Global Regenerative Medicine Market By Type, Therapy, Application and Forecast Report by 2030 – Cole of Duty

The increasing incidence of genetic disorders and chronic diseases is one of the biggest factors responsible for the burgeoning sales of regenerative medicine throughout the globe. The rising adoption of sedentary lifestyles and unhealthy dietary habits of the people all around the world are the main reasons causing the high prevalence of chronic diseases across the world. According to the World Health Organization (WHO), almost 17.9 million deaths are recorded every year because of cardiovascular diseases. Moreover, the cardiovascular diseases account for nearly 31% of the total deaths occurring across the world every year.

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The other major factors propelling the demand for regenerative medicine are the soaring investments being made by the governments of many countries in research and development activities in the domain of regenerative medicine, surging number of regenerative medicine companies throughout the world, and rapid technological developments in tissue engineering areas and stem cell research. Due to these factors, the global regenerative medicine market is expected to exhibit huge expansion over the coming years.

Across the globe, the regenerative medicine market is predicted to record the fastest growth in the Asia-Pacific (APAC) region in the upcoming years. This is mainly credited to the improving healthcare facilities and infrastructure in the region and the subsequent rise in stem cell research in the developing nations of APAC. For instance, the Chinese government has recently approved R&D activities pertaining to the human embryonic stem cells, which has in turn, encouraged more research on the clinical potential of the stem cells in the country.

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New CRISPR, gene therapy results strengthen potential for treatment of blood diseases – BioPharma Dive

Three people with the inherited blood diseases sickle cell and beta thalassemia remain free of burdensome blood transfusions and their worst symptoms, months after receiving an infusion of genetically modified stem cells.

One of the three, a young woman with a severe form of beta thalassemia, has now been followed for over a year since she was treated, while the second, a woman in her 30s with sickle cell disease, is more than nine months removed from her infusion. They are the first two patients in pioneering studies of a therapy, developed by CRISPR Therapeutics and Vertex, that's based on the gene editing technology known as CRISPR.

Both patients continue to respond to treatment, bolstering evidence of genetic medicine's potential to permanently alter the course of devastating hereditary conditions like sickle cell and transfusion-dependent beta thalassemia. A gene therapy developed by Bluebird Bio has shown similar potential.

First results from the two studies, disclosed last November, were "taking the promise of CRISPR and turning that into a reality," said Samarth Kulkarni, CRISPR Therapeutics' CEO, in an interview. The additional data and follow-up now available "show these effects can be long-lasting and durable."

And in beta thalassemia, the first patient's experience is now supported by results from another patient who was treated about five months ago. This individual has also been able to stop receiving blood transfusions.

Taken together, the two patients responses are "proof of concept," CRISPR Therapeutics and Vertex claim, that their approach to treating beta thalassemia has the potential to be curative.

In sickle cell, the companies are also hopeful. The one patient for whom they have data has not had a vaso-occlusive crisis, a painful episode caused by the disease's characteristic sickling of red blood cells, since her treatment.

"The clinical manifestation of the disease is different, but we see consistent outcomes across both diseases," said Bastiano Sanna, Vertex's head of cell and genetic therapies, in an interview.

Three other beta thalassemia patients and one other sickle cell disease patient have been treated in the two studies of CRISPR Therapeutics and Vertex's therapy, dubbed CTX001. If results continue to look positive, CTX001 could be another powerful way to help people for whom treatment options have long been limited.

CRISPR, an easy-to-use method of genetic surgery that's derived from a bacterial defense system, has become a mainstay in labs across the world for all types of experiments. Its potential use as a human therapeutic has drawn closer as companies harnessing the technology CRISPR Therapeutics, Editas Medicine and Intellia Therapeutics have advanced their research. CRISPR Therapeutics is the first of the three to deliver results from a clinical trial.

CRISPR and Vertex unveiled their updated results at the European Hematology Association's virtual meeting on Friday. Also being presented were the latest data from Bluebird's gene therapy, known as LentiGlobin.

Bluebird is much further along, having treated 60 patients with beta thalassemia and 37 with sickle cell disease across six different studies.

Updated results from three of those studies showed 23 of 27 evaluable patients with beta thalassemia were transfusion independent for at least a year following treatment. And in sickle cell, no serious vaso-occlusive crises were observed in the 18 patients who had at least six months of follow-up. An episode was previously reported in one patient several months after LentiGlobin treatment, but was judged to be non-serious.

One sickle cell patient died suddenly 20 months following infusion with LentiGlobin, Bluebird reported Friday. Both the treating physician and an independent study committee concluded the death, ruled to be cardiovascular in nature, was unlikely to be related to the gene therapy.

Both beta thalassemia and sickle cell are diseases caused by mutations in the beta globin gene, faulty DNA that results in either absent or warped hemoglobin. Without enough hemoglobin, patients' red blood cells can't carry needed oxygen throughout the body. And those with sickle cell have abnormal hemoglobin that makes red blood cells fragile and stiff, causing them to stick in blood vessels.

Both diseases require chronic blood transfusions, and can lead to organ damage and reduced lifespans. Treatment options are limited, although that's now changing. The Food and Drug Administration, over the past few years, has approved Reblozyl, for beta thalassemia, and Oxbryta and Adakveo, for sickle cell.

Adakveo reduces the frequency of vaso-occlusive crises, while Reblozyl and Oxbryta are chronic medicines meant to boost patients' hemoglobin levels.

CRISPR Therapeutics and Vertex, along with Bluebird, are trying to accomplish the same goal but in more dramatic fashion: raising hemoglobin levels high enough so patients can stop blood transfusions and, in sickle cell, avoid pain crises altogether.

CRISPR and Vertex use CRISPR/cas9 gene editing to modify the DNA of stem cells extracted from a patient's bone marrow. The cells are engineered to produce a type of hemoglobin that's present at birth but normally replaced soon after. Once returned to the body and engrafted in the bone marrow, these CRISPR'd cells substitute this so-called fetal hemoglobin for the missing adult hemoglobin.

In the three patients treated so far, that appears to be what's happened. Both beta thalassemia patients are producing hemoglobin at levels considered normal. The sickle cell patient now has enough fetal hemoglobin to dilute the effects of sickled hemoglobin, potentially helping to preserve red blood cells.

Crucially, CRISPR and Vertex shared data for the first time indicating a high percentage of edited cells are present in each patient's bone marrow, supporting their confidence that the effects of treatment might last.

Bluebird, by contrast, doesn't edit the DNA of extracted stem cells, but rather inserts a modified gene into those cells. Once infused and engrafted in a patient, the cells can produce gene therapy-derived hemoglobin.

In most beta thalassemia and sickle cell patients treated with Bluebird's LentiGlobin, hemoglobin levels rose to normal or near-normal levels.

LentiGlobin is already approved for certain beta thalassemia patients in Europe as Zynteglo. In the U.S., Bluebird has hit delays and pushed back when it expects to submit an application to the middle of next year. A filing for an accelerated approval in sickle cell would likely follow sometime in the second half of 2021.

CRISPR and Vertex, meanwhile, plan to enroll more patients into their two studies, which they hope could serve as sufficient for an approval application if positive, Kulkarni said.

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CAG Regimen Shows Strong Results as Salvage Therapy in T-ALL – AJMC.com Managed Markets Network

Patients with relapsed/refractory T-cell lymphoblastic leukemia face poor outcomes, and are generally treated by salvage therapy followed by allogeneic hematopoietic stem cell transplant. A new study suggests an optimal option for salvage therapy.

Investigators in China say the cytarabine, aclarubicin, and G-SCF (CAG) regimen is highly effective and safe in patients with R/R-T-ALL, confirming the experience of a single cancer centers smaller study. The new research may help build consensus in a therapeutic area in which patients face stiff odds and no single salvage therapy has emerged as the standard of care.

Writing in the journal Cancer Medicine,1 a team of investigators including Hong-Hu Zhu, MD, PhD, of the First Affiliated Hospital of Zhejiang University, in China, notes that patients who are newly diagnosed with T-ALL have been treated more successfully in recent years, but survival among patients with relapsed or refractory T-ALL face long-term survival rates of less than 10%.

The only curable treatment is initiating a salvage regimen to achieve complete remission (CR) and then rapidly performing allogeneic hematopoietic stem cell transplantation (allo-HSCT), the authors write. Therefore, selecting an effective salvage regimen is vital for R/R-T-ALL.

Thats where the trouble comes in, though. Zhu and colleagues note that although a number of regimens are being used, there is no consensus on the optimal therapy. Back in 2008, a team of Chinese investigators published findings2 showing promising results with the CAG regimen, but the study size was small.

In an effort to better evaluate the regimen, Zhu and his team constructed a 6-center retrospective analysis of patients with R/R-T-ALL who were at least 16 years old and who underwent the CAG regimen as salvage therapy between 2012 and 2019. The team measured complete remission (CR), partial response (PR), overall survival (OS), and event-free survival (EFS).

Out of a total of 41 patients, 33 achieved CR after one cycle of the CAG regimen, and 2 more patients achieved PR. Six patients failed to respond. Early T-cell precursor status did not affect CR rates, which were around 80% for both ETP and non-ETP patients.

Of the 41 patients, 27 underwent successful allo-HSCT, the majority of whom (22) were in CR. After 2 years, OS was estimated at 68.8% and EFS was estimated at 56.5%.

Our multicenter results show that the CAG regimen is associated with a high CR rate of 80.5% and is well-tolerated, enabling most patients to bridge to allo-HSCT, Zhu and colleagues report. Thus, this regimen represents a novel option for adult R/R-T-ALL patients.

Zhu and colleagues said the most surprising finding was the very high overall response rate of 85.4%. Furthermore, the fact that 66% of patients were able to bridge to allo-HSCT was highly encouraging, they said. The investigators note that the regimen is most commonly used in China for the treatment of acute myeloid leukemia (AML).

The CAG regimen seems to have low rates of hematological and non-hematological adverse events, something found in the current study but also in use in AML.

The authors note that the cancer is so rare that it will be difficult to study in much larger trials, though they are currently planning a study that will include 18 cancer centers in China to validate the results. In the meantime, they write that the regimen represents a ray of hope in a difficult disease category.

The CAG regimen enabled most patients to bridge to allo-HSCT and achieve improved outcomes; thus, it represents a novel option for this population with poor prognosis, they conclude.

References:

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CAG Regimen Shows Strong Results as Salvage Therapy in T-ALL - AJMC.com Managed Markets Network

Global NK Cell Therapy and Stem Cell Therapy Market Analysis, Growth, Size, Demand & Forecast 2020-2025 – Cole of Duty

The latest trending report Global NK Cell Therapy and Stem Cell Therapy Industry Market to 2025 available at MarketStudyReport.com is an informative study covering the market with detailed analysis. The report will assist reader with better understanding and decision making.

The research report on NK Cell Therapy and Stem Cell Therapy Industry market report comprises of an in-depth analysis of this industry vertical. The key trends that describe the NK Cell Therapy and Stem Cell Therapy Industry market during the forecast period are cited in the document, alongside additional factors including industry policies and regional scope. Moreover, the study specifies the impact of prevailing industry trends on potential investors.

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COVID-19, the disease it causes, surfaced in late 2020, and now had become a full-blown crisis worldwide. Over fifty key countries had declared a national emergency to combat coronavirus. With cases spreading, and the epicentre of the outbreak shifting to Europe, North America, India and Latin America, life in these regions has been upended the way it had been in Asia earlier in the developing crisis. As the coronavirus pandemic has worsened, the entertainment industry has been upended along with most every other facet of life. As experts work toward a better understanding, the world shudders in fear of the unknown, a worry that has rocked global financial markets, leading to daily volatility in the U.S. stock markets.

The report also provides with an overview of the competitive landscape along with a thorough analysis of the raw materials as well as the downstream buyers.

Revealing a summary of the competitive analysis of NK Cell Therapy and Stem Cell Therapy Industry market:

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Calquence showed long-term efficacy and tolerability for patients with chronic lymphocytic leukaemia in two trials | Vaccines | News Channels -…

DetailsCategory: VaccinesPublished on Saturday, 13 June 2020 12:40Hits: 358

ACE-CL-001 trial showed an overall response rate of 97% with a sustained safety profile for previously untreated patients after more than four years

In pivotal ASCEND trial, 82% of patients with relapsed or refractory disease treated with Calquence remained progression free at 18 months vs. 48% for comparators

LONDON, UK I June 12, 2020 I Detailed results from both the Phase II ACE-CL-001 trial and the pivotal Phase III ASCEND trial showed the long-term efficacy and tolerability of Calquence (acalabrutinib) in chronic lymphocytic leukaemia (CLL), one of the most common types of adult leukaemia.1,2,3

The results will be presented during the Virtual Edition of the 25th European Hematology Association (EHA) Annual Congress, 11 to 14 June 2020.

In the single-arm ACE-CL-001 trial, 86% of CLL patients treated with Calquence as a 1st-line monotherapy remained on treatment at a median follow up of more than four years. The trial showed an overall response rate of 97% (7% complete response; 90% partial response) and a 100% overall response rate in subgroups of patients with high-risk disease characteristics, including genomic aberrations (17p deletion and TP53 mutation), immunoglobulin mutation status (unmutated IGHV), and complex karyotype. Safety findings showed no new long-term issues.1,4

In the final analysis of ASCEND, an estimated 82% of patients with relapsed or refractory CLL treated with Calquence remained alive and free from disease progression at 18 months compared with 48% of patients on rituximab combined with idelalisib or bendamustine.2 The trial previously met the primary endpoint of Independent Review Committee-assessed progression-free survival at the interim analysis.5

Richard R. Furman, Director of the CLL Research Center, Weill Cornell Medicine said: These data demonstrate no new safety concerns for acalabrutinib, confirming its ability to safely provide meaningful, long-term clinical benefit for patients with treatment-naive and relapsed or refractory disease. The safety profile of acalabrutinib makes treatment to progression an important and plausible option for patients.

Jos Baselga, Executive Vice President, Oncology R&D said: These long-term data reaffirm that Calquence delivers a durable response with a favourable safety profile for chronic lymphocytic leukaemia patients. Patients with chronic lymphocytic leukaemia are typically 70 years or older with comorbidities and often require treatment over a long time, making the sustained safety and efficacy profile highly relevant to their quality of life.

Results from the Phase II ACE-CL-001 trial informed the development of the pivotal Phase III ELEVATE TN trial, which, along with findings from the Phase III ASCEND trial, formed the basis for the US approval of Calquence for the treatment of patients with CLL or small lymphocytic lymphoma (SLL).

Calquence in previously untreated CLL: 4.4-year follow-up from Phase II trial (abstract #S163)

The Phase II ACE-CL-001 trial investigated safety and efficacy of Calquence (100mg twice-daily [n=62] or 200mg once-daily [n=37]) in previously untreated patients with CLL.1 On 1 May 2015, patients receiving the 200mg dosing regimen were switched to the 100mg regimen.1

Key data from the Calquence Phase II ACE-CL-001 trial1

CI, confidence interval; CR, complete response; DoR, duration of response; EFS, event free survival; TTR, time to response; NR, not reached; ORR, overall response rate; PR, partial response

Response rates were 100% in each subgroup of patients with high-risk disease characteristics (unmutated IGHV [n=57], 17p deletion [n=9], TP53 mutation [n=9], and complex karyotype [n=12]), and reduction in lymph node disease was noted in all patients tested (n=97).1

At the time of data cut-off, 85 (86%) patients receiving Calquence remained on treatment. Six patients discontinued treatment due to adverse events (AEs) and three patients discontinued for progressive disease (PD). No patient discontinued Calquence due to bleeding events, hypertension, or atrial fibrillation. Incidence of AEs generally diminished with time on the trial. The most common AEs (40%) of any grade in the trial were diarrhoea (52%), headache (45%), upper respiratory tract infection (44%), arthralgia (42%), and contusion (42%). All-grade and Grade 3 events of clinical interest included infection (84% and 15%, respectively), bleeding events (66%, 3%), hypertension (22%, 11%), leukopenia (9%, 9%), and thrombocytopenia (3%, 1%). Atrial fibrillation (all grades) occurred in 5% of patients with Grade 3 occurring in 2%. Second primary malignancies (SPM) excluding non-melanoma skin (all grades) occurred in 11% of patients.1 Serious adverse events (SAEs) were reported in 38% of patients. SAEs occurring in more than two patients included pneumonia (n=4) and sepsis (n=3).1

Final results of Calquence Phase III ASCEND trial in relapsed or refractory CLL (abstract #S159)

ASCEND was a global, randomised, multicentre, open-label, Phase III trial that investigated the efficacy and safety of Calquence (100mg twice-daily) versus investigators choice of rituximab combined with idelalisib (IdR) or bendamustine (BR) in patients with relapsed or refractory CLL.2

Key data from the final analysis of the Calquence Phase III ASCEND trial2

BR, rituximab in combination with bendamustine; CI, confidence interval, DoR, duration of response; HR, hazard ratio; IdR, rituximab in combination with idelalisib; INV, investigator; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival

Sixteen per cent of patients on Calquence, 56% of patients on IdR, and 17% of patients on BR discontinued treatment because of AEs. Common AEs occurring in greater than 15% of patients of any grade in the Calquence arm of the trial included headache (22%), neutropenia (21%), diarrhoea (20%), upper respiratory tract infection (20%), cough (16%), and anaemia (16%). Events of clinical interest for Calquence versus controls included atrial fibrillation (all grade, 6% and 3%, respectively), major haemorrhage (all grade, 3% in both arms), infections (Grade 3, 20% and 25%, respectively), and SPM excluding non-melanoma skin cancer (all grade, 5% and 2%, respectively). SAEs (any grade) occurred in 33% of patients receiving Calquence, 56% of IdR patients, and 26% of BR patients.2

Chronic lymphocytic leukaemia

Chronic lymphocytic leukaemia (CLL) is one of the most common types of leukaemia in adults, with an estimated 105,000 new cases globally in 2016 and 21,040 new cases in the US in 2020, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.3,6,7,8 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.3 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets.3 This could result in anaemia, infection, and bleeding.3 B-cell receptor signalling through Brutons tyrosine kinase is one of the essential growth pathways for CLL.

Calquence

Calquence(acalabrutinib) is a next-generation, selective inhibitor of Brutons tyrosine kinase (BTK).Calquencebinds covalently to BTK, thereby inhibiting its activity.4,9 In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.4

Calquenceis approved for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) in nine countries and for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy in 14 countries. The US MCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluatingCalquencein 23 company-sponsored clinical trials.Calquenceis being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenstrm macroglobulinaemia, follicular lymphoma, and other haematologic malignancies.

AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Companys haematology franchise includes two US FDA-approved medicines and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZenecas haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca's main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates - and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visitastrazeneca.comand follow the Company on Twitter@AstraZeneca.

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References

1. Byrd JC, et al. Acalabrutinib in Treatment-Nave Chronic Lymphocytic Leukemia: Mature Results From Phase 2 Study Demonstrating Durable Remissions and Long-Term Tolerability. Abstract S163 presented at the Virtual Edition of the 15th European Hematology Association (EHA) Annual Meeting. Available online. Accessed June 2020.

2. Ghia P, et al. Acalabrutinib (Acala) vs Idelalisib plus Rituximab (IdR) or Bendamustine plus Rituximab (BR) in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): ASCEND Final Results. Abstract S159 presented at the Virtual Edition of the 15th European Hematology Association (EHA) Annual Meeting. Available online. Accessed June 2020.

3. National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)Patient Version. Available online. Accessed June 2020.

4.Calquence(acalabrutinib) [prescribing information]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.

5. Ghia P, et al. ASCEND Phase 3 Study of Acalabrutinib vs Investigators Choice of Rituximab Plus Idelalisib (IdR) or Bendamustine (BR) in Patients with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL). Abstract LB2606 at the 2019 European Hematology Association (EHA) Annual Meeting. Available online. Accessed June 2020.

6. Global Burden of Disease Cancer Collaboration. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016. JAMA Oncol. 2018;4(11):1553-1568.

7. American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Available online. Accessed June 2020.

8. Jain N, et al. Prevalence and Economic Burden of Chronic Lymphocytic Leukemia (CLL) in the Era of Oral Targeted Therapies. Blood. 2015;126:871.

9. Wu J, Zhang M & Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor.J Hematol Oncol. 2016;9(21).

SOURCE: AstraZeneca

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Calquence showed long-term efficacy and tolerability for patients with chronic lymphocytic leukaemia in two trials | Vaccines | News Channels -...