer. First we created so-called mesodermal progenitor cells from pluripotent stem cells. Under the right conditions, such progenitor cells are capable of producing blood vessels, immune cells and connective tissue cells.

To demonstrate the potential of the mesodermal progenitor cells, the scientists mixed these cells with tumour cells and brain stem cells that had previously been generated from human iPS cells. This mixture grew to form complex 3D tumour or brain organoids in the Petri dish featuring functional blood vessels, connective tissue, and in the case of the brain tissue, brain-specific immune cells.

In the future, the miniature organ models generated with this new technique can help scientists shed light on the processes involved in the genesis of diseases and to analyse the effect of therapeutic substances in more detail before using them on animals and human patients, added Sleyman Ergn.

This would allow the number of animal experiments to be reduced. Moreover, the organ models could contribute to gaining a better understanding of embryonic development processes and grow tissue that can be transplanted efficiently.

The project was published Scientific Reports.

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Major step taken in creating complex organs in the lab - Drug Target Review

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