Category Archives: Gene therapy

DUBLIN, Sept. 22, 2020 /PRNewswire/ -- The "Global Regenerative Medicine Market: Size & Forecast with Impact Analysis of COVID-19 (2020-2024)" report has been added to ResearchAndMarkets.com's offering.

Global Regenerative Medicine Market: Size & Forecast with Impact Analysis of COVID-19 (2020-2024), provides an in-depth analysis of the global regenerative medicine market with description of market sizing and growth. The analysis includes market by value, by product, by material and by region. Furthermore, the report also provides detailed product analysis, material analysis and regional analysis.

The global regenerative medicine market has surged at a progressive rate over the years and the market is further anticipated to augment during the forecasted years 2020 to 2024. The market would propel owing to numerous growth drivers like growth in geriatric population, rising global healthcare expenditure, increasing diabetic population, escalating number of cancer patients, rising prevalence of cardiovascular disease and surging obese population.

Though, the market faces some challenges which are hindering the growth of the market. Some of the major challenges faced by the industry are: legal obligation and high cost of treatment. Whereas, the market growth would be further supported by various market trends like three dimensional bioprinting , artificial intelligence to advance regenerative medicine, etc.

Moreover, the report also assesses the key opportunities in the market and outlines the factors that are and would be driving the growth of the industry. Growth of the overall global regenerative medicine market has also been forecasted for the years 2020-2024, taking into consideration the previous growth patterns, the growth drivers and the current and future trends.

Some of the major players operating in the global regenerative medicine market are Novartis AG, Medtronic Plc, Bristol Myers Squibb (Celgene Corporation) and Smith+Nephew (Osiris Therapeutics, Inc.), whose company profiling has been done in the report. Furthermore, in this segment of the report, business overview, financial overview and business strategies of the respective companies are also provided.

Key Topics Covered:

1. Executive Summary

2. Introduction2.1 Regenerative Medicine: An Overview2.2 Regeneration in Humans: An Overview2.3 Expansion in Peripheral Industries of Regenerative Medicine2.4 Approval System for Regenerative Medicine Products2.5 Regenerative Medicine Segmentation

3. Global Market Analysis3.1 Global Regenerative Medicine Market: An Analysis3.1.1 Global Regenerative Medicine Market by Value3.1.2 Global Regenerative Medicine Market by Products (Cell Therapy, Tissue Engineering, Gene Therapy and Small Molecules and Biologics)3.1.3 Global Regenerative Medicine Market by Material (Biologically Derived Material, Synthetic Material, Genetically Engineered Materials and Pharmaceuticals)3.1.4 Global Regenerative Medicine Market by Region (North America, Europe, Asia Pacific and ROW)

3.2 Global Regenerative Medicine Market: Product Analysis3.2.1 Global Cell Therapy Regenerative Medicine Market by Value3.2.2 Global Tissue Engineering Regenerative Medicine Market by Value3.2.3 Global Gene Therapy Regenerative Medicine Market by Value3.2.4 Global Small Molecules and Biologics Regenerative Medicine Market by Value

3.3 Global Regenerative Medicine Market: Material Analysis3.3.1 Global Biologically Derived Material Market by Value3.3.2 Global Synthetic Material Market by Value3.3.3 Global Genetically Engineered Materials Market by Value3.3.4 Global Regenerative Medicine Pharmaceuticals Market by Value

4. Regional Market Analysis

5. COVID-195.1 Impact of Covid-195.2 Response of Industry to Covid-195.3 Variation in Organic Traffic5.4 Regional Impact of COVID-19

6. Market Dynamics6.1 Growth Drivers6.1.1 Growth in Geriatric Population6.1.2 Rising Global Healthcare Expenditure6.1.3 Increasing Diabetic Population6.1.4 Escalating Number of Cancer Patients6.1.5 Rising Prevalence of Cardiovascular Disease6.1.6 Surging Obese Population6.2 Challenges6.2.1 Legal Obligation6.2.2 High Cost of Treatment6.3 Market Trends6.3.1 3D Bio-Printing6.3.2 Artificial Intelligence to Advance Regenerative Medicine

7. Competitive Landscape7.1 Global Regenerative Medicine Market Players: A Financial Comparison7.2 Global Regenerative Medicine Market Players' by Research & Development Expenditure

8. Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/w50udm

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Global Regenerative Medicine Market Report 2020-2024 with Impact Analysis of COVID-19 - Artificial Intelligence to Advance Regenerative Medicine -...

City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, today announced that it has licensed intellectual property relating to its pioneering chlorotoxin chimeric antigen receptor (CLTX-CAR) T cell therapy to Chimeric Therapeutics Limited, an Australian biotechnology company.

The therapy is currently being used in a phase 1 clinical trial at City of Hope to treat glioblastoma (GBM), a type of brain tumor. The first patient in the trial was recently dosed; Behnam Badie, M.D., chief of City of Hopes Division of Neurosurgery and The Heritage Provider Network Professor in Gene Therapy, is leading this innovative, first-of-its-kind trial.

Chimeric has acquired the exclusive worldwide rights to develop and commercialize certain patents relating to City of Hopes CLTX-CAR T cells, as well as to further develop the therapy for other cancers.

City of Hope is excited to enter into this agreement with Chimeric as it supports our innovative research in CAR T cell therapy and our commitment to extend these therapies to more patients, particularly those with GBM and other solid tumors that are difficult to treat, said Christine Brown, Ph.D., The Heritage Provider Network Professor in Immunotherapy and deputy director of City of Hopes T Cell Therapeutics Research Laboratory. Chimeric shares our goal of providing effective CAR T cell therapies to more patients with current unmet medical needs.

Led by Brown and Michael Barish, Ph.D., chair of City of Hopes Department of Developmental and Stem Cell Biology, and Dongrui Wang, Ph.D., a recent graduate of City of Hopes Irell & Manella Graduate School of Biological Sciences, the team developed and tested the first CAR T cell therapy using CLTX, a component of scorpion venom, to direct T cells to target brain tumor cells. The research was published this past March in Science Translational Medicine.

Chimeric is excited to join City of Hope in its quest to find more effective cancer therapies. This is an exceedingly rare opportunity to acquire a promising technology in one of the most exciting areas of immuno-oncology today, said Paul Hopper, executive chairman of Chimeric.

Furthermore, the CLTX-CAR T cell therapy has completed years of preclinical research and development, and recently enrolled its first patient in a phase 1 clinical trial for brain cancer.CARs commonly incorporate a monoclonal antibody sequence in their targeting domain, enabling CAR T cells to recognize antigens and kill tumor cells. In contrast, the CLTX-CAR uses a synthetic 36-amino acid peptide sequence first isolated from death stalker scorpion venom and now engineered to serve as the CAR recognition domain.

In this recent study, City of Hope researchers used tumor cells in resection samples from a cohort of patients with GBM to compare CLTX binding with expression of antigens currently under investigation as CAR T cell targets. They found that CLTX bound to a greater proportion of patient tumors, and cells within these tumors.

CLTX binding included the GBM stem-like cells thought to seed tumor recurrence. Consistent with these observations, CLTX-CAR T cells recognized and killed broad populations of GBM cells while ignoring nontumor cells in the brain and other organs. The study team demonstrated that CLTX-directed CAR T cells are highly effective at selectively killing human GBM cells without off-tumor targeting and toxicity in cell-based assays and in animal models.

City of Hope, a recognized leader in CAR T cell therapies for GBM and other cancers, has treated more than 500 patients since its CAR T program started in the late 1990s. The institution continues to have one of the most comprehensive CAR T cell clinical research programs in the world it currently has 30 ongoing CAR T cell clinical trials, including CAR T cell trials for HER-2 positive breast cancer that has spread to the brain, and PSCA-positive bone metastatic prostate cancer. It was the first and only cancer center to treat GBM patients with CAR T cells targeting IL13R2, and the first to administer CAR T cell therapy locally in the brain, either by direct injection at the tumor site, through intraventricular infusion into the cerebrospinal fluid, or both. In late 2019, City of Hope opened a first-in-human clinical trial for patients with recurrent GBM, combining IL13R2-CAR T cells with checkpoint inhibitors nivolumab, an anti-PD1 antibody, and ipilimumab, blocking the CTLA-4 protein.

Both an academic medical center and a drug development powerhouse, City of Hope is known for creating the technology used in the development of human synthetic insulin and numerous breakthrough cancer drugs. Its unique research and development hybrid of the academic and commercial creates an infrastructure that enables City of Hope researchers to submit an average of 50 investigational new drug applications to the U.S. Food and Drug Administration each year. The institution currently holds more than 450 patent families.

"City of Hope is delighted to license this technology to Chimeric, said Sangeeta Bardhan Cook, Ph.D., City of Hope director of the Office of Technology Licensing. We are impressed with the ability of their executive team to push and bring therapies to market expeditiously. At City of Hope, our mission is to transform the future of health care. We believe Chimeric has the vision to offer innovative therapies to cancer patients.

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City of Hope enters licensing agreement with Chimeric to develop its pioneering chlorotoxin CAR T cell therapy - OncLive

Garner Insights has added a new report titled, Global Gene Therapy Market Professional Report 2026 to its vast repository of research reports. This is a thorough report focused on the current and future prospects of the Global Gene Therapy Market. The report offers data of previous years along with an in-depth analysis from 2020 to 2026 on the basis of revenue (USD Billion). Besides, the report offers a comprehensive analysis about the factors driving and restraining the growth of the market coupled with the impact they have on the demand over the forecast period.

The market is segmented into different sections such as: by product type, by technology type, by application, by end-users, by deployment mode, and by key geography. The report then employs market breakdown and data triangulation procedures to complete the overall market engineering process and arrive at the exact statistics for all segments and sub-segments. The report on the Global Gene Therapy Markethas been curated by analyzing the top players functioning in the market. In order to get an in-depth analysis of the market, the report carried out SWOT analysis, Porters five forces analysis, and Pestel analysis.

Request Sample Report of Global Gene Therapy Market @ (https://garnerinsights.com/Gene-Therapy-Market-Research-Global-StatusForecast-by-Geography-TypeApplication-2016-2026#request-sample)

The report is segmented as follows:

Top Key Players: Sangamo, Spark Therapeutics, Dimension Therapeutics, Avalanche Bio, Celladon, Vical, Advantagene

By Product Type:Ex vivo, In vivo

By Application:Cancer Diseases, Monogenic Diseases, Infectious Diseases, Cardiovascular Diseases, Others

By Regions:

This report forecasts revenue growth at the global, regional, and local levels and provides an analysis of the most recent industry trends from 2020 to 2026 in each of the segments and sub-segments.In addition, the report highlights the impact of COVID-19 on the Global Gene Therapy Market. Some of the major geographies included in the market are given below:

North America (U.S., Canada)Europe (U.K., Germany, France, Italy)Asia Pacific (China, India, Japan, Singapore, Malaysia)Latin America (Brazil, Mexico)Middle East & Africa

Request for Discount on report @ (https://garnerinsights.com/Gene-Therapy-Market-Research-Global-StatusForecast-by-Geography-TypeApplication-2016-2026#discount)

Key Questions Answered in the Report:

What is the current scenario of the Global Gene Therapy Market? How is the market going to prosper throughout the next 6 years?What are the emerging technologies that are going to profit the market?What is the historical and the current size of the Global Gene Therapy Market?Which segments are the fastest growing and the largest in the market? What is their market potential?What are the driving factors contributing to the market growth during the short, medium, and long term?What are the lucrative opportunities for the key players in the market?Which are the key geographies from the investment perspective?What are the major strategies adopted by the leading players to expand their market shares?Who are the distributors, traders and dealers of Global Gene Therapy market?What are sales, revenue, and price analysis by types and applications of market?

Full Description @ (https://garnerinsights.com/Gene-Therapy-Market-Research-Global-StatusForecast-by-Geography-TypeApplication-2016-2026#description)

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Impact of Covid-19 on Gene Therapy Market Trends by Countries, Type and Application | Sangamo, Spark Therapeutics, Dimension Therapeutics, Avalanche...

Management to Highlight Progress in Bone Marrow Transplant (BMT) and Chimeric Antigen Receptor T Cell (CAR T) Business Collaborations

Tel Aviv, Israel, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Cellect Biotechnology Ltd. (NASDAQ: APOP”), a developer of innovative technology which enables the functional selection of cells facilitating safer and more efficacious cell and gene therapies, today announced that the leadership will be presenting at the Cell & Gene Meeting on the Mesa, which is being held from October 12th 16th. In addition to providing an overview of the Company, the management team will provide a progress update on the clinical and development programs and an overview of the Company’s business strategy. Management will be virtually meeting cell and gene therapy companies to support collaborations.

This is one of the most prestigious meetings for our industry, and despite it being virtual this year due to the COVID-19 pandemic, it will not dampen our enthusiasm” commented Dr. Yarkoni. We have successfully adjusted our operations, and we continue to make significant progress with our Israel and U.S.-based clinical trials. We are also taking meaningful steps to accelerate nearer-term revenue opportunities as we are collaborating with several partners that are looking to leverage our technology platform to help improve their products, especially in high-growth areas such as CAR T, NK (natural killers) and MSC’s. We are looking forward to sharing the progress we have made and also look forward to meeting with current and potential partners developing cell and gene therapies.”

To schedule a meeting with the Company’s Chief Executive Officer, Dr. Shai Yarkoni or Chief Operating Officer, Amos Ofer, please request a meeting through the meeting portal and/or contact the Company direct at shai@cellect.co or amoso@cellect.co. The presentation will be available on the Company’s website prior to the commencement of the meeting. The Cell & Gene Meeting on the Mesa is the sector’s foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures.

About Cellect Biotechnology Ltd.

Cellect Biotechnology (APOP) has developed a breakthrough technology, for the functional selection of cells that aims to improve the robustness, safety and efficacy of a variety of cell and gene therapies. The Company’s technology can be used by researchers, clinical community and pharma companies in a wide variety of applications including next generation Car T, NK, MSC and gene therapies.

The Company is also developing its own product that is an improved BMT which is in a current clinical trial for cancer treatment.

Forward Looking Statements

This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as believe”, expect”, intend”, plan”, may”, should”, could”, might”, seek”, target”, will”, project”, forecast”, continue” or anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect’s expectations regarding timing of the commencement of its planned U.S. clinical trial and its plan to reduce operating costs. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company’s history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company’s ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Company’s ability to obtain regulatory approvals; the Company’s ability to obtain favorable pre-clinical and clinical trial results; the Company’s technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company’s clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company’s ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company’s industry; unforeseen scientific difficulties may develop with the Company’s technology; the Company’s ability to retain or attract key employees whose knowledge is essential to the development of its products; and the Company’s ability to pursue any strategic transaction or that any transaction, if pursued, will be completed. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading Risk Factors” in Cellect Biotechnology Ltd.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, http://www.sec.gov, and in the Company’s periodic filings with the SEC.

Contact Cellect Biotechnology Ltd. Eyal Leibovitz, Chief Financial Officer http://www.cellect.co +972-9-974-1444

Or

EVC Group LLC Michael Polyviou (732) 933-2754 mpolyviou@evcgroup.com

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Cellect Biotechnology to Present at the 2020 Cell & Gene Meeting on the Mesa - Stockhouse

BOSTON, Sept. 22, 2020 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (Ziopharm or the Company) (Nasdaq:ZIOP), today announced the appointment of J. Kevin Buchi to the Companys Board of Directors and as Chair of the Boards Audit Committee. Additionally, Ziopharm announced that, in response to the results from the Companys recent annual meeting of stockholders, Doug Pagn has resigned from the Board.

Mr. Buchi has deep life sciences industry experience, notably 15 years with Cephalon, including serving as its Chief Executive Officer during Cephalons acquisition by Teva Pharmaceuticals in 2011 for $6.8 billion. Subsequently, Mr. Buchi served as Chief Executive Officer of TertraLogic Pharmaceuticals, and more recently as Chief Executive Officer of Biospecifics Technologies, prior to his retirement.

We are delighted to welcome Kevin to our Board of Directors, said Scott Tarriff, Chairman of the Ziopharm Board of Directors. Kevin is an accomplished executive and director, whose extensive industry experience and business and financial acumen will complement the Board. We also wish to thank Doug for his many contributions since joining the Ziopharm Board in 2018, a critical time in the Companys history, while we exited a corporate partnership and established the foundation for our core programs today. Over the past year, we have added four strong directors to our Board, including James Huang in July and Dr. Chris Bowden and Heidi Hagen last year. Looking ahead, we expect our Board will continue to evolve to reflect the needs of our business as we evolve into a commercial-stage company.

Mr. Buchi added, This is an exciting time for Ziopharm, as the Company has established a broad portfolio of innovative clinical programs to treat solid tumors and a talented team to drive company-sponsored trials in all three core programs. I am delighted to begin collaborating with Laurence and his team, as well as the other members of Ziopharms Board of Directors.

Following the acquisition of Cephalon by Teva in 2011, Mr. Buchi served as corporate vice president of global branded products at Teva. Subsequently, he was CEO TetraLogic Pharmaceuticals and Biospecifics Technologies. In addition, Mr. Buchi currently serves as chairman of Dicerna Pharmaceuticals, and as a director of Amneal Pharmaceuticals and Benitec Biopharma Ltd. Mr. Buchi earned a B.A. in Chemistry from Cornell University and a Masters in Management, Accounting and Finance from the Kellogg School of Management at Northwestern University.

The Companys Board consists of eight directors, including seven non-executive directors. The Board will continue to actively review the Board membership to ensure the skills and experience of directors support the progress and future prospects of the business.

About Ziopharm Oncology, Inc.Ziopharm is developing non-viral and cytokine-driven cell and gene therapies that weaponize the bodys immune system to treat the millions of people globally diagnosed with a solid tumor each year. With its multiplatform approach, Ziopharm is at the forefront of immuno-oncology with a goal to treat any type of solid tumor. Ziopharms pipeline is built for commercially scalable, cost effective T-cell receptor T-cell therapies based on its non-viral Sleeping Beauty gene transfer platform, a precisely controlled IL-12 gene therapy, and rapidly manufactured Sleeping Beauty-enabled CD19-specific CAR-T program. The Company has clinical and strategic collaborations with the National Cancer Institute, The University of Texas MD Anderson Cancer Center and Regeneron Pharmaceuticals. For more information, please visit http://www.ziopharm.com.

Forward-Looking Statements DisclaimerThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the growth of Ziopharm from a development-stage entity to a commercial-stage company, development of its clinical portfolio and research and development programs. Although Ziopharms management team believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Ziopharm, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, changes in our operating plans that may impact our cash expenditures, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Ziopharms product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies and for which indication; the strength and enforceability of Ziopharms intellectual property rights; competition from other pharmaceutical and biotechnology companies as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by Ziopharm, including those risks and uncertainties listed in Ziopharms Quarterly Report on Form 10-Q filed by Ziopharm with the Securities and Exchange Commission. We are providing this information as of the date of this press release, and Ziopharm does not undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

Investor Relations Contacts:Ziopharm Oncology: Chris Taylor VP, Investor Relations and Corporate CommunicationsT: 617.502.1881E: ctaylor@ziopharm.com

LifeSci Advisors:Mike MoyerManaging DirectorT: 617.308.4306E: mmoyer@lifesciadvisors.com

Media Relations Contact:LifeSci Communications:Patrick BurseyT: 646.876.4932E: pbursey@lifescicomms.com

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Ziopharm Oncology Appoints Kevin Buchi to its Board of Directors - BioSpace

University of Bristol researchers have treated a mouse model of glaucoma using a single gene therapy injection

Pixabay/Arek Socha

Writing in Molecular Therapy, scientists described how CRISPR gene editing was used to inactivate a gene in the ciliary body of the eye, decreasing intraocular pressure.

Visiting senior research fellow at Bristol Medical School, Dr Colin Chu, said the team hoped to advance towards clinical trials of the therapy in the near future.

If it's successful it could allow a long-term treatment of glaucoma with a single eye injection, which would improve the quality of life for many patients whilst saving the NHS time and money," Dr Chu said.

Researchers note that while eye drops are currently used to reduce intraocular pressure in glaucoma patients, the drops may have side effects and there are issues of patient compliance in administering the drops daily.

Gene editing to provide a single but permanent therapeutic alteration is an appealing approach given glaucoma is a chronic disease that requires lifelong intervention, the study authors emphasised.

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Gene therapy as a potential treatment for glaucoma - AOP

A biotech company spun out of the University of Edinburgh will utilise research to develop new gene therapies to target different types of cancer.

The company, Cellinta Limited, was born out of research from scientists at the University of Edinburgh, and received funding through investments from SV Health Investors and Cancer Research UK.

The funding will be used to develop a pipeline of highly selective gene therapies targeting cancer stem cells in a variety of solid tumour types.

It will draw on research led by Professor Steven Pollard at the University of Edinburgh, which delved into stem cell biology, synthetic biology and cancer genomics.

Cellinta has entered into a collaborative research agreement with the University, and retains the option to license intellectual property developed from research conducted there.

Professor Pollard will join the Cellinta team as scientific founder and a senior adviser, while Dr Soraya Bekkali will take the helm as chief executive officer of the new company.

I am delighted to be leading such an exciting company, said Dr Bekkali.

Cellintas approach offers the opportunity to deliver combinations of therapies selectively to cancer stem cells, bypassing the limitations of traditional treatments which often target single genes or redundant signalling pathways, she added.

Meanwhile, Mike Ross managing partner at London-based SV Health Investors has been appointed chairman of Cellinta.

Cellinta represents a unique opportunity to build a leading company based on exciting and innovative science, with the potential to develop first-in-class therapies, said Ross.

We are delighted with the progress the company has made and extremely pleased to appoint Soraya, who has deep experience in gene therapy across various therapeutic areas, as CEO. We look forward supporting Cellinta in its progress as a pioneer in the field, he added.

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University of Edinburgh spinout Cellinta will develop gene therapies for cancer - PharmaTimes

Xtalks Life Science Webinars

TORONTO (PRWEB) September 21, 2020

The International Organization for Standardization (ISO) has recently issued its eagerly awaited guidance on the transportation of cells for therapeutic use (ISO 21973). The ISO document is meant to provide general requirements and points to consider for transportation service providers, clients and senders to ensure cell quality, safety and efficacy during the transportation process. This webinar will discuss the key recommendations and changes that interested parties should review and evaluate when planning their clinical and commercial distribution strategies for cell and gene therapies. Some of the elements to be discussed are documentation, traceability, validation and qualification activities, temporary storage, as well as cleaning and disinfection.

Join Robert Jones, Vice President, BioServices, Cryoport Systems in a live webinar on Thursday, October 1, 2020 at 11am EDT (4pm BST/UK).

For more information or to register for this event, visit Addressing the Recent ISO 21973 Guidance: Considerations for Cell and Gene Therapy Distribution.

ABOUT CRYOPORT, INC.

Cryoport, Inc. is redefining temperature controlled supply chain support for the life sciences industry by providing a broad platform of temperature-controlled supply chain solutions, serving the Biopharma, Reproductive Medicine, and Animal Health markets. Our mission is to support life and health on earth by providing reliable and comprehensive solutions for the life sciences industry through our advanced technologies, global supply chain network and dedicated scientists, technicians and supporting team of professionals. Through our purpose-built, proprietary Cryoport Express Shippers; Cryoportal information technology; validated Global Logistics Centers; smart and sustainable temperature-controlled logistics solutions; and biostorage/biobanking services, Cryoport serves clients in life sciences research, clinical trials, and product commercializations. We support life-saving advanced cell and gene therapies and deliver vaccines, protein producing materials, and IVF materials in over 100 countries around the world. For more information, visit http://www.cryoport.com or follow @cryoport on Twitter at http://www.twitter.com/cryoport for live updates.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.comFor information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Addressing the Recent ISO 21973 Guidance: Considerations for Cell and Gene Therapy Distribution, Upcoming Webinar Hosted by Xtalks - PR Web

BOTHELL, Wash., Sept. 21, 2020 /PRNewswire/ -- BioLife Solutions. (NASDAQ: BLFS)("BioLife" or the "Company"), a leading developer and supplier of a portfolio of class-defining bioproduction tools for cell and gene therapies, today announced it has entered into a definitive agreement to acquire SciSafe, a privately held multi-facility provider of biological materials storage to the cell and gene therapy and pharmaceutical industries. The transaction is expected to close on September 30th.

SciSafe had 2019 unaudited revenue of $6 million and positive EBITDA and is anticipated to be accretive during 2021.

Under the terms of the agreement, BioLife will pay $15 million in cash and $15 million in newly issued shares of BioLife common stock for 100% of the outstanding shares of SciSafe. SciSafe's shareholders are also eligible over the next four years to receive up to 626,000 additional shares of BioLife common stock based on the achievement of annual revenue milestones.

Mike Rice, Chief Executive Officer of BioLife Solutions, commented, "This acquisition enables BioLife to offer even more value to our cell and gene therapy customers through an established business with an excellent reputation, marquee customers and seasoned team. Through SciSafe, we are accelerating profitable growth by expanding into the high growth biostorage segment with a robust quality system, a scalable business model and strong financial performance. We anticipate several vertical integration cost synergies including using SciSafe facilities for cGMP storage of our biopreservation media products, leveraging our CBS facility to manufacture walk-in freezer rooms for SciSafe and deploying our evo Smart Shippers and evoIS cloud app for the thousands of annual inbound and outbound biologic materials shipments managed by SciSafe."

Garrie Richardson, President of SciSafe, remarked, "I'm thrilled to be joining forces with BioLife. With BioLife's stellar reputation in the cell and gene therapy market, key customer relationships, financial resources and commitment to fund our growth, the SciSafe team is poised to deliver significant high-margin incremental revenue to BioLife's growing enterprise."

Benefits of the Transaction

Entry into the fast-growing biostorage segment

Cross-selling opportunities

Potential vertical integration cost synergies

Financial Impact of SciSafe Acquisition

BioLife expects the acquisition of SciSafe to impact the Company's financial performance as follows:

About SciSafeFounded in 2010, SciSafe offers dedicated pharmaceutical and biological specimen storage in its four fully cGMP-compliant state-of-the-art sample management facilities. SciSafe has built flourishing relationships with over 300 of the world's leading and most admired organizations. Clients have repeatedly chosen to store their most valued and irreplaceable biological samples because they trust SciSafe to care for them as if they were their own. SciSafe values and respects its long-term client relationships. With over 60 years combined experience specifically in life sciences, SciSafe personnel fully appreciate the vital requirements of all areas of specimen storage and cold chain management. For more information, please visit http://www.scisafe.com.

About BioLife SolutionsBioLife Solutions is a leading supplier of a portfolio of class-defining cell and gene therapy bioproduction tools and services. Our tools portfolio includes our proprietaryCryoStorfreeze media and HypoThermosolshipping and storage media, ThawSTARfamily of automated, water-free thawing products, evocold chain management system, and Custom Biogenic Systemshigh capacity storage freezers. Services include SciSafe biologic and pharmaceutical materials storage. For more information, please visit http://www.biolifesolutions.com, and follow BioLife on Twitter.

Cautions Regarding Forward Looking Statements Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements concerning the expected financial performance of the company following the completion of its acquisition of SciSafe, the expected synergies between the company and SciSafe, the company's ability to realize all or any of the anticipated benefits associated with the acquisition of SciSafe, the company's ability to implement its business strategy and anticipated business and operations, including following the acquisition of SciSafe, the potential utility of and market for the company's and SciSafe's products and services, guidance for financial results for 2020 and 2021, including regarding SciSafe's revenue, and potential revenue growth and market expansion, including with consideration to our acquisition of SciSafe. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding unexpected costs, charges or expenses resulting from the company's acquisition of SciSafe or the 2019 acquisitions, charges or expenses resulting from the acquisition of SciSafe; market adoption of the company's products (including the company's recently acquired products) or SciSafe's products; the ability of the SciSafe acquisition to be accretive on the company's financial results; the ability of the company to implement its business strategy; uncertainty regarding third-party market projections; market volatility; competition; litigation; the impact of the COVID-19 pandemic; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Media & Investor RelationsRoderick de GreefChief Financial Officer(425) 686-6002rdegreef@biolifesolutions.com

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SOURCE BioLife Solutions, Inc.

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BioLife Solutions to Acquire SciSafe, a High-Growth Biostorage Service Provider to the Cell and Gene Therapy Industry - BioSpace

The first part of the CPhI Annual Report 2020, released ahead of the CPhI Festival of Pharma (taking place online October 5-16) predicts dramatic growth of new mAb production in China. It also forecasts capacity shortages for cell and gene therapies in the US, as well as widespread global adoption of single-use technologies, with only limited continuous bioprocessing.

In the document, CPhI experts from BioPlan Associates (Vicky Qing XIA, senior project manager; Leo Cai Yang, project manager; and Eric Langer, president and managing partner) delve into the rapidly evolving biologics markets. The report highlights implications for contract outsourcing and Chinas continually increasing presence emergence as a hub for both bio innovation and contract services.

The report predicts rapid bio growth in China to continue, forecasting that more than 10 new mAbs likely will be launched each year by 2025. Overall, the authors estimate the total market size will quadruple by 2025, reaching nearly $18b (120b RMB) by that point and rising to more than $28b (190b RMB) by 2030.

As most early-stage biotech in China lack manufacturing facilities, the need for contract manufacturing services is rising quickly, and has been accelerated further by the 2016 MAH reforms, XIA commented.

According to the report, bioprocessing outsourcing in China is currently highly stratified with four tiers and just one domestic company in tier one (WuXi Biologics), with a number of international CDMOs (including BI, Lonza and Merck).

However, by 2025 the report anticipates as many as five more domestic CDMOs may have reached tier one status, with US Food and Drug Administration (FDA) and EU facility approvals. Significantly, pending regulatory changes for contract vaccine production will likely spur further rapid growth amongst the existing tier one CDMOs.

WuXi Biologics in 2019 realized 35.3% of its total revenue of USD 0.57 billion from China, which is ~USD 0.2 billion and would translate to ~35% of the total biopharma outsourcing service market in China1. However, despite sizable growth in revenue, its overall share of the market will now fall, as the mAb market expands rapidly, added XIA.

Langer explained, Because preclinical and clinical pipeline products require flexible manufacturing, SUS lends itself to these scales, but many of these will fail as they progress through the pipeline. This means that while more commercial-scale biologics are going to be made in SUS platforms, or hybrid systems, over the next 2+ years, stainless platforms are, and will remain, critical to bioprocessing as well.

The report also suggested that in the US and European markets will likely ocme under a cell and gene therapy capacity crunch by 2025, seeing CDMOs investing in this area already expanding in an attempt to meet the pipelines impending demand.

However, capacity alone is not the biggest challenge as there is a shortage of both specialized platforms, and trained personnel to operate them. Significantly, for some facilities in these emerging areas the equipment required for expansion and up-scaling may not yet exist, nor are regulatory authorities fully aligned with issues around patient treatments which could slow approvals.

Tara Dougal, head of content at CPhI Festival of Pharma, explained, The cell and gene therapy space is hugely fast-moving and we will run a session on the potential for M&As as both manufacturers and CDMOs try to buy-in expertise rather than build. More generally, our report also points to sustained bio growth in China, almost universal adoption of single use technologies, with continuous processing growing but from a far lower base."

Dougal added that CPhI has engaged Jefferson Institute for Bioprocessing to expand on the topic, exploring current strategies and looking ahead at future approaches.

Langer is scheduled to participate in a panel discussion on M&A activity in the cell and gene sector, taking place at CPhI Festival of Pharma October 6, 2 to 3 pm CET.

The CPhI Festival of Pharma takes place digitally October 5 to 16. For more information about the program or to register, go to https://www.cphi.com/festival-of-pharma/en/home.html.

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CPhI: cell and gene therapy capacity shortages on the horizon - OutSourcing-Pharma.com