Mesoblast To Evaluate Anti-Inflammatory Cell Therapy Remestemcel-L For Treatment Of COVID-19 Lung Disease – BioSpace

NEW YORK, March 10, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited(Nasdaq: MESO; ASX:MSB) today announced that it plans to evaluate its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the United States, Australia, China and Europe. The Company is in active discussions with various government and regulatory authorities, medical institutions and pharmaceutical companies to implement these activities.

Mortality in COVID-19 infected patients with the inflammatory lung condition acute respiratory distress syndrome (ARDS) is reported to approach 50%, and is associated with older age, co-morbidities such as diabetes, higher disease severity, and elevated markers of inflammation.1 Current therapeutic interventions do not appear to be improving in-hospital survival.1

Remestemcel-L has potential for use in the treatment of ARDS, which is the principal cause of death in COVID-19 infection.1 This is supported by recently published results from an investigator-initiated clinical study conducted in China which reported that allogeneic MSCs cured or significantly improved functional outcomes in all seven treated patients with severe COVID-19 pneumonia.2

Additionally, in post-hoc analyses of a 60-patient randomized controlled study in chronic obstructive pulmonary disease (COPD), remestemcel-L infusions were well tolerated, significantly reduced inflammatory biomarkers, and significantly improved pulmonary function in those patients with elevated inflammatory biomarkers. Since the same inflammatory biomarkers are also elevated in COVID-19, these data suggest that remestemcel-L could be useful in the treatment of patients with ARDS due to COVID-19.The COPD study results have been submitted for presentation at an international conference, with full results to be submitted for publication shortly.

Remestemcel-L is being studied in numerous clinical trials across several inflammatory conditions, including in elderly patients with lung disease and adults and children with steroid-refractory acute graft versus host disease (aGVHD).3-5 This product candidate is currently being reviewed by the United States Food and Drug Administration (FDA) for potential approval in the treatment of children with steroid-refractory aGVHD.

Remestemcel-L Remestemcel-L is being developed for rare pediatric and adult inflammatory conditions. It is an investigational therapy comprising culture-expanded MSCs derived from the bone marrow of an unrelated donor and is administered in a series of intravenous infusions. Remestemcel-L is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in several 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.

Intellectual PropertyMesoblasts intellectual property (IP) portfolio encompasses over 1,000 patents or patent applications in all major markets and includes the use of MSCs obtained from any source for patients with acute respiratory distress syndrome (ARDS),and for inflammatory lung disease due to coronavirus (COVID-19), influenza and other viruses. Additionally, these patents cover Mesoblasts manufacturing processes that yield industrial-scale cellular medicines.This IP position is expected to provide Mesoblast with substantial commercial advantages as it develops its product candidates for these conditions.

References1. Liu Y et al. Clinical features and progression of acute respiratory distress syndrome in coronavirus disease 2019. Medrxiv 2020; https://doi.org/10.1101/2020.02.17.200241662. Leng Z, et al. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia[J]. Aging and Disease, 10.14336/AD.2020.02283. Kurtzberg J et al. Annual Meeting of the American Society for Transplantation Cell Therapy, 2020.4. Chaudhury S et al. A Phase 3 Single-Arm, Prospective Study of Remestemcel-L, Ex-Vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Steroid Refractory Acute GVHD in Pediatric Patients. Biol Blood Marrow Transplant 2018; 24:S119S290.5. Kurtzberg J et al. Allogeneic human mesenchymal stem cell therapy (remestemcel-L, Prochymal) as a rescue agent for severe refractory acute graft-versus-host disease in pediatric patients. Biol Blood Marrow Transplant. 2014 Feb;20(2):229-35.

About MesoblastMesoblast Limited (Nasdaq: MESO; ASX: MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblasts 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 has filed a Biologics License Application to the United States Food and Drug Administration (FDA) to seek approval of its product candidate RYONCIL (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. 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

Forward-Looking StatementsThis announcement 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, 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 To Evaluate Anti-Inflammatory Cell Therapy Remestemcel-L For Treatment Of COVID-19 Lung Disease - BioSpace

Biotech company makes new discovery in hormone imbalance research – The Badger Herald

A biotech startup achieved a significant breakthrough in the development of therapies that seek to reverse age related hormone imbalances.

JangoBio, a Madison based startup, announced the breakthrough in a press release Feb. 18. The company successfully created organ-like tissue clusters capable of producing ovarian and testicular hormones.

University of Wisconsin endocrinology professor and JangoBio CEO Craig Atwood founded the company in 2014 to address limitations in the current approach to treating hormone imbalances that occur with age.

As ovaries and testes start to decline in function theres a loss of dozens of different hormones which are very important for maintaining tissue health, Atwood said.

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Atwood said the current limitations are the ability to only be able to give back one or two sex steroids. Atwood added JangoBios strategy of utilizing cell based therapy allows for the synthesis of dozens of hormones to get the entire axis back into balance.

In the bodies of humans or animals, the therapy being developed by JangoBio would involve the injection of organoids, Atwood said. Organoids are tiny, self-organized three-dimensional tissue cultures that are derived from stem cells, according to the Harvard Stem Cell Institute.

The new developments allow JangoBio to begin testing the therapy in animal models, Atwood said. Such testing would be necessary to demonstrate the therapys efficacy and would be an important step towards introducing it in the human market, Atwood said.

JangoBio plans on commercializing the veterinary applications of the therapy by introducing it to companion animals within a year and begin clinical trials on humans shortly after, the COO Bill Kohl said. Starting with companion animals would allow the company to test and refine the therapy while simultaneously generating funding to pursue human applications.

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We can utilize that data and research that results from the animal side to refine the treatments for humans while at the same time sustaining our research without going out and getting additional investor money, Kohl said.

Atwood said a colleague previously determined reproductive hormones played a role in the neurodegeneration that occurs with Alzheimers disease. Atwood added the observation led them to develop the Reproductive Cell Cycle theory of aging which maintains that the improper regulation in sex hormones drives the gradual deterioration of bodily function that occurs with age.

Atwood said he founded JangoBio as a means of translating his findings into a therapy that could benefit both humans and animals.

The funding required to move such a product forward is more easily obtainable in the private sector than the public sector, Atwood said. Its really tied into finding sufficient capital to be able to move this vision forward to the point where it has practical applications and utility in humans and animals.

JangoBio was able to establish itself through a small business grant from the National Institute of Health for more money than they initially requested in their application, Kohl said. The grant was especially validating given the vigorous vetting applicants undergo from both scientists and people in industry, Kohl said.

The company raised $2 million from investors in a seed financing round, Atwood said.

Now were positioned to national investment firms for the next round of growth as we develop commercialization in the animals, Kohl said.

The broad potential of organoid therapy is what prompted Kohl to join the JangoBio team in the first place.

Atwood approached Kohl five years ago to begin and manage the business aspects of JangoBio so Atwood could focus on the research and scientific development, Kohl said. Like a number of roles on the executive board, the COO position is unpaid.

Theres rarely the opportunity in life for you to get to be involved in something that will have so much impact, Kohl said. The long term [goal] is going to be to stave off and mitigate age related diseases.

Kohl said by reversing hormone decline and restoring the tissues responsible for keeping hormones at their peak youthful levels, JangoBio has every indication from animal models this is going to have that type of impact.

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Applications for JangoBios hormone therapy go beyond humans and companion animals, Kohl said. The agriculture industry could potentially apply the therapy to extend breeding times for stead animals and production time for dairy animals, Kohl said.

While Atwood considers the company to be cutting edge in the development of hormone based organoids, Atwood said a number of companies are conducting parallel research in developing similar stem cell based therapies, particularly in the field of Type 1 diabetes.

JangoBio is one of 10 other biotech companies in the Madison area, all part of a thriving biotech industry born as a result of research conducted at UW, according to the Wisconsin State Journal.

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Biotech company makes new discovery in hormone imbalance research - The Badger Herald

Duke researchers may have found a path to correcting loss of smell – WRAL Tech Wire

DURHAM Is it possible for an adult brain to make new nerve cells? Scientists have debated this question for decades, with many concluding that neuron-making stops after childhood, or around the age of 13.

However, a research team recently rocked the debate again after finding a thriving neuron nursery in a section of adult human nose tissue, the olfactory neuroepithelium. Neurons are the specialized cells in the brain designed to transmit information to other nerve cells and muscles. The olfactory area of the nose houses the neural receptors that give us the ability to smell.

Previously, studies had been limited to nasal tissue samples from mice. In the human samples used in the current study, the researchers found that immature neurons or baby neurons produced by stem cells represented more than half of the neurons in the tissue samples, suggesting that new neurons were produced in the tissue. The findings were published in the journalNature Neuroscience. The finding has implications for correcting conditions that cause smell damage or loss, and add insights for treating the nervous system as a whole.

We do not fully understand why people lose their sense of smell, which can occur for many reasons, and our data sets provide a wealth of information about the cell populations present in adult olfactory tissue, saidBrad Goldstein, M.D., Ph.D., an associate professor at Duke University and vice chair for research in theDepartment of Head and Neck Surgery and Communication Sciences, senior author of the study. This is an important step in developing treatment strategies for conditions when this tissue may be damaged.

Approximately one in eight Americans over age 40up to 13.3 million peoplehave measurable smell dysfunction, according to the National Institute on Deafness and Other Communication Disorders.

It will be very useful to use this window to analyze samples from people with conditions in which the nervous system has degeneration, such as Alzheimers disease, said Goldstein. Alzheimers is of particular interest, since these patients lose their sense of smell quite early in the disease process, and we have few treatments for Alzheimers disease. So, it may make sense to look carefully at regions of the olfactory system in these patients.

Hiroaki Matsunami, Ph.D., a professor in the Department of Molecular Genetics and Microbiology and co-author on the paper, noted that while the researchers werent able to observe the neurons being made because of the nature of human samples, the molecular makeup of the immature neurons in the sample provide strong evidence that they were made in the nose during adulthood.

Because the nose is exposed to the external environment, it might be possible we could one day collect these neuronal stem cells from patients and use them to treat their own brain disorders, said Matsunami. It is not outside of the realm of possibility.

Other co-authors on the paper include Michael A. Durante, Stefan Kurtenbach, Zoukaa B. Sargi, J. William Harbour, Rhea Choi, Sarah Kurtenbach, and Garrett M. Goss.

(C) Duke University

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Duke researchers may have found a path to correcting loss of smell - WRAL Tech Wire