Stem Cell Clinic

Regenerative Stem Cell Therapy Pioneer, Celavie Biosciences, LLC, to Attend Cell & Gene Meeting on the Mesa on October 2 4 in Carlsbad,…

OXNARD, Calif.--(BUSINESS WIRE)--Celavie Biosciences, LLC, a company working to improve lives and restore hope by advancing innovations in CNS diseases with regenerative stem cell-based therapies, announced today their attendance at the Alliance of Regenerative Medicines (ARM) Cell & Gene Meeting on the Mesa to be held October 2nd 4th in Carlsbad, California.

Sandy Solmon, CEO and President, and Oleg Kopyov, MD, PhD, Executive Vice President and Chief Scientific Officer, will attend the conference and take meetings to explore collaboration and funding opportunities for further development of Celavies human and veterinary clinical programs.

At partnering meetings, Celavie will discuss their lead clinical program for the application of the companys human undifferentiated allogeneic pluripotent stem cells in Parkinsons disease (PD). Celavie recently published exploratory clinical data in 7 PD patients with four-year follow-up in Cell Transplantation. Celavie anticipates filing an IND with the FDA for a Phase I clinical trial in patients with moderate to advanced PD.

Celavie will also discuss their pre-clinical program in cerebellar ataxia and plans for taking their programs into further clinical development. Additionally, Celavie is actively seeking opportunities to out-license subsidiary Celavets veterinary applications in equine tendonitis and other indications.

To schedule a meeting with Celavie Biosciences at the Cell & Gene Meeting on the Mesa, please contact Sandy Solmon or Dr. Oleg Kopyov via the Cell & Gene Meeting on the Mesa partnering portal: https://www.meetingonthemesa.com/partnering/.

About the Cell & Gene Meeting on the Mesa

The Cell & Gene Meeting on the Mesa is the sector's foremost annual conference bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies. The program features expert-led panels, extensive partnering capabilities, exclusive networking opportunities, and 70+ dedicated presentations by the leading publicly traded and privately held companies in the space. Attracting over 1,150 attendees over 20% of which are C-level executives this conference enables key partnerships through more than 2,200 one-on-one meetings while highlighting the significant clinical and commercial progress in the field. For more information, visit the website: https://www.meetingonthemesa.com/.

About Celavie Biosciences

Celavie Biosciences is a privately-held company whose mission is to improve lives and restore hope by advancing regenerative stem cell therapies for the treatment of Parkinsons disease and other disorders of the central nervous system (CNS). The company develops undifferentiated, unmodified allogeneic pluripotent stem cell-based therapies, holds a strong IP portfolio, including 18 issued patents, and has an experienced management team blending expertise in concept and cell technology, product scalability and entrepreneurship. Celavet, a subsidiary, applies the same proprietary technologies for the treatment and prevention of serious veterinary diseases. More information is available at https://www.celavie.com/.

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Regenerative Stem Cell Therapy Pioneer, Celavie Biosciences, LLC, to Attend Cell & Gene Meeting on the Mesa on October 2 4 in Carlsbad,...

ElevateBio Launches HighPassBio to Advance Novel Targeted T Cell Immunotherapies with Technology from Fred Hutchinson Cancer Research Center -…

CAMBRIDGE, Mass.--(BUSINESS WIRE)--ElevateBio, a Cambridge-based biotechnology holding company, today announced it has established and launched HighPassBio, a company dedicated to advancing novel targeted T cell immunotherapies. The companys lead product is an engineered T cell receptor (TCR) T cell therapy for HA-1 expressing tumors, which is designed to treat and potentially prevent relapse of leukemia following hematopoietic stem cell transplant (HSCT). The product and approach were developed by researchers at Fred Hutchinson Cancer Research Center.

At ElevateBio we are committed to building therapeutics companies with the worlds leading innovators in cell and gene therapy to advance novel treatments that have strong potential to dramatically improve patient lives, said David Hallal, Chairman and CEO of ElevateBio. We look forward to leveraging our centralized industry-leading cell and gene therapy process development and manufacturing capabilities while working closely with Dr. Marie Bleakley and her team, to accelerate their impressive work through clinical development with the goal of serving patients who have no other treatment options. Additionally, we will explore this approach as a potential treatment for other diseases that are treated by stem cell transplants.

HighPassBios scientific founder is Marie Bleakley, M.D., Ph.D., M.ClinEpi, pediatric oncologist and stem cell transplant physician at Fred Hutchinson Cancer Research Center and chair of the scientific advisory board (SAB) of HighPassBio. As the chair of HighPassBios SAB, Dr. Bleakley will continue working with ElevateBio to advance and accelerate this innovative program through clinical development toward patients.

A Phase 1 clinical trial has treated initial patients and is recruiting adult and pediatric patients who have relapsed with leukemia or related conditions following blood and marrow transplantation (also known as stem cell transplantation). More details on http://www.clinicaltrials.gov under the study ID number NCT03326921.

About TCR-Engineered T Cell Therapy

A key role of the immune system is to detect tumor antigens, engage T cells and eradicate the tumor. However, the immune response to tumor antigens varies and is often insufficient to prevent tumor growth and relapse. An approach known as adoptive T cell therapy, using T cell receptors, or TCRs, can overcome some of the obstacles to establishing an effective immune response to fight off the target tumor. TCRs are molecules found on surface of T cells that can recognize tumor antigens that are degraded to small protein fragments inside tumor cells. Unlike CAR T cells that recognize only surface antigens, TCRs can recognize small protein fragments derived from intracellular and surface antigens offering a more diverse way to attack tumors. These small protein fragments show up on the tumor cell surface with another protein called major histocompatibility complex (MHC), get recognized by the TCRs and consequently signal the bodys immune system to respond to fight off and kill the tumor cells.

Tumor-specific TCRs can be identified and then engineered into T cells that recognize and attack various types of cancers, representing a novel approach to treating and potentially preventing disease.

Adoptive T cell therapy can be applied to tackling relapse of leukemia post hematopoietic stem cell transplant (HSCT) by targeting the antigens expressed only by the patient and not by the stem cell transplant donor, known as minor histocompatibility antigens, or HA1. HA1 is expressed predominantly or exclusively on hematopoietic cells and leukemic cells. There is evidence that T cells specific for HA1 can induce a potent and selective antileukemic effect. HA1 TCR T cell therapy is a new investigational immunotherapy for the management of post transplantation leukemia relapse.

About Leukemia post HSCT Treatment and the Risk of Relapse

Leukemia, a cancer of the blood or bone marrow characterized by an abnormal proliferation of blood cells, is the tenth most common type of cancer in the U.S. with an estimated 60,140 new cases and 24,400 deaths in 2016. Leukemia arises from uncontrolled proliferation of a specific type of hematopoietic (blood) cell that is critical for a functional immune system. As a result, when patients are given very high doses of chemotherapy to eradicate leukemic cells most normal cells are killed as well, necessitating a transplant of hematopoietic stem cells from a donor to reconstitute the patients bone marrow and circulating hematopoietic cells. In some cases, the transplanted T cells from the donor can also recognize and eliminate the hematopoietic cells, including leukemia, from the recipient, thus preventing relapse.

While the majority of HSCT recipients are cured, 25-50 percent of HSCT recipients relapse, leukemia relapse remains the major cause of allogeneic HSCT failure, and the prognosis for patients with post-HCT relapse is poor. Relapse occurs following allogeneic HSCT in approximately one-third of patients with acute leukemia who undergo the procedure, and most patients subsequently die of their disease.

About HighPassBio

HighPassBio, an ElevateBio portfolio company, is working to advance a novel approach to treating hematological malignancies by leveraging T cell receptor (TCR)-engineered T cells, known as TCR T cells. The companys lead program is designed to treat or potentially prevent relapse of leukemia in patients who have undergone hematopoietic stem cell transplant (HSCT). The technology was born out of Fred Hutchinson Cancer Research Center by world renowned expert, Dr. Marie Bleakley.

About ElevateBio

ElevateBio, LLC, is a Cambridge-based cell and gene therapy holding company, established to create and operate a broad portfolio of cell and gene therapy companies with leading academic researchers, medical centers and entrepreneurs. ElevateBio builds single- and multi-product companies by providing scientific founders with fully integrated bench-to-bedside capabilities including world-class scientists, manufacturing facilities, drug developers and commercial expertise. ElevateBio BaseCamp, a company-owned Cell and Gene Therapy Center of Innovation, will serve as the R&D, process development and manufacturing hub across the entire ElevateBio portfolio while also supporting selected strategic partners.

ElevateBios lead investors are the UBS Oncology Impact Fund (OIF) managed by MPM Capital, as well as F2 Ventures. Investors also include EcoR1 Capital, Redmile Group, and Samsara BioCapital.

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ElevateBio Launches HighPassBio to Advance Novel Targeted T Cell Immunotherapies with Technology from Fred Hutchinson Cancer Research Center -...

Positive Study Results of Phase IIa Clinical Trial Using Intravenous Administration of Mesenchymal Stem Cells for Ischemic Stroke Published in…

SAN DIEGO, Sept. 30, 2019 /PRNewswire/ -- Results from a study sponsored by Stemedica Cell Technologies, Inc., a global biotechnology company that uses allogeneic stem cells for ischemic conditions, form the basis for a peer-reviewed paper published inStrokeentitled "Phase I/II Study of Safety and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Chronic Stroke." Co-authors include Michael L. Levy, MD, PhD, John R. Crawford, MD, Nabil Dib, MD, Lev Verkh, PhD, Nikolai Tankovich, MD, PhD and Steven C. Cramer, MD.

As indicated in theStrokepublication, "Stroke is perennially among the leading causes of human disability and the leading neurological cause of lost disability-adjusted life years. The mean survival after stroke is 6-7 years, with more than 85% of patients living past the first-year post-stroke, many with years of enduring disability. Many restorative therapies are under study to improve outcomes after stroke." However, restorative therapies often have a short time window for improvement usually measured in days-months.

"Based on Stemedica's preclinical data that supported the safety and efficacy of its MSCs as a restorative therapy to improve outcomes after stroke, the company was granted approval by the FDA to conduct a Phase I/IIa dose escalation trial that examined the effects of a single IV infusion of Stemedica's cGMP manufactured allogeneic ischemia-tolerant MSCs," said Dr. Lev Verkh, Chief Regulatory and Clinical Development Officer of Stemedica.

Study:The target population included patients with chronic ischemic stroke and substantial functional deficits; a group for whom treatment options remained limited. The primary outcome of the study was safety, based on serial measures of behavior, CT scans, and laboratory testing. Four secondary endpoints were scored serially to derive estimates of behavioral changes relatively to the baseline over a period of 12 months: NIH Stroke Scale (NIHSS) for neurological assessment, Barthel Index (BI) for ability to perform daily tasks, Mini-Mental Status Exam (MMSE) for mental status, and Geriatric Depression Scale (GDS) for degree of depression. The study was conducted at three centers: University of California, San Diego (UCSD); Mercy Gilbert Medical Center, Gilbert, Arizona; and University of California, Irvine (UCI).

Entry criteria included ischemic stroke >6 months prior to administration, substantial functional deficits (subject confined to a wheelchair, had home-nursingcare, orneeded assistance withactivities ofdailyliving), no substantial improvement in neurologic orfunctional deficits for the2 months prior to enrollment in thestudypermedical history, and NIHSS score=6-20.

Enrollees received a single intravenous dose of allogeneic mesenchymal bone marrow cells. Phase I used a dose escalation design (3 tiers, n=5 each). Phase IIa (n=21) was an expanded safety cohort. The primary endpoint was safety over 1-year. Secondary endpoints examined behavior, with a pre-specified focus at 6-months.

Subject status at enrollment prior to treatment:At baseline, subjects (n=36) averaged 4.24.6 years post-stroke, age 61.110.8 years, NIHSS score 8 [6.5-10], and Barthel Index 6529.

Safety:Study testing disclosed no safety concerns. No subject showed a positive reaction to intradermal testing. In Phase I, each dose (0.5, 1.0, and 1.5 million cells/kg body weight) was found safe, as a result Phase IIa subjects received 1.5 million cells/kg. Two subjects were lost to follow-up, one was withdrawn, and two died (unrelated to study treatment). There were 15 serious adverse events, none possibly or probably related to study treatment. Two mild adverse events were possibly related to study treatment, a urinary tract infection and IV site irritation. Treatment was determined to be safe based on serial exams, EKGs, laboratory tests, and pan-CT scans.

Behavioral Effects:Improvements across all subjects post-transfusion and for all four secondary endpoints were achieved. Improvements in each index were: Barthel Index (6.811.4 points, p=0.002); in NIHSS (-1.251.7 points, p<0.001); Mini Mental Status Exam (1.82.8 points, p<0.001); and Geriatric Depression Scale (-1.63.8 points, p=0.015). At baseline 11.4% (4/35 subjects) had Barthel Index=95-100 (favorable outcome); at 6-months, 27.3% (9/33); by 12-months, 35.5% (11/31).

Conclusions:The current study is the largest trial of intravenous MSCs in patients with chronic stroke and the first to evaluate allogeneic MSC therapy in this population. It is also the first study to evaluate MSCs grown under hypoxic conditions favorable to cell proliferation, gene expression, cytokine production and migration. While patients with stroke in the chronic stage generally show significant functional decline, enrollees in the current study showed 12 months of continued functional improvements across all secondary endpoints.

Intravenous transfusion of allogeneic ischemia tolerant MSCs in patients with chronic stroke and substantial functional deficits was safe and suggested behavioral gains. These data support proceeding to a randomized, placebo-controlled study of this therapy in this population.

Dr. Nikolai Tankovich, President and Chief Medical Officer added, "Stemedica is encouraged by the results of the study which demonstrated safety and preliminary efficacy of its cell therapy product for the treatment of chronic ischemic stroke patients. It is a significant milestone for Stemedica to bring this new cellular medication to patients with debilitating conditions caused by a stroke. Stemedica plans to move forward to a Phase-IIb discussion with the FDA."

Michael Levy, MD, PhD, FACS, FAANS, Professor of Neurosurgery at UCSD and the Principal Investigator of this study commented: "Based on my clinical trial work in Stemedica's Ischemic Stroke trial, my experience to date with Stemedica's allogeneic ischemic tolerant mesenchymal stem cell product suggests that the product is first and foremost safe and secondarilyhas the potential to produce unparalleled medical benefits."

About Stemedica Cell Technologies, Inc.Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for ischemic stroke, and Alzheimer's Disease. Stemedica's cell are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California and can be found online atwww.stemedica.com.

Forward Looking StatementsThis press release may contain forward-looking statements. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements. These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release.

Media ContactStemedica Cell Technologies, Inc.Dave McGuiganEVP, Marketing & Business Developmentdmcguigan@stemedica.com+1 858-658-0910 x7203

SOURCE Stemedica Cell Technologies, Inc.

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Positive Study Results of Phase IIa Clinical Trial Using Intravenous Administration of Mesenchymal Stem Cells for Ischemic Stroke Published in...

The Shocking Culture of Nurses and the Treatment of Patients with Sickle Cell – Nurse.org

By: Portia Wofford

September is National Sickle Cell Awareness Month. Sickle Cell hits close to home for me. My nephew has the trait. My goddaughter has the disease and is frequently in crisis. Several other family members and friends are also fighting this illness.

One of the most common issues they all deal with is treatment by healthcare professionals particularly nurses when they seek treatment for this disease. Its shameful, but often their symptoms often cause them to be mistaken for:

These are all terms thrown at people with Sickle Cell Disease (SCD). The treatment or mistreatment of Sickle Cell patients contradicts our title as the most trusted profession.

So, nurses, what can we do? How do we advocate, treat, and care for this population of patients?

SCD is a group of red blood cell disorders. Unlike healthy red blood cells (RBC) which are round, patients with SCD have RBC that take on a C or sickle shape. Sickle cells die early which causes a constant shortage of red blood cells.

SDC commonly affects those whose ancestors came from:

The only cure for SCD is bone marrow or stem cell transplant.

When sickle cells travel through small blood vessels, they get stuck and clog the blood flow causing excruciating pain and other serious problems including:

SCD warriors and their caregivers report being stigmatized when they seek care. With patients showing signs as early as birth, nurses attitudes can contribute to negative stigmatization and may affect patients' response to sickle cell cues, potentially causing patients not to seek care and negatively impacting patient outcomes.

Cleverly Changing founder Elle Cole's daughter has SCD. She gives a brief description of an ER visit after a physicians assistant at their primary care office suggested her daughter go to the nearest hospital via ambulance.

Elle recalls, In the ER, the nurse was upset and asked why we were there and which clinic sent us. She stated my daughter didnt need any oxygen, the hematologist was busy (but would come in about an hour), and she needed to get a mucus sample. My daughter was scared and started to cry. Then, the nurse told four nurses to join her, and they proceeded to hold my daughter down and extract the mucus from her nostrils. I was completely terrified! My husband was at work. I felt alone and scared with my daughter.

One mom, Shaynise Robinson, drives three to four hours to seek care for her daughter, because of the lack of understanding from nurses and other healthcare professionals at their local hospital.

In an article posted on Pubmed, researchers found that sickle cell patients in one hospital waited for 60% longer to get pain medication although other patients reported less severe pain. They were also triaged into a less serious category. 63% of nurses surveyed said many patients with sickle cell are addicted to opioids, according to another study. But according to Dr. Alexis Thompson, president of the American Society of Hematology, rates of addiction among SCD patients are no higher than the general populations.

Elle Cole, who has a blog that brings awareness to SCD, wants nurses to be patient. Asking questions that indicate that you are genuinely concerned about your patients wellbeing can help open communication with your patient.

Shauna Chin, RN, says, In my experience, in addition to the pain, many patients with SCD exhibit symptoms of depression. The nurse needs to distinguish between solemness due to pain and solemness due to despondence. Many symptoms of depression go undiagnosed and can be remedied by encouraging health providers to engage in dialogue with the patient. She expresses that nurses can advocate best for patients with SCD by identifying early non-verbal signs and symptoms of pain and anticipate their patient's needs.

Anaya Spearman, RN, BSN, believes more education is needed during nursing school. Noting in the last five years, few co-workers were adequately informed about the disease. SCD was just 'glanced over' and not taught about in-depth, in nursing school, she says. Spearman believes that SCD patients need to have a holistic care approach.

Shaynise Robinson encourages nurses to go through diversity training. Give patients the benefit of the doubt. Understand that they are looking for pain relief and equal treatment, she says. Proper bedside manner is a concern for her as well.

Sickle Cell Disease doesn't just affect the body, but the holistic health of those with the disease. Education and awareness are critical for nurses to provide proper care. Shaynise Robinson leaves us with this: The same compassion thats shown to cancer patients should be shown to sickle cell patients.

To learn more about sickle cell visit:

Sickle Cell Disease Association of America

American Sickle Cell Anemia Association

Sickle Cell Society

Portia Wofford is a staff development and quality improvement nurse, content strategist, healthcare writer, entrepreneur, and nano-influencer. Chosen as a brand ambassador or collaborative partner for various organizations, Wofford strives to empower nurses by offering nurses resources for developmentwhile helping healthcare organizations and entrepreneurs create engaging content. Follow her on Instagram and Twitter for her latest.

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The Shocking Culture of Nurses and the Treatment of Patients with Sickle Cell - Nurse.org

CBMG: Initiating Coverage of Cellular Biomedicine Group; Multiple Cell-Based Therapies to Treat Cancer and Degenerative Diseases – Zacks Small Cap…

By David Bautz, PhD

NASDAQ:CBMG

READ THE FULL CBMG RESEARCH REPORT

Initiating CoverageWe are initiating coverage of Cellular Biomedicine Group, Inc. (NASDAQ:CBMG) with a valuation of $24.00. Cellular Biomedicine Group is a biopharmaceutical company developing cell-based therapies for cancer and degenerative diseases, with a focus on the Chinese market. In addition to a full pipeline of development products comprised of CAR-T, TIL, and TCR, along with stem-cell based therapies for the treatment of osteoarthritis, Cellular Biomedicine Group signed a collaboration agreement last year with Novartis for the production of Kymriah in China. CAR-T products targeting multiple myeloma and non-Hodgkin lymphoma are currently being evaluated in clinical trials and we anticipate additional clinical trials initiating in other indications over the next six to twelve months.

Robust Pipeline with Multiple Cell-Therapy Development ProductsCellular Biomedicine Group has a robust pipeline of products derived from in-house discovery and strategic in-licensing including CAR-T, TIL, TCR, and stem cell products for which we anticipate at least six modalities being in Phase 1 clinical trials by the end of 2019.

Investigator-Initiated Trials to Speed-Up Development TimelinesCellular Biomedicine Group has begun investigator-initiated trials in China for its CAR-T products in patients with multiple myeloma and non-Hodgkin lymphoma, with additional trials starting later in 2019 and early 2020. These trials are intended to quickly evaluate safety and proof-of-concept in a cost-effective manner before moving to larger trials in China and the U.S. We anticipate initial data readouts from the ongoing trials at the end of 2019 or early 2020.

Collaboration with Novartis for Kymriah in ChinaIn 2018, Cellular Biomedicine Group signed a collaboration agreement with Novartis to manufacture and supply Kymriah in China. Included in the deal was a $40 million equity purchase from Novartis, which represents a 9% equity stake in the company. Cellular Biomedicine Group will be responsible for manufacturing the product while receiving an escalating single-digit royalty on net product sales of Kymriah in China, while Novartis will be responsible for distribution, regulatory, and commercialization efforts in China. This deal validates Cellular Biomedicine Groups cell manufacturing technology and we believe puts them at the forefront of cell therapy companies in China.

First-Mover Advantage in ChinaThe company is leveraging its expertise in the Chinese regulatory environment to establish itself as the leader in the Chinese cell therapy market. Very few other companies have the requisite expertise to handle the various compliance, quality assurance, and regulatory issues inherent in the Chinese market while simultaneously working to improve manufacturing timelines for cell therapy clinical trials and commercial launch.

Proprietary Manufacturing Processes for Cellular TherapiesThrough collaborations with GE Healthcare Life Sciences and ThermoFisher Scientific, Cellular Biomedicine Group has developed an automated, closed, integrated cell manufacturing system with complete control of the chain-of-custody. The company maintains manufacturing facilities totaling 100,000 ft2 in Shanghai and Wuxi that meet the quality management systems requirements of ISO 9001:2015, and the facilities of Shanghai and Wuxi sites meet local regulatory standards.

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Brestoff, Theunissen recognized by NIH for innovative research – Washington University School of Medicine in St. Louis

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Honored with NIHs High-Risk, High-Reward Research Program awards

Thorold Theunissen, PhD, (left) and Jonathan Brestoff, MD, PhD, have received High-Risk, High-Reward Research awards from the National Institutes of Health (NIH), supporting their research programs.

Obesity expert Jonathan R. Brestoff, MD, PhD, and regenerative medicine specialist Thorold Theunissen, PhD, both of Washington University School of Medicine in St. Louis, have received High-Risk, High-Reward Research awards from the National Institutes of Health (NIH). The program supports scientists showing exceptional creativity and pursuing innovative research programs with the potential to have a wide impact in biomedical, behavioral and social sciences.

Brestoff, an assistant professor of pathology and immunology, received an NIH Directors Early Independence Award to study how the immune system regulates weight gain, with a goal of finding new ways to treat obesity beyond simply limiting food consumption. Early Independence Awards provide an opportunity for outstanding junior scientists with the intellect, scientific creativity, drive and maturity to flourish independently, launch independent research careers and bypass the traditional postdoctoral training period. The award provides up to $250,000 a year for five years.

Brestoff and others have shown that immune cells in fat tissue control how calories are stored. Recently, he discovered that fat cells can transfer their mitochondria tiny organelles responsible for generating energy in cells to macrophages, a kind of immune cell known to be involved in regulating obesity. With the new award, Brestoff will develop tools to disrupt mitochondria transfer in mice to determine the impact of this process on the function of immune cells and on the development of metabolic diseases such as obesity. The goal is to discover potential targets for medications to treat metabolic diseases.

I am honored and humbled to be selected for the NIH directors High-Risk, High-Reward program, Brestoff said. The Early Independence Award is allowing me to take my science in new, unanticipated directions at a critical point in my program and will enable my lab to explore highly innovative questions that keep me up at night. I am grateful and excited to have the opportunity to start my lab here at Washington University School of Medicine and join this incredible community of investigators.

Brestoff earned his bachelors degree at Skidmore College, followed by a masters in public health at University College Cork National University of Ireland. He then returned to the United States and earned his medical and doctoral degrees at Perelman School of Medicine at the University of Pennsylvania before completing a residency in clinical pathology at Barnes-Jewish Hospital. He joined the faculty of the School of Medicine this year. Brestoff is also a new medical director of clinical immunology in the Division of Laboratory and Genomic Medicine, where he helps to support clinical tests of the human immune system.

Theunissen, an assistant professor of developmental biology, has received an NIH Directors New Innovator Award. The award supports unusually innovative research from early-career investigators who are within 10 years of their final degrees or clinical residencies. The award provides $300,000 per year in direct funding for five years.

Theunissen studies the biology of pluripotent stem cells, which have the potential to heal or regenerate different types of tissues and organs that are damaged or diseased. Recently, he isolated a more primitive type of human stem cell that closely resembles the cells of the early human embryo. The award supports a project aimed at understanding the epigenome of these stem cells and their utility for modeling human diseases.

The epigenome refers to the layer of genetic instructions that govern how genes are regulated whether certain genes are turned off or on and to what degree they are activated. Theunissen and his research team are developing a road map to help understand the epigenetic changes that stem cells undergo as they divide and differentiate toward one tissue type or another.

It is an honor to receive this NIH directors award, Theunissen said. My colleagues in the lab and I look forward to continuing our research into the regulatory details of distinct stem cell states that could help us better understand healthy human development and what can go wrong to cause disease.

Theunissen earned his bachelors degree in biology in 2007 from Harvard University. He went on to earn a masters degree in developmental biology from the University of Cambridge in 2008 and a doctorate in biochemistry and stem cell biology, also from Cambridge, in 2011. He continued his training at the Whitehead Institute for Biomedical Research at the Massachusetts Institute of Technology, where he was a Sir Henry Wellcome postdoctoral fellow. In 2017, he joined the faculty of the Department of Developmental Biology at the School of Medicine, where he is also a researcher at the Center of Regenerative Medicine.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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Brestoff, Theunissen recognized by NIH for innovative research - Washington University School of Medicine in St. Louis

Major Talent Acquisition Takes Montreal-Based Morphocell Technologies to the Next Level – BioSpace

Sept. 30, 2019 14:00 UTC

MONTREAL--(BUSINESS WIRE)-- Morphocell Technologies drive to create new clinical tools to treat currently untreatable liver conditions shifted into high gear this week with the impending addition of Dr. Jennifer Moody to its senior management team.

Dr. Moody is a stem cell commercialization and business operations expert with deep experience in the Canadian and global stem cell ecosystems, who most recently served as Senior Director of Research Operations at BlueRock Therapeutics in Toronto. She brings with her 23 years of experience in stem cell science, 13 of those years in industry commercializing products spanning from stem cell reagents to cell-based therapeutics.

Dr. Moody will assume the role of Morphocells Chief Operating Officer beginning October 7th, 2019.

It has been several years since I first met the Morphocell team and I have enthusiastically followed their progress, said Dr. Moody. The vision and drive of the founding team has significantly progressed and de-risked their technologies. I am excited to be joining the team and look forward to contributing to the advancement of Morphocells proprietary engineered liver tissue to create a cell therapy product to address the significant unmet medical need that currently exists for liver disease.

Morphocell is currently developing three revolutionary stem cell-derived products for use in acute, chronic and acute-on-chronic liver failure, which afflict millions worldwide:

We are incredibly fortunate to add Dr. Moody to our team as we ramp up toward first-in-human clinical trials for ReLiverELT, said Dr. Massimiliano Paganelli, pediatric transplant hepatologist at Sainte-Justine University Hospital Center in Montreal and co-founder of Morphocell. She brings a whole new level of expertise and savviness to our R&D, clinical trial and commercialization programs and will be a tremendous collaborator going forward.

About Morphocell Technologies

Morphocell is a Montreal-based start-up on a crusade to transform the treatment of liver disease. Preclinical assessments of the first effective stem cell-derived interventions for acute, chronic and acute-on-chronic liver failure are underway. http://www.morphocell.com / @MorphocellTech

View source version on businesswire.com: https://www.businesswire.com/news/home/20190930005189/en/

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Major Talent Acquisition Takes Montreal-Based Morphocell Technologies to the Next Level - BioSpace

Lineage Cell Therapeutics to Present New OpRegen Data at American Academy of Ophthalmology Annual Meeting on October 14, 2019 – Business Wire

CARLSBAD, Calif.--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that updated results from a Phase I/IIa study of its lead product candidate, OpRegen, a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (Dry-AMD), will be presented at the 2019 American Academy of Ophthalmology Annual Meeting (AAO 2019), to be held at the Moscone Center in San Francisco, CA (October 12-15, 2019). The abstract presentation, entitled, Phase 1/2a Study of Subretinally Transplanted Human Embryonic Stem Cell-Derived RPE Cells in Advanced Dry-Form AMD Patients will be presented as part of the OP07 Retina, Vitreous Original Paper Session on Monday, October 14th, 2019 between 9:45am 11:00am Pacific Time by Eyal Banin, M.D., Ph.D., Professor of Ophthalmology, Director, Center for Retinal and Macular Degenerations, Department of Ophthalmology at Hadassah-Hebrew University Medical Center (abstract number PA039). The abstract will provide updated data from patient cohorts 1 through 4 of the clinical study and will include data on the first patient dosed with the Orbit Subretinal Delivery System (Orbit SDS) as well as with a new Thaw-and-Inject formulation of OpRegen.

The American Academy of Ophthalmology is the worlds largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, the AAO protects sight and empowers lives by setting the standards for ophthalmic education and advocating for our patients and the public. AAO innovates to advance our profession and to ensure the delivery of the highest-quality eye care. For more information, please visit http://www.aao.org or follow the academy on Twitter @AAO.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical assets include (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase I/IIa development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in Phase I development for the treatment of non-small cell lung cancer. Lineage is also evaluating potential partnership opportunities for Renevia, a facial aesthetics product that was recently granted a Conformit Europenne (CE) Mark. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

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Lineage Cell Therapeutics to Present New OpRegen Data at American Academy of Ophthalmology Annual Meeting on October 14, 2019 - Business Wire

Platelet BioGenesis Receives $56 Million Contract from the Biomedical Advanced Research and Development Authority (BARDA) to Develop Human Stem…

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Platelet BioGenesis, Inc. (PBG), the leader in stem cell-derived, on-demand human platelets (PLTs+) and genetically engineered platelet-based therapeutics, announced today that it has signed a $56 million contract with the Biomedical Advanced Research and Development Authority (BARDA), an agency of the US government's Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. PBG will use the funding to develop and establish donor-independent platelets as a medical countermeasure for treating victims of a nuclear or radiological event.

As part of national biodefense preparedness, BARDA has prioritized the development and procurement of therapies for trauma resulting from chemical, biological, radiological and nuclear defense threats, including exposure to high doses of radiation. BARDA, with its extensive experience working with organizations focused on blood-related therapies, has evaluated PBGs technology platform and determined that donor-independent platelets could be a critical medical countermeasure in case of a national threat.

This is a significant milestone for PBG and a highly valuable and timely validation of the groundbreaking work of our scientific founder, Dr. Jonathon Thon, and the research, development and manufacturing teams at PBG, allowing us to use human induced pluripotent stem cells to manufacture platelets on-demand, said Sam Rasty, Ph.D., President and CEO of Platelet BioGenesis. With BARDAs expertise in the development of blood-related therapies, their decision to award us this significant contract will further bolster the companys resources to advance this technology into the clinic. The funding will not only help bring our unique donor-independent platelets to patients as a medical countermeasure but will also expedite the advancement of our broader donor-independent PLTs+ platform.

In a radiological or nuclear emergency, impacted communities will face a significant blood product shortage, explained BARDA Director Rick Bright, Ph.D. We are exploring donor-independent platelet technology to increase surge capacity within the blood industry. Our nation must find innovative ways to make essential blood products available to save lives in any type of mass casualty incident.

PBGs research, development and manufacturing activities under the contract will specifically focus on the development of PLTs+ for the treatment of thrombocytopenia induced by exposure to nuclear radiation. In addition to the funding, BARDA will provide a comprehensive, integrated portfolio approach through mentorship, the facilitation of future partnerships and the enablement of government collaborations with agencies such as the FDA.

About Platelet BioGenesis

Platelet BioGenesis (PBG) has created the only platform that can generate human platelets at scale. The stem cell-derived, on-demand platelets will be the first donor-independent source of platelets to address the chronic shortage worldwide. The company is also developing genetically engineered platelet-based therapeutics, a new treatment modality for cancer and other life-threatening diseases. PBGs platform is patented and cGMP-compliant. The company was spun out of Harvard University and has received venture funding from Qiming Venture Partners USA, Ziff Capital Partners and other investors and obtained grant funding from the Massachusetts Life Sciences Center, the National Institutes of Health and the U.S. Department of Defense. Learn more at plateletbiogenesis.com and follow us on Twitter @plateletbio.

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Platelet BioGenesis Receives $56 Million Contract from the Biomedical Advanced Research and Development Authority (BARDA) to Develop Human Stem...

Manav Rachna International Institute of Research and Studies, Faridabad and Advancells Announce Industry-Academia, Noida – Business Wire India

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Manav Rachna International Institute of Research and Studies, Faridabad and Advancells Announce Industry-Academia, Noida - Business Wire India