Horizon Research Fellow job with UNIVERSITY OF LEEDS | 203439 – Times Higher Education (THE)

Would you like to be involved in cutting edge research to develop novel solutions for smart resorbable bone implants for controllable and fast bone restoration, and to testa new generation acellular scaffold with bone-like architecture? Are you interested in acquiring and/or developing your skills to develop new tissue engineering solutions for in vitro reprogramming of adult stem cells for embedding into the smart implant?

Applications are invited for a Postdoctoral Fellow position working with Prof Peter Giannoudis and Dr Elena Jones on the Horizion 2020project SBR Smart Resorbable Bone and a small industry funded project Greenbone. Based on the St. James Campus, you will co-ordinate projects related to several SBR Work Packages (WPs).

More specifically you will be working on the WPs 6 with the aims to:

You will also be responsible for delivering Greenbone project to assess the biological support that GreenBone scaffold can provide for MSCs and endothelial cells.

Reporting to Dr Jones, your work will be carried out in collaboration with consortium members based in Patras, Greece and Munich, Germany.

Capitalising on the infrastructure and samples collected through the Leeds Institute of Rheumatic and Musculoskeletal medicine based across St Jamess University Hospital and LGI, you will generate primary MSC cells to be used by other consortium partners. You will develop and validate assays to assess the behaviour of MSCs on electrospun biocompatible scaffolds, as well as optimise the MSCs uptake of several bioactive DDRs. In collaboration with partners in Greece and Germany, you will also develop and validate assays for the assessment of MSC functionality on bioactive implants. In Greenbone project, you will be testing the attachment and growth of human bone marrow cells onGreenBone scaffold, as well as the endothelial cell-MSC interactions on the scaffold surface.

The post holder will also liaise with the research group, specifically dedicated to this project, and based in the School of Chemical and Process Engineering, as required.

To explore the post further or for any enquiries you may have, please contact:

Dr Elena Jones, Associate Professor (Non-Clinical)

Tel: +44 (0)113 2065647; email:e.jones@leeds.ac.uk

OR

Professor Peter Giannoudis, Professor of Orthopaedic Surgery

Tel + 44 (0) 113 0113-20-67068; email:P.Giannoudis@leeds.ac.uk.

Further Information

The University of Leeds is committed to providing equal opportunities for all and offers a range offamily friendly policies. The University is a charter member of Athena SWAN and holds the Bronzeaward. The School of Medicine holds theGoldaward. We are committed to being an inclusive medical school that values all staff, and we are happy to consider job share applications and requests for flexible working arrangements from our employees.

Location:Leeds - St James University HospitalFaculty/Service:Faculty of Medicine & HealthSchool/Institute:Leeds Institute of Rheumatic & Musculoskeletal Medicine (LIRMM)Section:Section of Experimental RheumatologyCategory:ResearchGrade:Grade 7Salary:33,797 to 40,322 p.a.Working Time:100% FTEPost Type:Full TimeContractType:Fixed Term (Available immediately on a fixed term basis for 27 months or until 31 December 2023 (wichever is sooner))ClosingDate:Tuesday 21 April 2020Reference:MHLRM1130Downloads:CandidateBrief

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Horizon Research Fellow job with UNIVERSITY OF LEEDS | 203439 - Times Higher Education (THE)

What You Need to Know About the FDA’s Approval of Opdivo-Yervoy for Hepatocellular Carcinoma – Curetoday.com

The Food and Drug Administration approved the dual immunotherapy of Opdivo and Yervoy for the treatment of patients with advanced hepatocellular carcinoma. Heres what you need to know.

This is the only dual immunotherapy approved by the FDA in this setting of patients with HCC and was based on the results of the phase 1/2 CheckMate-040 trial. The overall trial was to look at Opdivo in patients with advanced HCC, with the Opdivo and Yervoy cohort showing a duration of responses that lasted from 4.6 to 30.5 months with 88% of responses lasting at least 6 months, 56% at least 12 months and 31% at least 24 months, according to a Bristol Myers Squibb spokesperson.

HCC is an aggressive disease in need of different treatment approaches, Dr. Anthony B. El-Khoueiry, lead investigator and phase 1 program director at the Keck School of Medicine, University of Southern California (USC) and the USC Norris Comprehensive Cancer Center, said in the original press release regarding the approval. As the incidence of liver cancer rises in the United States, HCC has become the most common and aggressive from of the disease with relapsed patients in need of new treatments after the first line of treatment fails. This is why the FDA granted accelerated approval to the Opdivo and Yervoy combination for this patient group previously treated with Nexavar, a chemotherapy for liver cancers.

The CheckMate-040 trial is a phase 1/2, dose-escalation/dose expansion, open-label study of Opdivo in patients with advanced hepatocellular carcinoma with or without chronic viral hepatitis C or B. Researchers envaulted the Opdivo-Yervoy combination in 49 patients with advanced HCC, 33% of these patients responded to this treatment with 8% demonstrating a complete response and 24% exhibiting a partial response after a minimal follow up of 28 months. Overall response was reported in 35% of patients.

According to a Bristol Myers Squibb spokesperson, the Opdivo-Yervoy combination acts on the CTLA-4 and PD-1 immune checkpoints that while beneficial alone there is evidence that the mechanisms can work together to produce a greater effect in patients. In the case of Yervoy, it may help the patients immune system to activate more T cells that help fight cancer cells while Opdivo assists in already active T cells discovering cancer cells. The researchers believe the combination can work to discover and then deploy newly activated T cells in the fight against cancer.

However, according to a Bristol Myers spokesperson, this combination therapy can cause the immune system to attack normal organs and tissues which can lead to serious complications and may happen more often on this combination therapy.

In the CheckMate-040 trial serious side effects were seen in 59% of patients on the treatment, including pyrexia, diarrhea, anemia, increased aspartate aminotransferase, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin and pneumonitis in more than 4% of patients. The most common of these side effects was rash, pruritus, musculoskeletal pain, diarrhea, cough, decreased appetite, fatigue, pyrexia, abdominal pain, headache, nausea, dizziness, hypothyroidism and weight decrease reported in more than 20% of patients.

The approval for the Opdivo-Yervoy combination was granted on March 10th, 2020.

Read CUREs original coverage of the approval.

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What You Need to Know About the FDA's Approval of Opdivo-Yervoy for Hepatocellular Carcinoma - Curetoday.com

MSC-based therapies from Mesoblast, Cynata advance to tackle COVID-19 ARDS – BioWorld Online

PERTH, Australia Australian stem cell therapy company Mesoblast Ltd. announced that the FDA gave it the green light to test its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19).

Were going to be evaluating whether an injection of our cells intravenously can tone down the immune system just enough so it gets rid of the virus but doesnt destroy your lungs at the same time, Mesoblast CEO Silviu Itescu told BioWorld.

What people are dying of is acute respiratory distress syndrome, which is the bodys immune response to the virus in the lungs, and the immune system goes haywire, and in its battle with the virus it overreacts and causes severe damage to the lungs, Itescu said.

The FDA clearance provides a pathway in the United States for use of remestemcel-L in patients with COVID-19 ARDS, where the prognosis is very dismal, under both expanded access compassionate use and in a planned randomized controlled trial.

The company is in active discussions with various governments, regulatory authorities, medical institutions and pharmaceutical companies.

Recently published results from an investigator-initiated clinical study conducted in China reported that allogeneic MSCs cured or significantly improved functional outcomes in all seven treated patients. A post-hoc analysis of a randomized, placebo-controlled study in 60 patients with chronic obstructive pulmonary disease demonstrated that remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also observed in patients with COVID-19 ARDS.

Remestemcel-L is being developed for various inflammatory conditions and is believed to counteract the inflammatory processes implicated in those diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

The safety and therapeutic effects of remestemcel-L intravenous infusions have been evaluated in more than 1,100 patients in various clinical trials.

The stem cell therapy was successful in a phase III trial for steroid-refractory acute graft-vs.-host disease (aGVHD) in children, a potentially fatal inflammatory condition due to a similar cytokine storm process as is seen in COVID-19 ARDS.

Cynata in preclinical ARDs studies

Fellow Aussie regenerative medicine company Cynata Therapeutics Ltd. is studying the utility of its Cymerus MSCs as a treatment for ARDS associated with COVID-19 with the Critical Care Research Group at Prince Charles Hospital in Brisbane, Australia.

Acute respiratory distress syndrome is a huge problem worldwide and is prevalent aside from COVID-19, but suddenly it is on the front page because people are dying of this. The data behooves us to see if MSC treatment can rescue people from this, Cynata CEO Ross Macdonald told BioWorld.

The Critical Care Research Group has long seen the need to improve interventions in patients who have ARDS, and they have an interest in MSCs and came to us, he said.

ARDS is an inflammatory process leading to the build-up of fluid in the lungs and respiratory failure. It can occur due to infection, trauma and inhalation of noxious substances. ARDS often affects previously healthy individuals and accounts for roughly 10% of all ICU admissions, with almost 25% of patients requiring mechanical ventilation. Survivors of ARDS are often left with severe long-term illness and disability.

The study will investigate Cynatas Cymerus MSCs as a treatment for ARDS, in combination with extracorporeal membrane oxygenation (ECMO). ECMO circulates blood through an artificial lung, oxygenating the blood before putting it back into the bloodstream of a patient. ECMO has emerged as a treatment adjunct to support the vital organs in patients with severe ARDS, which can provide short- to medium-term mechanical pulmonary support.

MSC therapy could be used as a possible treatment for ARDS due to the ability of MSCs to reduce inflammation, enhance clearance of pathogens and stimulate tissue repair.

The study will first seek to determine if Cymerus MSC treatment improves oxygenation in sheep with ARDS supported by ECMO, and to evaluate the effects on lung mechanics, blood flow, inflammation and lung injury, as well as safety.

If the study is successful, the data would support progression to a clinical trial of Cymerus MSCs in humans with ARDS undergoing ECMO support.

The study is being funded by the Queensland State Government, the National Health and Medical Research Council (NHMRC), the Intensive Care Society UK, and the Prince Charles Hospital Foundation.

If the FDA or TGA wants us to step in, were all ears. Our product is manufactured in the United States, and supply is not an issue. In theory, were ready to go, Macdonald said.

He was quick to point out that what differentiates Cynatas stem cell product from competitors is that its MSCs are derived from induced pluripotent stem cells (iPSCs), and most stem cell companies rely on multiple donors to donate either bone marrow or adipose tissue as their primary tissue sources. From those sources they derive a small number of MSCs, which represent the starting material of their manufacturing process.

Cynatas Cymerus MSC therapy comes from a single donor and can be produced in limitless quantities, giving it the potential to create a new standard, Macdonald said. The platform technology is based on versatile stem cells known as mesenchymoangioblasts (MCAs), which are a precursor of mesenchymal stem cells.

That process allows the company to make MSCs derived from iPSCs in large amounts without losing their potency, and that forms the basis for the companys platform technology, which it calls Cymerus.

Cynata is gearing up for three phase II trials with its Cymerus MSCs in graft-vs.-host disease (GVHD), critical limb ischemia and osteoarthritis.

Mesoblasts remestemcel-L is being studied in clinical trials across several inflammatory conditions, including in elderly patients with lung disease and adults and children with steroid-refractory aGVHD, heart failure and chronic low back pain due to intervertebral disc degeneration.

The FDA recently accepted Mesoblasts BLA for priority review for remestemcel-L for children with aGVHD. It has a PDUFA date of Sept. 30 for the product branded as Ryoncil.

Mesoblast shares (ASX:MSB) were up nearly 34% to AU$1.78 from AU$1.32 per share by market close April 6.

Cynatas shares (ASX:CYP) were trading at AU86 cents on April 7.

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MSC-based therapies from Mesoblast, Cynata advance to tackle COVID-19 ARDS - BioWorld Online

CYTOVIA Therapeutics and MACROMOLTEK to Develop Dual-Acting Natural Killer Immunotherapy Against SARS CoV2 (COVID-19) | DNA RNA and Cells | News…

DetailsCategory: DNA RNA and CellsPublished on Tuesday, 07 April 2020 18:50Hits: 403

NEW YORK, NY and AUSTIN, TX, USA I April 07, 2020 I Cytovia Therapeutics (Cytovia), an emerging biopharmaceutical company developing Natural Killer (NK) immunotherapies for cancer and infectious diseases, announced today that it is expanding its programs to help urgently address the current SAR CoV2 (COVID-19) crisis.

Natural Killer cells are a first line of defense not only against tumor cells but also against severe acute infectious diseases. Using a bi-functional approach has the potential to minimize virus escape from the immune response thereby inhibiting the intensification of the inflammation leading to Acute Respiratory Syndrome (ARS). The activation of NK cells through the NKp46 receptor aims to destroy the virus-infected cells while the other arm can either block the entry of the virus into epithelial cells or neutralize circulating viruses.

Dr Daniel Teper, co-founder, Chairman and CEO of Cytovia said: Our goal is to bring the best candidate to clinical trials by the end of the year 2020 and make it available to patients in 2021. As we become more prepared for potential next waves of the pandemic, physicians will need therapeutic options to strengthen the immune response and prevent rapid worsening of the disease. We expect that our novel approach might also be applied in the future to other severe acute infectious diseases, an area that still has significant unmet medical needs. Partnering with Macromoltek will fast-track this process.

Dr Monica Berrondo, co-founder and CEO of Macromoltek added: Our computational approach to antibody design allows to fast track the development of optimal therapeutic candidates in weeks rather than months. In the fight against SARS CoV2, time is of the essence. We are delighted to be part of a multi-disciplinary team passionate about winning the race against the virus with novel therapeutic solutions.

Cytovia will lead a highly coordinated team of scientific collaborators in order to achieve aggressive timelines for its COVID-19 therapeutic program. Cytovia will leverage its own proprietary bi-functional technology, developed by co-founder Dr Kadouche, NK activating antibodies licensed last month from Yissum, the technology transfer company of the Hebrew University of Jerusalem, and novel antibodies neutralizing or blocking SARS CoV2, designed by Macromoltek, a computational antibody discovery company. The selected bi-functional antibodies will further benefit from the Fast to Clinic approach implemented by STC Biologics, a Boston, MA based antibody development and manufacturing company.

About Cytovia TherapeuticsCytovia aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and applies precision medicine tools to develop the right therapy for the right patient at the right stage of the disease. Cytovia has secured access to multiple advanced technologies, including an induced pluripotent stem cell (iPSC) platform for NK cell therapy, gene editing of Chimeric Antigen Receptors (CAR) to enhance targeting of NK cells, and NK engager multi-functional antibodies. Cytovia partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF) and the Hebrew University of Jerusalem. Learn more at http://www.cytoviatx.com.

About MacromoltekMacromoltek, a computationalde novodrug design company, rapidly producesaccurate and credible antibody designs. They have built a proprietary platform that enables design against difficult targets inaccessible by traditional methods. A Y Combinator cohort company, they are already designing antibodies for several large biopharmas and smaller biotechs. https://www.macromoltek.com

SOURCE: Cytovia Therapeutics

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CYTOVIA Therapeutics and MACROMOLTEK to Develop Dual-Acting Natural Killer Immunotherapy Against SARS CoV2 (COVID-19) | DNA RNA and Cells | News...

AlloVir Appoints Ugo Capolino Perlingieri Head of Europe and Middle East Operations – Yahoo Finance

Appointment enables global development and commercialization planning for AlloVirs growing pipeline of allogeneic, off-the-shelf, virus-specific T cell therapies

AlloVir, a late-clinical stage T-cell immunotherapy company, today announced that Ugo Capolino Perlingieri has been appointed to the newly created position of General Manager of Europe and Middle East operations. In this role, he will be responsible for implementing clinical and commercial programs to pave the way for regulatory review and eventual commercialization of the companys full range of investigational T-cell therapies.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200406005378/en/

Ugo Capolino Perlingieri, Head of Europe and Middle East Operations, AlloVir (Photo: Business Wire)

"Ugo is an outstanding leader with decades of global operations experience and an unparalleled track record of successfully launching transformative orphan drugs to patients in need," said Jeroen van Beek, PhD, Chief Commercial Officer of AlloVir. "His deep relationships with European health authorities, healthcare professionals, and European transplant centers will be essential to our goal of building a world-class organization serving patients across a multi-country platform."

Mr. Capolino Perlingieri joins AlloVir with more than 30 years of experience in operational management at biopharmaceutical and medical device companies. Prior to joining AlloVir, he spent 11 years as Vice President and General Manager at Alexion Pharma Italy, where he launched and led the companys Italian subsidiary. Mr. Capolino Perlingieri has served various positions at multinational and startup organizations. He began his career at Baxter International, Inc. where he held various European-based positions, including that of European Business Director of the stem cell transplant-focused Baxter Immunotherapy Division.

"Ive had the great pleasure of building and leading operational and commercial teams across Europe and have gained an understanding of the challenges and opportunities in providing faster diagnosis and more effective treatments to patients with rare diseases and those receiving stem cell transplantation," said Mr. Capolino Perlingieri. "I look forward to helping AlloVir establish broad access to our innovative pipeline of multi-virus specific T-cell therapies for immunocompromised patients at risk of life-threatening viral diseases."

Mr. Capolino Perlingieri graduated summa cum laude with a degree in Economics and Commerce from Federico II University in Naples, Italy and has an MBA from Columbia Business School in New York.

AlloVir will initiate Phase 3 pivotal and Phase 2 proof-of-concept studies this year with its lead product, Viralym-M (ALVR105), an allogeneic, off-the-shelf, multi-virus specific T-cell therapy, targeting six devastating and life-threatening viral pathogens. Viralym-M received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration in 2019. This year, the European Medicines Agency granted AlloVir two designations for Viralym-M: PRIority MEdicines (PRIME) and Orphan Drug Designation. Viralym-M is one of only seven investigational therapies, to date, to receive both PRIME and RMAT designations from the EMA and FDA, respectively.

Story continues

About AlloVir

AlloVir, formerly ViraCyte, is an ElevateBio portfolio company that was founded in 2013 and is the leader in the development of novel cell therapies with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The companys technology platforms deliver commercially scalable solutions by leveraging off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viral pathogens for immunocompromised patients under viral attack. AlloVirs technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio.

AlloVirs investors include Fidelity Research and Management Company, Gilead Sciences, F2 Ventures, The Invus Group, Redmile Group, EcoR1, Samsara Biocapital, and Leerink Partners Co-investment Fund, LLC.

For more information visit http://www.allovir.com.

About ElevateBio

ElevateBio, LLC, is a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies. It begins with an environment where scientific inventors can transform their visions for cell and gene therapies into reality for patients with devastating and life-threatening diseases. Working with leading academic researchers, medical centers, and corporate partners, ElevateBios team of scientists, drug developers, and company builders are creating a portfolio of therapeutics companies that are changing the face of cell and gene therapy and regenerative medicine. Core to ElevateBios vision is BaseCamp, a centralized state-of-the-art innovation and manufacturing center, providing fully integrated capabilities, including basic and transitional research, process development, clinical development, cGMP manufacturing, and regulatory affairs across multiple cell and gene therapy and regenerative medicine technology platforms. ElevateBio portfolio companies, as well as select strategic partners are supported by ElevateBio BaseCamp in the advancement of novel cell and gene therapies.

ElevateBios investors include F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, Samsara BioCapital, The Invus Group, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures HC.

ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass. For more information, please visit http://www.elevate.bio.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200406005378/en/

Contacts

Courtney HeathScientPRAlloVirPR@scientpr.com 617-872-2462

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AlloVir Appoints Ugo Capolino Perlingieri Head of Europe and Middle East Operations - Yahoo Finance

What does the public know about COVID-19? – University of Miami

Survey aims to shed light on any misconceptions so that public agencies can address them.

Two University of Miami researchers are investigating how much people truly know about COVID-19and whether they would be willing to take a drug to prevent themselves from getting the disease, if one existed.

Dr. Dushyantha T. Jayaweera, a professor of medicine in the infectious disease research unit at the Miller School of Medicine, and public health graduate student Russell Saltzman often work together on clinical trials. Recently, they were brainstorming ways to help slow the spread of coronavirus, and Saltzman thought it would be helpful to find out if people are receiving the correct information about the virus that has prompted a global pandemic.

Ive heard people say that there has been a lot of inconsistent messaging by the authorities about COVID-19, so we wanted to figure out where the misconceptions lie, said Saltzman, who is also a clinical research coordinator at the Interdisciplinary Stem Cell Institute at the Miller School.

Both Saltzman and Jayaweera acknowledged the constant government advisories are a lot to keep up witheven for health care professionalsbut said it is their goal to ensure that the public has as much information as possible to stay healthy.

Things are moving so fast that its easy to be out of the loop, so its important to know what people know to inform the policymakers, Saltzman said. If we can identify gaps in knowledge, that can help focus efforts for disseminating information about the disease.

After about a month of data collection, the two will publish their research, making it accessible to government agencies and state health departments, Jayaweera said.

To gather the information, Saltzman created a 10-minute electronic survey and made it available through social media and several email listservs. The researchers hope participants will share it with friends so they can gain 10,000 participants from around the country.

Also through the survey, Jayaweera and Saltzman hope to gauge public attitudes toward a study that would examine the use of a drug called hydroxychloroquine (HCQ) as amedication topreventor slow the transmission of COVID-19. In two to three weeks, Jayaweera will begin a clinical trial funded by the National Institutes of Health examining whether the drug can help prevent infection in health care providers and shorten the disease course in general.

To participate in the survey, visit https://umiami.qualtrics.com/jfe/form/SV_blNe3xhV8Xx4uGN.

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What does the public know about COVID-19? - University of Miami

India Based Stem Cell Research Firm To Test Its Stem Cell Product For Acute Respiratory Disease Syndrome (ARDS) COVID-19 – IndianWeb2.com

Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), announced today that it has partnered with Global Consortium of cell therapy companies seeking European Commission Funding to Fight Against Corona! (FAC!). Under this partnership, Stempeutics will export its stem cell product Stempeucel (subject to regulatory approvals) for treating critically ill COVID-19 patients with lung disease. First the product will be clinically tested and upon successful outcomes, it intends to export the product on a regular basis. In this connection it is signing up an alliance with Educell Ltd, Slovenia.

Currently, no specific drugs or vaccines are available to cure the patients with COVID-19 infection. Mortality in COVID-19 infected patients with the inflammatory lung condition ARDS (Acute Respiratory Distress Syndrome)is reported to approach 50%, and is associated with older age, co-morbidities such as diabetes, cardiovascular disease, COPD (chronic obstructive pulmonary disease), higher disease severity, and elevated markers of inflammation. Current therapeutic interventions (with the exception of ventilators/respirators which are in very short supply) do not appear to be improving in-hospital survival. Hence, there is a large unmet need for a safe and effective treatment for COVID-19 infected patients, especially in severe cases. A promising new therapy for the ARDS, the terminal stage of COVID-19, using MSCs can quickly (2-4 days) reduce inflammation of the lung tissue, and allow patients to more quickly come off of the ventilatory support and hopefully fully recover with less significant lung damage.

Stempeucel is an allogeneic, off the shelf, pooled mesenchymal stromal cells having anti- inflammatory and immune-modulatory properties which prevents the over activation of the immune system. Stempeucel product exhibits a wide range of potent therapeutic properties. The product exhibits potent immunomodulatory and anti-inflammatory properties which could help in reducing the inflammation caused due to the cytokine storm elicited by the bodys immune cells in response to SARS-CoV-2 (COVID-19) related infection in the lungs. Also, the growth factor, Angiopoietin-1 (Ang-1) is effective in reducing alveolar epithelium permeability in the lung. Hence it is envisaged, Stempeucel will reduce the fatal symptoms of COVID 19 induced pneumonia and its progression to ARDS.

Commenting on this initiative, Dr. Miomir Knezevic, Leader of the Global Consortium and Founder of Educell said, We are happy to partner with Stempeutics since its product Stempeucel is already designated as an ATMP1 in Europe and also Stempeucel technology has been patented in many countries in Europe. Stempeutics manufacturing process is scalable and the product is affordable which are key to meet the demands of COVID-19 patients

Mr. BN Manohar, CEO of Stempeutics said, From the clinical data using Stempeucel in different clinical trials in other indications it may be postulated that Stempeucel has the potential capability for treating COVID-19 infection. Together with the safety profile observed from DCGI approved clinical trials involving more than 350 patients injected with Stempeucel by different routes of injection, this therapy may help in mitigating the lung tissue damaging effects of COVID-19 infection.

Dr. Stephen Minger, Scientific Advisor for the Global Consortium and ex Global Director of R&D, Cell Technologies GE Healthcare added The most severely affected CV-2 infected patients will often go on to develop ARDS which necessitates assisted ventilation to preserve breathing and lung function. Moreover, many ARDS patients will also experience an acute but severe life-threatening inflammatory response (cytokine storm) which can result in long-term damage to lung tissue and lung function. Treating ARDS patients with allogeneic expanded bone marrow derived MSCs could alleviate and ameliorate lung inflammation and compromised lung function and significantly reduce the time required for patients to be ventilated.

Dr. Raviraja N S, Sr. Director Business Development and Innovation, Stempeutics, said, Given the severe shortage of ventilators in the world, and the high mortality rate of patients who develop ARDS (approx. 50%), the clinical use of MSCs in COVID-19 ADRS patients could drastically impact on the healthcare burden currently occurring due to very large patient numbers, limited equipment and overworked medical personnel.

Mr. B N Manohar MD & CEO, Stempeutics Research

Manohar is the MD & CEO of Stempeutics Research a leading stem cell research and product development company in India. He earned his B.E. degree in Electronics & Communication from REC Trichy in 1977. Post that he did M.E. in Computer Science from College of Engineering, Guindy. Manohar has transformed Stempeutics a life science start-up from R&D to Commercialization stage with Global recognition. Stempeutics has developed an innovative drug called Stempeucel for addressing major unmet medical needs in India and Globally.

This drug developed by an Indian company has received many Global Recognitions. Fourteen countries including US & Japan has granted patent for the novelty and inventiveness of the drug. Europe has recognized this drug by granting Advanced Therapy Medicinal Product classification and Orphan Drug Designation. Recently it became the FIRST stem cell product to be approved by DCGI for conditional marketing for treating patients suffering from life threatening disease call Buergers Disease. Stempeutics has put India on the World map of Regenerative Medicine. Under Manohars leadership Stempeutics has been recognized as Indias hottest start-ups by Business Today in 2008 and Karnataka Government bestowed Emerging Company of the Year award in 2011 and 2013. In 2017 Manohar was awarded Biotechnologist of the Year award by Wockhardt Foundation, India. He raised US$ 10M in 2009 by establishing business alliance with major pharma company Cipla. Recently Stempeutics has tied up with Alkem Labs for Osteoarthritis indication. Prior to Joining Manipal Group, Manohar has had 12 years successful stints at Wipro GE Medical Systems. At GE Medical he has handled multiple senior assignments including Vice President Customer Service where he received GE Asia Service Award for highest revenue growth in 1998. Currently Manohar serves in the Boards of Stempeutics and MentisSoft.

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India Based Stem Cell Research Firm To Test Its Stem Cell Product For Acute Respiratory Disease Syndrome (ARDS) COVID-19 - IndianWeb2.com

Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2020 Size, Share and Growth Analysis Research Report by 2025. Top Companies are…

With the systematic study performed by the experts, Autologous Stem Cell and Non-Stem Cell Based Therapies Market parameters are studied which are used to offer best solution. It becomes easy to create sustainable and profitable business strategies by using helpful and actionable market insights covered in this Autologous Stem Cell and Non-Stem Cell Based Therapies Market report. Analysts and market experts deal with formalised and managerial approach to know the minds of their target markets, their feelings, their preferences, their attitudes, convictions and value systems. Furthermore, big sample sizes have been utilized for the data collection in the Autologous Stem Cell and Non-Stem Cell Based Therapies Market business research report which suits the necessities of small, medium as well as large size of businesses.

TheGlobalAutologous Stem Cell and Non-Stem Cell Based Therapies Marketis expected to reach USD113.04 billion by 2025, from USD 87.59 billion in 2017 growing at a CAGR of 3.7% during the forecast period of 2018 to 2025. The upcoming market report contains data for historic years 2015 & 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025.

For In depth Information Get Sample Copy of this Report @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-autologous-stem-cell-and-non-stem-cell-based-therapies-market

Some of the major players operating in the globalautologous stem cell and non-stem cell based therapies marketareAntria (Cro), Bioheart, Brainstorm Cell Therapeutics, Cytori, Dendreon Corporation, Fibrocell, Genesis Biopharma, Georgia Health Sciences University, Neostem, Opexa Therapeutics, Orgenesis, Regenexx, Regeneus, Tengion, Tigenix, Virxsys and many more.

Market Definition:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

In autologous stem-cell transplantation persons own undifferentiated cells or stem cells are collected and transplanted back to the person after intensive therapy. These therapies are performed by means of hematopoietic stem cells, in some of the cases cardiac cells are used to fix the damages caused due to heart attacks. The autologous stem cell and non-stem cell based therapies are used in the treatment of various diseases such as neurodegenerative diseases, cardiovascular diseases, cancer and autoimmune diseases, infectious disease.

According to World Health Organization (WHO), cardiovascular disease (CVD) causes more than half of all deaths across the European Region. The disease leads to death or frequently it is caused by AIDS, tuberculosis and malaria combined in Europe. With the prevalence of cancer and diabetes in all age groups globally the need of steam cell based therapies is increasing, according to article published by the US National Library of Medicine National Institutes of Health, it was reported that around 382 million people had diabetes in 2013 and the number is growing at alarming rate which has increased the need to improve treatment and therapies regarding the diseases.

Browse Detailed TOC Herehttps://www.databridgemarketresearch.com/toc/?dbmr=global-autologous-stem-cell-and-non-stem-cell-based-therapies-market

Market Segmentation:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

Competitive Analysis:Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market

The global autologous stem cell and non-stem cell based therapies market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of autologous stem cell and non-stem cell based therapies market for global, Europe, North America, Asia Pacific and South America.

Major Autologous Stem Cell and Non-Stem Cell Based Therapies Market Drivers and Restraints:

Introduction of novel autologous stem cell based therapies in regenerative medicine

Reduction in transplant associated risks

Prevalence of cancer and diabetes in all age groups

High cost of autologous cellular therapies

Lack of skilled professionals

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market 2020 Size, Share and Growth Analysis Research Report by 2025. Top Companies are...

Fate Inks $100M Deal With Janssen for Stem Cell-Derived Cancer Therapies – Xconomy

XconomySan Diego

Fate Therapeutics has signed an agreement with Janssen Biotech to develop new cancer cell therapies that are derived from stem cells and landed $100 million up front as part of the global collaboration deal.

The San Diego-based biotech has built a pipeline of experimental cell therapies that use induced pluripotent stem cells (iPSCs) to create chimeric antigen receptor (CAR) T-cell and CAR natural killer (NK) cell treatments. Fate (NASDAQ: FATE) has used iPSCs to make clonal cell lines that it likens to the cell lines used to create make monoclonal antibodies and other drugs.

Sourcing material for cell therapies this way is meant to reduce the manufacturing challenges associated with currently available cell therapy products. The two FDA-approved cell therapies, CAR-Ts, use a patients own living cells. Off-the-shelf versions in development, which use cells from healthy donors, face similar obstacles when it comes to cost-effective mass production, including variability between batches.

Janssen will provide Fate with proprietary antigen-binding domains for up to four targets associated with antigens that are overexpressed on tumors. Fate will use them to research and develop new preclinical iPSC-derived cell therapy candidates, both CAR-T-cell and CAR NK cell product candidates. Janssen will reimburse Fate for that R&D work.

Once a candidate is submitted to the FDA for permission to move into the clinic, Janssen will have the option to exclusively license it.

SVB Leerink analyst Daina Graybosch, in a research note, called the deal a major validation of Fates regenerative medicine platforms. The agreement also removes near-term cash concerns for Fate at a time when clinical research across the biotech industry is being delayed by COVID-19 disruptions, she wrote.

Under the deal terms, Fate gets $50 million in cash and $50 million from a sale of newly issued shares of its stock to Janssen parent company Johnson & Johnson (NYSE: JNJ) at $31 per share, a 47 percent premium over Fates closing price Thursday of $21.07 apiece.

The deal makes Fate eligible for payments of up to $1.8 billion tied to development and regulatory milestones and up to $1.2 billion if candidates are commercialized, plus royalties. The company also retains the option to co-commercialize each collaboration candidate in the US.

Fates stock price popped about 9 percent on the news Friday, reaching nearly $23 per share as of market close.

Previous collaborations Fate has struck include a 2018 deal with Japans Ono Pharmaceutical for joint development and commercialization of two off-the-shelf iPSC-derived CAR-Ts, and a four-year deal to help Juno Therapeutics (now part of Bristol Myers Squibb) find small molecules to enhance its T-cell immunotherapies, an agreement that concluded last year.

Fate, which launched in 2007, has four of its own iPSC-derived cell therapies in Phase 1 testing: two targeting blood cancers and two designed to treat advanced solid tumors.

The company also has three iPSC programs in preclinical testing, and two in research. Two of the preclinical programs are on track to be submitted to the FDA for its OK to move into the clinic in the second quarter of this year, Fate said.

In addition, the biotech has developed off-the-shelf cell therapies not derived from iPSCs that use NK cells from healthy donors modified to improve their biological properties and therapeutic function, but according to the companys latest annual report, it doesnt plan to further develop those therapies.

Since its initial public offering in 2013, the company has raised about $363 million across three stock sales, the most recent in September 2019.

Image: iStock/seb_ra

Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.

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Fate Inks $100M Deal With Janssen for Stem Cell-Derived Cancer Therapies - Xconomy

Mesoblast’s remestemcel-L receives FDA IND clearance for treating COVID-19 patients with acute respiratory distress – Small Caps

Regenerative medicine company Mesoblast (ASX: MSB) has received US Food and Drug Administration Investigational New Drug (IND) clearance for its remestemcel-L treatment to be used in COVID-19 patients presenting with acute respiratory distress syndrome.

According to Mesoblast chief medical officer Dr Fred Grossman, the FDA IND approval now enables US-based COVID-19 patients with poor prognosis to be treated with remestemcel-L under compassionate usage grounds and in a planned randomised controlled trial.

Remestemcel-L is an anti-inflammatory treatment that has been developed for use in various inflammatory conditions including steroid-refractory acute graft versus host disease.

Mesoblast claims the drug works by counteracting the inflammatory processes in these diseases by down-regulating the production of pro-inflammatory cytokines, while boosting production of anti-inflammatory cytokines and enabling recruitment of the ant-inflammatory cells to the involved tissues.

To-date, the safety and therapeutic impact of remestemcel-L intravenous infusions have been evaluated in over 1,100 patients in clinical trials.

In a phase 3 trial, remestemcel-L was found useful in treating acute graft versus host disease, which Mesoblast claims produces a similar cytokine storm process as seen in COVID-19 patients with acute respiratory distress syndrome.

Additionally, post hoc analysis of a previous study involving 60 patients with chronic obstructive pulmonary demonstrated remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also seen in COVID-19 acute respiratory distress syndrome patients.

COVID-19 patients most at risk of developing acute respiratory distress syndrome include the elderly and those with co-morbidities such as diabetes.

According to Mesoblast, patients with COVID-19 that have developed acute respiratory distress syndrome have an almost 50% fatality rate.

Remestemcel-L is an allogeneic mesenchymal stem cell product, with preliminary data from China indicating allogeneic mesenchymal stem cells have either cured or significantly improved functional outcomes for seven patients with COVID-19 in the small trial.

By mid-morning trade, Mesoblasts shares were up almost 30% to $1.74.

Original post:
Mesoblast's remestemcel-L receives FDA IND clearance for treating COVID-19 patients with acute respiratory distress - Small Caps