Incyte and MorphoSys to Host Investor Event to Discuss the Unmet Need and Global Opportunities for Tafasitamab in Non-Hodgkin Lymphomas – Business…

WILMINGTON, Del. & PLANEGG & MUNICH, Germany--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) today announced that the companies intend to host a conference call and webcast to discuss global development, unmet need and commercial opportunities for tafasitamab.

Dr. Gilles Salles will join Incyte and MorphoSys leadership as an expert speaker. Dr. Salles was the principal investigator and first author of the ICML 2019 and EHA 2020 data presentations, as well as first author of the 2020 Lancet Oncology publication of the L-MIND trial investigating tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

The conference call and webcast will be held on Tuesday, September 29, 2020 from 9:00 11:00 a.m. EDT / 3:00 5:00 p.m. CEST. The live webcast and replay will be available via http://www.morphosys.com and investor.incyte.com.

To access the conference call, U.S. domestic callers please dial 877-423-0830. Callers outside of the U.S. please dial +49 69201744220 or +44 2030092470. When prompted, provide the conference pin number, 83557299#.

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi(tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG.

XmAb is a registered trademark of Xencor, Inc.

Important Safety Information

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

The most common side effects of MONJUVI include:

These are not all the possible side effects of MONJUVI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

About MorphoSys

MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, 27 of which are currently in clinical development. In 2017, Tremfya, marketed by Janssen for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020 the U.S. Food and Drug Administration approved the companys proprietary product Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at http://www.morphosys.com.

Tremfya is a registered trademark of Janssen Biotech.

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Incyte and MorphoSys to Host Investor Event to Discuss the Unmet Need and Global Opportunities for Tafasitamab in Non-Hodgkin Lymphomas - Business...

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Researchers Discover a Way To Create Induced Tropoblast Stem Cells – Technology Networks

An international collaboration involving Monash University and Duke-NUS researchers have made an unexpected world-first stem cell discovery that may lead to new treatments for placenta complications during pregnancy.

While it is widely known that adult skin cells can be reprogrammed into cells similar to human embryonic stem cells that can then be used to develop tissue from human organs - known as induced pluripotent stem cells (iPSCs) - the same process could not create placenta tissue.

iPSCs opened up the potential for personalised cell therapies and new opportunities for regenerative medicine, safe drug testing and toxicity assessments, however little was known about exactly how they were made.

An international team led by ARC Future Fellow Professor Jose Polo from Monash University's Biomedicine Discovery Institute and the Australian Research Medicine Institute, together with Assistant Professor Owen Rackham from Duke-NUS in Singapore, examined the molecular changes the adult skin cells went through to become iPSCs. It was during the study of this process that they discovered a new way to create induced trophoblast stem cells (iTSCs) that can be used to make placenta cells.

This exciting discovery, also involving the expertise of three first authors, Dr. Xiaodong Liu, Dr. John Ouyang and Dr. Fernando Rossello, will enable further research into new treatments for placenta complications and the measurement of drug toxicity to placenta cells, which has implications during pregnancy.

"This is really important because iPSCs cannot give rise to placenta, thus all the advances in disease modelling and cell therapy that iPSCs have brought about did not translate to the placenta," Professor Polo said.

"When I started my PhD five years ago our goal was to understand the nuts and bolts of how iPSCs are made, however along the way we also discovered how to make iTSCs," said Dr Liu.

"This discovery will provide the capacity to model human placenta in vitro and enable a pathway to future cell therapies," commented Dr Ouyang.

"This study demonstrates how by successfully combining both cutting edge experimental and computational tools, basic science leads to unexpected discoveries that can be transformative," Professor Rackham said.

Professors Polo and Rackham said many other groups from Australian and international universities contributed to the study over the years, making it a truly international endeavour.

Reference:Liu, X., Ouyang, J.F., Rossello, F.J. et al. Reprogramming roadmap reveals route to human induced trophoblast stem cells. Nature (2020). https://doi.org/10.1038/s41586-020-2734-6

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Chicken Biobank to cut numbers of birds for research – Poultry World

Frozen reproductive cells hatched by surrogate hens will lead to the formation of a chicken biobank for breeds of chickens used in research. Scientists are looking to develop a new technology to limit the number of chickens required for research by freezing reproductive cells and using sterile surrogates to hatch the required breeds.

The method, say scientists, will enable genetic diversity which helps limit risk of poor health to be maintained in those chickens created from frozen material. A team from the Roslin Institute, Scotland, will aim to transfer frozen reproductive stem cells from many individuals of one chicken breed into eggs from sterile surrogate chickens of a different breed. The hatched offspring from the injected eggs that results will look like the sterile line, but will lay eggs of the transferred breed and retain genetic diversity.

A biobank of breeds used in research would help to reduce the number of research chickens, currently bred in large numbers across the world, needed to maintain a genetically diverse population and prevent problems with inbreeding.

Text continues underneath image

A team from the Roslin Institute, Scotland, will aim to transfer frozen reproductive stem cells from many individuals of one chicken breed into eggs from sterile surrogate chickens of a different breed. - Photo: Mark Pasveer

Dr Mike McGrew, of the Roslin Institute, said: Discovering a way to easily freeze avian reproductive cells and subsequently bring back a genetically diverse flock will help the preservation of endangered breeds of poultry, increase food security from disease outbreaks and reduce numbers of animals used in research.

Scientists will optimise how to freeze reproductive cells by studying three breeds of chickens used in research. The team will then aim to show that a surrogate parent can lay eggs that come from many individual donor birds.

This result will determine the ability to capture the genetic diversity of a chicken flock. This will validate the development of biobanks for flocks of poultry for research purposes, which will limit the number of animals bred for use in this way. The method could also be used to preserve rare chicken breeds.

The adult surrogate birds will have only their reproductive cells changes to the genetics of the transferred cells, and therefore will be largely unaffected, with the exception that their offspring will be a different breed of chicken.

Their projects requires new insights into avian reproduction, which differs considerably from mammalian specie. Researchers hope to recreate the practices applied in other research species, where reproductive materials are frozen to secure future availability while reducing the numbers of animals used in research, as well as preserving the genetics of the species.

Such an approach can also avoid the random genetic changes that can occur naturally between generations of animals bred for research, which can lead to unhealthy animals.

The study, which is supported with funding from the UK Governments Foreign and Commonwealth Office, the Centre for Tropical Livestock Genetics and Health and the National Centre for the Replacement Refinement and Reduction of Animals in Research.

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Keeping kids and adults alike healthy with Colostrum – North Coast Courier

Did you know that your childs immune system isnt fully developed until the age of 7 or 8 years, and that they are exposed to thousands of germs each and every day?

Kids will be kids, and who we cannot keep them wrapped in bubble wrap but there are ways to strengthen their immune response.

Key to doing this is to maintain and strengthen your childs gut health.

Ballito based New Image International consultant, Prema Naidoo recommends the Alpha Lipid Dinotabs a Colostrum-based product in the form of a tablet which children can take daily from the age of 12 months and upwards.

Containing Bovine Colostrum, these strawberry flavoured tablets provide important immune factors antibodies which may help your child to cope with the constant challenges they may face with their immune health.

Bovine Colostrum is a milky fluid which comes from the udders of cows during the first few days after giving birth (before true milk appears) this is filled with proteins, carbohydrates, fats, vitamins, minerals and specific kinds of proteins called antibodies, which help fight bacteria and viruses.

Taken daily, Colostrum supports digestion by providing nutrients to your child which nourishes a healthy digestive tract.

Dinotabs also improves bone and dental health.

And while youre busy running after your child, you may need something to aid with replenishing, rejuvenating and revitalising your own bodys natural cellular repair process. This can be done by taking Alpha Lipid Colostem, which supports stem cell nutrition.

Colostrum has stem cell releasing properties. Stem cells have the ability to develop into many different cell types, which can range from muscle cells to brain cells.

Acting as a universal repair system while also maintaining the regeneration of cells throughout the body, adult stem cells divide to replenish dying cells.

Alpha Lipid Colostem supports this natural process, adding antioxidants and nutrients to boost your immunity and leave your body feeling restored, healthy and protected.

For more information, contact Prema Naidoo at 079 694 7893.

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Orthopedic Regenerative Medicine Market Growing Massively By 2020-2027 Major Players: Curasan, Inc., Carmell Therapeutics Corporation, Anika…

The Global Orthopedic Regenerative Medicine MarketIndustry Report is a professional and in-depth study on the current state of the Orthopedic Regenerative Medicine Market by CMI. The Orthopedic Regenerative Medicine market is supposed to demonstrate a considerable growth during the forecast period of 2020 2027. The company profiles of all the key players and brands that are dominating the market have been given in this report. Their moves like product launches, joint ventures, mergers and acquisitions and the respective effect on the sales, import, export, revenue and CAGR values have been studied completely in the report. The scope of this Orthopedic Regenerative Medicine market report can be expanded from market scenarios to comparative pricing between major players. The emerging trends along with major drivers, challenges and opportunities in the market are also identified and analysed in this report.

Orthopedic Regenerative Medicine help organizations to develop cogent, coherent plans of action to improve their performance.

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Orthopedic Regenerative Medicine Market report provides a thoroughly researched abstract of the key players with considerable shareholdings at a global level regarding demand, sales, and income by providing better products and services. Research Report outlines a forecast for the Orthopedic Regenerative Medicine market between 2020 and 2027. In terms of value, the Orthopedic Regenerative Medicine industry is expected to register a steady CAGR during the forecast period.

The report offers a systematic presentation of the existing trends, growth opportunities, market dynamics that are expected to shape the growth of the Orthopedic Regenerative Medicine market. The various research methods and tools were involved in the market analysis, to uncover crucial information about the market such as current & future trends, opportunities, business strategies and more, which in turn will aid the business decision-makers to make the right decision in future.

The report begins with a brief introduction and market overview of the Orthopedic Regenerative Medicine industry followed by its market scope and size. Next, the report provides an overview of market segmentation such as type, application, and region. The drivers, limitations, and opportunities for the market are also listed along with current trends and policies in the industry.

The key players profiled in this report include:

Curasan, Inc., Carmell Therapeutics Corporation, Anika Therapeutics, Inc., Conatus Pharmaceuticals Inc., Histogen Inc., Royal Biologics, Ortho Regenerative Technologies, Inc., Swiss Biomed Orthopaedics AG, Osiris Therapeutics, Inc., and Octane Medical Inc.

Regions included:

o North America (United States, Canada, and Mexico)

o Europe (Germany, France, UK, Russia, and Italy)

o Asia-Pacific (China, Japan, Korea, India, and Southeast Asia)

o South America (Brazil, Argentina, Colombia)

o Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

Detailed Segmentation:

By Procedure Cell TherapyTissue EngineeringBy Cell TypeInduced Pluripotent Stem Cells (iPSCs)Adult Stem CellsTissue Specific Progenitor Stem Cells (TSPSCs),Mesenchymal Stem Cells (MSCs)Umbilical Cord Stem Cells (UCSCs)Bone Marrow Stem Cells (BMSCs)By SourceBone MarrowUmbilical Cord BloodAdipose TissueAllograftsAmniotic FluidBy ApplicationsTendons RepairCartilage RepairBone RepairLigament RepairSpine RepairOthers

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Key Benefits:

o This study gives a detailed analysis of drivers and factors limiting the market expansion of Orthopedic Regenerative Medicine

o The micro-level analysis is conducted based on its product types, end-user applications, and geographies

o Porters five forces model gives an in-depth analysis of buyers and suppliers, threats of new entrants & substitutes and competition amongst the key market players

o By understanding the value chain analysis, the stakeholders can get a clear and detailed picture of this Orthopedic Regenerative Medicine market

The research study can answer the following Key questions:

Table of Contents

Report Overview: It includes the Orthopedic Regenerative Medicine market study scope, players covered, key market segments, market analysis by application, market analysis by type, and other chapters that give an overview of the research study.

Executive Summary: This section of the report gives information about Orthopedic Regenerative Medicine market trends and shares, market size analysis by region and analysis of global market size. Under market size analysis by region, analysis of market share and growth rate by region is provided.

Profiles of International Players: Here, key players of the Orthopedic Regenerative Medicine market are studied on the basis of gross margin, price, revenue, corporate sales, and production. This section gives a business overview of the players and shares their important company details.

Regional Study: All of the regions and countries analyzed in the Orthopedic Regenerative Medicine market report is studied on the basis of market size by application, the market size by product, key players, and market forecast.

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Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Southeast Asia.

About Author:

Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having office at global financial capital in the U.S. Our client base includes players from across all business verticals in over 150 countries worldwide. We are uniquely positioned to help businesses around the globe deliver practical and lasting results through various recommendations about operational improvements, technologies, emerging market trends and new working methods.

Mr Raj ShahCoherent Market Insights 1001 4th Ave,#3200 Seattle, WA 98154, U.S.Phone +1-206-701-6702[emailprotected]

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Study: Brain cells of people with autism differ even before theyre born – Study Finds

PHILADELPHIA Autism is a neurodevelopmental disorder which creates difficulties with social interactions, communication, and repetitive behaviors. According to the Centers for Disease Control and Prevention, autism affects one in 54 children in the United States. Although autism typically isnt diagnosed until children are at least 18 months-old, a new study finds that abnormal brain cell development likely occurs much earlier.

Researchers say this even occurs while babies are still in the womb.

To study developing brain cells, a team from Kings College London and Cambridge University use a type of cell known as an induced pluripotent stem cell (or iPSC). Essentially, iPSCs are adult cells that scientists force to become immature embryonic-like stem cells. Scientists can program iPSCs to become one of many different cell types, including neurons. Since iPSCs are forced to restart their cellular development, they mimic the processes occurring in the womb. This allows them to serve as a useful means of studying early brain development.

Using iPSCs from hair samples is the most ethical way to study early brain development in autistic people, explains study author Dwaipayan Adhya in a media release. It bypasses the need for animal research, it is non-invasive, and it simply requires a single hair or skin sample from a person.

Adhya is a molecular biologist at the Autism Research Centre in Cambridge and Department of Basic and Clinical Neuroscience at Kings College London.

To create the iPSCs, the study analyzes hair samples from nine adults with autism and six neurotypical adults. The hair cells were then treated with growth factors (naturally occurring bodily substances that regulate cell division and survival). The authors looked at the cells appearance and genetic makeup at different phases of development.

The scientists results reveal iPSCs from neurotypical people look different from those participants with autism. At day nine, neurons from neurotypical people develop a characteristic pattern of neural rosettes, which have a dandelion-like shape. In contrast, cells from people with autism have smaller rosettes or dont form them at all. Cells from autistic individuals also express lower levels of important developmental genes.

The use of iPSCs allows us to examine more precisely the differences in cell fates and gene pathways that occur in neural cells from autistic and typical individuals, co-author Deepak Srivastava explains. These findings will hopefully contribute to our understanding of why there is such diversity in brain development.

The brain has been the ultimate black box. Here, the authors have used nerve cells derived from peripheral stem cells to peek inside this box. This important study suggests that this is possible and is deepening our understanding of autism, says John Krystal, Editor-in-Chief of the journal Biological Psychiatry.

The study is published in the June 22 edition of Biological Psychiatry.

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CAR T-Cell Therapies Continue to Raise the Bar in Lymphoma Management – OncLive

CAR T-cell therapies continue to elicit encouraging responses with manageable toxicity in older patients with lymphomas who may be unable to tolerate more intensive approaches, according to Pashna N. Munshi, MD.

In July 2020, the FDA approved brexucabtagene autoleucel (Tecartus; formerly KTE-X19)for the treatment of adult patients with relapsed/refractory mantle cell lymphoma (MCL) based on data from the ZUMA-2 trial. In 60 patients evaluable for efficacy based on a minimum duration of follow-up for response of 6 months, results showed that a single infusion of the product resulted in an 87% objective response rate (ORR), with a 62% complete remission (CR) rate.1

Brexucabtagene autoleucel is going to provide patients with MCL with another treatment option. MCL is a very heterogeneous disorder; it can behave indolently in some patients, but in others, it's a very aggressive disease, said Munshi, associate clinical director of the Stem Cell Transplant and Cellular Immunotherapy Program at MedStar Georgetown University Hospital. Patients who relapse early often don't do very well and cannot get into remission. Having an option like CAR T-cell therapy gives these patients a chance to receive [a treatment] that is targeted, with manageable toxicities.

The ZUMA-5 trial with axicabtagene ciloleucel (axi-cel; Yescarta) showed similarly impressive response rates, according to Munshi. Results from an interim analysis revealed that at a median follow-up of 15.3 months, patients with follicular lymphoma and marginal zone lymphoma (MZL) who received treatment with the CAR T-cell product experienced an ORR of 93% and a CR rate of 80%.2

In an interview withOncLive during the 2020 Institutional Perspectives in Cancer webinar on Leukemia/Lymphoma, Munshi, who is also an assistant professor of medicine at Georgetown University, discussed the CAR T-cell therapies that have emerged in the lymphoma space and highlighted the next steps for research with these products.

OncLive: Could you highlight some of the CAR T-cell products that are generating excitement in lymphoma?

Munshi: The most recently approved therapy was brexucabtagene autoleucel, which was evaluated in the ZUMA-2 trial; this was a phase 2, single-arm, open-label, multicenter trial done in patients with relapsed/refractory MCL. This product is similar to the CD19-targeted CAR T-cell product axicabtagene ciloleucel, although some differences exist.[Results showed] an ORR of 93%, with CR rates of 67% in a total of 68 patients. The ORR and the durability of those responses resulted in the approval of the product.

Another important clinical trial that is currently underway is ZUMA-5, which is being done in patients with relapsed/refractory indolent non-Hodgkin lymphoma. This trial had 2 cohorts: patients with follicular lymphoma and those with MZL. The follicular lymphoma cohort is now closed to enrollment and the results were [presented during] the 2020 ASCO Virtual Scientific Program and those results will be presented at the 2020 ASH Annual Meeting.

Ninety-six patients were evaluable for efficacy. [The ORR] was 95% in the follicular lymphoma arm and 81% for the MZL arm. At the time of data cutoff, 68% of patients had ongoing responses, so this is a very exciting therapy. We hope this will be a new indication for the treatment of patients with relapsed/refractory indolent lymphoma, especially follicular lymphoma.

What is the clinical significance of the brexucabtagene autoleucel approval?

One type of treatment approach that patients with MCL are offered is a high-dose chemotherapy with autologous stem cell transplantation. However, many patients may not be eligible for such high-intensity chemotherapy. Patients may be older, frail, and not in good enough shape to receive high-intensity treatment. CAR T-cell therapy may be given to these patients.

[In the ZUMA-2] trial, there was a substantial number of older patients [who achieved] very good responses [with the therapy]. The ORR was 87% at a median follow-up of about 8.6 months; this was later updated because 4 patients in the initial study were deemed as nonresponders by an independent radiology review. This therapy can potentially be given more up front for patients with MCL who have progressed on 2 or more lines of therapy.

Many older patients were also included on the ZUMA-5 trial. Could you expand on this? What does the safety look like with this product?

The median age range of participants was vast; the trial included patients who were as young as 34 years up to those who were 79 years. Many of these patients were older; they were over 60 years and yet, they could tolerate this therapy with really impressive ORRs.

Even though these therapies do have toxicities, such as cytokine release syndrome (CRS) and neurological effects, they are well [managed] by experts. We use therapies, such as the IL-6 inhibitor tocilizumab(Actemra) up front to treat CRS, as well as up-front steroids, in patients who may have some level of neurological involvement. In terms of the ZUMA-5 trial, it is important to note the age range and the fact that at least 73% of these patients were refractory to the last therapy they had received.

What are some of the updates that have been reported with tisagenlecleucel (tisa-cel; Kymriah)?

The [manufacturers of] tisa-cel presented real-world data with their commercial product and compared it with clinical trial results. They saw, if not similar, an almost improved toxicity profile and similar response rates which were reflective of their clinical trial.

Based on the initial JULIET study, 92% of patients were allowed bridging therapy. Only 72% to 75% of patientsreceived bridging therapy on the commercial side. The real-world data showed a median ORR of approximately 60%, with approximately 40% achieving a CR; [this] is similar to the 40% best responses observed on the clinical trial.

The grade 3 or higher toxicities were very low; only 4.3% of patients experienced CRS; that is remarkable. More patients are increasingly being given up-front tocilizumab or steroid use, which is mitigating the toxicity of these therapies and making it safer for patients.

What are the next steps for research with this modality?

A Pandora's box has been opened. Were not limited to CAR T-cell therapies; many, many targets are now being explored. There are CAR natural killer cell therapies; there are specific targets in leukemia that are being studied. CD33-targeted CAR T-cell trials are being done, and investigators are also exploring a combination of CD33-targeted and CD123-targeted products.

[Additionally], there are bispecific CAR T-cell engagers. Different methods are being used to try to see why relapse happens with CAR T-cell therapy. Maybe 1 antigen is lost and, therefore, you need a second antigen to be targeted, [hence] the CD19/CD22 combinations being examined in acute lymphoblastic leukemia. Many different forms of therapies are under exploration.

The next step is to find a way to [minimize] toxicities and relapse in the CAR T-cell world.The final stage is to look at off-the-shelf or allogeneic CAR T products. With these options, patients may not have to wait for their own cells to be processed as CAR T cells; the product will be readily available. That will really change how quickly these patients receive treatment, and it also potentially shifts the bar for many diseases.

For example, if this [approach] is successful in acute myeloid leukemia, many patients may get this therapy when they were not otherwise eligible for allogeneic stem cell therapy. If this therapy were to put them in remission, they could potentially make it to an allogeneic stem cell transplant or may not even need to undergo a transplant if these therapies prove durable. It's a very exciting future for CAR T cells.

What is your take-home message to your colleagues?

What I'd like to tell all the providers out there who are seeing patients with lymphoma and myeloma, especially with regard to refractory lymphomas, early referral is key. This is an autologous product, so it can take anywhere from 2 weeks to 3 weeks [to manufacture], depending on the type of product. When patients have an active malignancy, they're really waiting with active disease and it's hard to treat them with new therapy in between while they wait to receive CAR T-cells.

There is an aspect of overcoming insurance hurdles with some of these patients, as these are expensive products. Many milestones need to be achieved before patients can [receive] these therapies. Family members need education about the care that patients need once they're sent home. Also, referring providers may need to see these patients more frequently after they're treated with CAR T-cells, depending on their need.

There is some education that goes into this and we are armed as specialized, authorized treatment centers to arm patients and their caregivers with the knowledge about these therapies, the adverse effects of these approaches, and potentially provide them with a therapy that would make a change to the cancer in their body.

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CAR T-Cell Therapies Continue to Raise the Bar in Lymphoma Management - OncLive

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Stem Cells Market is Expected to Thrive at Impressive CAGR by 2025 – Scientect

This report studies the Stem Cells market size (value and volume) by players, regions, product types and end industries, history data 2013-2017 and forecast data 2018-2025; This report also studies the global market competition landscape, market drivers and trends, opportunities and challenges, risks and entry barriers, sales channels, distributors and Porters Five Forces Analysis.

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Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types. Commonly, stem cells come from two main sources: Embryos formed during the blastocyst phase of embryological development (embryonic stem cells) and Adult tissue (adult stem cells).

Both types are generally characterized by their potency, or potential to differentiate into different cell types (such as skin, muscle, bone, etc.).

Stem Cells market, by technology, is Cell Acquisition, Cell Production, Cryopreservation, Expansion, and Sub-Culture. Stem Cell Therapy in China is not mature, so in this report we mainly cover Stem Cell Banking market.

Stem Cells market, by technology, is Cell Acquisition, Cell Production, Cryopreservation, Expansion, and Sub-Culture. Stem Cell Therapy in China is not mature, so in this report we mainly cover Stem Cell Banking market.

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Geographically, this report is segmented into several key regions, with sales, revenue, market share and growth Rate of Stem Cells in these regions, from 2013 to 2025, covering

North America (United States, Canada and Mexico)

Europe (Germany, UK, France, Italy, Russia and Turkey etc.)

Asia-Pacific (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Malaysia and Vietnam)

South America (Brazil etc.)

Middle East and Africa (Egypt and GCC Countries)

The various contributors involved in the value chain of the product include manufacturers, suppliers, distributors, intermediaries, and customers. The key manufacturers in this market include

CCBC

Vcanbio

Boyalife

Beikebiotech

By the product type, the market is primarily split into

Umbilical Cord Blood Stem Cell

Embryonic Stem Cell

Adult Stem Cell

Other

By the end users/application, this report covers the following segments

Diseases Therapy

Healthcare

We can also provide the customized separate regional or country-level reports, for the following regions:

North America

United States

Canada

Mexico

Asia-Pacific

China

India

Japan

South Korea

Australia

Indonesia

Singapore

Malaysia

Philippines

Thailand

Vietnam

Rest of Asia-Pacific

Europe

Germany

France

UK

Italy

Spain

Russia

Rest of Europe

Central & South America

Brazil

Rest of Central & South America

Middle East & Africa

GCC Countries

Turkey

Egypt

South Africa

Rest of Middle East & Africa

The study objectives of this report are:

To study and analyze the global Stem Cells market size (value & volume) by company, key regions/countries, products and application, history data from 2013 to 2017, and forecast to 2025.

To understand the structure of Stem Cells market by identifying its various subsegments.

To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).

Focuses on the key global Stem Cells manufacturers, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.

To analyze the Stem Cells with respect to individual growth trends, future prospects, and their contribution to the total market.

To project the value and volume of Stem Cells submarkets, with respect to key regions (along with their respective key countries).

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.

To strategically profile the key players and comprehensively analyze their growth strategies.

About Us:

Precision Business Insights is one of the leading market research and management consulting firm, run by a group of seasoned and highly dynamic market research professionals with a strong zeal to offer high-quality insights. We at Precision Business Insights are passionate about market research and love to do the things in an innovative way. Our team is a big asset for us and great differentiating factor. Our company motto is to address client requirements in the best possible way and want to be a part of our client success. We have a large pool of industry experts and consultants served a wide array of clients across different verticals. Relentless quest and continuous endeavor enable us to make new strides in market research and business consulting arena.

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Stem Cells Market is Expected to Thrive at Impressive CAGR by 2025 - Scientect

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Crohns Disease Treatment Market Unidentified Segments The Biggest Opportunity2018 2025 – Kentucky Journal 24

Crohns Disease is a type of inflammatory bowel disease (IBD) causing inflammation and damage to the digestive tract usually affecting the end of small intestine and beginning of colon, but inflammation may occur anywhere along the digestive tract. The disease may be hereditary or grow due to the malfunctioning of the immune system. It includes some risk factors, such as genetics, combined with an overactive immune system & the environmental changes, and certain bacteria, like, mycobacterium, etc.

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Demand Scenario

Theglobal Crohns disease treatment marketwas USD 9,674 million in 2018 and is estimated to reach USD 12,834 million by 2025 at a CAGR of 4.12% during the forecast period

Growth by Region

North America accounted for the largest market share in 2018 due to the largest contribution from the growing US market. Growth in Europe is driven by the higher per capita income and strong healthcare penetration in the region. Asia Pacific is likely to create significant growth opportunities for the market players owing to develop infrastructure, R&D activities related to biologics and increase in prevalence of Crohns disease in the region. Emerging countries such as India and China are expected to show the fastest growth owing to increase in R&D investment and healthcare expenditure in these countries.

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Drivers and Restraints

The major driver for Crohns disease treatment market is increase in number of people being infected by the disease. Moreover, increase in demand for biologics and high unmet needs within the anti-TNF refractory patient group that presents untapped market opportunities. Moreover, strong pipeline and novel mechanisms to treat Crohns disease are boosting the growth of the market. However, patent expiry of the important drugs, high cost of treatment, high R&D investment for development of biological drugs and unknown aetiology of the Crohns disease are the factors hindering the market growth.

Industry Trends and Updates

In March 27, 2018, Researchers at the University of Alberta (Canada), published the study of the potential biomarkers they have developed to help reduce the suffering of Crohns disease patients. These scientists used high performance liquid chromatography with mass spectrometry and created a profile of potential biomarkers. In April 03, 2018, TiGenix NV (Belgium), a global cell therapy company and Takeda Pharmaceutical (Japan), the largest global pharmaceutical company, together announced approval from the EC (European Commission) for the treatment Alofisel (darvadstrocel) that they have developed to treat the complex perianal fistulae in adult patients with non-active(mildly active) luminal Crohns disease. This is the initial allogeneic stem cell therapy (originating from donor stem cells) to receive central marketing authorisation (MA) approval in Europe.

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Crohns Disease Treatment Market Unidentified Segments The Biggest Opportunity2018 2025 - Kentucky Journal 24

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Genmab Announces Janssen Granted U.S. FDA Approval for DARZALEX (daratumumab) in Combination with Carfilzomib and Dexamethasone in Relapsed or…

Company Announcement

Copenhagen, Denmark; August 20, 2020 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 carfilzomib and dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. A supplemental Biologics License Application (sBLA) for this indication was submitted by Genmabs licensing partner, Janssen Biotech, Inc. (Janssen), in February 2020. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

We are extremely pleased that multiple myeloma patients in the U.S. will now have yet another treatment option as this is the eighth overall U.S. FDA approval for DARZALEX and the fifth in the relapsed/refractory setting. In addition, DARZALEX is now the first CD38 antibody approved for use in combination with carfilzomib, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The combination has been approved in two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the Phase 3 CANDOR and Phase 1b EQUULEUS studies. CANDOR was an Amgen-sponsored study, co-funded by Janssen Research & Development, LLC. EQUULEUS was sponsored by Janssen Research & Development, LLC.

About the CANDOR studyThe Phase 3 trial (NCT03158688) was a randomized, open-label study that included 466 patients with multiple myeloma who had relapsed after 1 to 3 prior therapies. Patients were randomized to receive either DKd or carfilzomib and dexamethasone (Kd) alone. In the daratumumab treatment arm, patients received 8 milligrams per kilogram (mg/kg) on days 1 and 2 of cycle 1, then 16 mg/kg once weekly for the remaining doses of the first 2 cycles, then every 2 weeks for 4 cycles (cycles 3 to 6), and then every 4 weeks for the remaining cycles or until disease progression. In both treatment arms carfilzomib was dosed twice weekly (20 mg/m2 on cycle 1 days 1 and 2 and 56 mg/m2 beginning on cycle 1 day 8 and thereafter) and dexamethasone was given weekly (40 mg orally or via IV infusion). The primary endpoint of the study was progression free survival (PFS).

About the EQUULEUS (MMY1001) Study The Phase 1b EQUULEUS (NCT01998971) study was an open label, multi-cohort trial that evaluated the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma. Among the regiments evaluated, the combination of DKd compared to Kd alone was studied in 85 patients with relapsed/refractory multiple myeloma who had received one to three prior lines of therapy using a once-weekly dosing regimen. DKd was evaluated at a starting dose of 20 mg/m2, which was increased to 70 mg/m2 on Cycle 1, Day 8 and onward.

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) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; 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 for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: 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 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 therapy7. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. 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 intravenous infusion is approved for the treatment of adult patients: 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 relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients 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.8 DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma.

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).6,9,10,11,12

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 and T-cell acute lymphocytic leukemia (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 is the creator of the following approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. 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 sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

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 most recent Annual Report on Form 20-F 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 and Kesimpta are trademarks of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.

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 20166 DARZALEX Prescribing information, September 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf Last accessed September 20197 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed June 20208 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20209 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: 1840-1848.10 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: 311-21.11 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: 384-94.12 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. 38CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces Janssen Granted U.S. FDA Approval for DARZALEX (daratumumab) in Combination with Carfilzomib and Dexamethasone in Relapsed or...

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