Gamida Cell Submits Biologics License Application for Omidubicel to the FDA – Pharmacy Times

The drug is being evaluated as the first potential allogeneic advanced cell therapy donor source for patients with blood cancers in need of a transplant.

Gamida Cell has completed the rolling biologics license application (BLA) submission to the FDA for omidubicel for the treatment of individuals with blood cancer who need an allogenic hematopoietic stem cell transplant, the company said in a statement.1

Omidubicel is an advanced cell therapy candidate that was developed as an allogeneic hematopoietic stem cell transplant for individuals with blood cancer. It is the first stem cell transplant donor source to receive breakthrough therapy designation from the FDA.1

Additionally, it has received orphan drug designation in the European Union and the United States.1

The BLA submission marks an important milestone for both Gamida and the transplant community, as omidubicel has the potential to be the first approved advanced cell therapy product for allogeneic stem cell transplantation, Julian Adams, PhD, CEO of Gamida Cell, said in the statement.1

Completion of this BLA submission is a key inflection point in our mission to deliver a new treatment option for patients with blood cancers. We look forward to working closely with the FDA to bring this potentially important therapy to patients, Adams said.1

The FDA has 60 days to determine whether the BLA for omidubicel is acceptable for filing.1

The BLA is supported by the results of a phase 3 study published in Blood, the journal of the American Society of Hematology. The study met its primary endpoint of the median time to neutrophil engraftment in individuals with hematologic malignancies undergoing allogeneic bone marrow transplant, with patients receiving omidubicel having a median time of 12 days compared with 22 days for the umbilical cord blood graft group.1

In the key secondary endpoints of the study, approximately 55% of individuals receiving omidubicel achieved platelet engraftment by day 42 compared with approximately 35% for the comparator.1

Additionally, the rate of infection was significantly reduced, with the cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for individuals randomized to omidubicel being 37% compared with 57% for the comparator.1

Hospitalization in the first 100 days after transplant was significantly reduced with a median number of days alive and out of hospital for individuals randomized to omidubicel was 61 days compared with 48 days for the comparator.1

Furthermore, 1-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by a significant reduction in infectious complications and reduced non-relapse mortality. There was no significant increase in increases in graft-versus-host-disease rates or the relapse rate.1

The results showed that transplantation after an individual received omidubicel had fewer bacterial and viral infections and less time in the hospital, investigators said.2

Omidubicel was generally well tolerated in the phase 3 study.1

Investigators reported that the incidence of treatment-emergent serious adverse events were similar in both arms, with approximately 40% in the omidubicel group and 41% for the comparator.2

References

1. Omidubicel has orphan drug designation and breakthrough therapy designation. Gamida Cell. News release. June 2, 2022. Accessed June 3, 2022. https://investors.gamida-cell.com/news-events/press-releases/news-release-details/gamida-cell-completes-rolling-biologics-license

2. Horwitz ME, Stiff PJ, Cutler C, Brunstein C, et al; Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021;138(16):1429-1440. doi: 10.1182/blood.2021011719

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Second CAR T Infusion Could Lead to New Response in B-ALL – Targeted Oncology

Several treatment options are being explored for patients who have residual disease or who relapse after CAR T-cell therapy, including a possible second infusion with the same CAR T-cell product.

Young patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who had a suboptimal response or relapse after chimeric antigen receptor (CAR) T-cell therapy could benefi t from reinfusion, according to a retrospective review (NCT03827343).

Our study provides important insights into [second CAR T-cell infusion] outcomes, including with antigen targets beyond CD19, the study authors, including corresponding author Nirali N. Shah, MD, MHSc, of the National Cancer Institute (NCI), wrote in their report published in the Journal for ImmunoTherapy of Cancer.

Several treatment options are being explored for patients who have residual disease or who relapse after CAR T-cell therapy, including a possible second infusion with the same CAR T-cell product.

The retrospective review looked at patients with B-ALL who received a reinfusion in 1 of 3 phase 1 NCI-based clinical trials (NCT01593696, NCT02315612, NCT0344839). At fi rst CAR T-cell therapy infusion, patients received either an anti-CD19, anti-CD22, or an anti-CD19/CD22 agent. If the patients had relapse after complete remission (CR) or suboptimal response and CAR expansion, they were offered a second infusion (n = 18).

The primary aim of the review was to assess CR rates of second infusions and the rate of adverse events (AEs). Secondary goals included the characterization of CAR expansion and antigen expression as well as the impact of the intensity of lymphodepletion.

A total of 136 patients were treated across the 3 studies, but only 18 (13.2%) went on to receive a second infusion with the same CAR product. As of the time of the second infusion, the median age of patients was 19 (range, 8-31). A majority of the patients were male (88.9%), White (66.7%), and of non-Hispanic ethnicity (83.3%). As of the second infusion, 88.9% had active medullary disease, 22.2% had low marrow involvement, 66.7% had high disease burden, and 11.1% had isolated CNS disease.

Patients had received a median of 6 lines of prior therapy (range, 2-13), including prior hematopoietic stem cell transplantation (HSCT) in 77.8%, prior immunotherapy in 44.4%, and prior alternate CAR T-cell therapy in 50%.

Seven patients (38.7%) had a suboptimal response to the fi rst infusion of either partial response or stable disease, including 4 who did not have a CR from first infusion, and 11 patients (61.1%) had an antigen-positive relapse; all 18 patients had CAR expansion. The median time between the fi rst and second infusion was 116.5 days (range, 35-373), and 38.9% received therapy in between.

The second infusion was administered at the same dose for 15 patients (83.3%), at a lower dose in 2 patients (11.1%) and a higher dose in 1 (5.5%).

Seven patients (38.9%) achieved an objective marrow response to the second infusion, with 5 of these patients (71.4%) achieving a minimal residual disease (MRD) negative CR, and 6 (33.3%) had a morphologic CR.

Long-term survival with second CAR infusion was limited. All patients eventually relapsedincluding 2 with CNS disease, 3 with medullary relapse, and 1 with both medullary and extramedullary relapse and none were eligible for HSCT. The median duration of remission was 77 days (range, 54-292).

Our results suggest that diminished CAR T-cell expansion alongside antigen downregulation and loss impeded robust responses to CART2. Further exploration of the mechanisms underlying CART2 response is needed, Shah et al wrote.

Cytokine release syndrome (CRS) was observed in 83.3% of patients with fi rst infusion, including severe CRS of grade 3 or higher in 27.8%. Only 22.2% reported CRS with second infusion at a maximum severity of grade 1. Neurologic toxicity was reported with fi rst infusion in 22.2% and with second infusion in 11.1%.

Observed peripheral blood CAR T-cell expansion was higher with the fi rst infusion than the second (median, 24.05 vs 1.69 cells/mL, respectively; P = .03). Five patients (27.8%) showed no CAR expansion post second infusion. CAR expansion tended to be higher with the CD22-targeted agent than the other CAR T-cell products.

REFERENCE:

Holland EM, Molina JC, Dede K, et al. Efficacy of second CAR-T (CART2) infusion limited by poor CART expansion and antigen modulation. J Immunother Cancer. 2022;10(5):e004483. doi:10.1136/jitc-2021-004483

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Second CAR T Infusion Could Lead to New Response in B-ALL - Targeted Oncology

Asymmetrex’s Kinetic Stem Cell (KSC) Counting Technology Is Featured in the Parent’s Guide to Cord Blood Foundation June Newsletter – PR Web

The Parent's Guide to Cord Blood features Asymmetrex's technology for determining the dosage of therapeutic cord blood stem cells.

BOSTON (PRWEB) June 15, 2022

The Parent's Guide to Cord Blood Foundation is well known for its excellence in advocacy and education to support parents negotiating medical treatments for their children that involve umbilical cord blood and tissues. The Parent's Guide monthly newsletter has a goal of presenting new advances in umbilical cord medical research and treatments in terms that are accessible by parents and others who are not experts. The June 2022 issue, published June 14, provides a graphical presentation of stem cell biotechnology company Asymmetrex's technology that provides the dose of therapeutic umbilical cord stem cells for the first time.

Determining the dosage of therapeutic tissue stem cells is a long-standing unmet need for all tissue stem cell therapies. More commonly mis-called adult stem cells, tissue stem cells include stem cells found in adults, children, and birth tissues like the placenta and the umbilical cord. Donor umbilical cords are currently a major focus for sourcing therapeutic tissue stem cells, which are found in both their blood (hematopoietic stem cells) and their walls (mesenchymal stem cells). Whereas the medical potential of cord mesenchymal stem cells is still under investigation, the medical efficacy of cord blood hematopoietic stem cells is well established for use in the treatment of childhood leukemias.

Cord blood treatments for children have a continuing need for a method to determine the dose of the therapeutic stem cells. The Parents Guide newsletter feature describes the two industry standards for certifying cord blood units, flow cytometry and the colony-forming unit (CFU) test. Although they are currently industry certification requirements, neither of these methods gives the stem cell dose or tells which cord blood units will be effective. By some reports, this deficiency leaves nearly 20% of treated children at risk for death.

This Junes article is the Parents Guide newsletters second feature on Asymmetrexs tissue stem cell counting technology. The first feature appeared in the January 2019 issue of the newsletter. It related the historical context, envisioned applications, and potential impact of kinetic stem cell (KSC) counting, but did not delve into how the technology worked. The latest feature uses a graphical slide format to illustrate how Asymmetrex applies computational simulation to conventional cell count data to determine the number of tissue stem cells in a sample. Asymmetrexs President and CEO James L. Sherley, M.D., Ph.D. is confident that the newsletters presentation will help both non-experts and experts to understand how Asymmetrex counts therapeutic tissue stem cells.

In the intervening 3 years, the companys KSC counting technology has advanced greatly. Just in the previous week, at the Meeting in the Millyard Summit of the Advanced Regenerative Manufacturing Institute, the company announced rapid-counting algorithms that will make stem cell counting sufficiently efficient to be performed routinely for research and medicine. CEO Sherley says that he is looking forward to a future Parents Guide newsletter reporting the use of KSC counting to identify cord blood units that work all of the time for children, instead of only about 80% of the time as now.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The companys U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems stem cell-specific quantification and stem cell expansion that have stood in the way of more-effective use of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets kinetic stem cell (KSC) counting, the first technology for determination of the dose and quality of tissue stem cell preparations for use in stem cell transplantation medicine and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute | BioFabUSA (ARMI) and the Massachusetts Biotechnology Council (MassBio).

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I’ve Been Diagnosed with Cancer TwiceThese Are the Lessons I’ve Learned – Prevention Magazine

I expected to be diagnosed with breast cancer ever since my identical twin sister Karen started treatment for the disease seven years ago. It was only a matter of time. And while I wasnt happy to hear the words, I felt ready for the fightagain.

You see, Ive been diagnosed with cancer beforea rare, incurable blood cancer called multiple myeloma, and I wasnt expected to live more than three years. That was more than 20 years ago. Since then, Ive become a healthcare pro who shepherds patients through the system to find their cures. So when a small spot on one of my regular screenings turned out to be early stage breast cancer, I said to myself: Ive got this, its what I do. No problem.

But as I painfully re-learned with my second cancer diagnosis, cancer can be humbling. Even for a cancer expert. Even for someone who has been through this before.

When I first started battling cancer decades ago, I didnt know what I know now. But after years of research, difficult decisions and grueling treatmentsinduction therapy, chemo, stem cell transplant with my sister, maintenance therapy, relapse, infusions, side effectsI learned a fair amount about how to beat cancer. I also gained a great deal of hard-won wisdom about how the disease burdens friends and family along the way. Mine were there for me no matter how difficult the treatment, or the patient. And I could be difficult. No one knows that better than my sister.

Karen was my first call after being diagnosed with myeloma. She calmed me down when my test results were bad and bore my rage when I vented Why me? And then, when my myeloma became active and aggressive, she became my stem cell donor.

Then in 2014, eight years after giving me the life-saving gift of a stem cell transplant, Karen was diagnosed with breast cancer. Stage III. It was my turn to pay her back.

Together, we searched the internet, called every doctor and patient group, read every medical publication. Again, many decisions and years of debilitating treatments: surgery, chemo, radiation, and at least five years on therapy. Even today, she still warriors through the scans, the test results, the fear.

So how would I address my new diagnosis? I followed my tried-and true playbook, the one Id used with my sister and refined with an untold number of other patients: Google wisely, get a second opinion, find the right team, check your coverage, and always ask for the most current tests and treatments. My doctor laid out the options and encouraged me to speak with other doctors. One said low-dose tamoxifen. Another said lumpectomy, with treatment and/or radiation. Another said double mastectomy: You spent 20 years of your life trying to cure one disease; in one fell swoop you can cure this one. In the end I had all the data and science in the world. But no clear answer. The decision would be mine. The decision would be personal.

I reached out to family, to friends. My sister and I spoke endlessly about the toll of her ongoing treatment, from shortness of breath to the neuropathy that feels like shooting needles in her feet; having endured years of treatment issues myself for myeloma, I didnt know how many more I could bear, let alone more scans, more false positives, more biopsies. More restless nights and honest entries in my journal.

I spoke with friends about the burden I had put on them. On my husband, my children. Id been riding the cancer roller coaster for 25-plus years. I wanted off. And besides, having lived through a stem cell transplant, I figured double mastectomy would be easy (despite my doctors warning otherwise). Surgery on Tuesday, Moms birthday on Sunday, back to work on Monday. I put make-up on before surgery so I would look bright and healthy in a quick photo sent off to our children. This time I wouldnt burden anyone.

I was wrong. The surgery was harder than I imagined. I dont know how I could have managed without my friends to bring my favorite ginger tea, my kids to cook and walk the dog when I still couldnt hold the leash, my husband to drive me 90 minutes to each appointment, sit in with the doctor, and give me (very gentle) hugs when I needed them, and my sister to just agree it suckedno sense sugar-coating. And then there were the Zoom calls. Putting on my game face when I could barely reach for my lip gloss and concealer. Going into surgery I felt strong, in control. Coming out, I felt small. Full of doubts. Beaten up.

Sitting in her office a week later, I asked my doctor if Id made the right decision. Her response: There is no wrong answer, there is only the right answer for you.

After more than 25 years of curing my own cancer, and advising countless others how to cure theirs, heres what I know now about cancer:

My someones make me know I chose rightfor me. Thats what friends and family do. They are your sounding board to help you decide, and then they give unconditional support for that decision, and see you through no matter how hard the journey might be. Their comfort is your cure.

When facing cancer, even a cancer expert needs help.

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I've Been Diagnosed with Cancer TwiceThese Are the Lessons I've Learned - Prevention Magazine

World Sickle Cell Day 2022: Know all about symptoms and treatment of the disease – Firstpost

Symptoms of the disease are usually visible at the age of 5 months and change over time. Some of the common symptoms include pain, anaemia, frequent infections, swelling of hands and feet and vision problem

Sickle-shaped cells and normal blood cells in human blood. Image courtesy: Wikimedia Commons/Dr Graham Beards

World Sickle Cell Day is marked every year on 19 June with an aim to raise awareness about sickle cell disease. Sickle Cell Disease is a group of disorders that impact haemoglobin, the molecule in red blood cells which deliver oxygen to cells throughout the body.

Individuals who live with this disease have haemoglobin S, an atypical haemoglobin molecule which distorts red blood cells into a sickle or a crescent shape. The disease is usually transmitted from parents to children.

What are the symptoms?

Symptoms of the disease are usually visible at the age of 5 months and change over time. Some of the common symptoms include pain, anaemia, frequent infections, swelling of hands and feet and vision problem.

What are the different types of Sickle Cell Disease?

If one of the parents has a problem gene, then the child will not have symptoms but will possess sickle cell trait.

What is the treatment?

The disease can be detected in an infant during the screening process of a newborn. In case, there is a family history of the Sickle Cell disease, it can even be diagnosed at the time of pregnancy.

The only way to cure it is either stem cell or a bone marrow transplant. The symptoms can also be dealt with the use of antibiotics, periodic blood transfusion, pain killers, and vaccinations.

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NK Cell Therapy and Stem Cell Therapy Market Share, Size Global Industry Revenue, Business Growth, Demand and Applications Market Research Report to…

Global NK Cell Therapy and Stem Cell Therapy Market segments and their analysis offer a complete In-depth view of the industry to readers including stakeholders, vendors, suppliers, investors, buyers, and others too.

Global NK Cell Therapy and Stem Cell Therapy Market research report represents a In-Depth overview of the current market situation and forecast till 2029. The study perhaps a perfect mixture of qualitative and quantitative information highlighting key market developments, challenges, competition industry analysis and new opportunities available and trend within the NK Cell Therapy and Stem Cell Therapy Market. Further, this report gives NK Cell Therapy and Stem Cell Therapy Market size, recent trends, growth, share, development status, market dynamics, cost structure, and competitive landscape. The research report also includes the present market and its growth potentials in the given period of forecast. An exhaustive and professional study of the global NK Cell Therapy and Stem Cell Therapy market report has been completed by industry professionals and presented in the most particular manner to present only the details that matter the most. The report mainly focuses on the most dynamic information of the global market.

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About NK Cell Therapy and Stem Cell Therapy Market:-

The NK Cell Therapy and Stem Cell Therapy market has witnessed a growth from USD million to USD million from 2017 to 2022. With a CAGR of this market is estimated to reach USD million in 2029.

The report focuses on the NK Cell Therapy and Stem Cell Therapy market size, segment size (mainly covering product type, application, and geography), competitor landscape, recent status, and development trends. Furthermore, the report provides strategies for companies to overcome threats posed by COVID-19.

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The global NK Cell Therapy and Stem Cell Therapy market size is segmented on the basis of application, end user, and region, with focus on manufacturers in different regions. The study has detailed the analysis of different factors that increase the industries growth. This study also provides the scope of different segments and applications that can potentially influence the industry in the future. Pricing analysis is covered in this report according to each type, manufacturer, regional analysis, price. NK Cell Therapy and Stem Cell Therapy Market Share report provides overview of market value structure, cost drivers, various driving factors and analyze industry atmosphere, then studies global outline of industry size, demand, application, revenue, product, region and segments. In addition, this report introduces market competition situation among the distributers and manufacturers profile, besides, market value analysis and cost chain structure are covered in this report.

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TOP Manufactures in NK Cell Therapy and Stem Cell Therapy Market are:

NK Cell Therapy and Stem Cell Therapy Market Forecast by regions, type and application, with sales and revenue, from 2021 to 2029. NK Cell Therapy and Stem Cell Therapy Market Share, distributors, major suppliers, changing price patterns and the supply chain of raw materials is highlighted in the report.NK Cell Therapy and Stem Cell Therapy Market Size report provides important information regarding the total valuation that this industry holds presently and it also lists the segmentation of the market along with the growth opportunities present across this business vertical.This Report Focuses on the NK Cell Therapy and Stem Cell Therapy Market manufacturers, to study the sales, value, market share and development plans in the future. It is Define, describe and forecast the NK Cell Therapy and Stem Cell Therapy Market Growth by type, application, and region to Study the global and key regions market potential and advantage, opportunity and challenge, restraints and risks. Know significant trends and factors driving or inhibiting the NK Cell Therapy and Stem Cell Therapy Market growth opportunities in the market for stakeholders by identifying the high growth segments. Strategically it examines each submarket with respect to individual growth trend and their contribution to the NK Cell Therapy and Stem Cell Therapy Market.

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On the basis of product, this report displays the production, revenue, price, market share and growth rate of each type, primarily split into

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including

The Global NK Cell Therapy and Stem Cell Therapy Market Trends,development and marketing channels are analysed. Finally, the feasibility of new investment projects is assessed and overall research conclusions offered.The global NK Cell Therapy and Stem Cell Therapy Market Growth is anticipated to rise at a considerable rate during the forecast period, between 2021 and 2029. In 2021, the market was growing at a steady rate and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

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NK Cell Therapy and Stem Cell Therapy Market Trend for Development and marketing channels are analysed. Finally, the feasibility of new investment projects is assessed and overall research conclusions offered. NK Cell Therapy and Stem Cell Therapy Market Report also mentions market share accrued by each product in the NK Cell Therapy and Stem Cell Therapy market, along with the production growth.

Regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13:

North America (Covered in Chapter 6 and 13)

Europe (Covered in Chapter 7 and 13)

Asia-Pacific (Covered in Chapter 8 and 13)

Middle East and Africa (Covered in Chapter 9 and 13)

South America (Covered in Chapter 10 and 13)

Chapters Included in NK Cell Therapy and Stem Cell Therapy Market Report:

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Some of the Key Questions Answered in this Report:

Detailed TOC of Global NK Cell Therapy and Stem Cell Therapy Market Development Strategy Pre and Post COVID-19, by Corporate Strategy Analysis, Landscape, Type, Application, and Leading 20 Countries

1 Market Overview 1.1 Product Definition and Market Characteristics 1.2 Global NK Cell Therapy and Stem Cell Therapy Market Size 1.3 Market Segmentation 1.4 Global Macroeconomic Analysis 1.5 SWOT Analysis

2. Market Dynamics 2.1 Market Drivers 2.2 Market Constraints and Challenges 2.3 Emerging Market Trends 2.4 Impact of COVID-19 2.4.1 Short-term Impact 2.4.2 Long-term Impact

3 Associated Industry Assessment 3.1 Supply Chain Analysis 3.2 Industry Active Participants 3.2.1 Suppliers of Raw Materials 3.2.2 Key Distributors/Retailers 3.3 Alternative Analysis 3.4 The Impact of Covid-19 From the Perspective of Industry Chain

4 Market Competitive Landscape 4.1 Industry Leading Players 4.2 Industry News 4.2.1 Key Product Launch News 4.2.2 MandA and Expansion Plans

5 Analysis of Leading Companies

6 Market Analysis and Forecast, By Product Types 6.1 Global NK Cell Therapy and Stem Cell Therapy Sales, Revenue and Market Share by Types(2017-2022) 6.1.1 Global NK Cell Therapy and Stem Cell Therapy Sales and Market Share by Types(2017-2022) 6.1.2 Global NK Cell Therapy and Stem Cell Therapy Revenue and Market Share by Types (2017-2022) 6.1.3 Global NK Cell Therapy and Stem Cell Therapy Price by Types (2017-2022) 6.2 Global NK Cell Therapy and Stem Cell Therapy Market Forecast by Types (2017-2022) 6.2.1 Global NK Cell Therapy and Stem Cell Therapy Market Forecast Sales and Market Share by Types(2022-2029) 6.2.2 Global NK Cell Therapy and Stem Cell Therapy Market Forecast Revenue and Market Share by Types(2022-2029) 6.3 Global NK Cell Therapy and Stem Cell Therapy Sales, Price and Growth Rate by Types(2017-2022)

7 Market Analysis and Forecast, By Applications 7.1 Global NK Cell Therapy and Stem Cell Therapy Sales, Revenue and Market Share by Applications(2017-2022) 7.1.1 Global NK Cell Therapy and Stem Cell Therapy Sales and Market Share by Applications(2017-2022) 7.1.2 Global NK Cell Therapy and Stem Cell Therapy Revenue and Market Share by Applications(2017-2022)

8 Market Analysis and Forecast, By Regions 8.1 Global NK Cell Therapy and Stem Cell Therapy Sales by Regions(2017-2022) 8.2 Global NK Cell Therapy and Stem Cell Therapy Market Revenue by Regions(2017-2022) 8.3 Global NK Cell Therapy and Stem Cell Therapy Market Forecast by Regions(2022-2029)

9 North America NK Cell Therapy and Stem Cell Therapy Market Analysis 9.1 Market Overview and Prospect Analysis 9.2 North America NK Cell Therapy and Stem Cell Therapy Market Sales and Growth Rate(2017-2022) 9.3 North America NK Cell Therapy and Stem Cell Therapy Market Revenue and Growth Rate(2017-2022) 9.4 North America NK Cell Therapy and Stem Cell Therapy Market Forecast 9.5 The Influence of COVID-19 on North America Market 9.6 North America NK Cell Therapy and Stem Cell Therapy Market Analysis by Country

10 Europe NK Cell Therapy and Stem Cell Therapy Market Analysis 10.1 Market Overview and Prospect Analysis 10.2 Europe NK Cell Therapy and Stem Cell Therapy Market Sales and Growth Rate(2017-2022) 10.3 Europe NK Cell Therapy and Stem Cell Therapy Market Revenue and Growth Rate(2017-2022) 10.4 Europe NK Cell Therapy and Stem Cell Therapy Market Forecast 10.5 The Influence of COVID-19 on Europe Market 10.6 Europe NK Cell Therapy and Stem Cell Therapy Market Analysis by Country

11 Asia-Pacific NK Cell Therapy and Stem Cell Therapy Market Analysis 11.1 Market Overview and Prospect Analysis 11.2 Asia-Pacific NK Cell Therapy and Stem Cell Therapy Market Sales and Growth Rate(2017-2022) 11.3 Asia-Pacific NK Cell Therapy and Stem Cell Therapy Market Revenue and Growth Rate(2017-2022) 11.4 Asia-Pacific NK Cell Therapy and Stem Cell Therapy Market Forecast 11.5 The Influence of COVID-19 on Asia Pacific Market 11.6 Asia-Pacific NK Cell Therapy and Stem Cell Therapy Market Analysis by Country

12 South America NK Cell Therapy and Stem Cell Therapy Market Analysis 12.1 Market Overview and Prospect Analysis 12.2 South America NK Cell Therapy and Stem Cell Therapy Market Sales and Growth Rate(2017-2022) 12.3 South America NK Cell Therapy and Stem Cell Therapy Market Revenue and Growth Rate(2017-2022) 12.4 South America NK Cell Therapy and Stem Cell Therapy Market Forecast 12.5 The Influence of COVID-19 on South America Market 12.6 South America NK Cell Therapy and Stem Cell Therapy Market Analysis by Country

13 Middle East and Africa NK Cell Therapy and Stem Cell Therapy Market Analysis 13.1 Market Overview and Prospect Analysis 13.2 Middle East and Africa NK Cell Therapy and Stem Cell Therapy Market Sales and Growth Rate(2017-2022) 13.3 Middle East and Africa NK Cell Therapy and Stem Cell Therapy Market Revenue and Growth Rate(2017-2022) 13.4 Middle East and Africa NK Cell Therapy and Stem Cell Therapy Market Forecast 13.5 The Influence of COVID-19 on Middle East and Africa Market 13.6 Middle East and Africa NK Cell Therapy and Stem Cell Therapy Market Analysis by Country

14 Conclusions and Recommendations 14.1 Key Market Findings and Prospects 14.2 Advice for Investors

15 Appendix 15.1 Methodology 15.2 Research Data Source

Continued

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Alopecia: Are there any new treatments on the horizon? – Pharmaceutical Technology

Last Friday, the US FDA decided to keep the popular anti-baldness drug finasteride on the market, but is now requiring its makers to add suicidal ideation to a list of potential side effects.

Relatedly, on 13 June, the FDA also approved Eli Lillys and Incytes Olumiant (baricitinib), the first treatment for alopecia areata, another form of baldness, which also has a positive Committee for Medicinal Products for Human Use (CHMP) recommendation for an EMA approval. Alopecia areata is an autoimmune disorder when the bodys immune cells attack the hair follicles, while androgenic alopecia is a genetically determined pattern of hair loss.

These recent regulatory actions have brought attention to the hair loss space which has ample demand for treatments, but relatively few unique assets in development.

Though we are seeing new developments in the treatment of androgenetic alopecia (AGA) emerge in recent years, such as low dose oral minoxidil and bicalutamide, effective management remains challenging, writes Dr Dmitri Wall, consultant dermatologist at Hair Restoration Blackrock in Dublin, via email.

Marketed by Organon, a Merck spinoff, finasteride sold as Propecia had global sales of $292 million in 2005, as per GlobalData. The first generic was introduced in 2006. The FDAs most recent action came in response to a petition launched by a non-profit group called the Post-Finasteride Syndrome Foundation.

In 1988, the FDA approved minoxidil, a 2% topical solution then marketed by the company Upjohn under names such as Rogaine, for male use, before receiving approval for women in 1992. Several years later, a stronger 5% formula was approved for men in 1997, with a female version receiving the green light in 2014. Upjohn merged with the Swedish company Pharmacia AB in 1995, before being acquired by Pfizer in 2002.

Almost a decade after the initial approval of minoxidil, the FDA authorized the use of 1mg finasteride tablets in 1997, a dihydrotestosterone (DHT) blocker.

Finasteride is currently not approved for use by women and is contraindicated for pregnancy, as based on Propecias FDA label. However, there are cases of advised off-label use amongst postmenopausal and occasionally premenopausal women, says Eva Proudman, consultant trichologist and chair of the Institute of Trichologists.

Finasteride and minoxidil are used with roughly 80% of patients in Proudmans estimates, seeing a very positive result. While side effects do exist, she says her practice always discusses any safety concerns.

This isnt the first time finasterides potential side effects have received attention. In 2012, the FDA requested an update of the drugs label to include mention of risks of potential sexual dysfunction. According to Mercks label for Propecia, decreased libido and erectile dysfunction were reported in 1.8% and 1.3% of 945 treated subjects respectively. The latest suicidal ideation warning comes after internal records from Merck showed the company was aware of over 200 cases of depression since 2009, as described in a Reuters exclusive last February.

At the same time, it is important to note that hair loss can prove as a very emotional process for some and there are more factors surrounding potential depression or suicidal ideation than just in case of finasteride use, says Proudman. As such, understanding what these treatments can potentially do is needed, she adds.

Moreover, some studies show that the topical treatment minoxidil is also potentially not for everyone. In a Pfizer-sponsored one-year observational study of minoxidils 5% solution from 2004, the treatment shrunk the targeted hair-loss area in 62% of subjects, but it remained unchanged in 35.1%. In the same study, 15.9% of the subjects rated the treatment as very effective, but 20.6% found it only moderately effective and 15.7% found no effects. The topical solution is intended for use in the crown and is not aimed for the treatment of frontal baldness or a receding hairline, as based on Rogaines label.

Dutasteride, another DHT blocker sold by GSK under the name Avodart, has also displayed efficacy in reducing hair loss. But the treatment has not yet been approved by the FDA for the treatment of androgenic alopecia, despite off label use.

Outside of these two established treatments, cosmetic procedures such as scalp micropigmentation, scalp reduction or hair transplantation are becoming increasingly prominent. We continue to await the delivery of safe and effective stem-cell therapy that has promised much, while limited evidence regarding adjuvant therapies such as platelet rich plasma (PRP) and low-level laser therapy (LLLT) is yet to convincingly prove their benefit, says Wall, who is also an assistant professor at the Charles Institute of Dermatology at University College Dublin.

According to GlobalDatas Pharma Intelligence Centre, there are currently 20 assets in development for androgenic alopecia. This ranges from minoxidil that is in pre-registration in Taiwan, to IVL3001, a month-lasting injection of finasteride made by the South Korean company Inventage Lab, and treatments previously unused within the space such as Cosmo Pharmaceuticals topical solution Breezula (clascosterone).

Other approaches include antiandrogens such as GT-20029 or KX-826 (pyrilutamide), developed by the Chinese pharma company Kintor Pharmaceuticals. Pyrilutamide is currently in two Phase II studies, with one for male androgenic alopecia subjects in the US, and the other for female subjects in China.

At the same time, Proudman stresses the need for efficacious products, rather than those with promises. In June 2021, the Swedish company Follicum announced its discontinuing a Phase IIa hair loss treatment FOL-005 after an independent review led to revised data showing no significant improvement.

In this sense, Proudman says it is likely that upcoming treatments will be similar to those in the available armamentarium.

"Even with the emergence of novel therapies, it remains most likely that optimal, sustained responses will require combination therapy that should be chosen after consideration of individual factors," notes Wall.

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Global Rheumatoid Arthritis Stem Cell Therapy Market 2022 Swot Analysis by Top Key Vendors, Demand And Forecast Research to 2028 Designer Women -…

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Sernova to Participate in the Truist Securities Cell Therapy Symposium, Symposia-cel in June – StreetInsider.com

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LONDON, Ontario, June 15, 2022 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-stage company and leader in regenerative medicine cell therapeutics, today announced that Dr. Philip Toleikis, President & CEO of Sernova Corp, will be participating in the Truist Securities Cell Therapy Symposium, Symposia-cel being held in person at the Lotte New York Palace on Tuesday, June 28, 2022. Company management will also be participating in 1x1 meetings during the event.

* Further details available on the Truist event website

If you are interested in arranging a 1x1 meeting request, please contact your Truist representative.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp is a clinical-stage biotechnology company that is developing regenerative medicine therapeutic technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders like hemophilia A. Sernova is currently focused on finding a functional cure for insulin-dependent diabetes with its lead asset, the Cell-Pouch SystemTM, a novel implantable and scalable medical device which forms a natural environment in the body for long-term survival and function of therapeutic cells that release necessary proteins or factors missing from the body to treat chronic diseases. Sernovas Cell Pouch System has already shown it can potentially provide a functional cure to people with type 1 diabetes in an ongoing Phase I/II study at the University of Chicago. Sernova is also working on technology with the University of Miami to cloak the implant from the immune system, to eliminate the need for immunosuppressives to protect the cells from immune system attack. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) beta cell replacement therapy. This partnership provides Sernova an unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova is also gearing up to be in the clinic in two additional programs that utilize its Cell Pouch System an implantable cell therapy for benign thyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral factor 8 gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. [emailprotected] 519-902-7923 http://www.sernova.com

Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC [emailprotected] 212-915-2577

Media: Elizabeth Miller, M.D. LifeSci Communications [emailprotected]

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Sernova to Participate in the Truist Securities Cell Therapy Symposium, Symposia-cel in June - StreetInsider.com

Scientists harness light therapy to target and kill cancer cells in world first – The Guardian

Scientists have successfully developed a revolutionary cancer treatment that lights up and wipes out microscopic cancer cells, in a breakthrough that could enable surgeons to more effectively target and destroy the disease in patients.

A European team of engineers, physicists, neurosurgeons, biologists and immunologists from the UK, Poland and Sweden joined forces to design the new form of photoimmunotherapy.

Experts believe it is destined to become the worlds fifth major cancer treatment after surgery, chemotherapy, radiotherapy and immunotherapy.

The light-activated therapy forces cancer cells to glow in the dark, helping surgeons remove more of the tumours compared with existing techniques and then kills off remaining cells within minutes once the surgery is complete. In a world-first trial in mice with glioblastoma, one of the most common and aggressive types of brain cancer, scans revealed the novel treatment lit up even the tiniest cancer cells to help surgeons remove them and then wiped out those left over.

Trials of the new form of photoimmunotherapy, led by the Institute of Cancer Research, London, also showed the treatment triggered an immune response that could prime the immune system to target cancer cells in future, suggesting it could prevent glioblastoma coming back after surgery. Researchers are now also studying the new treatment for the childhood cancer neuroblastoma.

Brain cancers like glioblastoma can be hard to treat and, sadly, there are too few treatment options for patients, the study leader, Dr Gabriela Kramer-Marek, told the Guardian. Surgery is challenging due to the location of the tumours, and so new ways to see tumour cells to be removed during surgery, and to treat residual cancer cells that remain afterwards, could be of great benefit.

The ICRs team leader in preclinical molecular imaging added: Our study shows that a novel photoimmunotherapy treatment using a combination of a fluorescent marker, affibody protein and near-infrared light can both identify and treat leftover glioblastoma cells in mice. In the future, we hope this approach can be used to treat human glioblastoma and potentially other cancers, too.

The therapy combines a special fluorescent dye with a cancer-targeting compound. In the trial in mice, the combination was shown to dramatically improve the visibility of cancer cells during surgery and, when later activated by near-infrared light, to trigger an anti-tumour effect.

Scientists from the ICR, Imperial College London, the Medical University of Silesia, Poland, and the Swedish company AffibodyAB believe the novel treatment could help surgeons more easily and effectively remove particularly challenging tumours, such as those in the head and neck.

The joint effort was largely funded by the Cancer Research UK Convergence Science Centre at the ICR and Imperial College London a partnership that brings together international scientists from engineering, physical and life sciences specialisms to find innovative ways to tackle cancer.

Multidisciplinary working is critical to finding innovative solutions to address the challenges we face in cancer research, diagnosis and treatment and this study is a great example, said Prof Axel Behrens, the leader of the cancer stem cell team at the ICR and scientific director of the Cancer Research UK Convergence Science Centre.

This research demonstrates a novel approach to identifying and treating glioblastoma cells in the brain using light to turn an immunosuppressive environment into an immune-vulnerable one, and which has exciting potential as a therapy against this aggressive type of brain tumour.

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After decades of progress in treating cancer, the four main forms in existence today surgery, chemotherapy, radiotherapy and immunotherapy mean more people who are diagnosed with the disease can be treated effectively, and large numbers can live healthily for many years.

However, the close proximity of some tumours to vital organs in the body means it is vital new ways to treat cancer are developed so doctors can overcome the risk of harming healthy parts of the body. Experts believe that photoimmunotherapy could be the answer.

When tumours grow in sensitive areas of the brain such as the motor cortex, which is involved in the planning and control of voluntary movements, glioblastoma surgery can leave behind tumour cells that can be very hard to treat and which mean the disease can come back more aggressively later.

The new treatment uses synthetic molecules called affibodies. These are tiny proteins engineered in the lab to bind with a specific target with high precision, in this case a protein called EGFR which is mutated in many cases of glioblastoma.

The affibodies were then combined with a fluorescent molecule called IR700, and administered to the mice before surgery. Shining light on the compounds caused the dye to glow, highlighting microscopic regions of tumours in the brain for surgeons to remove. The laser then switched to near-infrared light, which triggered anti-tumour activity, killing the remaining cells after surgery.

Photoimmunotherapies could help us to target the cancer cells that cant be removed during surgery, which may help people live longer after their treatment, said Dr Charles Evans, the research information manager at Cancer Research UK. He cautioned that there were still technical challenges to overcome, such as reaching all parts of a tumour with near-infrared light, but added that he was excited to see how this research will develop.

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Scientists harness light therapy to target and kill cancer cells in world first - The Guardian