Starving Cancer by Cutting Off Its Favorite Foods, Glucose and Glutamine – American Council on Science and Health

Your body cells, particularly neurons, love the sugar glucose. This is the reason that your body closely regulates the level of glucose in your blood. Your brain would literally starve without it. If you do not consume enough carbohydrates in your diet, your body will synthesize the glucose you need.

Unfortunately, cancer also loves glucose. It loves it so much that cancer cells are willing to burn through glucose as quickly as possible, similar to the way muscle cells burn through glucose during rigorous exercise (a process known as glycolysis). Cancer cells also supplement their "diet" with glutamine, an amino acid found in proteins.

In order to implement this metabolic shift, cancer cells put more glucose transporters (which import glucose) into their membranes and rely on glutamine to satisfy other nutritional requirements. This has led to the hypothesis that blocking the import of glucose and the metabolism of glutamine could serve as powerful weapons against cancer. In other words, starving cancer cells of their favorite foods could inhibit tumor growth.

Starving Cancer Cells of Glucose and Glutamine

Reporting in the journal Cell Chemical Biology, a team of researchers led by Elena Reckzeh describe the discovery of a new, high-potency molecule (which they called Glutor) that blocked several varieties of the glucose transport protein. This is significant because previous inhibitors were low potency and/or only blocked one kind of glucose transport protein.

The first image depicts the molecular mechanism of their proposed chemotherapeutic strategy. The first part of the strategy involves treating cancer with Glutor, which will shut down glucose metabolism. Indeed, the authors showed that 44 different cancer cell lines were potently inhibited by Glutor in vitro. Non-cancerous cell lines were not inhibited.

The second leg of their strategy involves blocking an enzyme responsible for metabolizing glutamine. When the treatments are combined, they act together to suppress cancer cell growth. (See second image. The blue region depicts the synergy of the two drugs acting in concert.)

What the Discovery Means

While this discovery is certainly very exciting, many obstacles remain. For instance, chemotherapy always has side effects, usually due to the targeting of rapidly dividing cells. It's not only cancer cells that divide quickly; so do immune cells, adult stem cells, and hair follicle cells, among many others. It is for these reasons that people on chemotherapy are usually immunodeficient and bald.

Additionally, an accompanying commentary by William Katt and colleagues indicated that there are no FDA-approved drugs that target glucose and glutamine metabolism. This is because previous drug candidates proved to be too toxic for use in humans.

So while the characteristics of Glutor are quite appealing from a pharmacologic standpoint, there is still much to prove before the drug could be available on the market.

Sources

(1) Elena S. Reckzeh et al. "Inhibition of Glucose Transporters and Glutaminase Synergistically Impairs Tumor Cell Growth." Cell Chemical Biology 26 (9) 1214-1228.E25. Published: 19-Sept-2019. doi: 10.1016/j.chembiol.2019.06.005

(2) William P. Katt et al. "Starving the Devourer: Cutting Cancer Off from Its Favorite Foods." Cell Chemical Biology 26 (9): 1197-1199. Published: 9-Sept-2019. doi: 10.1016/j.chembiol.2019.09.005

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Starving Cancer by Cutting Off Its Favorite Foods, Glucose and Glutamine - American Council on Science and Health

We’re making tiny brains in the lab should we be worried for them? – CBC.ca

The announcement this summer that researchers had detected brain waves in "mini-brains" they'd grown in the lab has raised a whole new set of important ethical questions around this kind of fundamental research.

Brain organoids have emerged in recent years as a powerful new biomedical tool to study human brain developmentand disorders of the brain like Alzheimer's and multiple sclerosis.

But as researchers develop techniques to grow these nodules of brain tissue ever larger andwith more neurological complexity, the workis raising profound ethical questions about whether they might one day be able to think and feel pain.

"If we really are capable of producing something similar to the human brain, then this will open a can of ethical worms that will distinguish [brain organoid] research from other areas of biomedical inquiry," Canadian bioethicist Kalina Kamenova told Quirks & Quarks host Bob McDonald.

For the last decade, researchers have been using stem cells to grow clusters of neurons and glial cells the critical cell types that make up the brain in bio-reactors that provide carefully tailored conditions for growth. As the cells multiply, they're able to self-organize to resemble a fragment brain tissue similar to a piece of a developing brain.

"Brain organoids provide us an opportunity to study how the human brain develops and functions, and provide us key insights into neurological disorders that we simply could not study before," said Paul Tesar, from the Department of Genetics and Genome Sciences at Case Western Reserve University School of Medicine in Cleveland, Ohio.

Tesar has been using human brain organoidsto test new treatments for multiple sclerosis. MS is characterized by the loss of myelin an insulating sheath around nerve cells. In previous work,Tesar and his colleagues had developed a drug that proved effective in stimulating brain tissue to regenerate myelin which they had tested in mice.

Using human brain organoids, the team was able to show the drug was also effective in human brain tissue, and they're now moving towardsclinical trials in MS patients.

Work on brain organoids took a new turn when prominent neuroscientist Alysson Muotrifrom the University of California at San Diego, published a paper in August that reported on the detection of brain waves in brain organoidsfor the first time.

Muotri is a scientist known for pushing boundaries in research, having previously studied the effects of space travel on brain organoids and developed brain organoids from stem cells modified with Neanderthal genes.

Prior to the publication of Muotri's most recent work, many organoid researcher had been skeptical that brain organoidswould ever generate brain waves. Outside of a body, many thought the conditions weren't right for brain organoids to mature and form the neural circuits necessary for coordinated electrical activity.

Muotri's lab was able to optimize their growth formula so they could grow organoids that could live for several years.

Initially,they observed no coordinated activity, just occasional random firing of neurons.However, as the brain organoids started to mature, they began to observe increasing synchronization of activity as the neurons formed synapses over time. Eventually, this developed into waves of neural electrical activity that were similar to brainwaves observed inpreterm infants.

Muotri thinks his experiments have demonstrated that brain organoids are capable of forming the sophisticated networks that are associated with human behaviour and cognition.

"What we see in the brain organoid is the beginning of something that will lead to these sophisticated networks," said Muotri. "That's why this is so important."

Muotriis so convinced of the value of brain organoids in studying human brain disorders that he wants to continue to push the field forward, and facethe ethical hurdles as they come.

Even the most advanced organoid models today are far from a fully functioning brain. They don't represent all the cell types in the brain, let alone the differentiation of different brain regions.

But Muotri is pushing for that development, and thinks it's entirely possible to do so. His lab has already grown organoids similar to cortical tissue and is working on a mini-thalamus. He's looking towards interconnecting these, perhaps providing sensory information to the brain organoids to help them 'see.'

"As we do that, what we expect to happen is the maturation of these organoids to increase and to become closer to the adult brain."

Could this mean brain organoids could one day feel other sensations, like pain or even at some point become self-aware. Muotri admits it's possible.

"We're getting closer and closer to a more grey zone," he admits. But he thinks the protocols we've already established for working humanely with animals and human subjects can help us understand the limits.

"That's when we team up with the ethicists to really decide how to use this material, and how to treat these brain organoids."

Canadian bioethicist Kalina Kamenova advises caution to be taken with the fieldgoing forward, and advocates for ethical oversight to monitor the research and to establish boundaries.

"[At some point], we'll need to establish whether we're dealing with human beings here and what moral standingit has, and what kind of legal protection should be afforded to it."

Muotri agrees that the field will need to be regulated in the future so as to ensure we treat brain organoids ethically perhaps mandating how to discard them after use and how many organoids to grow for each experiment. But he cautions against putting the brakes on the research too soon.

"I think the first thing we need to do is to see if we can actually get to that stage where these organoids are self-aware or if they feel pain," said Muotri. "I think,right now, it's premature and might actually damage the research. If we do actually get to that level, then I think it's time to pause and think about the consequences, and discuss with everybody in the field how far is too far and where is the limit."

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We're making tiny brains in the lab should we be worried for them? - CBC.ca

Female Scientist To Lead Advanced Cancer Research Project In Space – SheThePeople

The China Space Station is ready to undertake research projects around 2022. It will include an advanced cancer research project called Tumours in Space. A Canadian origin Norway researcher will head it. The project will explore the functions of both microgravity and cosmic radiation in tumour growth and development.

The project is one of just nine chosen by the United Nations Office for Outer Space Affairs (UNOOSA) and the China Manned Space Agency (CMSA) to accommodate scientists from all over the globe with the chance to fly experiments on the CSS. Only one among the nine selected projects will be headed by a woman.

The idea is to transmit three-dimensional stem cell organoids from both healthy and cancer tissue from the same body into space. Here we will examine mutations and look at how the cells DNA is altered by weightlessness and cosmic radiation, says Tricia L. Larose, Principal Investigator for the Tumours in Space project.

Read Also:Astronaut Jessica Meirs Dream Just Came True, Will Do Spacewalk Soon

At UNOOSA, we are happy with our cooperation with the China Manned Space Agency. It will make it plausible for such an interesting experiment to be administered onboard the CSS, said Simonetta Di Pippo, UNOOSA Director. Space is continually opening up new boundaries for humanity to progress, as illustrated by this project. It aims to find novel approaches to reduce tumours, one of the chief killers of our time.

Weightless tumours

The research will rely on three-dimensional cancerous tumours, called organoids. These organoids are produced from adult human stem cells. These are a kind of cell that can divide endlessly and create distinct types of cells in doing so. Researchers have developed their ability to grow organoids, so they form tiny structures that simulate different organs.

Earlier cancer research that has been directed in space has adopted simpler 2D cells, which give researchers only restricted data. The 3D organoids that will be utilised in the project present better information. They have features of the organs that they have been created to mimic.

Larose hypothesizes that the cancer organoid growth will slow or stop when they are not influenced by Earths gravity. Previous research on two-dimensional cells has revealed that weightlessness controls gene expression linked to tumour development.

Read Also:Dr. Susmita Naskar: Indian Woman Scientist Impacting Aerospace Industry

Identifying cancer cell noise

Mutations in cancer cells transmit a kind of fingerprint in the DNA of the cells called a mutational signature; each type of cancer has its own.

When we look at mutational signatures in cancer cells, there is a lot of noise. The turbulence is something we do not know a lot about, says Larose. Part of my experimental method is identifying new causes of that noise, and some of that might be gravity.

Her theory is that some unknown noise in the cancer cells is there as a consequence of gravity. Since healthy cells and cells with cancer are affected by gravity, the researchers should be able to identify this in the fingerprints in all our cells.

Laroses studies of cosmic radiation will also assist with solving the cancer hazard for astronauts on long-duration missions in the space station

Only female principal investigator

The United Nations Office for Outer Space Affairs and the China Manned Space Agency chose just nine projects from 42 aspirants from 27 different nations. As one of the nine selected projects, Tumours in Space, is the only project with a female principal researcher.

We are proud to be shouldering a female scientist to manage this project. Our office also concentrates on developing the partnership of women in the space sector and STEM sectors more extensively, UNOOSA Director said.

Read Also:Contingency Plans for the Apocalypse Explores Eternal Conundrums: An Excerpt

Image- China Manned Space Agency

Saumya Rastogi is an intern with SheThePeople.TV

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Female Scientist To Lead Advanced Cancer Research Project In Space - SheThePeople

Cancer cells to be tested in zero gravity on Chinese Space Station – E&T Magazine

Cancer cells are to be transported into space to see if weightlessness can stop their growth, in one of nine research projects destined for the new China Space Station (CSS) in 2022.

Upon completion, the CSS will include a cancer research project called Tumours in Space, headed by a Canadian researcher based in Norway. The project will examine the roles of both microgravity and cosmic radiation in tumour growth and development. The project is one of just nine selected by the UN Office for Outer Space Affairs (UNOOSA) and the China Manned Space Agency (CMSA) under their programme to provide scientists from all over the world with the opportunity to fly experiments on the CSS.

The plan is to send three-dimensional stem cell organoids from both healthy and cancer tissue from the same person into space. Here we will study mutations and look at how the cells DNA is affected by weightlessness and cosmic radiation, said the projects principal investigator Tricia L. Larose.

The experiment will rely on three-dimensional cancerous tumours, called organoids. These organoids are grown from adult human stem cells, which are a kind of cell that can divide indefinitely and create different types of cells in doing so. Researchers have perfected their ability to grow organoids so they actually form tiny structures that mimic different organs. Larose theorises that the cancer organoid growth will slow or stop when they are not affected by Earths gravity. Previous research on two-dimensional cells has shown that weightlessness has an influence on gene expression linked to tumour development.

When we look at mutational signatures in cancer cells, there is a lot of noise. The noise is something we simply do not know a lot about, she said. Part of my experimental process is identifying new causes of that noise, and some of that might be gravity

Her theory is that some of the unknown noise in the cancer cells is there as a result of gravity. Since both healthy cells and cells with cancer are affected by gravity, the researchers should be able to detect this in the fingerprints in all our cells.

Im looking for the molecular fingerprint for the gravitational force, she said; this could help explain the meaning of some of the noise in the cancer cells.

She added that the mutational signature of gravity has never been studied or even proposed as a concept. The experiment will also test how cosmic radiation affects the DNA of the healthy organoids and whether this leads to mutations and cancer. The various causes of cancer, such as smoking, UV radiation and ionizing radiation, also leave mutational signatures. Identifying mutational signatures from cancer-causing exposures can be used for risk prediction, eventually leading to better diagnostics and therapeutics.

My ground-based research with ionising radiation will also help us understand the side effects of radiation therapy for cancer patients on Earth, she said.

The studies of cosmic radiation will also help with understanding the cancer risk for astronauts on long-duration missions in the space station, or longer journeys, such as to Mars.

The biggest challenge with human spaceflight and exploration for long-duration missions to Mars and beyond, is the cancer risk for crew due to exposure of cosmic radiation. By identifying the mutational signature of cosmic radiation and comparing that to the known signature of ionising radiation, we may be better able to predict risk and protect crew on a long-duration space mission Larose said.

It is thought that astronauts on a mission to Mars would be exposed to at least 60 per cent of the total radiation dose limit recommended for their career during the journey alone to and from the Red Planet.

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Cancer cells to be tested in zero gravity on Chinese Space Station - E&T Magazine

Bone Therapeutics to present preclinical data on the osteogenic properties of ALLOB in bone repair at 27th Annual Meeting of the European Orthopaedic…

Press release

Gosselies, Belgium, 2 October 2019, 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the leading biotech company focused on the development of innovative cell and biological therapies to address high unmet medical needs in orthopaedics and bone diseases, announces that the Company will today present at the 27th Annual Meeting of the European Orthopaedic Research Society (EORS), in Maastricht, The Netherlands.

The Annual EORS Meeting is Europe's Summit for orthopaedic research and is attended by scientists, clinicians and entrepreneurs in the field. In the oral presentation, Bone Therapeutics will highlight additional preclinical in vitro and in vivo results demonstrating the potent osteogenic properties of its allogeneic bone-forming cell therapy platform, ALLOB, to promote bone-formation and improve fracture healing in relevant models.

ALLOB is the Companys allogeneic product that consists of human bone-forming cells derived from cultured bone marrow mesenchymal stem cells of healthy adult donors, and is manufactured through a proprietary, scalable production process. ALLOB successfully completed two Phase II studies in two indications and the Company is on track to submit a Clinical Trial Application with the regulatory authorities before the end of the year to allow the start of the next clinical development phase in patients with delayed-union fractures.

Presentation Details:

Title: Injectable cryopreserved allogenic bone-forming cells derived from bone marrow MSC (ALLOB) display potent osteogenic and bone repair propertiesAuthors: Sylvain Normand, Delphine De Troy, Coline Muller, Pierre-Yves Laruelle, Anna Tury, Sandra PietriSession: Cellular Regenerative Medicine (FP16)Date: Wednesday, 2 October 2019Time: 5:30pm CESTLocation: Room 08, Maastricht Exhibition & Congress Centre (MECC), Maastricht, The Netherlands

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy and an innovative biological product in later-stage clinical development across a number of disease areas, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics core technology is based on its allogeneic cell therapy platform (ALLOB) which uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, cutting-edge manufacturing process.

The Companys ALLOB product pipeline includes a cell therapy product candidate that is expected to enter PhaseII/III clinical development for the treatment of delayed-union fractures and a PhaseII asset in patients undergoing a spinal fusion procedure. In addition, the Company is also developing an off-the-shelf protein solution, JTA-004, which is expected to enter PhaseIII development for the treatment of pain in knee osteoarthritis.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. Further information is available at http://www.bonetherapeutics.com.

Contacts

Bone Therapeutics SAThomas Lienard, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0) 71 12 10 00investorrelations@bonetherapeutics.com

International Media Enquiries:Consilium Strategic CommunicationsMarieke VermeerschTel: +44 (0) 20 3709 5701bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: + 33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics to present preclinical data on the osteogenic properties of ALLOB in bone repair at 27th Annual Meeting of the European Orthopaedic...

Global Stem Cell Therapy Market Report, 2019-2030 : Focus on Treatment Type, Cell Source, Indication and Competitive Landscape – Space Market Research

The global stem cell therapy market growth has been primarily attributed to the major drivers in this market such as the increasing prevalence of chronic diseases, rising number of clinical trials for cell-based therapy, steady investment, and consolidation in the regenerative medicine market, and favorable regulatory environment.

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Key Players in the Stem Cell Therapy Market are:

Market Definition: Stem Cell Therapy Market

Stem cells are human cells that have the ability to develop into various cell types such as muscle cells, brain cells they also have the unique ability to repair damaged tissue. Stem cells are divided into two major categories namely: embryonic stem cells and adult stem cells. The embryonic stem cell that is being used to conduct research today came from unused embryos resulting from an in vitro fertilization process which were later donated to science. These embryonic stem cells are pluripotent this basically means that they can turn into more than one type of cell. There are two types of adult stem cells- one of the type comes from fully developed tissues, such as the brain, the skin, and even bone marrow. The second type is induced pluripotent stem cells. These are adult stem cells that have been manipulated in a laboratory to take on characteristic of embryonic stem cells which enables them to turn into more than one type of cell.

The worldwide Stem Cell Therapy Market report give point by point data about the Stem Cell Therapy Market with a fitting examination of a few parameters and patterns impacting its advancement at a worldwide premise.

Scope of the Market :

The stem cell therapy market research provides a holistic view of the stem cell therapy market in terms of various factors influencing it, including regulatory reforms, and technological advancements.

The scope of this report is centered upon conducting a detailed study of the products allied with the therapeutic application of stem cells. In addition, the study also includes exhaustive information on the unmet needs, perception on the new products, competitive landscape, market share of leading manufacturers, the growth potential of each underlying sub-segment, and company, as well as other vital information with respect to global stem cell therapy market.

Market Segmentation

Market drivers: Stem Cell Therapy Market

Market Restraints: Stem Cell Therapy Market

Key Developments: CRISPR Technology Market

Stem cell therapy is accelerating at a huge growth circle that promises a potential for diversified career opportunities.

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Table of Contents

INTRODUCTION

RESEARCH METHODOLOGY

In light of the examination of affecting development and constraining parameters, the exact information showing the future development pattern of the market can be gotten, which is altogether clarified in the Stem Cell Therapy Market research report. The data with respect to the moving toward circumstances that can help the market capitalization is additionally incorporated into the report. The report likewise involves fundamental data, for example, yearly income age, advertise esteem, use, yearly deals, and other significant measurable information, with respect to the key market contenders which incorporate a few associations, firms, item makers, sellers, and wholesalers.

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Global Stem Cell Therapy Market Report, 2019-2030 : Focus on Treatment Type, Cell Source, Indication and Competitive Landscape - Space Market Research

Genmab Announces U.S. FDA Approval of DARZALEX (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone for Frontline Multiple…

Company Announcement

Copenhagen, Denmark; September 26, 2019 Genmab A/S (Nasdaq:GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The supplemental Biologics License Application (sBLA) for this indication was submitted by Genmabs licensing partner, Janssen Biotech, Inc. (Janssen) in March 2019. The U.S. FDA subsequently granted priority review to the sBLA, with a Prescription Drug User Fee Act (PDUFA) target date of September 26, 2019. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

The approval was based on data from part one of the Phase III CASSIOPEIA study of daratumumab in combination with VTd as treatment for patients newly diagnosed with multiple myeloma who are candidates for ASCT. The study is sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen.

Todays approval is an important step forward for patients with multiple myeloma. There are now three different treatment combinations that include DARZALEX for patients newly diagnosed with multiple myeloma, whether they are eligible for ASCT or not. We are grateful for the efforts of the IMF, HOVON and Janssen that led to the strong data from the CASSIOPEIA trial, which formed the basis of this new approval, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the CASSIOPEIA (MMY3006) studyThis Phase III study is a randomized, open-label, multicenter study, run by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen, including 1,085 newly diagnosed patients with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant. In the first part of the study, patients were randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or bortezomib, thalidomide and dexamethasone alone. The primary endpoint is the proportion of patients that achieve a stringent Complete Response (sCR). In the second part of the study (currently ongoing), patients that achieved a response will undergo a second randomization to either receive maintenance treatment of daratumumab 16 mg/kg every 8 weeks for up to 2 years versus no further treatment (observation). The primary endpoint of this part of the study is progression free survival (PFS).

About multiple myelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX (daratumumab)DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma and in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan. For more information, visit http://www.DARZALEX.com.

Story continues

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,7,8,9,10

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, DARZALEX (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with core sites in Utrecht, the Netherlands and Princeton, New Jersey, U.S.

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs final prospectus for our U.S. public offering and listing and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra is a trademark of Novartis AG or its affiliates. DARZALEX is a trademark of Janssen Pharmaceutica NV.

1 American Cancer Society. "Multiple Myeloma Overview." Available at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed June 2016.2 National Cancer Institute. "A Snapshot of Myeloma." Available at http://www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2016. 3 Globocan 2018. United States of America Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/840-united-states-of-america-fact-sheets.pdf.4 Globocan 2018. World Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2018.5 American Cancer Society. "How is Multiple Myeloma Diagnosed?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 2016.6 DARZALEX Prescribing information, July 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s019lbl.pdf Last accessed July 20197 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.8 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.9 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.10 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974.

Company Announcement no. 46CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces U.S. FDA Approval of DARZALEX (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone for Frontline Multiple...

Troy resident ‘gets it done’ with ground-breaking treatment – Troy Daily News

For Miami Valley Today

TROY Bill Willoughby has always been an optimist. This positive approach to life would serve him well after being diagnosed with non-Hodgkins lymphoma in 2015.

I was going to a doctor and at one point he said with my condition, the best he could do was try to keep me in remission, explained Bill, a Troy resident. So, he referred me to Dr. Faber at OHC for a stem cell transplant. Being an optimist, I agreed and said, Im all in. Lets get it done.

Bill went to OHC for his chemotherapy followed by the stem cell transplant for his lymphoma. OHCs stem cell transplant experts have performed more than 2300 transplants since 1989.

Stem cell transplant is a life-saving option for many people with blood cancers, explained Edward Faber, Jr., MD, MS, an OHC medical oncologist, hematologist and transplant specialist. But for Bill, months later he relapsed and the cancer was in his lungs, liver and in his bones. Weve had excellent success with stem cell transplants. Unfortunately, there are some patients for whom it just doesnt work. Our entire team was sad to learn that Bill was one of those patients.

With the cancer now in his bones, Bill was experiencing more pain than before not good for someone who still hasnt retired from the building and rental property business. So, when Dr. Faber suggested another treatment option, Bill was again optimistic.

Bill was an ideal candidate for a relatively new treatment called chimeric antigen receptor T cell immunotherapy, or CAR-T, said Dr. Faber. This is a ground-breaking treatment that has demonstrated incredible outcomes in some patients for whom all hope was lost. OHC has been using CAR-T for almost a year now and were seeing positive results. Were hopeful this will be the case for Mr. Willoughby.

CAR-T is still relatively new for treating cancers. In fact, OHC is the only adult cancer practice in the region to offer CAR-T to adults with blood cancers. With CAR-T, doctors remove immune system cells from a patient, modify them in a lab so they will recognize and kill cancer cells, then infuse them back into the patient through an IV. The cells that are injected back into the patient stay in the body, becoming what some researchers refer to as living drugs in that they are ready to attack if that same cancer returns.

I had never heard of CAR-T when Dr. Faber told me about it, Bill said. He explained that it helps your immune system cells fight the cancer. So, I looked it up, especially because I was running out of options, and it seemed like a wonderful theory. They said Im the fourth OHC patient to get this treatment.

After completing his research and weighing his options, once again, Bills response was, Im all in. Lets get this done. Bill received his CAR-T treatment in July and today hes feeling good.

I had my last scan a few weeks ago and they said the cancer in my lungs is gone, the cancer in my liver has decreased, and I still have some spots in my bones but they too have decreased, Bill said. Ive started back to work. Ive been passionate about building and construction since I was 15 years old. Now Im 70 and Im still into it, although I mostly subcontract the work. But I have rental properties and still do that maintenance work.

CAR-T has demonstrated success like no other treatment before. It received breakthrough therapy designation from the Food and Drug Administration, which means the process for approval is moved along more quickly after initial clinical trials show strong results. The procedure is currently performed in a designated center, originally as a hospital inpatient procedure that is now being administered in a hospital outpatient department.

OHC is launching new clinical trials to determine if it can be given in a doctors office treatment suite setting, like OHC, said Dr. Faber. And soon, we hope to introduce clinical trials that will look to expand CAR-T to treat other cancers, like solid tumors.

We still have a way to go with CAR-T and other immunotherapies, but if its successful, it will forever change the way the world treats cancer. Its a whole new frontier for medicine, Dr. Faber added.

Ive always been an optimist and a Christian, and I look at this as a great thing thats happened to me, Bill added. So does my family. Ive already recommended it to a couple people I know whove also run out of options. I tell them to call Dr. Faber and see if he can get it for them. When your chances become limited and then you learn about this, you start to see a possible light at the end of the tunnel.

OHC is the only adult cancer group in the region to offer this advanced treatment to adults. For more information including an educational video, visit https://www.ohcare.com/service/car-t-cell-therapy/ or call (888) 649-4800.

Provided photo Pictured is OHC patient Bill Willoughby back at work thanks to CAR T-cell immunotherapy.

Willoughby undergoes stem cell transplant

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Troy resident 'gets it done' with ground-breaking treatment - Troy Daily News

The unexpected functional diversity of reactive astrocytes – Baylor College of Medicine News

When the brain is injured or diseased astrocytes are the first to respond. They become reactive and play roles that can be both beneficial and deleterious, but little is known about how these diverse responses to injury are regulated.

In his lab at Baylor College of Medicine, Dr. Benjamin Deneen, professor of neurosurgery and theCenter for Stem Cell and Regenerative Medicine, has long been studying astrocytes, the most abundant cells in the brain. In this publication, he and his colleagues reported surprising discoveries regarding both the generation and activity of the first responders to brain injury.

Reactive astrocytes are associated with most forms of neurological disorders, from acute injury to degeneration, but their contributions to disease are only now coming to light, Deneen said.

In the current study, Deneen and his colleagues focused on identifying a regulator of reactive astrocytes. They looked into nuclear factor I-A (NFIA), a known regulator of astrocyte development, and investigated whether it also was involved in the generation and regulation of reactive astrocytes.

First, they determined that NFIA is abundant in human pediatric and adult reactive astrocytes found in a host of neurological injuries. Then, to explore the role NFIA plays in the response of reactive astrocytes to injury, the researchers turned to mouse models. They generated mice in which NFIA was specifically eliminated in astrocytes, and compared the reactive astrocyte response of these NFIA-deficient mice to that of mice with NFIA, after different types of neurological injury.

The results were surprising, said Deneen, who holds the Dr. Russell J. and Marian K. Blattner Chair and is a member of the Dan L Duncan Comprehensive Cancer Center at Baylor. Until now, it was thought that, regardless of the type of injury or where it occurred in the central nervous system, reactive astrocytes would respond in the same way. Knocking out NFIA allowed us to uncover a previously unknown layer of functional diversity in reactive astrocytes.

When white matter injuries occurred in the spinal cord of NFIA-deficient mice, reactive astrocytes were generated and migrated toward the injury, but were not able to remodel the injured blood brain barrier as well as the reactive astrocytes of normal mice did. Consequently, the white matter was not repaired.

But when the researchers tested the response to a different form of injury in another region of the central nervous system a stroke in the cerebral cortex they observed something different. While normal mice (with NFIA) responded to stroke by producing reactive astrocytes that migrated toward the injury to repair the bleeding, NFIA-deficient mice did not generate reactive astrocytes and the injury was not healed. In both cases, in the spinal cord and in the cerebral cortex, the injury was not properly repaired, but the underlying reasons were different in each case.

These findings suggest that NFIAs function in reactive astrocytes is dependent upon the type of injury and brain region in which the injury occurs. In the cerebral cortex, NFIA is crucial for making reactive astrocytes, while in the spinal cord NFIA is important for sealing off leaking blood vessels. These results hint at an extensive reservoir of reactive astrocyte responses that vary according to form and location of injury, Deneen said.

In addition, the researchers began to define the molecular mechanisms underpinning the generation of reactive astrocytes. They found that NFIA directly regulates the production of thrombospondin 4, an essential regulator of the generation of reactive astrocytes that had been previously identified in the lab of co-author Dr. Chay T. Kuo, associate professor of cell biology and neurobiology at Duke University.

Although our study was conducted in mice and more research is needed, we think our findings may reflect what occurs in people, as NFIA also is abundantly present in reactive astrocytes in both pediatric and adult neurological injuries, Deneen said.

We also are interested in investigating the role NFIA plays in reactive astrocytes involved in neurodegenerative diseases, such as Alzheimers and Parkinsons disease. Its possible it has a completely different set of functions in these conditions, Deneen said.

The study appears in The Journal of Clinical Investigation.

Other contributors of this work include Dylan Laug, Teng-Wei Huang, Navish A. Bosquez Huerta, Yu-Szu Huang, Debosmita Sardar, Joshua Ortiz, Jeffrey C. Carlson, Benjamin R. Arenkiel, Carrie A. Mohila, Stacey M. Glasgow and Hyun Kyoung Lee. The authors are affiliated with one or more of the following institutions: Baylor College of Medicine, Texas Childrens Hospital, Duke University and the University of California San Diego.

This work was supported by grants from the National Multiple Sclerosis Society (RG-1501-02756 and FG-1607-25417), the National Institutes of Health (NIH) (NS096096 and S071153), the National Heart, Lung, and Blood Institute (NHLBI), NIH (T32-HL902332) and the David & Eula Winterman Foundation MS Research Endowment.

By Ana Mara Rodrguez, Ph.D.

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The unexpected functional diversity of reactive astrocytes - Baylor College of Medicine News

Stem Cell Assay Market Overview by Industry Chain Information, Upstream Raw Materials & Downstream Industry 2017 2025 – Herald Space

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The undifferentiated biological cells that can differentiate into specialized cells are called as stem cells. In the human body during early life and growth phase, stem cells have the potential to develop into other different cell types. Stem cells can differ from other types of cells in the body. There are two types of stem cells namely the embryonic stem cells and adult stem cells. Adult stem cells comprise of hematopoietic, mammary, intestinal, neural, mesenchymal stem cells, etc. All stem cells have general properties such as capability to divide and renew themselves for long period. Stem cells are unspecialized and can form specialized cell types. The quantitative or qualitative evaluation of a stem cells for various characteristics can be done by a technique called as stem cell assay. The identification and properties of stem cells can be illustrated by using Stem Cell Assay. The new developments in the field of stem cell assay research related to the claim of stem cell plasticity have caused controversies related to technical issues. In the study of stem cell assay, most conflicting results arise when cells express stem cell characteristics in one assay but not in another. The most important factor is that the true potential of stem cells can only be assessed retrospectively. The retrospective approach refers to back drop analysis which provides quantitative or qualitative evaluation of stem cells. The development in embryonic & adult stem cells assay will be beneficial to the global stem cell assay market. Stem cell assays find applications in pharmaceutical & biotechnology companies, academic & research institutes, government healthcare institutions, contract research organizations (CROs) and others. The influential factors like chronic diseases, increased investment in research related activities, and technological advancements in pharmaceutical & biotech industry is anticipated to drive the growth of the global stem cell assay market during the forecast period. The cost of stem cell based therapies could be one of the major limiting factor for the growth of the global stem cell assay market.

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The global stem cell assay market has been segmented on the basis of kit type, application, end user and region. The global stem cell assay market can be differentiated on the basis of kit type into human embryonic stem cell kits and adult stem cell kits. The adult stem cell kit includes hematopoietic stem cell kits, mesenchymal stem cell kits, induced pluripotent stem cell kits (IPSCs), and neuronal stem cell kits. The adult stem cell kits are projected to witness the highest CAGR during the forecast period due to the ease of use, cost & effectiveness of this type of kit in stem cell analysis.

Based on application global stem cell assay market is based on drug discovery and development, therapeutics and clinical research. The therapeutics segment includes oncology, dermatology, cardiovascular treatment, orthopedic & musculoskeletal spine treatment, central nervous system, diabetes and others.

Depending on geographic segmentation, the global stem cell assay market is segmented into five key regions: Asia Pacific, North America, Europe, Latin America, and Middle East & Africa. North America is expected to contribute significant share to the global stem cell assay market. The stem cell assay market in Europe, has gained impetus from the government & industrial initiatives for stem cell based research and the market in Europe is expected to grow at a remarkable pace during the forecast period. The major players in the global stem cell assay market include GE Healthcare, Promega Corporation, Thermo Fisher Scientific Inc., Merck KGaA, Cell Biolabs, Inc., Hemogenix Inc., Stemcell Technologies Inc., Bio-Rad Laboratories Inc., R&D Systems Inc., and Cellular Dynamics International Inc.

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Stem Cell Assay Market Overview by Industry Chain Information, Upstream Raw Materials & Downstream Industry 2017 2025 - Herald Space