Creating hairy human skin: Not as easy as you think – Science Codex

For more than 40 years, scientists and commercial companies have been recreating human skin in laboratories around the world. Yet all of these products lack important aspects of normal skin--hair, nerves, and fat.

In new research, cultured human skin cells embedded with fat and nerves and capable of growing hair are a reality. The achievement represents more than five years of study that started in the laboratory of Karl Koehler, PhD (then at Indiana University School of Medicine) and completed in Koehler's new laboratory at Boston Children's Hospital in the departments of otolaryngology and communication enhancement and plastic and oral surgery research. The technique appears in a paper published this week in Nature.

"In this latest work, we discovered a way to grow both layers of human skin together," says Koehler, referring to the top and bottom layers of human skin (the epidermis and dermis, respectively). "Those cells talk to each other in a skin organoid culture - or skin in a dish we created - and sprout hair follicles accompanied by fat cells and neurons."

Taking the discovery a step further, the team transplanted the human hairy skin into mice. The mice eventually sprouted human hair follicles at the site of transplantation. Potential applications include testing cosmetics, drugs, and burn treatments.

Skin in a dish includes mini organs

Skin in a dish models are not new. And like many, Koehler and his colleagues thought that the challenge of growing fully functional, hairy skin cells, had long been solved. Skin cells are some of the first cells to have been grown in cultures outside of the body and incubator.

But the skin that people make in a dish never has mini organs or appendages, like hair follicles or sweat glands, embedded in the skin. These mini organs are important for heat regulation, touch sensation, and appearance.

In 2018, the team published a paper showing they could generate hairy skin from mouse stem cells. To create human hairy skin cells, the team started with human induced pluripotent stem cells, which are human adult skin cells that are coaxed back to an embryonic form.

"So we applied a cocktail of growth factors and small molecules, kind of a cooking recipe for human pluripotent stem cells," says Koehler.

The team first noticed co-development of skin epidermis and the dermis. The interaction and signaling between the two tissue layers led to budding of hair follicles at 70 days, which lines up well with the timing of hair development in the human fetus.

In addition to growing hair, the organoids produce fat and muscle-like cells of the skin, as well as, nerves similar to those that mediate touch sensation. "The fat is an unsung hero of the skin and recent studies suggest it plays a critical role in wound healing," says Jiyoon Lee, PhD, first-author on the paper and research associate in the department of otolaryngology at Boston Children's Hospital.

The organoids also produce Merkel cells, specialized touch responsive cells of the skin that have also been implicated in diseases such as Merkel cell carcinoma. "The inclusion of these other cell types likely expands the potential uses of the skin organoid model to research on sensory disorders and cancer," she adds.

Mice grew pigmented human hairs

To see if the technique worked in a living animal, the team cultured the organoids for over four months and then implanted them on the back of mice specially developed not to reject the grafts. "We noticed that within a month, tiny brown hairs sprang up from the transplant site," explains Lee. "This showed us, amazingly, that pigment cells also developed in the organoids."

They compared the transplanted skin with adult human skin samples observing several unique features of human skin in the transplants. One includes 'rete ridges' or valleys in the wavy pattern of human epidermis that helps anchor it into skin membranes. And, the transplanted hair developed elaborate sebaceous glands that produced sebum, the natural oil that lubricates human skin.

An unexpected and fortuitous discovery

This new discovery is literally an outgrowth of work Koehler began at Indiana University when working on a system of recapitulating the inner ear. His goal at the time was to create cells that sense auditory stimuli - sound - to model hearing loss disorders and test gene therapies for hearing loss and balance disorders.

There, he manipulated human induced pluripotent stem cells with the same cocktail of chemicals and proteins used during normal embryonic development guiding them to become inner ear structures.

In the production of this technique, as the inner ear cells were budding during early development, the team found that skin tissue formed as a byproduct.

"This was surprising and we initially tried to get rid of the skin tissue, thinking it was a pesky off-target tissue, like a weed in a garden," recalls Koehler. "Once we saw the scientific value of growing hairy skin in dish, we switched tactics, trying to eliminate the inner ear organoids in favor of growing skin."

In their purification attempts, they discovered that the skin tissue contained both layers of skin, epidermis and dermis. In culture, the skin formed outgrowing hair follicles.

A proof of concept

Translating any mouse study into humans is a long road. "But we think we have developed a proof of concept showing that the cells integrate into skin and form outgrowing hair follicles," says Koehler.

The team hopes that in the long term, they can use the technology to seed wound beds with cultured skin to reconstruct skin, such as in the case of extensive burns or scars.

And while it might be tempting to think of the approach as a "cure" for baldness, Koehler cautions that many challenges lay ahead. "We now have a technique that could generate nearly unlimited hair follicles for transplantation" he says. "But immune rejection is a major hurdle and generating follicles tailored to an individual will be incredibly costly and take a year or more." To meet these challenges, the team is working on ways to accelerate development in a dish, engineer organoids to evade immune detection, or produce similar skin organoids from adult patient-derived cells.

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Creating hairy human skin: Not as easy as you think - Science Codex

Cellular Reprogramming Tools Market Research Key Players, Industry Overview and forecasts to | 2026 – Weekly Wall

The market research report is a brilliant, complete, and much-needed resource for companies, stakeholders, and investors interested in the global Cellular Reprogramming Tools market. It informs readers about key trends and opportunities in the global Cellular Reprogramming Tools market along with critical market dynamics expected to impact the global market growth. It offers a range of market analysis studies, including production and consumption, sales, industry value chain, competitive landscape, regional growth, and price. On the whole, it comes out as an intelligent resource that companies can use to gain a competitive advantage in the global Cellular Reprogramming Tools market.

Key companies operating in the global Cellular Reprogramming Tools market include , Celgene, BIOTIME, Human Longevity, Advanced Cell Technology, Mesoblast, STEMCELL Technologies, Osiris Therapeutics, Cynata, Astellas Pharma, FUJIFILM Holdings, EVOTEC, Japan Tissue Engineering Cellular Reprogramming Tools

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

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Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Cellular Reprogramming Tools market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Global Cellular Reprogramming Tools Market Segment By Type:

, Adult Stem Cells, Human Embryonic Stem Cells, Induced Pluripotent Stem Cells, Other

Global Cellular Reprogramming Tools Market Segment By Application:

, Drug Development, Regenerative Medicine, Toxicity Test, Academic Research, Other

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global Cellular Reprogramming Tools market.

Key companies operating in the global Cellular Reprogramming Tools market include , Celgene, BIOTIME, Human Longevity, Advanced Cell Technology, Mesoblast, STEMCELL Technologies, Osiris Therapeutics, Cynata, Astellas Pharma, FUJIFILM Holdings, EVOTEC, Japan Tissue Engineering Cellular Reprogramming Tools

Key questions answered in the report:

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TOC

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Cellular Reprogramming Tools Revenue1.4 Market by Type 1.4.1 Global Cellular Reprogramming Tools Market Size Growth Rate by Type: 2020 VS 2026 1.4.2 Adult Stem Cells 1.4.3 Human Embryonic Stem Cells 1.4.4 Induced Pluripotent Stem Cells 1.4.5 Other1.5 Market by Application 1.5.1 Global Cellular Reprogramming Tools Market Share by Application: 2020 VS 2026 1.5.2 Drug Development 1.5.3 Regenerative Medicine 1.5.4 Toxicity Test 1.5.5 Academic Research 1.5.6 Other 1.6 Study Objectives 1.7 Years Considered 2 Global Growth Trends2.1 Global Cellular Reprogramming Tools Market Perspective (2015-2026)2.2 Global Cellular Reprogramming Tools Growth Trends by Regions 2.2.1 Cellular Reprogramming Tools Market Size by Regions: 2015 VS 2020 VS 2026 2.2.2 Cellular Reprogramming Tools Historic Market Share by Regions (2015-2020) 2.2.3 Cellular Reprogramming Tools Forecasted Market Size by Regions (2021-2026) 2.3 Industry Trends and Growth Strategy 2.3.1 Market Top Trends 2.3.2 Market Drivers 2.3.3 Market Challenges 2.3.4 Porters Five Forces Analysis 2.3.5 Cellular Reprogramming Tools Market Growth Strategy 2.3.6 Primary Interviews with Key Cellular Reprogramming Tools Players (Opinion Leaders) 3 Competition Landscape by Key Players3.1 Global Top Cellular Reprogramming Tools Players by Market Size 3.1.1 Global Top Cellular Reprogramming Tools Players by Revenue (2015-2020) 3.1.2 Global Cellular Reprogramming Tools Revenue Market Share by Players (2015-2020) 3.1.3 Global Cellular Reprogramming Tools Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Cellular Reprogramming Tools Market Concentration Ratio 3.2.1 Global Cellular Reprogramming Tools Market Concentration Ratio (CR5 and HHI) 3.2.2 Global Top 10 and Top 5 Companies by Cellular Reprogramming Tools Revenue in 20193.3 Cellular Reprogramming Tools Key Players Head office and Area Served3.4 Key Players Cellular Reprogramming Tools Product Solution and Service3.5 Date of Enter into Cellular Reprogramming Tools Market3.6 Mergers & Acquisitions, Expansion Plans 4 Market Size by Type (2015-2026)4.1 Global Cellular Reprogramming Tools Historic Market Size by Type (2015-2020)4.2 Global Cellular Reprogramming Tools Forecasted Market Size by Type (2021-2026) 5 Market Size by Application (2015-2026)5.1 Global Cellular Reprogramming Tools Market Size by Application (2015-2020)5.2 Global Cellular Reprogramming Tools Forecasted Market Size by Application (2021-2026) 6 North America6.1 North America Cellular Reprogramming Tools Market Size (2015-2020)6.2 Cellular Reprogramming Tools Key Players in North America (2019-2020)6.3 North America Cellular Reprogramming Tools Market Size by Type (2015-2020)6.4 North America Cellular Reprogramming Tools Market Size by Application (2015-2020) 7 Europe7.1 Europe Cellular Reprogramming Tools Market Size (2015-2020)7.2 Cellular Reprogramming Tools Key Players in Europe (2019-2020)7.3 Europe Cellular Reprogramming Tools Market Size by Type (2015-2020)7.4 Europe Cellular Reprogramming Tools Market Size by Application (2015-2020) 8 China8.1 China Cellular Reprogramming Tools Market Size (2015-2020)8.2 Cellular Reprogramming Tools Key Players in China (2019-2020)8.3 China Cellular Reprogramming Tools Market Size by Type (2015-2020)8.4 China Cellular Reprogramming Tools Market Size by Application (2015-2020) 9 Japan9.1 Japan Cellular Reprogramming Tools Market Size (2015-2020)9.2 Cellular Reprogramming Tools Key Players in Japan (2019-2020)9.3 Japan Cellular Reprogramming Tools Market Size by Type (2015-2020)9.4 Japan Cellular Reprogramming Tools Market Size by Application (2015-2020) 10 Southeast Asia10.1 Southeast Asia Cellular Reprogramming Tools Market Size (2015-2020)10.2 Cellular Reprogramming Tools Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Cellular Reprogramming Tools Market Size by Type (2015-2020)10.4 Southeast Asia Cellular Reprogramming Tools Market Size by Application (2015-2020) 11 India11.1 India Cellular Reprogramming Tools Market Size (2015-2020)11.2 Cellular Reprogramming Tools Key Players in India (2019-2020)11.3 India Cellular Reprogramming Tools Market Size by Type (2015-2020)11.4 India Cellular Reprogramming Tools Market Size by Application (2015-2020) 12 Central & South America12.1 Central & South America Cellular Reprogramming Tools Market Size (2015-2020)12.2 Cellular Reprogramming Tools Key Players in Central & South America (2019-2020)12.3 Central & South America Cellular Reprogramming Tools Market Size by Type (2015-2020)12.4 Central & South America Cellular Reprogramming Tools Market Size by Application (2015-2020) 13Key Players Profiles13.1 Celgene 13.1.1 Celgene Company Details 13.1.2 Celgene Business Overview 13.1.3 Celgene Cellular Reprogramming Tools Introduction 13.1.4 Celgene Revenue in Cellular Reprogramming Tools Business (2015-2020)) 13.1.5 Celgene Recent Development13.2 BIOTIME 13.2.1 BIOTIME Company Details 13.2.2 BIOTIME Business Overview 13.2.3 BIOTIME Cellular Reprogramming Tools Introduction 13.2.4 BIOTIME Revenue in Cellular Reprogramming Tools Business (2015-2020) 13.2.5 BIOTIME Recent Development13.3 Human Longevity 13.3.1 Human Longevity Company Details 13.3.2 Human Longevity Business Overview 13.3.3 Human Longevity Cellular Reprogramming Tools Introduction 13.3.4 Human Longevity Revenue in Cellular Reprogramming Tools Business (2015-2020) 13.3.5 Human Longevity Recent Development13.4 Advanced Cell Technology 13.4.1 Advanced Cell Technology Company Details 13.4.2 Advanced Cell Technology Business Overview 13.4.3 Advanced Cell Technology Cellular Reprogramming Tools Introduction 13.4.4 Advanced Cell Technology Revenue in Cellular Reprogramming Tools Business (2015-2020) 13.4.5 Advanced Cell Technology Recent Development13.5 Mesoblast 13.5.1 Mesoblast Company Details 13.5.2 Mesoblast Business Overview 13.5.3 Mesoblast Cellular Reprogramming Tools Introduction 13.5.4 Mesoblast Revenue in Cellular Reprogramming Tools Business (2015-2020) 13.5.5 Mesoblast Recent Development13.6 STEMCELL Technologies 13.6.1 STEMCELL Technologies Company Details 13.6.2 STEMCELL Technologies Business Overview 13.6.3 STEMCELL Technologies Cellular Reprogramming Tools Introduction 13.6.4 STEMCELL Technologies Revenue in Cellular Reprogramming Tools Business (2015-2020) 13.6.5 STEMCELL Technologies Recent Development13.7 Osiris Therapeutics 13.7.1 Osiris Therapeutics Company Details 13.7.2 Osiris Therapeutics Business Overview 13.7.3 Osiris Therapeutics Cellular Reprogramming Tools Introduction 13.7.4 Osiris Therapeutics Revenue in Cellular Reprogramming Tools Business (2015-2020) 13.7.5 Osiris Therapeutics Recent Development13.8 Cynata 13.8.1 Cynata Company Details 13.8.2 Cynata Business Overview 13.8.3 Cynata Cellular Reprogramming Tools Introduction 13.8.4 Cynata Revenue in Cellular Reprogramming Tools Business (2015-2020) 13.8.5 Cynata Recent Development13.9 Astellas Pharma 13.9.1 Astellas Pharma Company Details 13.9.2 Astellas Pharma Business Overview 13.9.3 Astellas Pharma Cellular Reprogramming Tools Introduction 13.9.4 Astellas Pharma Revenue in Cellular Reprogramming Tools Business (2015-2020) 13.9.5 Astellas Pharma Recent Development13.10 FUJIFILM Holdings 13.10.1 FUJIFILM Holdings Company Details 13.10.2 FUJIFILM Holdings Business Overview 13.10.3 FUJIFILM Holdings Cellular Reprogramming Tools Introduction 13.10.4 FUJIFILM Holdings Revenue in Cellular Reprogramming Tools Business (2015-2020) 13.10.5 FUJIFILM Holdings Recent Development13.11 EVOTEC 10.11.1 EVOTEC Company Details 10.11.2 EVOTEC Business Overview 10.11.3 EVOTEC Cellular Reprogramming Tools Introduction 10.11.4 EVOTEC Revenue in Cellular Reprogramming Tools Business (2015-2020) 10.11.5 EVOTEC Recent Development13.12 Japan Tissue Engineering 10.12.1 Japan Tissue Engineering Company Details 10.12.2 Japan Tissue Engineering Business Overview 10.12.3 Japan Tissue Engineering Cellular Reprogramming Tools Introduction 10.12.4 Japan Tissue Engineering Revenue in Cellular Reprogramming Tools Business (2015-2020) 10.12.5 Japan Tissue Engineering Recent Development 14Analysts Viewpoints/Conclusions 15Appendix15.1 Research Methodology 15.1.1 Methodology/Research Approach 15.1.2 Data Source15.2 Disclaimer15.3 Author Details

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Cellular Reprogramming Tools Market Research Key Players, Industry Overview and forecasts to | 2026 - Weekly Wall

Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX (daratumumab) for the Treatment of Patients with…

Company Announcement

Copenhagen, Denmark; June 4, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for the subcutaneous (SC) formulation of DARZALEX (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved daratumumab intravenous (IV) formulation indications in frontline and relapsed / refractory settings. The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV daratumumab, which is given over several hours. Patients currently on daratumumab IV will have the choice to switch to the SC formulation. In August 2012, Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

We are extremely pleased that patients in Europe with multiple myeloma will now, like patients in the U.S., have the opportunity for treatment with the subcutaneous formulation of daratumumab. With consistent efficacy, and greater convenience for patients and health care providers with dosing time reduced from hours to just minutes and fewer infusion-related reactions, this formulation provides significant benefits for patients, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which is evaluating SC daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 24th European Hematology Association (EHA) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) Annual Meeting in December 2019.

About the COLUMBA (MMY3012) studyThe Phase III trial (NCT03277105) is a randomized, open-label, parallel assignment study that included 522 adults diagnosed with relapsed and refractory multiple myeloma. Patients were randomized to receive either: SC daratumumab, as 1800 mg daratumumab with rHuPH20 2000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study; or 16 mg/kg IV daratumumab once weekly in Cycle 1 and 2, every two weeks in Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study. The co-primary endpoints of the study are overall response rate and Maximum trough concentration of daratumumab (Ctrough; defined as the serum pre-dose concentration of daratumumab on Cycle 3 Day 1).

About the PLEIADES (MMY2040) studyThe Phase II trial (NCT03412565) is a non-randomized, open-label, parallel assignment study that includes 265 adults either newly diagnosed or with relapsed or refractory multiple myeloma. Patients with newly diagnosed multiple myeloma are being treated with 1,800 mg SC daratumumab in combination with either bortezomib, lenalidomide and dexamethasone (D-VRd) or bortezomib, melphalan and prednisone (D-VMP). Patients with relapsed or refractory multiple myeloma are being treated with 1,800 mg SC daratumumab plus lenalidomide and dexamethasone (D-Rd). An additional cohort of patients with relapsed and refractory multiple myeloma treated with daratumumab plus carfilzomib and dexamethasone (D-Kd) was subsequently added to the study. The primary endpoint for the D-VMP, D-Kd and D-Rd cohorts is overall response rate. The primary endpoint for the D-VRd cohort is very good partial response or better rate.

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.1 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 therapy2. Daratumumab is the first subcutaneous CD38-directed 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.3 DARZALEX FASPRO is the first subcutaneous CD38-directed 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).1,4,5,6,7

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 three 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, Arzerra (ofatumumab, under agreement with Novartis AG), for the treatment of certain chronic lymphocytic leukemia indications in the U.S., Japan and certain other territories 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, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), has been approved in the U.S. for the treatment of adult patients with certain multiple myeloma indications. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of 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 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 is a trademark 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 DARZALEX Prescribing information, April 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s027lbl.pdf Last accessed April 20202 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed October 20193 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20204 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: 1840-1848.5Overdijk, 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: 311-21.6 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: 384-94.7 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. 24CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces European Marketing Authorization for the Subcutaneous Formulation of DARZALEX (daratumumab) for the Treatment of Patients with...

Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia – Business Wire

BOSTON--(BUSINESS WIRE)--Follica, Inc. (Follica), a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions, today announced positive feedback from a meeting with the U.S. Food and Drug Administration (FDA) as the company prepares to advance its lead program into Phase 3 development following a successful safety and efficacy optimization study for the treatment of hair loss in male androgenetic alopecia announced in December 2019.

Follica plans to launch its Phase 3 program this year. Overall, approximately 280 patients will be enrolled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. The randomized, controlled, double-blinded studies will be conducted in multiple centers across the U.S. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting.

In the U.S. alone, 47 million men are affected by progressive hair loss caused by androgenetic alopecia, a condition that is largely unresolved today, leaving many dissatisfied with the current available treatments and looking for a new alternative. Our recent safety and optimization study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair, said Jason Bhardwaj, chief executive officer of Follica. Were grateful to the FDA for their guidance as we prepare for our pivotal program, and we look forward to advancing the development of our treatment regimen, which has demonstrated strong potential to address the current need for those who seek treatment for androgenetic alopecia.

Follicas approach is based on generating an embryonic window in adult scalp cells via a series of short office-based treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles. A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.

Follica reported topline results from its safety and optimization study in December 2019. That trial was designed to select the optimal treatment regimen using Follicas proprietary HFN device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products established statistical significance (p = 0.005).

In addition to the safety and optimization study, Follica has validated its approach in prior clinical studies using prototype HFN devices with different treatment parameters and therapeutic compounds. Follicas translational work builds on research by George Cotsarelis, M.D., who isolated and characterized the expression pattern of stem cells from a critical region of the follicle. An expert in epithelial stem cell biology, Dr. Cotsarelis is chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

About Androgenetic AlopeciaAndrogenetic alopecia represents the most common form of hair loss in men and women, with an estimated 90 million people who are eligible for treatment in the United States alone. Only two drugs, both of which have demonstrated a 12% increase of non-vellus hair count over baseline for their primary endpoints, are currently approved for the treatment of androgenetic alopecia1. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible. As a result, there remains a significant need for safe, effective, non-surgical treatments to grow new hair.

About FollicaFollica is a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions. Founded by PureTech (LSE:PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follicas experimental treatment platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The companys proprietary treatment is designed to induce an embryonic window via a device with optimized parameters to initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica completed a safety and efficacy optimization study in 2019, and its Phase 3 program in male androgenetic alopecia is expected to begin in 2020. Follicas technology is based on work originating from the University of Pennsylvania that has been further developed by Follicas internal program. Follicas extensive IP portfolio includes IP exclusively licensed from the University of Pennsylvania as well as Follica-owned IP.

1 Olsen EA et al, J Am Acad Dermatol. 2002 Sep;47(3):377-85Olsen EA et al, J Am Acad Dermatol. 2007 Nov;57(5):767-74. Epub 2007 Aug 29Price VH et al, J Am Acad Dermatol. 2002 Apr;46(4):517-23Kaufman et al, J Am Acad Dermatol. 1998 Oct; 39(4):578-589

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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia - Business Wire

Global Stem Cell Characterization Kits Market : Analysis and In-depth Study on Market Size Trends, Emerging Growth Factors and Forecasts to 2029 – The…

Stem cells are biological cells that can be converted into specific type of cells as per the bodys requirement. Stem cells are of two types, i.e., adult stem cells and embryonic stem cells. Stem cells can be used to treat various diseases such as cancer, neurodegenerative disorder, cardiovascular disorder and tissue regeneration. Stem cell characterization is the initial step for stem cell research. Stem cell characterization is a challenging and also an evolving process. Stem cell characterization kits are used for identification of stem cell biology markers. In stem cell characterization, stem cell biology marker profiles differ based on their species, maturity and site of origin. Stem cell characterization kit is required to understand the utility of the stem cells in downstream experiments and to confirm the pluripotency of the stem cell.Request Free Sample Report-https://www.factmr.com/connectus/sample?flag=S&rep_id=2691

Based on type of stem cell, the stem cell characterization kits market is segmented into:Stem Cell Characterization Kits for Adult Stem CellsStem Cell Characterization Kits for Induced Pluripotent Stem CellsStem Cell Characterization Kits for Mesenchymal Stem CellsStem Cell Characterization Kits for Neural Stem CellsStem Cell Characterization Kits for Hematopoietic Stem CellsStem Cell Characterization Kits for Umbilical Cord Stem CellsStem Cell Characterization Kits for Human Embryonic Stem CellsBased on application, the stem cell characterization kits market is segmented into:ResearchDrug Discovery & DevelopmentRegenerative MedicineBased on end user, the stem cell characterization kits market is segmented into:Biopharmaceutical CompaniesContract Research OrganizationsAcademics and Research InstitutesBiotechnology CompaniesHave Any Query? Ask our Industry Experts-https://www.factmr.com/connectus/sample?flag=AE&rep_id=2691

Examples of some of the key participants in the stem cell characterization kits market identified across the value chain include Merck KGaA, Celprogen, Inc., Creative Bioarray, Thermo Fisher Scientific Inc., BD Biosciences, R&D Systems, Inc., System Biosciences, Cosmo Bio USA, BioCat GmbH, and DS Pharma Biomedical Co., Ltd.Pertinent aspects this study on the Stem Cell Characterization Kits market tries to answer exhaustively are: What is the forecast size (revenue/volumes) of the most lucrative regional market? What is the share of the dominant product/technology segment in the Stem Cell Characterization Kits market? What regions are likely to witness sizable investments in research and development funding? What are Covid 19 implication on Stem Cell Characterization Kits market and learn how businesses can respond, manage and mitigate the risks? Which countries will be the next destination for industry leaders in order to tap new revenue streams? Which new regulations might cause disruption in industry sentiments in near future? Which is the share of the dominant end user? Which region is expected to rise at the most dominant growth rate? Which technologies will have massive impact of new avenues in the Stem Cell Characterization Kits market? Which key end-use industry trends are expected to shape the growth prospects of the Stem Cell Characterization Kits market? What factors will promote new entrants in the Stem Cell Characterization Kits market? What is the degree of fragmentation in the Stem Cell Characterization Kits market, and will it increase in coming years?Why Choose Fact.MR?

Fact.MR follows a multi- disciplinary approach to extract information about various industries. Our analysts perform thorough primary and secondary research to gather data associated with the market. With modern industrial and digitalization tools, we provide avant-garde business ideas to our clients. We address clients living in across parts of the world with our 24/7 service availability.

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Mesoblast (NASDAQ:MESO) Stock Rating Lowered by Zacks Investment Research – MarketBeat

Mesoblast (NASDAQ:MESO) was downgraded by Zacks Investment Research from a "buy" rating to a "hold" rating in a report released on Wednesday, Zacks.com reports.

According to Zacks, "Mesoblast Limited is a global leader in developing innovative cell-based medicines. The Company has leveraged its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to establish a broad portfolio of late-stage product candidates. Mesoblast's allogeneic, 'off-the-shelf' cell product candidates target advanced stages of diseases with high, unmet medical needs including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncologic/hematologic conditions. "

A number of other brokerages have also recently weighed in on MESO. ValuEngine upgraded Mesoblast from a "hold" rating to a "buy" rating in a report on Thursday, April 2nd. Maxim Group started coverage on Mesoblast in a research note on Friday, May 29th. They issued a "buy" rating and a $16.00 price objective for the company. LADENBURG THALM/SH SH upped their target price on shares of Mesoblast from $13.00 to $15.25 and gave the stock a "buy" rating in a research note on Thursday, May 28th. TheStreet raised shares of Mesoblast from a "d+" rating to a "c-" rating in a report on Friday, May 22nd. Finally, HC Wainwright reiterated a "buy" rating and set a $21.00 price target (up previously from $14.00) on shares of Mesoblast in a report on Thursday, May 28th. Two research analysts have rated the stock with a hold rating and seven have issued a buy rating to the company. The company has an average rating of "Buy" and a consensus target price of $14.91.

Our Technical Analysis Guide will give you the insight into todays fast-moving markets. Its designed to give you a head start in learning the basics of various TA tools and techniques.

NASDAQ:MESO opened at $13.39 on Wednesday. The company has a market capitalization of $1.49 billion, a P/E ratio of -20.92 and a beta of 3.53. The company has a quick ratio of 1.21, a current ratio of 1.21 and a debt-to-equity ratio of 0.15. Mesoblast has a 52 week low of $3.12 and a 52 week high of $20.57. The stock's fifty day moving average is $10.75 and its two-hundred day moving average is $8.08.

Mesoblast (NASDAQ:MESO) last announced its earnings results on Wednesday, May 27th. The company reported ($0.14) earnings per share (EPS) for the quarter, meeting analysts' consensus estimates of ($0.14). Mesoblast had a negative return on equity of 13.60% and a negative net margin of 197.65%. The company had revenue of $12.20 million for the quarter, compared to analyst estimates of $9.38 million. Sell-side analysts anticipate that Mesoblast will post -0.57 earnings per share for the current fiscal year.

Institutional investors and hedge funds have recently added to or reduced their stakes in the business. Tobias Financial Advisors Inc. acquired a new stake in Mesoblast during the 4th quarter worth $191,000. Wilbanks Smith & Thomas Asset Management LLC boosted its stake in shares of Mesoblast by 6.0% during the fourth quarter. Wilbanks Smith & Thomas Asset Management LLC now owns 25,025 shares of the company's stock worth $184,000 after buying an additional 1,425 shares during the period. Ingalls & Snyder LLC acquired a new stake in shares of Mesoblast during the first quarter worth about $53,000. Aperio Group LLC purchased a new position in shares of Mesoblast during the first quarter worth about $81,000. Finally, Cetera Advisor Networks LLC acquired a new position in Mesoblast in the 1st quarter valued at about $44,000. 2.12% of the stock is currently owned by institutional investors.

Mesoblast Company Profile

Mesoblast Limited, a biopharmaceutical company, develops and commercializes allogeneic cellular medicines. Its proprietary regenerative medicine technology platform is based on specialized cells known as mesenchymal lineage adult stem cells. The company's products under the Phase III clinical trials include MSC-100-IV for steroid refractory acute graft versus host disease; MPC-150-IM for advanced heart failure; and MPC-06-ID for chronic low back pain due to degenerative disc disease.

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This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest and most accurate reporting. This story was reviewed by MarketBeat's editorial team prior to publication. Please send any questions or comments about this story to [emailprotected]

13 Stocks Institutional Investors Won't Stop Buying

University endowments, pension funds, sovereign wealth funds, hedge funds and other institutional investors have recently been pouring money into a a group of 13 elite stocks.

These institutional investors don't get easily swayed by hot stocks that are popular with retail investors. You probably won't see a Tesla or a SnapChat in this group, because institutional investors know that these "popular kid" stocks almost always aren't great investments. However, you will find some incredibly solid companies on this list backed by real earnings and real fundamentals.

In order to identify these stocks, we had to comb through every 13D and 13F filing that institutional investors have filed with the SEC in the last quarter. After reviewing more than 5,000 filings, we have identified 13 companies that institutional investors have been buying left. Big money investors are pouring hundreds of millions of dollars into these stocks.

View the "13 Stocks Institutional Investors Won't Stop Buying".

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Mesoblast (NASDAQ:MESO) Stock Rating Lowered by Zacks Investment Research - MarketBeat

Mesenchymal Stem Cells Market trends by manufacturers, states, type and application, forecast to 2019 2027 – WhaTech Technology and Markets News

Mesenchymal Stem Cells Market Trends by Manufacturers, States, Type and Application, Forecast to 2019 2027

Global Mesenchymal Stem Cells Market: Snapshot

The increasing use of mesenchymal stem cells (MSCs) for the treatment of diseases and disabilities of the growing aging population is having a positive influence on the global mesenchymal stem cells market. Mesenchymal stem cells are adult stem cells that are of various types such as adipocytes, osteocytes, monocytes, and chondrocytes.

The main function of mesenchymal stem cells is to replace or repair damaged tissue.

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Mesenchymal stem cells are multipotent, i.e. they can produce more than one type of specialized cells.

These specialized cells have their own distinguishing shapes, structures, and functions, with each of them belonging to a particular tissue.

Mesenchymal stem cells are traditionally found in the bone marrow. However, these cells can also be separated from other tissues such as cord blood, fallopian tube, peripheral blood, and fetal liver and lung.

Mesenchymal stem cells have long thin cell bodies containing a large nucleus. MSCs have enormous capacity for renewal keeping multipotency.

Due to these virtues, mesenchymal stem cells have huge therapeutic capacity for tissue repair.

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Mesenchymal stem cells can differentiate into a number of cell types that belong to our skeletal tissues that include cartilage, bone, and fat. Research is underway to discover if mesenchymal stem cells can be used to treat bone and cartilage diseases.

Scientists are also exploring the possibility if mesenchymal stem cells differentiate into other type of cells apart from skeletal tissues. This includes nerve cells, liver cells, heart muscle cells, and endothelial cells.

This will lead to mesenchymal stem cells to be used to treat other diseases.

Stem cells are specialized cells which have the capability of renewing themselves through cell division and differentiate into multi-lineage cells. Mesenchymal stem cells (MSCs) are non- hematopoietic, multipotent adult stem cells which can be isolated from bone marrow, cord blood, fat tissue, peripheral blood, fallopian tube, and fetal liver and lung tissue.

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Mesenchymal stem cells have the capacity to differentiate into mesodermal lineages, such as chondrocytes, adipocytes, and osteocytes, and non-mesodermal lineages such as ectodermal (neurocytes) and endodermal lineages (hepatocytes). These stem cells have specific features such as multilineage potential, secretion of anti-inflammatory molecules, and immunomodulation.

These cells have emerged as promising therapeutic agents for regenerating skeletal tissues such as damaged bone and cartilage tissues and treatment of chronic diseases owing to their specific features.

The global mesenchymal stem cells market is expected to be driven by the increasing clinical application of mesenchymal stem cells for the treatment of chronic diseases, bone and cartilage diseases, and autoimmune diseases. Studies have shown that these stem cells enhance the angiogenesis in myocardium and allow the reduction of myocardial fibrotic area.

The pre-clinical studies for using mesenchymal stem cells in treatment of cardiovascular diseases, liver diseases, and cancer are projected to create new market opportunities for mesenchymal stem cells. Mesenchymal stem cells also produce anti-inflammatory molecules which modulate humoral and cellular immune responses.

Features of these stem cells such as ease of isolation, regenerative potential, and immunoregulatory, the mesenchymal stem cell therapy has emerged as a promising tool for the treatment of chronic diseases, degenerative, inflammatory, and autoimmune diseases.

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Clinical studies are exploring MSCs for various conditions such as orthopedic injuries, graft versus host disease following bone marrow transplantation, and genetic modification of MSCs to overexpress antitumor genes for use as anticancer therapy, which are exhibiting new opportunities in therapeutic area. However, the mesenchymal stem cell research studies are tedious, lengthy, and complex.

In some cases, due to some adverse effects transplanted mesenchymal stem cells rapidly removed from the body which limits use of stem cells in therapeutic treatments. The conflicting results and regulatory compliances for approvals may also hamper the growth of this market.

The global mesenchymal stem cells market is segmented on the basis of source of isolation, end-user, and region. Stem cells are isolated from the bone marrow, peripheral blood, lung tissue, umbilical cord blood, amniotic fluids, adipose tissues, and synovial tissues.

Traditionally the MSCs were isolated from bone marrow aspiration which is associated with risk of infection and painful for the patient. The MSCs from adipose tissues are usually isolated from the biological material generated during liposuction, lipectomy procedures by using collagenase enzymatic digestion followed by centrifugation and washing.

In terms of end-user, the market is segmented into clinical research organizations, biotechnological companies, medical research institutes, and hospitals.

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Geographically, the global mesenchymal stent cells market is distributed over North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global market and is projected to continue its dominance in terms of market share during the forecast period owing to high R&D expenditure, availability of advanced research facilities and skilled professionals, and government initiatives.

Europe is the second largest market after North America. The Asia Pacific market is projected to expand at a high CAGR during the forecast period due to increased R&D budgets in Japan, China, and India.

Key global players operating in the mesenchymal stem cells market include R&D Systems, Inc., Cell Applications, Inc., Axol Bioscience Ltd., Cyagen Biosciences Inc., Cytori Therapeutics Inc., Stemcelltechnologies Inc., BrainStorm Cell Therapeutics, Stemedica Cell Technologies, Inc., and Celprogen, Inc.

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Mesenchymal Stem Cells Market trends by manufacturers, states, type and application, forecast to 2019 2027 - WhaTech Technology and Markets News

AgeX Therapeutics and ImStem Biotechnology Sign Non-Binding Letter of Intent Regarding Investigational MSC Candidate IMS001 for COVID-19 and Other…

ALAMEDA, Calif. & FARMINGTON, Conn.--(BUSINESS WIRE)--AgeX Therapeutics, Inc. (AgeX: NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, and ImStem Biotechnology, Inc., a biopharmaceutical company developing human embryonic stem cell-derived mesenchymal stem cells (hES-MSC), today announced their signing of a non-binding letter of intent for ImStem to obtain from AgeX a non-exclusive license to use AgeXs embryonic stem cell line ESI 053 to derive ImStems investigational MSC product IMS001 for development in COVID-19 as well as acute respiratory distress syndrome (ARDS) due to other causes. AgeX and ImStem are co-operating to finalize financial terms and other provisions of a license agreement.

ImStem has previously used AgeX ESI 053 to derive the ImStem IMS001 product which is being investigated for multiple sclerosis under an IND. Earlier this year, the U.S. Food and Drug Administration (FDA) cleared IMS001 to begin a Phase 1 clinical study in patients with multiple sclerosis, after a clinical hold on its Investigational New Drug (IND) application was removed. This is believed to be the first MSC product derived from human embryonic stem cells to be accepted for a clinical trial by the FDA. AgeX and ImStem already have a commercial license in place, which grants ImStem rights to use AgeXs ESI 053 to derive IMS001 as a product candidate for development in autoimmune disease, including multiple sclerosis.

To date, in patients with pneumonia and ARDS due to COVID-19, preliminary literature suggests MSCs, such as ImStems hES-MSC candidate IMS001, may warrant further development consideration. An early clinical study conducted in China by an unrelated group with a different MSC product, Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia, and published in Aging and Disease (2020, Vol. 11, No. 2, pp. 216-228) showed that an intravenous infusion of a different MSC product appeared safe and improved functional outcomes in seven treated patients with COVID-19 pneumonia. MSCs are well recognized to be immunomodulatory in nature, possessing immunosuppressive and anti-inflammatory properties.

Even before their application to COVID-19, MSCs were being investigated as a potential therapeutic option in ARDS, and emerging data in preclinical models has been encouraging. ARDS remains an area of considerable unmet medical need, affecting around 200,000 patients annually in the U.S., accounting for 10% of all intensive care unit patients, and having a mortality of approximately 40%. At the present time, no specific direct therapies exist for ARDS and only supportive treatment is available.

We feel privileged to be part of a global effort to combat COVID-19. This is a unique opportunity for AgeX to leverage its resources to help with the public health challenge at hand. Decades of pioneering work with human embryonic stem cells means this technology is now at a point where it may play a role in the development of a cell-based approach to combating COVID-19. We are very excited by the prospect of expanding our relationship with ImStem to include COVID-19 and ARDS, said Dr. Nafees Malik, Chief Operating Officer of AgeX.

We welcome the opportunity to continue to collaborate with AgeX and explore future development of our IMS001 product in COVID-19 and ARDS from other causes, commented Richard Kim, M.D., Chief Medical Officer of ImStem Biotechnology.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. AgeXs PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About ImStem Biotechnology

ImStem Biotechnology, Inc. is aspiring to revolutionize how serious diseases with significant unmet needs are treated with a new generation of regenerative and cellular therapies. Pioneering research by its current founder and Chief Technology Officer Dr. Xiaofang Wang and Dr. Ren-He Xu, former director of UConn Stem Cell Institute, led to the proprietary state-of-the-art pluripotent stem cell technology, enabling off-the-shelf, allogeneic stem cell-derived products to be manufactured in scale, differentiating itself from the typical challenges imposed by autologous adult cell therapy products. The company's mission is to advance the science and understanding of human pluripotent stem cell based regenerative cellular therapies through novel and creative development pathways and to fulfill unmet medical needs in serious diseases. And its development strategy focuses on neurologic, autoimmune, degenerative, and rare orphan diseases. ImStem Biotechnology Inc. is a privately held company headquartered in Farmington, CT.

For more information, visit http://www.imstem.com.

Forward-Looking Statements for AgeX

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. In addition, with respect to AgeXs letter of intent with ImStem there is no assurance that (i) AgeX and ImStem will successfully conclude negotiations and enter into a license agreement; (ii) ImStem will be successful in developing any therapeutic products from a stem cell line licensed by AgeX or that any therapeutic product that may be developed will receive FDA or foreign regulatory approval, or (iii) AgeX will derive revenue or other financial benefits from any license agreement that might be signed with ImStem. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

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AgeX Therapeutics and ImStem Biotechnology Sign Non-Binding Letter of Intent Regarding Investigational MSC Candidate IMS001 for COVID-19 and Other...

Stem Cell Assay Market to Witness Growth Acceleration During 2017-2025 – Cole of Duty

Stem Cell Assay Market: Snapshot

Stem cell assay refers to the procedure of measuring the potency of antineoplastic drugs, on the basis of their capability of retarding the growth of human tumor cells. The assay consists of qualitative or quantitative analysis or testing of affected tissues andtumors, wherein their toxicity, impurity, and other aspects are studied.

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With the growing number of successfulstem cell therapytreatment cases, the global market for stem cell assays will gain substantial momentum. A number of research and development projects are lending a hand to the growth of the market. For instance, the University of Washingtons Institute for Stem Cell and Regenerative Medicine (ISCRM) has attempted to manipulate stem cells to heal eye, kidney, and heart injuries. A number of diseases such as Alzheimers, spinal cord injury, Parkinsons, diabetes, stroke, retinal disease, cancer, rheumatoid arthritis, and neurological diseases can be successfully treated via stem cell therapy. Therefore, stem cell assays will exhibit growing demand.

Another key development in the stem cell assay market is the development of innovative stem cell therapies. In April 2017, for instance, the first participant in an innovative clinical trial at the University of Wisconsin School of Medicine and Public Health was successfully treated with stem cell therapy. CardiAMP, the investigational therapy, has been designed to direct a large dose of the patients own bone-marrow cells to the point of cardiac injury, stimulating the natural healing response of the body.

Newer areas of application in medicine are being explored constantly. Consequently, stem cell assays are likely to play a key role in the formulation of treatments of a number of diseases.

Global Stem Cell Assay Market: Overview

The increasing investment in research and development of novel therapeutics owing to the rising incidence of chronic diseases has led to immense growth in the global stem cell assay market. In the next couple of years, the market is expected to spawn into a multi-billion dollar industry as healthcare sector and governments around the world increase their research spending.

The report analyzes the prevalent opportunities for the markets growth and those that companies should capitalize in the near future to strengthen their position in the market. It presents insights into the growth drivers and lists down the major restraints. Additionally, the report gauges the effect of Porters five forces on the overall stem cell assay market.

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Global Stem Cell Assay Market: Key Market Segments

For the purpose of the study, the report segments the global stem cell assay market based on various parameters. For instance, in terms of assay type, the market can be segmented into isolation and purification, viability, cell identification, differentiation, proliferation, apoptosis, and function. By kit, the market can be bifurcated into human embryonic stem cell kits and adult stem cell kits. Based on instruments, flow cytometer, cell imaging systems, automated cell counter, and micro electrode arrays could be the key market segments.

In terms of application, the market can be segmented into drug discovery and development, clinical research, and regenerative medicine and therapy. The growth witnessed across the aforementioned application segments will be influenced by the increasing incidence of chronic ailments which will translate into the rising demand for regenerative medicines. Finally, based on end users, research institutes and industry research constitute the key market segments.

The report includes a detailed assessment of the various factors influencing the markets expansion across its key segments. The ones holding the most lucrative prospects are analyzed, and the factors restraining its trajectory across key segments are also discussed at length.

Global Stem Cell Assay Market: Regional Analysis

Regionally, the market is expected to witness heightened demand in the developed countries across Europe and North America. The increasing incidence of chronic ailments and the subsequently expanding patient population are the chief drivers of the stem cell assay market in North America. Besides this, the market is also expected to witness lucrative opportunities in Asia Pacific and Rest of the World.

Global Stem Cell Assay Market: Vendor Landscape

A major inclusion in the report is the detailed assessment of the markets vendor landscape. For the purpose of the study the report therefore profiles some of the leading players having influence on the overall market dynamics. It also conducts SWOT analysis to study the strengths and weaknesses of the companies profiled and identify threats and opportunities that these enterprises are forecast to witness over the course of the reports forecast period.

Some of the most prominent enterprises operating in the global stem cell assay market are Bio-Rad Laboratories, Inc (U.S.), Thermo Fisher Scientific Inc. (U.S.), GE Healthcare (U.K.), Hemogenix Inc. (U.S.), Promega Corporation (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), STEMCELL Technologies Inc. (CA), Cell Biolabs, Inc. (U.S.), and Cellular Dynamics International, Inc. (U.S.).

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Stem Cell Assay Market to Witness Growth Acceleration During 2017-2025 - Cole of Duty

Study reveals birth defects caused by flame retardant – University of Georgia

Research focuses on mans exposure prior to contraception

A new study from the University of Georgia has shown that exposure to a now-banned flame retardant can alter the genetic code in sperm, leading to major health defects in children of exposed parents.

Published recently in Scientific Reports, the study is the first to investigate how polybrominated biphenyl-153 (PBB153), the primary chemical component of the flame retardant FireMaster, impacts paternal reproduction.

In 1973, an estimated 6.5 million Michigan residents were exposed to PBB153 when FireMaster was accidentally sent to state grain mills where it made its way into the food supply. In the decades since, a range of health problems including skin discoloration, headache, dizziness, joint pain and even some cancers have been linked to the exposure.

More striking, the children of those who were exposed seemed to experience a host of health issues as well, including reports of hernia or buildup in the scrotum for newborn sons and a higher chance of stillbirth or miscarriage among adult daughters.

Yet, little work has been done to understand how the chemical exposure could have impacted genes passed from an exposed father, said study author Katherine Greeson.

It is still a relatively new idea that a mans exposures prior to conception can impact the health of his children, said Greeson, an environmental health science doctoral student in Charles Easleys lab at UGAs College of Public Health and Regenerative Bioscience Center.

Most studies where a toxic effect is observed in children look only to the mothers and the same has been true of studies conducted on PBB153, she said.

Greeson and a team of researchers from UGA and Emory University used a unique combination of observational and laboratory approaches to demonstrate how PBB153 acted on sperm cells.

Typically, scientific studies are either epidemiological in nature and inherently observational or focus on bench science, but in this study, we did both, said Greeson.

This approach allowed the researchers to mimic the known blood exposure levels of PBB153 in a lab environment.

We were uniquely able to recreate this effect using our previously characterized human stem cell model for spermatogenesis, she said, which allowed us to study the mechanism that causes this effect in humans.

The team looked at the expression of different genes in their human spermatogenesis model after dosing with PBB153 and found marked alterations in gene expression between dosed and undosed cells, specifically at genes important to development, such as embryonic organ, limb, muscle, and nervous system development.

PBB153 causes changes to the DNA in sperm in a way that changes how the genes are turned on and off, said Greeson. PBB153 seems to turn on these genes in sperm which should be turned off, said Greeson, which may explain some of the endocrine-related health issues observed in the children of exposed parents.

Though the study used this model to directly replicate exposure to PBB153, Greeson says this approach could be used to better understand the impact of other environmental exposures on reproduction, including large-scale accidental exposures to toxic chemicals or everyday exposures.

Hopefully this work will lead to more studies combining epidemiology and bench science in the future, which will tell us more about why were seeing an effect from an environmental exposure in human populations and encourage experimental studies to more closely mimic human exposures, she said.

The study, Detrimental Effects of Flame Retardant, PBB153, Exposure on Sperm and Future Generations, published May 22. It is available online.

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