Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the Remestemcel-L BLA for SR-aGVHD – GlobeNewswire

NEW YORK, Oct. 02, 2022 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) substantial new information on clinical and potency assay items identified in the Complete Response Letter (CRL) received from FDA in September 2020 to the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast has maintained an active dialog with the FDA since receiving the CRL, and the substantial new information submitted to the Investigational New Drug (IND) file for remestemcel-L in the treatment of children with SR-aGVHD, as guided by FDA, represents a major milestone in the Companys complete response to the FDA. Remestemcel-L has been granted Fast Track Designation and BLA Priority Review from the FDA.

Survival outcomes have not improved over the past two decades for children or adults with the most severe forms of SR-aGVHD.1-3 The lack of any approved treatments for children under 12 means that there is an urgent need for a therapy that improves the dismal survival outcomes in children.

The submission summarizes controlled data providing further evidence of remestemcel-Ls ability to save lives, said Dr. Silviu Itescu, Chief Executive of Mesoblast. Additionally, the improved process controls we have put in place to assure robust and consistent commercial product, together with a potency assay that predicts consistent survival outcomes, makes remestemcel-L a compelling treatment for these children.

About Steroid-refractory Acute Graft Versus Host Disease Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, including about 20% in pediatric patients.4,5 SR-aGVHD is associated with mortality as high as 90% and significant extended hospital stay costs.6,7 There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD.

About Mesoblast Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast is developing product candidates for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease, biologic-resistant inflammatory bowel disease, and acute respiratory distress syndrome. Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

References / Footnotes

Forward-Looking Statements This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including BLA resubmission), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblasts expenses, future revenues, capital requirements and its needs for additional financing; Mesoblasts financial performance; developments relating to Mesoblasts competitors and industry; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the Remestemcel-L BLA for SR-aGVHD - GlobeNewswire

QC Kinetix (The Heights) Helping Patients Heal Better from Joint Pain Through Houston Heights Sports Medicine – Yahoo Finance

Houston, TX - (NewMediaWire) - October 03, 2022 - Joint pain is one of the leading causes of discomfort among the American populace. It is estimated that more than 65 million American adults suffer from low back pain, while over 16 million deal with acute or chronic joint pain due to arthritis. The number seems to be growing at an alarming rate annually, with the problem spreading to more young adults due to their lifestyle choices, occupation, accidents, and other reasons. QC Kinetix (The Heights) estimates that a whopping number of Americans will be battling chronic joint pain in years to come if no real step is taken.

As a pain control clinic focusing on health and wellness, QC Kinetix (The Heights) understands the health problems associated with heavy medication use to combat joint pain. The lead treatment provider at the clinic noted that more people who depend on medication for pain relief are growing tired and abandoning it because of its negative side effects on their bodies and organs. Others are too scared to consider surgical interventions which offer no real promises of long-term health benefits.

In the face of these health challenges, QC Kinetix (The Heights) is offering a better solution with better healing potential to patients suffering from joint pain and related problems. Speaking on their natural treatment therapies, the clinic's spokesperson maintained that they offer a minimally invasive and natural treatment solution that helps patients avoid the costs, risks, and complications associated with surgeries. He added that their treatment plan is also devoid of medication use, which means patients can significantly dump the unhealthy habit of medication consumption while improving their health and wellness through other natural means.

The clinic's spokesperson noted that their sports and regenerative medicine treatment focuses on each patient's challenges and finds a way to improve their body's natural healing abilities. Speaking on the treatment modality's effectiveness for Houston Heights back pain treatment, Scott Hoots said: "In our QC Kinetix The Heights regenerative medicine clinics, we serve our patients by providing leading regenerative therapies that reduce joint pain associated with direct trauma, a sports-related injury, or a degenerative medical condition. These techniques target the impacted area to reduce inflammation and repair damaged tissue. Our team of medical professionals receives the highest quality training and research to provide our clients with the latest therapies to alleviate their ailments. In addition, we pride ourselves on providing the highest level of respect and care for our clients, as returning their ability to live with pain relief is our primary goal."

Each patient coming into the clinic will have access to a personalized health and wellness service centered around their needs. The treatment providers offer an initial consultation service where they get to learn more about the patient's health, symptoms, past treatments, allergies, and other information. Patients will also have access to a comprehensive examination and physical assessment for diagnostic purposes. Once diagnosed, the team will determine the patient's suitability for the treatment and develop a personalized treatment plan to alleviate their pain and discomfort while equipping the body with the needed building blocks for long-term health and wellness.

Welcoming Houston residents to schedule an appointment, the lead treatment provider at the clinic noted that regenerative medicine offers a wide range of benefits to patients. He maintained that several of their patients have been able to save money and avoid the complications of surgical intervention through their natural treatment plans. He further noted that their minimally invasive treatments are low risks and require a shorter recovery time compared to surgeries. Using stem cell therapy, platelet-rich plasma therapy, Class IV laser therapy, and others, patients will also enjoy positive health benefits like reduced inflammation, pain relief, improved healing, and a better range of motion from the affected joints.

QC Kinetix (The Heights) is currently taking new patients as its appointment slots are filling up fast. The pain control clinic can be reached via phone at (713) 913-5285 or via its website. The clinic is located at 1900 North Loop West, Suite 300, Houston, TX, 77018, US.

Media Contact:

Company Name: QC Kinetix (The Heights)

Contact Person: Scott Hoots

Phone: (713) 913-5285

Address: 1900 North Loop West, Suite 300

City: Houston

State: TX

Postal Code: 77018

Country: USA

Website: https://qckinetix.com/houston/the-heights/

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QC Kinetix (The Heights) Helping Patients Heal Better from Joint Pain Through Houston Heights Sports Medicine - Yahoo Finance

Carbon Dioxide Incubators Market to Reach US$ 483.5 Million by 2027 as Application in In Vitro Fertilization Rises – Yahoo Finance

NEW YORK, Oct. 4, 2022 /PRNewswire/ --

Growing Use of IVF and Stem Cell Therapies to Create US$ 323 Million Market Opportunity for Carbon Dioxide Incubator Manufacturers

The carbon dioxide incubators market is well covered by Fact.MR for the upcoming decade. The study looks closely at key growth factors such trends, future projections, and business strategies. The research also provides a thorough analysis of the top segments including product, application, capacity, and region, in order to provide well-rounded perspective.

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Fact.MR A Market Research and Competitive Intelligence Provider: The global carbon dioxide incubators market is likely to reach US$ 483.5 Million by 2027, growing at 8.4% CAGR between 2022 and 2027. Growing investment in research and clinical trial activities is likely to fuel the sales of carbon dioxide incubators during the assessment period. Further, use of carbon dioxide incubators in IVF and stem cell treatments is also likely to drive growth.

The popularity and acceptance of in-vitro fertilizations has grown significantly. According toNational Library of Medicine, around 10% to 15% couples in the U.S. have trouble in having a baby. These challenges have been well-addressed by in vitro fertilization (IVF), owing to which it has become a popular healthcare solution.

Use of in-vitro fertilization (IVF) to help couples in becoming parents is likely to grow in the future, which is likely to drive demand for accessories and equipment used in this process. Owing to this, demand for carbon dioxide incubators is likely to witness an upward trend over the upcoming decade.

Further, sales of carbon dioxide incubators are also likely to increase on account of growth in overall stem cell procedures. For instance, as perHealth Resources and Services Administration, 4,864 unrelated and 4,160 related bone marrow and cold transplants were conducted in the U.S. in 2020. Growing use of stem cell treatment is likely to be a key factor driving the sales of carbon dioxide incubators during the assessment period.

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Globally, North America and Europe are likely to remain at the pinnacle of growth in the carbon dioxide incubators market. The U.S., U.K., France, and Germany are at the forefront of new innovation in R&D, and sales of medical accessories and equipment will also remain high, as per Fact.MR. Owing to these factors, carbon dioxide incubator manufacturers are likely to witness incremental growth opportunities across these regions.

Key Takeaways:

By product, water-jacketed carbon dioxide incubators are likely to reman preferred among end-users.

By capacity, below 100-liter carbon dioxide incubators are expected to witness high demand during the assessment period.

By application, use of carbon dioxide incubators in laboratory research and clinical applications is likely to remain high during the assessment period.

By region, North America and Europe are likely to hold sway over the forecast period, with the U.S. and the U.K. leading the growth.

China and India are expected to create sizeable opportunities for market players on the back of improved healthcare infrastructure.

Growth Drivers:

Increasing applications of carbon dioxide incubators in in-vitro fertilization (IVF) and stem cell treatment is likely to drive the market.

Use of carbon dioxide incubators in cell culture development and tissue engineering is expected to create growth avenues for market players.

Efficiency of incubators in maintaining consistent temperature during genetically modified organism (GMO) cultivation is expected to drive growth.

Advancement in carbon dioxide incubator technology is likely to create new growth avenues for market players.

Restraints:

Carbon dioxide incubators are highly prone to errors due to which they require highly experienced technicians. Due to skill shortage, sales of these incubators can be limited.

Lack of standardization is a longstanding challenge and failure to address this issue might hamper growth.

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Competitive Landscape:

Carbon dioxide incubator manufacturers are focusing on launching innovative technologies to consolidate their position in the market. Further, leading players are concentrating on providing training and guidelines to end-users so their products can be used without any issue.

For instance,

In May 2021, Esco introduced an innovative incubator featuring High Heat Sterilization that is highly effective in eliminating bacteria and vegetative cells.

In January 2020, CO2Meter Inc., launched incubators that regulate and monitor bacterial development patterns.

Key Companies Profiled by Fact.MR

More Valuable Insights on Carbon Dioxide Incubators Market

In its latest study, Fact.MR offers a detailed analysis of the global carbon dioxide incubators market for the forecast period of 2022 to 2027. This study also divulges key drivers and trends promoting the sales of carbon dioxide incubators through detailed segmentation as follows:

By Product:

Water Jacketed

Air Jacketed

Direct Heat

By Capacity:

Below 100 Litres

100-200 Litres

Above 200 Litres

By Application:

By Region:

North America

Latin America

Europe

East Asia

South Asia & Oceania

MEA

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Key Questions Covered in the Carbon Dioxide Incubators Market Report

What is the estimated market size of carbon dioxide incubators in 2022?

At what pace will worldwide carbon dioxide incubators sales increase till 2027?

What factors are driving demand in the carbon dioxide incubators market?

Which region is predicted to lead the worldwide carbon dioxide incubators market between 2022 and 2027?

What are the elements driving carbon dioxide incubators market sales during the forecast period?

What is the expected market estimation of the carbon dioxide incubators market during the forecast period?

Explore Fact.MR's Coverage on the Healthcare Domain

Biological Indicator Incubator Market:The biological indicator incubators market is projected to benefit from rising biopharmaceutical production. The market for biological indicator incubators may continue to increase quickly as a result of the manufacturing of biopharmaceuticals that are grown via cell culture.

Tissue Culture Incubator Market:The introduction of CO2 incubators with infrared radiation control systems and other technological advancements in tissue culture incubators, along with increased funding for tissue-based research, are anticipated to be major factors driving the growth of the tissue culture incubator market over the forecast period.

Pneumatic Nebulizers Market:Pneumatic nebulizer sales are anticipated to grow steadily at a CAGR of 4% and reach a market value of US$ 850.4 million by 2027 from US$ 699 million in 2022. An increase in local healthcare spending and patient awareness has spurred the need for pneumatic nebulizers.

Implantable Medical Devices Market: The global implantable medical devices market is predicted to reach US$ 155 billion by 2027. Key factors driving market growth include rising geriatric population & burden of chronic diseases and increasing demand for cosmetic dentistry.

Disinfection Caps Market: Key factors driving market growth include stringent regulations for safe injection practices and rising prevalence of hospital-acquired infections across the world. The global disinfection caps market is estimated to reach US$ 420 million by 2027.

Check it Out More Reports by Fact.MR on Healthcare Domain

https://www.factmr.com/industry/healthcare

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Fact.MR is a market research and consulting agency with deep expertise in emerging market intelligence. Spanning a wide range from automotive & industry 4.0 to healthcare, technology, chemical and materials, to even the most niche categories. We are committed to deliver insights that help businesses gain deeper understanding of their target markets. We understand that making sense of the vast labyrinth of data can be overwhelming for businesses. That's why focus on offering insights that can actually make a difference to bottom-lines.

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Carbon Dioxide Incubators Market to Reach US$ 483.5 Million by 2027 as Application in In Vitro Fertilization Rises - Yahoo Finance

Magrolimab Development Continues for the Treatment of AML and MDS – Targeted Oncology

There are 4 types of CD47 antibodies currently available in the clinic for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). According to Naval G. Daver, MD, a novel option magrolimab, could be the fifth CD47 antibody once data supporting the drug mature.

[Magrolimab] is a CD47 monoclonal antibody that has been combined with azacitidine [Vidaza] in the frontline setting and in a now completed a phase 1b study, which had 2 parts. One was for high-risk MDS patients.The other part was for TP53-mutated frontline AML, stated Daver, an associate professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, in an interview with Targeted OncologyTM.

Daver explained how first, a prospective, phase 1 trial (NCT03248479) evaluated single-agent magrolimab in patients with relapsed/refractory AML. Due to the overall positive findings from this trial, a new phase 3 ENHANCE trial (NCT04313881) has begun enrolling patients.

In the ENHANCE trial, the combination of magrolimab plus azacitidine will be examined vs azacitidine plus placebo in treatment-nave patients with higher-risk MDS. Investigators aim to evaluate the efficacy of magrolimab in combination with azacitidine in this patient population as measured by complete remission and overall survival.

During a panel at the 10th Annual Society of Hematologic Malignancies (SOHO), experts, including Daver, discussed on how to optimize frontline hypomethylating agent (HMA) and venetoclax (Venclexta).

Further, though the combination has only been approved for 4 years, research aims to examine the different ways to move beyond this treatment approach for this patient population as more work is always needed to improve better outcomes for patients.

In the interview, Daver discussed the approved and investigation CD47 monoclonal antibodies for patients with AML and MDS. He also provided a prediction on where research for AML and MDS is headed.

Targeted Oncology: Based on data from preclinical and clinical studies, which in type CD47 agents have shown promise as targeted therapies?

There are 4 different CD47 antibodies in clinic for AML and MDS. The one that has the most advanced clinical data, most mature so far, is a drug called magrolimab. This is a CD47 monoclonal antibody that has been combined with azacitidine in the frontline setting and in a now completed a phase 1b study, which had 2 parts. One was for high-risk MDS patients, including intermediate, high, or very high IPSS patients. The other part was for TP53-mutated frontline AML.

Overall, the data for the MDS patients was that we had 95 patients with this higher risk MDS, and the response rate is encouraging, 75% with a true CR rate of about 33% or 34%. What's interesting is in the subsets that included TP53 mutated, which made up about 25 of those 95 patients, the median survival is quite promising at greater than 16 months. Historically, pretty much in any other study that we have seen in MDS TP53, the survival has been between 9 and 12 months.

This is single arm, but this data looks quite promising. In the non-TP53 subgroup, the median survival has not been reached, with a median follow-up of about 18 months. Overall, it's a single-arm study, so it's hard to know for sure, but this data does look encouraging. This has led to a randomized phase 3 study now ongoing, called the ENHANCE study, which in fact just completed accrual a couple of weeks ago. We're hoping to start seeing some of the primary end point data early next year.

Then the AML study was looking at the most difficult population of AML called TP53-mutated AML patients. In these patients, historically, the response rate is about 30%-40%, with survival about 6-8 months. This is with azacitidine alone, azacitidine/ venetoclax, intensive chemotherapy, low dose cytarabine. With the azacitidine and magrolimab doublet, we're seeing a response rate of close to about 49% or 50% and a true complete response [CR] rate of 34%, which are better than what we have seen in the past with other therapies. Not hugely higher, but they looked to be slightly better response rates.

More importantly, the median survival was around 11 months. Even though that's not very high on its own, it's better than what we have ever seen with TP53. This has also led to a randomized study of azacitidine and magrolimab vs investigator choice, either intensive chemotherapy or azacitidine and venetoclax, and that study is ongoing.

What other CD47 inhibitors are available in this space?

There are other CD47s which are very early and ALX148 [evorpacept] is one of them. One of the potential benefits of evorpacept is it may cause less anemia. There was very early clinical data presented of about 12 patients. Some responses we're seeing, and it is very hard to know at this time if this is going to be in the same efficacy range as with the azacitidine and magrolimab, or different, and we hope for updates.

Then there are others that we don't have much clinical data yet they're ongoing in phase 1 studies such as lemzoparlimab [also known as TJ011133 or TJC4], TTI622, but hopefully, either by the end of this year or early next year, we will see more information from those. It's a very active field and a major target and pathway for clinical development in acute myeloid leukemia and MDS.

What were the key takeaways from your presentation given this year at 10th Annual Meeting of the Society of Hematologic Oncology?

There was a lot of discussion and focus on how to optimize frontline hypomethylating agent and venetoclax and moving beyond HMA and venetoclax. HMA and venetoclax has not been approved that long, it's only been around 4 years. But at MD Anderson Cancer Center, we were involved in and enrolled a large number of patients and led the studies. We realize that even though it's a good breakthrough, at the end of the day, the 3-year survival is about 35%. That is better than 10%, which it was before that for older unfit patients. But still a lot of work has to be done.

What has research focused on over the past few years?

Our effort over the last 2 or 3 years has been to identify molecular biomarkers of resistance. We have found that certain molecular groups like FLT3, TP53, RAS, KIT mutation, don't seem to have the same durability and survival with HMA and venetoclax as other molecular groups like NPM1, IDH1, IDH2, which do well.

Now, we've been trying to design ways to add targeted therapies in patients who don't have as good outcomes but have a particular targetable mutation. Sort of a rationalized personalized improvement of the HMA event. This is where several combos of HMA/venetoclax with second generation FLT3 inhibitor or HMA/venetoclax with an IDH inhibitor, HMA/venetoclax with CD47 for TP53, and coming soon, HMA/venetoclax with menin inhibitors.

Of course, the inherent issue with combining drugs is you have to be aware of and adjust for myelosuppression toxicities. With a lot of these combinations, the response rates are high with HMA and FLT3 and IDH, but we do see that there's an additional myelosuppression. Now we're cutting down the duration of them. FLT3, because of their response being so high, the synergy is good, and you may not need full doses of them. Now we're getting to a point where we are seeing synergy with less myelosuppression. But again, this has to be more mature before it can be adopted widely, but there was a lot of discussion about how we can optimize these doublets and triplets, and what is the benefit of using them upfront in combination vs sequencing. They were all great questions for clinical trials that are starting and will be coming.

What other panels stood out to you at SOHO 2022?

There was a very nice debate on MRD. The question was, is MRD the most critical marker for selecting subsequent therapy or prognosis? Is it the baseline molecular cytogenetic profile of the patient and is that information actually sufficient? Once you have that, do you benefit more from MRD data or not? It's quite a provocative question.

Going into the debate, I think a lot of us would say that MRD is the king and trumps all but both presenters gave very astute and useful arguments from both sides. What is true is that although MRD negativity is a good factor and is usually just associated with sensitivity or not resistance to chemotherapy, it is not really the eventual decision maker for most patients. Case in point, if you have a TP53-mutated AML, and even if they achieve MRD negativity, we would still consider a patient high-risk and go to transplant because we know that the TP53 biology is present in the leukemia stem cells and may be present at a very low level below the detection threshold. We don't feel comfortable that MRD eradication is sufficient to avoid it.

I think the point is that MRD may be useful in certain situations, NPM1, maybe FLT3 where we have effective therapies and presence of MRD. Despite that, effective therapy is poor. Maybe you need to do a transplant earlier. I escalate therapy. But for a large majority, the baseline molecular cytogenetic features, if you can really do them in a comprehensive fashion, will give you the similar predictive value as you would have gotten from MRD. And the advantages, you could get that upfront in the beginning. I think it really speaks to the need to enhance our comprehensive genomic cytogenetic potentially the near future RNA expression data. And hopefully then we can really segregate and triage the appropriate prognostic and therapeutic selection for AML.

What unmet needs still exist in this space?

The whole space is an unmet need because in general for AML, the frontline survival is about 35%-40% if you take all patients. It's a little better in the younger patients, those who are below 65, but the 5-year survival is closer to about 60%-65%. For those who are above 65, it's poor at about 20%-25%. In general, we are looking for new strategies for all of them. The most difficult group is probably in AML is TP53. With these, the median survival is 6-8 months across pretty much every therapy we have tried in the last decade, and the 5-year survival is less than 10%. There's usually a small subset of patients who if they can make a stem cell transplant with some degree of Disease Control, we could hope for 30%-35% long term survival.

Our goal is to get these people quickly to transplant if we can. The other big unmet need, both from a diagnostic perspective and therapeutic perspective is MRD [minimal residual disease]. We are getting better at identifying MRD with more sensitive techniques, especially molecular techniques including In single cell sequencing, potential duplex sequencing, and we're now able to probably get down to 10 raise to minus five or so routinely with some of these technologies. These have not yet been validated in prospective trials, hopefully they will be and then could be used prospectively potentially as Registration Status strategies.

The other big problem is we don't have great MRD eradicating strategies yet in the acute myeloid leukemia like we have in acute myeloid leukemia, lymphoma, and others. There has not yet been a chimeric antigen receptor T or bispecific that has shown that degree of activity, but there are many of these now in early stage or going into clinic. Hopefully, we will have some MRD based therapies. These are probably the 2 biggest areas of unmet need.

Then of course, in any relapse disease, the outcome is still poor. We look for targetable mutations, FLT3 IDH1, IDH2, MLL rearrangement, and for this, we do have targeted therapies with FLT3 inhibitors, IDH inhibitors, Menin inhibitors, but for the others, we still are looking at clinical trial options and nothing has really made a breakthrough yet.

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Magrolimab Development Continues for the Treatment of AML and MDS - Targeted Oncology

Hypertension Clinical Trials Pipeline Analysis: 90+ Companies are Working to Improve the Treatment Space | DelveInsight – GlobeNewswire

New York, USA, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Hypertension Clinical Trials Pipeline Analysis: 90+ Companies are Working to Improve the Treatment Space | DelveInsight

As per a statement of World Health Organization (WHO), Hypertension is one of the silent killers in 21st century and is one of the biggest global public health concerns. Factors like technological advancement, a growing aging population, and people affected by diabetes, and high blood pressure are favoring the market. Some of the key players contributing to the worldwide anti-hypertensive medication market include Quantum Genomics, Nicox, Santen Pharmaceuticals, Ionis Pharmaceuticals, United Therapeutics Corporation, and several others.

DelveInsights 'Hypertension Pipeline Insight 2022' report provides comprehensive global coverage of available, marketed, and pipeline hypertension therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the hypertension pipeline domain.

Key Takeaways from the Hypertension Pipeline Report

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The hypertension pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage hypertension products, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the hypertension pipeline landscape.

Hypertension Overview

High blood pressure (hypertension) is a common condition in which the blood's long-term force against your artery walls is high enough to cause health problems such as heart disease. Age, smoking, drinking, overweight are among the prominent factors for causes of hypertension.

Even when blood pressure readings reach dangerously high levels, most people with high blood pressure have no hypertension symptoms. Some people with high blood pressure may experience headaches, shortness of breath, or nosebleeds. Still, these signs and hypertension symptoms aren't specific and usually don't appear until the high blood pressure has progressed to a severe or life-threatening level.

Several tests such as ECG, EKG, Echocardiogram, Ambulatory monitoring, la tests, and others are used for hypertension diagnosis.

Find out more about hypertension medications @Hypertension Treatment Drugs

A snapshot of the Hypertension Pipeline Drugs mentioned in the report:

Learn more about the emerging hypertension pipeline therapies @Hypertension Clinical Trials

Hypertension Therapeutics Assessment

Thehypertension pipelinereport proffers an integral view of the hypertension emerging novel therapies segmented by stage, product type,molecule type, mechanism of action, and route of administration.

Scope of the Hypertension Pipeline Report

Dive deep into rich insights for drugs for hypertension treatment, visit @Hypertension Treatment

Table of Contents

For further information on the hypertension pipeline therapeutics, reach out @Hypertension Drugs

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Hypertension Clinical Trials Pipeline Analysis: 90+ Companies are Working to Improve the Treatment Space | DelveInsight - GlobeNewswire

Research Shows Promise for Directing Later Lines of Therapy for Hodgkin Lymphoma – Targeted Oncology

New therapies have improved outcomes for patients in frontline treatment for Hodgkin lymphoma, and research now is addressing how subsequent therapies can meet needs of patients who progress after early lines of treatment.

When a patient has progressed through chemotherapytheyve had a stem cell transplant, theyve had brentuximab vedotin [Adcetris; Seagen] and theyve had PD-1 blockade, [physicians] are unsure of what treatments are available, Alex F. Herrera, MD, associate professor in the Division of Lymphoma, Department of Hematology and Hematopoietic Cell Transplantation at City of Hope in Duarte, California, said in an interview with The SOHO Daily News before the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO 2022).

Most patients with Hodgkin lymphoma can be cured by chemotherapy and radiotherapy, but the 20% to 25% of patients who do not respond can be as difficult to treat as those with other cancers, says Herrera. This means reducing the number of patients who relapse is crucial. Two major breakthroughs in this setting have been the introduction of brentuximab vedotin and PD-1 blockade, both of which have advanced to being used in the early lines of therapy in the United States. As the standard becomes using novel agents like brentuximab vedotin in frontline therapy, and maybe someday PD-1 blockade in frontline therapy, it even makes this a more pressing need to find therapies that work after a patient has progressed on those therapies, Herrera says.

Herreras presentation at SOHO 2022 discusses approaches to subsequent therapy for patients who have received brentuximab vedotin and PD-1 blockade. He says that although they have improved the outcomes of patients with Hodgkin lymphoma, patients who are not cured by initial therapies are now often resistant to these treatments as well. More durable responses are also needed for those who do benefit from these therapies, since it is a minority of patients who will have a long-term durable response from these immunotherapies when they are used alone.

Hodgkin lymphoma is a disease that typically affects younger patients, says Herrera. If a patient is resistant to therapy, our goal is to be able to not just get a patient in response, but [to keep] a patient in response for as long as we can.

A wide range of options could offer survival benefit to patients with relapsed disease. Because few new agents have been approved for patients with relapsed disease after brentuximab vedotin and PD-1 blockade, clinical trials play a major role in offering patients the best available care.

Emerging Therapies

New agents such as antibody-drug conjugates (ADCs) could offer a next-line approach. Whereas brentuximab vedotin targets CD30, camidanlumab tesirine (ADCT-301) is another ADC that targets CD25, which is also located on or around Hodgkin lymphoma cells. A phase 2 trial (NCT04052997) is investigating this ADC in patients who previously received brentuximab vedotin and an antiPD-1 agent.

Extending the length of benefit from antiPD-1 agents and overcoming resistance to immune checkpoint inhibitors is an important area of investigation due to the major role antiPD-1 agents now play in treating Hodgkin lymphoma. One potential approach is combining PD-1 blockade with an epigenetic-based or other targeted therapy. These include hypomethylating agents such as decitabine and azacitidine as well as histone deacetylase inhibitors such as vorinostat (Zolinza; Merck) and entinostat.

A study conducted in China (NCT03250962, NCT02961101) showed a significantly longer duration of response and favorable efficacy with the addition of decitabine to the antiPD-1 agent camrelizumab for patients with Hodgkin lymphoma who were PD-1 nave as well as those who were resistant to prior antiPD-1 therapy.1,2 Herrera is helping lead a similar study (NCT05162976) at City of Hope evaluating azacitidine plus nivolumab (Opdivo; Bristol Myers Squibb) to assess how a hypomethylating agent can improve response to immunotherapy. He is also the principal investigator of a phase 1 study (NCT03150329) of vorinostat (Zolinza; Merck) combined with pembrolizumab (Keytruda; Merck) in patients with Hodgkin lymphoma and other lymphoma types.

Herrera says targeted therapy that can extend the duration of benefit from immunotherapy would be an ideal approach in patients with low disease burden or fewer symptoms, because they are not in need of a fast-acting regimen and can benefit from the greater tolerability of immunotherapy. When a patient is resistant to immunotherapy, if we can re-sensitize them with something thats reasonably well tolerated and get them another year or two of response, [and] buy them that time, that might be a valuable option, he says.

For patients with higher disease burden who are more heavily symptomatic, chemotherapy may be the best approach to get a strong, rapid response. Research has also shown that PD-1 blockade can cause patients to become more sensitive to subsequent treatments,3 meaning chemotherapy could be used in combination with immunotherapy or afterward in patients who previously progressed on therapies such as the ABVD combination regimen (doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine).

Drugs already in use such as lenalidomide (Revlimid; Bristol Myers Squibb), everolimus (Afinitor; Novartis), and temsirolimus (Torisel; Pfizer) can also have a role as subsequent therapies when patients need to achieve a strong anticancer response to improve their outcomes, according to Herrera.

Cellular Therapies

Cellular therapies such as chimeric antigen receptor (CAR) T-cell therapy have made an impact in non-Hodgkin lymphoma and other hematologic malignancies, providing long-term durable remissions in many patients who had few options remaining. Herrera says CD30-targeted CAR T-cell therapies are promising for Hodgkin lymphoma, although they are not yet approved, and several CAR T-cell trials such as the phase 2 CHARIOT study (NCT04268706) are under way. A lingering question for him is whether CAR T-cell products will lead to durable responses in the relapsed population that is resistant to chemotherapy, immunotherapy, and CD30-targeted ADCs.

Herrera says he and his colleagues look for patients who may benefit from trials of cellular therapies that evaluate CAR T cells or natural killer T cells that can result in a durable response. We are trying to refer patients [to trials] or give patients these types of cellular therapies when they are available, he said.

Although the advances in the field have deemphasized the need for patients to receive an allogeneic stem cell transplant, Herrera anticipates it may still have a role as survival is now extended for patients who now may receive 5 or more prior lines of therapy. Four or 5 years later, then you have all these patients who are now progressing on these later-line therapies and they need something else, he says. I think understanding the role allogeneic stem cell transplant may play isa bit of an unresolved question that probably is going to need to be explored again.

There is a range of options available to patients. Theres a lot of drug development happening. And I think that early results are promising and exciting, Herrera says. My talk is about just opening that door and showing folks that theres a lot out there that were studying and that is possible.

REFERENCES:

1. Nie J, Wang C, Liu Y, et al. Addition of low-dose decitabine to anti-PD-1 antibody camrelizumab in relapsed/refractory classical Hodgkin lymphoma.J Clin Oncol. 2019;37(17):1479-1489. doi:10.1200/JCO.18.02151

2. Liu Y, Wang C, Li X, et al. Improved clinical outcome in a randomized phase II study of anti-PD-1 camrelizumab plus decitabine in relapsed/refractory Hodgkin lymphoma.J Immunother Cancer. 2021;9(4):e002347. doi:10.1136/jitc-2021-00234

3. Rossi C, Gilhodes J, Maerevoet M, et al. Efficacy of chemotherapy or chemo-anti-PD-1 combination after failed anti-PD-1 therapy for relapsed and refractory Hodgkin lymphoma: a series from Lysa centers. Am J Hematol. 2018;93(8):1042-1049. doi:10.1002/ajh.25154

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Research Shows Promise for Directing Later Lines of Therapy for Hodgkin Lymphoma - Targeted Oncology

Transcenta Received IND Clearance from FDA for Its Best-In-Class MASP2 Targeting Antibody TST004 for the Treatment of IgA Nephropathy – PR Newswire

SUZHOU, China, Oct. 4, 2022 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that TST004, its best-in-class, humanized monoclonal antibody targeting MASP2, has received IND clearance from U.S. Food and Drug Administration (FDA).

MASP2, mannose-binding protein-associated serine protease 2, is a key enzyme in the lectin pathway initiation of complement activation. Studies have shown that lectin pathway activation contributes to multiple human diseases such as immunoglobulin A nephropathy (IgAN), hematopoietic stem-cell transplantationassociated thrombotic microangiopathy (HSCT-TMA). Therefore, inhibition of MASP2 might be a potential treatment approach for diseases related to lectin pathway activation.

TST004 is a humanized mAb targeting mannose-binding protein-associated serine protease 2 (MASP2) and designed to prevent the inflammation and tissue damage mediated by lectin pathway complement activation.

In June 2022, Transcenta was selected to present the preclinical data of TST004 at the 2022 ISN Frontiers Meetings of Complement-Related Kidney Diseases in Bergamo, Italy: https://www.transcenta.com/newsDet/id-93

"There is a high unmet medical need for patients with IgA nephropathy, with around 30 to 45% of them ultimately developing end stage kidney disease and available treatment options remaining symptomatic in nature. Targeting the lectin pathway activation with our best-in-class TST004 antibody is a potentially transformative therapeutic alternative." said Dr. Caroline Germa, Transcenta's Executive Vice President, Global Medicine Development and Chief Medical Officer.

About TST004

TST004 is a humanized mAb targeting mannose-binding protein-associated serine protease 2 (MASP2) and designed to prevent the lectin pathway complement-mediated inflammation. Transcenta discovered and developed TST004 in-house and plan to develop TST004 for IgA nephropathy (IgAN), a highly prevalent chronic kidney disease with very limited treatment options. TST004 also has therapeutic potential in a number of other indications, such as thrombotic microangiopathy (TMA), representing significant market potential.

About Transcenta Holding Limited

Transcenta (HKEX: 06628) is a clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing.

Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Princeton, US and in Beijing, Shanghai and Guangzhou of China, and External Partnering Center in Boston and Los Angeles, US. Transcenta has also initiated the construction of the Group Headquarters and the second high-end biopharmaceutical facility with ICB as its core technology in Suzhou Industrial Park. Transcenta is developing ten therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders.

For more information, please visit http://www.transcenta.com and https://www.linkedin.com/company/transcenta.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Transcenta, are intended to identify certain of such forward-looking statements. Transcenta does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Transcenta with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Transcenta's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Transcenta's competitive environment and political, economic, legal and social conditions.

Transcenta, the Directors and the employees of Transcenta assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

SOURCE Transcenta Holding Limited

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Transcenta Received IND Clearance from FDA for Its Best-In-Class MASP2 Targeting Antibody TST004 for the Treatment of IgA Nephropathy - PR Newswire

Jasper Therapeutics Announces Positive Clinical Data from Investigator Sponsored Study of JSP191 Conditioning in Fanconi Anemia Patients at IEWP…

REDWOOD CITY, Calif., Sept. 26, 2022 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (NASDAQ: JSPR), a biotechnology company focused on hematopoietic cell transplant therapies, today announced that data from the companys investigator-sponsored study of JSP191 as a conditioning agent in the treatment of Fanconi Anemia were presented at the annual conference of the Inborn Errors Working Party (IEWP), a research group of the European Society of Blood and Marrow Transplantation, held on September 23-25, 2022, in Paris, France.

The study is a Phase 1/2 clinical trial (NCT04784052) utilizing JSP191 to treat Fanconi Anemia patients in bone marrow failure requiring allogeneic transplant with non-sibling donors. The objective of the study is to develop cell therapy for Fanconi Anemia which enables enhanced donor hematopoietic and immune reconstitution with decreased toxicity by transplanting TCR ab+ T-cell/CD19+ B-cell depleted stem cells from a donor, after using JSP191 as a part of conditioning. Primary outcome measures include the number of patients without treatment-emergent adverse events following the administration of JSP191.

In the data series presented, 100% complete donor chimerism was achieved through six months for the first patient and at one month for the second patient. Neutrophil engraftment was reached on day 11 for both patients and platelet engraftment was achieved on days 9 and 14. JSP191 was cleared by day 9 after dosing and no treatment-related adverse events or toxicities were observed.

Patients affected by Fanconi anemia have increased sensitivity to conventional conditioning regimens and radiation due to innate defects in DNA repair, said Ronald Martell, President, and CEO of Jasper Therapeutics. JSP191 offers a targeted conditioning strategy that eliminates the need for radiation or alkylating agents like busulfan. Initial data from this study suggest that a conditioning regimen that includes JSP191 has the potential to achieve successful donor transplant with no JSP191-related adverse events or toxicities reported to date. The positive update presented gives us increased confidence in JSP191, which has now shown promise as a conditioning agent in four indications including acute myeloid leukemia, myelodysplastic syndromes, severe combined immunodeficiency, and Fanconi anemia. We look forward to continuing support for Stanfords investigation of JSP191 and advancing our broader pipeline for JSP191 to the next phase of development.

The details of the oral presentation are as follows:

Title: JSP 191 clinical trial update Session Name: Conditioning for HSCT in IEI Presenter: Rajni Agarwal-Hashmi, M.D., Professor of Pediatrics and Stem Cell Transplantation, the Stanford University School of Medicine Date/Time: Saturday, September 24, 2022, 2 pm CEST Location: The Imagine Institute in Paris, France

About Fanconi Anemia Fanconi Anemia (FA) is a rare but serious blood disorder that prevents the bone marrow from making sufficient new red blood cells. The disorder can also cause the bone marrow to make abnormal blood cells. FA typically presents at birth or early in childhood between five and ten years of age. Ultimately it can lead to serious complications, including bone marrow failure and severe aplastic anemia. Cancers such as AML and MDS are other possible complications. Treatment may include blood transfusions or medicine to create more red blood cells, but a hematopoietic stem cell transplant (HSCT) is the only cure.

About JSP191

JSP191 is a humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or genetically modified transplanted stem cells to engraft. To date, JSP191 has been evaluated in more than 100 healthy volunteers and patients. Four clinical trials for acute myeloid leukemia (AML)/ myelodysplastic syndromes (MDS), severe combined immunodeficiency (SCID), sickle cell disease (SCD) and Fanconi anemia are currently ongoing. The Company plans a new study of JSP191 as a second-line therapeutic in lower-risk MDS patients in 2022 as well as to a pivotal study in AML/MDS transplant in early 2023. Enrollment in additional studies are planned in patients with chronic granulomatous disease and GATA2 MDS who are undergoing hematopoietic cell transplantation as well as a study of JSP191 as a chronic therapeutic for low to intermediate risk MDS patients.

About Jasper Therapeutics

Jasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, an anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing hematopoietic cell transplantation. It is designed to enable safer and more effective curative allogeneic hematopoietic cell transplants and gene therapies. In parallel, Jasper Therapeutics is advancing its preclinical mRNA Stem Cell Graft Platform which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases, and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as believe, may, will, estimate, continue, anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the potential long-term benefits of hematopoietic stem cells (HSC) engraftment following targeted single-agent JSP191 conditioning in the treatment of severe combined immunodeficiency (SCID) and Jaspers ability to potentially deliver a targeted non-genotoxic conditioning agent to patients with SCID. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Jaspers product candidates; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that Jaspers product candidates may not be beneficial to patients or successfully commercialized; patients willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jaspers business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jaspers business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jaspers filings with the SEC. If any of these risks materialize or Jaspers assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jaspers assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts: John Mullaly (investors) LifeSci Advisors 617-429-3548 jmullaly@lifesciadvisors.com

Jeet Mahal (investors) Jasper Therapeutics 650-549-1403 jmahal@jaspertherapeutics.com

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Jasper Therapeutics Announces Positive Clinical Data from Investigator Sponsored Study of JSP191 Conditioning in Fanconi Anemia Patients at IEWP...

Mesenchymal stem cells market is projected to grow at a CAGR of 13.82% by 2032: Visiongain Research Inc – Yahoo Finance

Visiongain Reports Ltd

Visiongain has published a new report entitled Mesenchymal Stem Cells Market 2022-2032. It includes profiles of Mesenchymal Stem Cells Market and Forecasts Market Segment by Type {Product (Cell & Cell Lines, Kits Media & Reagents, Others), Services}, Market segment by Source (Bone Marrow, Adipose Tissue, Cord Blood, fallopian Tube, Fetal Liver, Lung, Peripheral Blood, Other Sources), Market Segment by Indication (Bone & Cartilage Repair, cardiovascular Disease, Cancer, GvHD, Inflammatory & Immunological Diseases, Liver Diseases, Other Diseases), Market Segment by Application (Disease Modelling, Drug Discovery & Development, Stem Cell Banking, Tissue Engineering, Toxicology Studies, Other Applications) plus COVID-19 Impact Analysis and Recovery Pattern Analysis (V-shaped, W-shaped, U-shaped, L-shaped), Profiles of Leading Companies, Region and Country.

The mesenchymal stem cells market was valued at US$2.44 billion in 2021 and is projected to grow at a CAGR of 13.82% during the forecast period 2022-2032.

Rising Awareness About Therapeutic Potential of Mesenchymal Stem Cells The mesenchymal stem cell (MSC) market has a huge potential for expansion as it's the most prevalent stem cell type used in regenerative medicine. MSCs are now the most commonly used stem cell type in clinical trials and the most researched stem cell type in the scientific literature. MSC-based therapies are also gaining popularity due to the rapidly aging population and rising prevalence of chronic diseases. Mesenchymal Stem cells play a significant role in effective management of disease and research initiatives in specialized areas such as genomic testing and personalized medicine. As a result of rising awareness of the therapeutic potential of stem cells and the scarcity of effective therapeutic treatments for rare diseases there is rise in investment leading to the growth of the market, however significant operational cost associated with the mesenchymal stem cell expansion and banking is anticipated to hinder the market growth.

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Mesenchymal Stem Cells Market Report 2022-2032

How has COVID-19 had a Significant Negative Impact on the Mesenchymal Stem Cells Market?

The biotechnology industry has experienced evolutionary changes with regards to the operational management. Typical biopharmaceutical companies manufacturing products for mesenchymal stem cell development had a better response to staff disruptions and challenges evolving due to COVID-19.

There was an impact on the research & development activities and clinical trials as there were interruptions in the new patient enrolment for the active clinical trial. However, the business focused on inventing new therapies for the treatment of COVID-19 disease. In the past years, MSCs have established itself to be an effective technique to treat pulmonary disease, including COVID-19. MSC derived stem cell therapies have showed the potential for the treatment of the Covid 19 disease. Therefore, an increase in the number of clinical trials using MSCs has been observed. Countries such as the US, the UK, Belgium, France, Spain and Mexico are conducting clinical trials with mesenchymal stem cells to be used in the treatment of COVID-19.

How will this Report Benefit you?

Visiongains 281-page report provides 117 tables and 184 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the mesenchymal stem cells market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for Mesenchymal Stem Cells Market. Get financial analysis of the overall market and different segments including type, Source, Indication, Application, and company size and capture higher market share. We believe that there are strong opportunities in this fast-growing mesenchymal stem cells market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.

What are the Current Market Drivers?

MSCs in the Development of Engineered Tissues and Organs hMSCs are considered as one of the prominent bio fabrication materials for decades as they are proved safe and effective in treating various injuries and diseases such as bone or cartilage regeneration, stroke & cancer. Bioprinting is a rapidly expanding tissue engineering area with a lot of promise for product customization and addressing the global tissue and organ scarcity, with a global market of $1.82 billion USD predicted by 2022. hMSCs have also been found to be capable of being guided toward hepatocyte differentiation thus indicating huge demand for hMSCs as tissue engineering of organ develops. The requirement for hMSC in engineered tissue and organ applications is, of course, reliant on cell generation, differentiation, and maturation technologies for the parenchymal cells required for organ function and thus it is expected that the increased availability of hMSC sources as a result of manufacturing technology advancements will pave the way for quick improvement and growth of the mesenchymal stem cells market.

Rise in Focus Towards Regenerative Medicine Therapies MSCs are a good cell source for tissue regeneration because of the following characteristics. MSCs can be sourced from various tissue, including umbilical cord, fetal liver, bone marrow, and synovium. MSCs have the ability to develop into practically any end-stage lineage cell, allowing them to seed specific scaffolds. MSCs are potential immune tolerant agents as they have characteristics such as anti-inflammatory, immunoregulatory & immunosuppressive. Several clinical papers back up MSC-based cell therapy's potential efficacy; while its efficacy is still restricted, the results are encouraging.

MSCs have been investigated and used extensively in regenerative medicine. MSCs have moved closer to therapeutic applications for disease therapy and tissue repair in recent years due to improvements in extraction, culture, and differentiation procedures , therefore future research into better biomaterials and effective inducing factors will help MSCs advance in their regenerative medicine applications.

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Mesenchymal Stem Cells Market Report 2022-2032

Where are the Market Opportunities?

MSC Therapy to Treat Multiple Sclerosis The therapeutic application of MSCs in treating Multiple Sclerosis has proved to provide huge potential by improving clinical symptoms, thereby stabilizing the disease progression. MSCs have properties such as immunomodulator, tissue-protector and repair promotion has proved MSCs to be an attractive therapy option in the treatment of Multiple Sclerosis as well as in other conditions such as inflammation and tissue injury.

MSCs when administered, combat the inflammation in body and regulate the immune system which will further prevent myelin degradation. Clinical trials demonstrating the application of MSCs in Multiple Sclerosis patients have shown increased energy levels, improved flexibility, strength, and mobility. It has also been observed that if MSCs are administered intravenously may have the ability to halt diseases progression for an extended time duration.

MSCs offer intrinsic benefits over hematopoietic stem cells, that MSCs can differentiate into a cell types, release immunoregulatory molecules and promote release of exosome and growth factors

Competitive Landscape The major players operating in the mesenchymal stem cells market are Thermo Fischer Scientific Inc., Merck KGaA (Millipore Sigma), STEMCELL Technologoes Inc., Cytori Therapeutics Inc. (Plus Therapeutics Inc.), Cyagen Biosciences, PromoCell GmbH, Celprogen Inc. Stemedica Cell Technologies Inc., Cell Application Inc., Lonza, Celltex Therapeutics Corporation. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launches.

Recent Developments

In August 2022, to meet rising demand for cell culture media globally used in the development and manufacturing of new biologics and vaccines, Thermo Fisher Scientific enhanced its dry powder media manufacturing facility in Grand Island, New York.

In March 2022, new large-volume electroporation technology was unveiled by Thermo Fisher Scientific, making it simpler for inventors of cell therapies to transition from clinical development to commercial manufacture. Without the use of conventional viral vectors, the Gibco CTS Xenon Electroporation System facilitates gene changes through the use of a closed

In March 2019, Celltex Therapeutics entered into an agreement with Saudi Arabias Research Products Development Company (RPDC) to help with the promotion and marketing of Celltexs proprietary stem cell technology.

Avoid missing out by staying informed order our report now.

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Do you have any custom requirements we can help you with?Any need for a specific country, geo region, market segment or specific company information? Contact us today, we can discuss your needs and see how we can help:dev.visavadia@visiongain.com

About Visiongain

Visiongain is one of the fastest-growing and most innovative independent market intelligence providers around, the company publishes hundreds of market research reports which it adds to its extensive portfolio each year. These reports offer in-depth analysis across 18 industries worldwide. The reports, which cover 10-year forecasts, are hundreds of pages long, with in-depth market analysis and valuable competitive intelligence data. Visiongain works across a range of vertical markets with a lot of synergies. These markets include automotive, aviation, chemicals, cyber, defence, energy, food & drink, materials, packaging, pharmaceutical and utilities sectors. Our customised and syndicatedmarket research reportsoffer a bespoke piece of market intelligence customised to your very own business needs.

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Mesenchymal stem cells market is projected to grow at a CAGR of 13.82% by 2032: Visiongain Research Inc - Yahoo Finance

CellResearch Corporation (CRC) to present promising new stem cell products for the treatment of chronic diabetic foot ulcers at the world’s premier…

- CRC data on cord lining media for the treatment of diabetic foot ulcers has been accepted at the DFCon, with Dr Wong Keng Lin Francis, CRC's latest KOL, presenting his findings to world leaders in the field of DFU. - Similarly, the results of Corlicyte's Phase 1 study on the treatment of chronic diabetic foot has also been accepted with the presentation being given by Dr Cecilia Low-Wang, the trials Principal Investigator. - DFCon is a global specialist multi-disciplinary congress that attracts specialists in the field of the diabetic foot and is considered the most influential event in the industry. It is co-founded by Dr David Armstrong, a pre-eminent expert in diabetic foot. - Dr Armstrong, who also serves on CRC's scientific advisory board, will be giving the opening address for CRC's breakfast symposium on their lead products Sollagen and Corlicyte. - CorLiCyte is an umbilical cord lining stem cell therapy, for patients suffering with diabetic foot ulcers (DFU), Sollagen is a brand targeting diabetic's skin. - Global diabetes patient population is set to grow from 537 million in 2021 to 783 million in 20451- DFU is a global health emergency that will affect close to 20% of the diabetic population in their lifetime

LOS ANGELES, Sept. 26, 2022 /PRNewswire/ -- CRC is delighted to announce attendance at DFCon, the global specialist multidisciplinary congress focused on the diabetic foot held in late September 2022 in Los Angeles, USA. The meeting is a gathering of a wide range of both generalists and specialists who diagnose and manage diabetic feet, to discuss best practice in diagnostics and interventions for both treatment and amputation prevention. It was co-founded and is co-chaired by Dr David Armstrong, a pre-eminent expert in diabetic foot who also serves on CRC's scientific advisory board.

Dr David Armstrong will be introducing CRC's headline symposium on Saturday morning where Dr Paul Kemp, the inventor of Apligraf and scientific advisory board member, and esteemed researchers Dr Brian Freed and Dr Wong Keng Lin Francis will present an overview of CRC's technology and data.

Furthermore, CRC have two scientific posters approved for presentation at DFCon on the data generated in Corlicyte and Sollagen:

The first poster "Results of the phase 1 open-label safety study of umbilical cord lining (Corlicyte) to heal chronic diabetic foot ulcers" details the Phase I study in Corlicyte and is authored by Cecilia Low Wang and the team from the University of Colorado who conducted the study.

The second poster by Dr Wong from Sengkang General Hospital/Duke NUS is titled "Early evaluation of Sollagen, a topical exosomal skin conditioner derived from Umbilical cord lining cell media, in treatment of persistent chronic DFU" and details the impressive early data generated with Sollagen in chronic diabetic foot ulcers.

Both posters are a testament to the immense potential of Corlicyte and Sollagen for the treatment of diabetic foot ulcer, a huge issue for patients and health care systems alike.

CRC's presence at such a specialized and well-regarded scientific and medical forum reflects the exciting data the company is generating. It is a strong indication of the academic and clinical network that the company is building to deliver products that can make a dramatic difference to patients with a large unmet medical need.

About CellResearch Corporation (CRC)

CellResearch Corporation was founded in 2002 as a contract research provider focusing on skin cells. In 2004, the company made the discovery that the umbilical cord lining of mammals was an abundant source of both mesenchymal and epithelial stem cells. Today, the company owns this technology through a family of patents and holds the rights to commercialize this technology in most major markets globally. While the closure of diabetic foot ulcers is the company's first allogeneic therapy to make it to the end of Phase 1 USFDA clinical trials, CellResearchCorp has a broad therapeutic pipeline at the pre-clinical stage. Further therapies include solid tumor therapy, inflammatory diseases, cardiac muscle repair, Parkinson's Disease, Age-related Macular Degeneration and Diabetes.

CellResearch Consumer Health, a wholly owned subsidiary of CellResearch Corp, is the commercialization vehicle for CALECIMProfessional and the newly launching Sollagen. It produces an innovative range of skincare and haircare products using cord lining stem cell media to power its products. It is used in clinics/hospitals and as part of an at-home anti-aging skincare regime. It is distributed globally through over 600 aesthetic physicians and online via their own website. It has a key distribution partnership with Menarini Group across Southeast Asia.

CellResearch Corp partner, Cordlife offers parents the opportunity to bank their child's umbilical cord tissue alongside their cord blood. Cordlife has what is believed to be the largest licensed bank of umbilical cord tissue globally. As cell therapies move into the clinic, Cordlife will have the ability to expand stem cells from a banked umbilical cord for autologous and donor-related uses.

http://www.cellresearchcorp.com

https://calecimprofessional.com

Business Development and Investor Relations:

Xavier Simpson

+65 8815 6139

xaviersimpson@cellresearchcorp.com

Cision

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CellResearch Corporation (CRC) to present promising new stem cell products for the treatment of chronic diabetic foot ulcers at the world's premier...