CRISPR and Vertex show durability of gene-editing therapy, hoping for one and done treatment – FierceBiotech

CRISPR Therapeutics and Vertex have presented updated data on the first patients treated with their CRISPR/Cas9 gene-editing therapy. The partners now have evidence that one-time treatment with CTX001 improves outcomes in sickle cell disease and beta thalassemia patients for up to 15 months.

In November, CRISPR and Vertex moved the gene-editing field beyond an early milestone by linking the use of CTX001 to sustained improvements in the health and biomarkers of two patients with the severe hemoglobinopathies sickle cell disease and transfusion-dependent beta thalassemia. Late last week, the partners used the European Hematology Association virtual congress to share an update on the studies.

CRISPR and Vertex now have data on two beta thalassemia patients. The first patient, who had nine months of follow up as of last years update, has now been tracked out to 15 months after treatment with CTX001. The patients levels of total hemoglobin, fetal hemoglobin and erythrocytes expressing fetal hemoglobin (F-cells) increased between the two updates.

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The partners also have five-month data on a second beta thalassemia patient. The hemoglobin and F-cell levels of the second patient are close to or above those of the first patient at the nine-month mark. Both patients experienced two serious adverse events, none of which the investigator considered to be related to CTX001.

CRISPR and Vertex also used the virtual event to share a nine-month update on a sickle cell patient. Compared to the four-month readout, total hemoglobin and F-cells are up. Fetal hemoglobin is down slightly, but still well above the level likely needed to be efficacious.

The improved biomarker data are supported by evidence the drug is making a meaningful difference to the lives of the patients. The beta thalassemia patients are transfusion independent, having required 34 and 61 units of packed red blood cells a year previously. The subject who required 34 blood units underwent 33 transfusions over the two years before consenting to join the study.

In the sickle cell trial, the patient used to suffer seven vaso-occlusive crises a year, on average. Over the nine months in the study, the patient has been free from vaso-occlusive crises.

The data, which the author of the abstract said demonstrate a functional cure, support the further assessment of CTX001. Efforts to gather more data were hindered by COVID-19, which led to the temporary cessation of elective hematopoietic stem cell transplants at sites in the U.S. and Europe. Some sites are now gearing up to reinitiate dosing.

Even if the restart progresses slowly, CRISPR and Vertex will still be in a position to share more data later in the year. Investigators dosed another three beta thalassemia patients and one sickle cell patient before COVID-19 hit, setting them up to share updates as those subjects pass follow-up milestones.

The updates should also feature longer-term data on the first three patients treated in the trials. In posting long-term data, CRISPR and Vertex will begin to show whether CTX001 has the durability to be a true one-time treatment and, in doing so, carve out a space in a market fought over by rivals such as bluebird bio.

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CRISPR and Vertex show durability of gene-editing therapy, hoping for one and done treatment - FierceBiotech

Trending news Covid-19 impact on Stem Cell Therapy Market Trending news Covid-19 impact on Stem Cell Therapy Market Key Vendors Countries and Forecast…

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

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

Final Stem Cell Therapy Report will add the analysis of the impact of COVID-19 on this Market.

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Major Players:

Osiris Therapeutics NuVasive Chiesi Pharmaceuticals JCRPharmaceutical Pharmicell Medi-post Anterogen Molmed Takeda (TiGenix)

Segmentation by Product:

Autologous Allogeneic

Segmentation by Application:

Musculoskeletal Disorder Wounds & Injuries Cornea Cardiovascular Diseases Others

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The global Stem Cell Therapy market was valued at $XX million in 2018, and MAResearch analysts predict the global market size will reach $XX million by the end of 2028, growing at a CAGR of XX% between 2018 and 2028.

This report provides detailed historical analysis of global market for Stem Cell Therapy from 2013-2018, and provides extensive market forecasts from 2020-2028 by region/country and subsectors. It covers the sales volume, price, revenue, gross margin, historical growth and future perspectives in the Stem Cell Therapy market.

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

The insight has been added in the report to provide realistic overview of the industry, consist of Stem Cell Therapy manufacturers data, i.e. shipment, price, revenue, gross profit, business distribution, etc., SWOT analysis, consumer preference, recent developments and trends, drivers and restrain factors, company profile, investment opportunity, demand gap analysis, forecast market size value/volume, services and product, Porters Five Models, socioeconomic factors, government regulation in Stem Cell Therapy industry. Market players can use the report to peep into the future of the global Stem Cell Therapy Market and bring important changes to their operating style and marketing tactics to achieve sustained growth.

Global Stem Cell Therapy Market: Competitive Rivalry The chapter on company profiles studies the various companies operating in the global Stem Cell Therapy Market. It evaluates the financial outlooks of these companies, their research and development statuses, and their expansion strategies for the coming years. Analysts have also provided a detailed list of the strategic initiatives taken by the Stem Cell Therapy Market participants in the past few years to remain ahead of the competition.

Table of Contents

Report Overview:It includes major players of the global Stem Cell Therapy Market covered in the research study, research scope, and Market segments by type, market segments by application, years considered for the research study, and objectives of the report.

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

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

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

Market Size by Application:Besides an overview of the global Stem Cell Therapy Market by application, it gives a study on the consumption in the global Stem Cell Therapy Market by application.

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

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

Company Profiles:Almost all leading players of the global Stem Cell Therapy Market are profiled in this section. The analysts have provided information about their recent developments in the global Stem Cell Therapy Market, products, revenue, production, business, and company.

Market Forecast by Production:The production and production value forecasts included in this section are for the global Stem Cell Therapy Market as well as for key regional markets.

Market Forecast by Consumption:The consumption and consumption value forecasts included in this section are for the global Stem Cell Therapy Market as well as for key regional markets.

Value Chain and Sales Analysis:It deeply analyzes customers, distributors, sales channels, and value chain of the global Stem Cell Therapy Market.

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

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COVID-19 and cancer care – Pursuit

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All republished articles must be attributed in the following way and contain links to both the site and original article: This article was first published on Pursuit. Read the original article.

Dr Nienke Zomerdijk

People with cancer may have compromised immunity due to their disease or its treatment. Early reports suggest cancer is a risk factor for severe COVID-19 disease as a result, many patients with cancer, and their families, are concerned about the risks and impacts of COVID-19.

Their concerns and distress are likely to be compounded by extensive media coverage of the pandemic, rapid changes in information about COVID-19 and continuing uncertainty about how to contain the disease.

On top of this, community transmission of COVID-19 has threatened the capacity of cancer services to provide routine investigations and care. In some cases, this has seen a prioritisation or modification of patients cancer therapies.

For example, chemotherapy may be postponed as this can compromise the immune system and make patients more vulnerable to developing COVID-19 disease.

Patients and families may, in turn, be frightened about not receiving proper treatment.

Another cause for concern is the change in the routine clinical management of cancer patients, partly because patients fear being infected. In Victoria, cancer hospitals have reported a 40 per cent decline in patient presentations for cancer management appointments since the stay-at-home guidelines in late March 2020.

This has raised concern among oncology health professionals about the health and wellbeing of vulnerable cancer patients whose health outcomes are likely to be negatively affected.

As patients are presenting less to hospital, it becomes crucial to develop new ways of identifying any distress in order to provide high-quality cancer management and supportive care.

The restrictions imposed by governments have been effective in limiting the spread of COVID-19, but social distancing, quarantine and visitor limitations have also reduced the opportunity for family support and connection important sources of strength and wellbeing.

These same government restrictions have also increased the use of telehealth to deliver care to cancer patients during COVID-19. Telehealth tools include simple patient health portal messages to relieve triage phone lines, e-consultation and telephone or video-based virtual visits.

The latest data from the Victorian COVID-19 Cancer Networks Telehealth Expert Group found that all of Victorias health services were now using telehealth for cancer care. And these tools may continue to expand, allowing greater access to supportive care beyond this crisis.

However, as useful as it is, this technology may pose issues of trust, isolation, disconnectedness and worries about abandonment as patients no longer benefit from the reassuring structure of the hospital oncology setting.

Telehealth may also not be possible for patients without a computer or internet access, which may create inequities in psychosocial care.

These issues should be considered if we upscale telehealth procedures for cancer patients and want to keep the best changes after the pandemic.

With respect to COVID-19, people with blood cancer are a particularly vulnerable group and require specialised attention and care. This is because blood cancers affect the production and functions of cells created in the bone marrow, which produces all the cells of our immune system.

Additionally, treatment for blood cancers compromise the immune system further, placing patients at very high risk of opportunistic infections, often for an extended period.

Even common respiratory viruses, like colds, can threaten survival. As a result, blood cancer specialists have recommended heightened surveillance and protective isolation for people with blood cancers.

A second major issue for blood cancer patients during the COVID-19 pandemic is the availability of donor stem cell products for patients undergoing haematopoietic stem cell transplantation.

Approximately 350 stem cell transplants are performed in Australia every year to treat blood cancers like leukaemia and multiple myeloma.

But finding a suitable stem cell donor is incredibly challenging, and about 80 per cent of donated stem cells come from overseas donors.

Unfortunately, COVID-19 has impacted donor availability due to border restrictions, flight changes and fear of becoming infected, creating very fearful scenarios for those waiting for potentially life-saving stem cell transplantation.

Victoria has already reported a case of a donor cancellation at short notice because the donor was worried about having been in contact with somebody with COVID-19.

The emotional consequences of the COVID-19 pandemic for people with blood cancers cannot be underestimated, nor can the consequences for the healthcare providers who care for them.

The COVID-19 pandemic has had a serious and disruptive effect.

In the short term, staff and resources at many hospitals have been reassigned to manage the rush of patients with COVID-19. Healthcare providers are faced with ethical dilemmas and required to make difficult treatment decisions without evidence-based guidelines.

Estimating the risk versus the benefit of administering potentially immunosuppressive treatment to patients with haematological cancers with a scarcity of knowledge about this novel disease, and balancing the individual and societal benefits with stretched resources, poses acute ethical dilemmas.

Making these challenging decisions can create fertile grounds for burnout and trauma.

More than ever, we need to develop ways to nurture healthcare providers.

Consideration of their unique experiences and needs during these exceptionally difficult times is important and we need to flexibly develop services to respond to those needs now and beyond this crisis.

But in developing such services, as well as recognising unmet needs, we have to acknowledge the problem-solving skills, resourcefulness and innovation that patients and healthcare providers have already undertaken as they have strived to adapt to managing cancer during COVID-19.

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Race Oncology confirms positive results from Bisantrene drug trial on patients with advanced acute myeloid leukaemia – Small Caps

Specialty pharmaceutical company Race Oncology (ASX: RAC) has reported positive data from an investigator-initiated Phase II clinical trial of historical cancer drug Bisantrene on patients with relapsed or refractory acute myeloid leukaemia.

Conducted at the Sheba Medical Centre in Israel, the open-label, single-agent trial studied 10 patients who, on average, had failed three prior lines of treatment.

Bisantrene was found to be well tolerated with no unexpected or serious toxicities, the company reported.

After a single course of treatment, the drug demonstrated an overall clinical response rate of 40%, with one patient progressing to complete remission and three achieving partial remission.

One patient was bridged to allogeneic stem cell transplantation (where cells are donated to the patient from a genetically-matched donor) and there were no removals or withdrawals from the study during treatment.

The drug also had marked activity in four patients with extramedullary (outside of the bone marrow) acute myeloid leukaemia such as leukemia cutis, chloromas, and central nervous system disease which has historically been difficult to treat.

The most frequently reported serious adverse events were thrombocytopaenia (low blood platelets) and mucositis (mouth ulcers), both of which were expected side effects of anthracyline and anthracene chemotherapeutics.

One patient experienced transient grade one kidney toxicity and there were no liver toxicities observed.

Race said there were no anaphylactoid-type reactions observed in any patient over the course of treatment. This type of reaction was a serious adverse event regularly observed in the historical trials.

Relapsed or refractory acute myeloid leukaemia remains a significant therapeutic challenge.

While meaningful gains have been achieved in recent years with the introduction of new targeted drugs, published studies claim the clinical outcomes remain unsatisfactory.

Bisantrene is a small molecule cancer drug related to anthracyclines the most widely-used class of chemotherapy drugs.

Unlike anthracyclines, it has a greatly reduced risk of cardiotoxicity (heart damage), meaning it can be used with patients who have reached their cardiotoxic limit with anthracyclines, or cannot tolerate anthracyclines due to existing heart conditions, age or other factors.

Bisantrene was tested in more than 40 phase II clinical trials during the 1980s and 1990s with up to $200 million put into its development, before it was lost in a series of big pharmaceutical mergers.

Race clinical advisory board chairman and international authority in clinical leukaemia and stem cell research, Professor Borje Andersson, said the trial confirmed historical results which used a different formulation of Bisantrene.

While Bisantrene had been demonstrated in the 1980s as an effective salvage drug against acute myeloid leukaemia, the [clinical] data we had was old, he said.

It was important for us to study it by todays standards using the current formulation, so we could confirm whether our strategy of repurposing this drug is sound.

We also wanted to confirm that Bisantrene could still generate a meaningful response rate in a highly-frail patient population with heavily pre-treated acute myeloid leukaemia, Professor Andersson added.

The study saw a reduction in the leukaemic disease burden and an overall response rate in 40% of the patients.

While we must study the drug further, it appears that with this kind of response, Bisantrene-based therapy may have the potential to serve as an important bridge to allogeneic stem cell transplantation in patients who otherwise have few therapeutic options, Professor Andersson said.

Race chief scientific officer Dr Daniel Tillett said a key focus of Phase II clinical trial was to determine Bisantrenes safety in a modern context.

These results are pleasing from a safety and activity perspective, particularly given the clinically-challenging patient population included in the trial, he said.

It was encouraging to see the drugs tolerability profile compared favourably with other commonly-used chemotherapy agents such as anthracyclines, while the side effects were in keeping with what we would expect to see with all chemotherapeutics of this class, Dr Tillett added.

Professor Andersson said the trial found Bisantrene to be an agent with an acceptable safety profile and promising anti-leukaemic activity.

As this was an open-label, single-agent trial, we can be confident that it was the Bisantrene exposure which generated the positive results, he said.

The patient cohort had advanced acute myeloid leukaemia and had previously failed an average of three lines of therapy, so they were always going to be tough to treat, but a 40% overall response rate after only a single course of treatment markedly exceeded our expectations.

It is a hugely promising result and one which reinforces our development plans for this drug, Professor Andersson added.

A follow-up study combining Bisantrene with other anti-leukaemic drugs is currently in the advanced planning stages.

At mid-morning, shares in Race Oncology were up 53.97% to $0.485.

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Race Oncology confirms positive results from Bisantrene drug trial on patients with advanced acute myeloid leukaemia - Small Caps

Biogen’s NURTURE Data, And Other News: The Good, Bad And Ugly Of Biopharma – Seeking Alpha

Biogen Reports Positive Data from Landmark NURTURE Study

Biogen Inc. (BIIB) reported new data from NURTURE which included nearly a year of additional follow-up for NURTURE study participants. It is the longest study of pre-symptomatic patients with spinal muscular atrophy. New data shows that in infants genetically diagnosed with SMA, early and sustained treatment with SPINRAZA for up to 4.8 years enabled unprecedented survival.

As of February 2020, all 25 patients treated were alive and remained free of permanent ventilation. All children who achieved the motor milestone of being able to walk independently, kept up that ability until the last visit. Kathryn Swoboda, M.D., the Katherine B. Sims, M.D., Endowed Chair in Neurogenetics and Director of the Neurogenetics Program, Massachusetts General Hospital said, The impact of early and sustained SPINRAZA treatment on these infants and their families is remarkable. Ive had the privilege to watch them grow into active young children, many of whom have experienced progress in motor function consistent with children their age who do not have SMA.

The patients enrolled in the study received their first dose of SPINRAZA before they were 6 weeks old. The new data showed that the participants who were previously able to walk independently and walk with assistance sustained their ability over the course of 11 months since the last data cut. Over the 11 months of follow-up, one child gained the ability to walk with assistance.

Patients with two copies of SMN2 were able to score and advance on the Hammersmith Functional Motor Scale Expanded scale. This development is atypical to the natural history of the disease. The drug candidate was found to be well-tolerated and did not show any new safety concerns over the extended follow-up period. further, no patient had to drop out of the study on account of adverse events concerned with the treatment.

SPINRAZA is the first approved therapy for treating infants, children and adults with spinal muscular atrophy, which is a rare, genetic, neuromuscular disease characterized by a loss of motor neurons in the spinal cord and lower brain stem. The drug candidate is an antisense oligonucleotide and is administered by intrathecal injection into the fluid surrounding the spinal cord. It has been developed using Ionis Pharmaceuticals (NASDAQ:IONS) proprietary technology, which aims to increase the amount of survival motor neuron protein.

Biogen licensed the global rights for developing, manufacturing and commercializing SPINRAZA from Ionis Pharmaceuticals, Inc. Both the companies collaborated for developing the therapy. Some of the most common adverse events associated with SPINRAZA are respiratory infection, fever, constipation and headache. Some patients also complained of renal toxicity.

SPINRAZAs main competitor in the market is Zolgensma, which has been developed by Novartis (NYSE:NVS). The therapy comes with a price tag of $750,000 for the first year and $375,000 per annum subsequently.

Biogen is mainly focused on developing therapies for neurological and neurodegenerative diseases. It has robust portfolio of medicines for a wide range of ailments such as multiple sclerosis and spinal muscular atrophy.

Magenta Therapeutics (MGTA) made a strategic decision to discontinue enrollment for its Phase 2 clinical trial for MGTA-456. The company stated that various factors including the impact of COVID 19 and the FDA feedback regarding the endpoints and design of a registrational study were behind the decision. Magenta stated that it plans to put its resources into promoting stem cell mobilization and conditioning programs.

Magenta made this announcement while providing portfolio update. The company also provided information about its other programs such as MGTA-145, which is a first line stem cell mobilization therapy. The data showed that the drug candidate, when used in conjunction with plerixafor, offers safe, same-day dosing, mobilization and collection of sufficient functional hematopoietic stem cells for transplant.

For MGTA-456, the company said that it has become aware of several challenges facing allogeneic stem cell transplant in patients with non-malignant diseases, leading to the decision to withdraw from the study. However, it expects the enrolment in the Phase 2 investigator-initiated trial in patients with blood cancers to be completed in the near future. Jason Gardner, CEO of the company said, As part of this strategic decision, we will discontinue enrollment in the Phase 2 study of MGTA-456 cell therapy in patients with inherited metabolic disorders. We thank the brave patients and their families who participated in the trial, as well as the dedicated investigators and team members at the clinical trial sites.

Magenta is a biotech firm which is mainly focused on developing novel medicines for various blood cancers, genetic diseases and autoimmune disorders. The company stock is currently trading nearly 30 percent low on Year to Date basis and is facing uncertainty on account of pandemic outbreak and several internal reasons.

Clovis Oncology (CLVS) announced that it has completed enrolment for its Phase 3 ATHENA trial. The company stated that it expects the topline data from the Rubraca monotherapy cohort to be available by the second half 2021, whereas the data from combination cohort will be out by the second half of 2022 or later.

ATHENA trial had the target of enrolling 1,000 ovarian cancer patients and these were enrolled in trial sites spread across 24 countries in North America, Europe and Asia. Patrick J. Mahaffy, CEO of Clovis Oncology, said, The completion of target patient enrollment in the Phase 3 ATHENA trial is an important milestone for Clovis and a critical step toward developing additional therapeutic options for women with advanced ovarian cancer.

Phase 3 ATHENA trial seeks to assess the combination of Rubraca and Opdivo as the first line maintenance treatment for newly diagnosed ovarian cancer patients after their initial treatment with platinum-based chemotherapy. Phase 3 trial is a multinational, randomized and double-blind study. This four-arm trial has investigator-assessed progression-free survival as its primary endpoint while its secondary endpoints include overall survival, response rate and duration of response. The company is using Bristol-Myers Squibb's (NYSE:BMY) PD-1 inhibitor OPDIVO for the combination arm.

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3. It is currently being tested for a wide range of solid tumors and ovarian cancer. In the United States, the drug candidate is already approved as the maintenance treatment of adult patients with recurrent epithelial ovarian, primary peritoneal cancer or fallopian tube who are in a complete or partial response to platinum-based chemotherapy. It is also approved in Europe for certain indications.

Clovis Oncology is mainly focused on developing therapies for various cancers. The company has several collaborations for its development processes.

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Biogen's NURTURE Data, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha