Category Archives: Cell Therapy

SAN DIEGO--(BUSINESS WIRE)--Stemson Therapeutics Corp., a private biotechnology company developing an iPSC-derived autologous cell therapy to regenerate healthy hair follicles, announced today that Paul Laikind, serial entrepreneur and former CEO of cell therapy company ViaCyte, has joined the Stemson Board of Directors. Paul brings significant company building and therapeutics development experience to the Stemson Board.

We welcome Paul as an important addition to our board of directors, said Matt Posard, Stemsons executive chairman of the board. With more than 35 years of experience founding and leading therapeutics development companies from preclinical to clinical stage development and from start-up through IPO, Paul will provide valuable guidance to accelerate Stemsons progress.

I am delighted and honored to join Stemsons Board of Directors, said Paul. Stemsons unique combination of novel technologies to bioengineer hair follicles not only has the potential to help millions of people suffering from hair loss, but can more broadly advance the capabilities for cell therapy development across the industry. I look forward to working with the team and supporting their journey.

Paul Laikind, PhD, was CEO of ViaCyte from 2012 until 2020, where he lead the development of the first stem cell-derived cell therapies designed to replace pancreatic beta cells for the treatment of Type 1 Diabetes. Paul led the company from the preclinical stage through the introduction of two product candidates into clinical trials before retiring at the end of 2020. A third product that Viacyte developed in collaboration with CRISPR Tx recently also entered clinical development.

Dr. Laikind served as Chief Business Officer and Senior Vice President of the Sanford Burnham Medical Research Institute from 2009 2011, focusing on enhancing the translational capabilities of the institute. From 1999 - 2009, Paul was cofounder and CEO of Metabasis Therapeutics, which concentrated on therapeutics development for metabolic and liver diseases. He took Metabasis from founding through IPO, and from preclinical to clinical stage development, with five products in the clinic. From 1986 1999, Paul cofounded and served as Vice President of Corporate Development at Gensia Pharmaceuticals where they developed small molecule therapies for the treatment of cardiovascular, neurological and inflammatory diseases. During that time, he cofounded and served as an advisor to Viagene from 1988 1994, the first commercially focused gene therapy company developing proprietary gene delivery technology to treat HIV, cancer and inherited disorders. Gensia, Viagene and Metabasis each completed successful initial public offerings and were eventually acquired for combined proceeds of over $3.5 billion.

Throughout his career, Dr. Laikind has played a leadership role in the evolving biotechnology industry. He serves or has served on the board of industry organizations including BIO, BIOCOM, CONNECT, and Alliance for Regenerative Medicine.

Paul earned his PhD in Biochemistry from the University of California, San Diego, and is a veteran of the US Navy.

We are very lucky to have Paul join us. The next stage of Stemsons development is to advance our first product toward human clinical trials, stated Geoff Hamilton, cofounder and CEO of Stemson Therapeutics. Pauls tremendous business leadership experience and industry relationships, as well as his involvement developing similar technologies to Stemsons while at ViaCyte, will help us guide the company toward that goal.

About Stemson Therapeutics

Stemson Therapeutics is a pre-clinical stage cell therapy company founded in 2018 with a mission to cure hair loss by leveraging the regenerative power of Induced Pluripotent Stem Cells. Based on the breakthrough innovation by Stemson Therapeutics co-founder, Dr. Alexey Terskikh, Stemson uses iPSC to regenerate the critical cells required to grow hair and which are damaged or depleted in patients suffering from hair loss. The iPSC-derived cells are used to grow de novo hair follicles, offering a new supply of hair to treat people suffering from various forms of Alopecia. Today, there are no available treatments capable of growing new hair follicles. Stemsons world class team of scientists, advisors and collaborators are passionate about delivering a scientifically based, clinically tested cure for hair loss to the millions of hair loss sufferers who seek help for their hair loss condition. Stemson Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.stemson.com.

Continued here:
Paul Laikind, PhD, Joins Stemson Therapeutics Board of Directors - Business Wire

The research, which appears in the journal Science Advances, lays the groundwork for developing future cancer treatments for humans.

An estimated 13% of diagnosed lung cancer is SCLC. According to the National Organization for Rare Diseases, SCLC is an aggressive type of cancer characterized by rapid, uncontrolled growth of certain cells in the lungs.

If SCLC is caught early and before it has spread, treatments can control the disease in up to 25% of cases.

The authors of the recent study wanted to understand the role of EP300 gene mutations in SCLC.

Medical News Today spoke with the corresponding authors of the study:

The current prognosis for SCLC patients is particularly poor with only 7% of patients surviving beyond 5 years. This reflects a lack of well-validated targets for therapy and a concomitant lack of targeted agents to treat the disease, they explained.

It is critical to garner further insights as to the drivers of the disease as well as develop drugs targeting those drivers. However, relevant pre-clinical models of SCLC carrying recurrent driver mutations were scarce, precluding the study to assess the physiological role of the mutations and the therapeutic impact of restoring their normal functions. So we built pre-clinical models using genetically engineered mice and cells.

By studying genetically engineered mouse models, the researchers found that EP300 the protein that the EP300 gene codes for can either promote or inhibit SCLC.

Specifically, they found that part of the EP300 protein known as the KIX domain was essential for the development of SCLC.

EP300 is a multi-functional protein and loss of its histone acetyltransferase domain function as predicted based on the mutations observed in SCLC patient tumors drives the cancer. This idea was validated by the findings from the pre-clinical models, they explained.

Unexpectedly, however, the models also showed that the KIX domain of the mutant EP300, which remains intact, drives the disease. Specifically, the protein-protein interactions mediated by the KIX domain of EP300 are critical for the survival of SCLC cells and vulnerable to inhibition. This was shown both in a mouse model as well as using human SCLC cell lines.

This validates the KIX domain of EP300 as a target for drug development for the treatment of SCLC, specifically a protein-protein interaction inhibitor of the KIX domain, said Drs. Park and Bushweller.

The finding may also have relevance for other types of cancer. According to the corresponding authors, EP300 mutations are widespread and have been implicated as having a critical role in other cancers including leukemia and triple-negative breast cancer.

MNT spoke with Dr. Charles Evans, research information manager at Cancer Research UK, who was not involved in the study.

This work highlights a key vulnerability that could be a target for potential new treatments, not only for small-cell lung cancer but also for other cancer types.

Dr. Evans

Right now, we only have a limited range of chemotherapy treatments available for people with small-cell lung cancer many of which can have harsh side effects, said Dr. Evans.

This study highlights a potential vulnerability for small-cell lung cancers, which could be exploited with new, targeted drugs in the future. However, more studies will be needed to confirm these results and develop a new treatment approach.

Dr. Evans said that the findings were one of a number of potential new treatment options for cancer.

There are other promising areas of research that are happening right now, such as the development of immunotherapies that can harness the power and precision of our immune systems to tackle cancer.

And innovations in radiotherapy, including new techniques such as proton beam therapy, have the potential to target tumors with a stronger dose far more precisely, limiting damage to surrounding tissue and reducing the burden of long-term side effects from treatment.

Excerpt from:
Gene found to block small-cell lung cancer proliferation in mice - Medical News Today

Presentations to highlight the Company's gene therapies for cancer and diabetes

AUSTIN, Texas, April 18, 2022 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its executive leaders will be providing an overview of the Company's gene therapies for cancer and diabetes to investors and industry professionals at the following investor and industry conferences in April 2022.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes.

Event: NobleCon 18Conference Dates: April 19-21, 2022Presentation Date: Wednesday, April 20Presentation Time: 11:30 a.m. ETLocation: Hard Rock Guitar Hotel, Hollywood, FL Seminole Ballroom BPresenter: Ryan Confer, Chief Financial Officer

A high-definition, video webcast of the presentation will be available the following day on the Company's website at http://www.genprex.com and as part of a complete catalog of presentations available at Noble Capital Markets' Conference website: http://www.nobleconference.com and on Channelchek http://www.channelchek.com the investor portal created by Noble. The webcast will be archived on the company's website, the NobleCon website and on Channelchek.com for a period of time following the event.

Event: Alliance for Regenerative Medicine's Cell & Gene Meeting on the Mediterranean (Virtual)Conference Dates: April 20-22, 2022Virtual Presentation Date: Available on-demand within the virtual platform for all delegates to view starting April 20, 2022Presenter: Mark Berger, Chief Medical Officer

This meeting will feature in-person and pre-recorded virtual presentations by leading public and private companies, highlighting technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, tissue engineering and broader regenerative medicine technologies.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its unique, proprietary, non-viral ONCOPREX Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is then administered intravenously, where it is then taken up by tumor cells that express proteins that are deficient. The Company's lead product candidate, REQORSA (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca's Tagrisso (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. In 2021, the FDA granted Fast Track Designation for REQORSA for NSCLC in combination therapy with Merck & Co's Keytruda (pembrolizumab) for patients whose disease progressed after treatment with Keytruda.

Story continues

For more information, please visit the Company's web site at http://www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A Risk Factors" in Genprex's Annual Report on Form 10-K and "Part II, Item 1A" of Genprex's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex's clinical trials and regulatory approvals, including the extent and impact of the COVID-19 pandemic; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; Genprex's future growth and financial status; Genprex's commercial and strategic partnerships including the scale up of the manufacture of its product candidates; and Genprex's intellectual property and licenses.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.(877) 774-GNPX (4679)

GNPX Investor Relationsinvestors@genprex.com

GNPX Media ContactKalyn Dabbsmedia@genprex.com

Cision

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Genprex to Participate in Upcoming Investor and Industry Conferences in April 2022 - Yahoo Finance

Dublin, April 18, 2022 (GLOBE NEWSWIRE) -- The "Global Cell Therapy Technologies Market Outlook Outlook 2020-2030" report has been added to ResearchAndMarkets.com's offering.

The global cell therapy technologies market is estimated to garner a revenue of around USD 45750 Million by the end of 2030, up from a revenue of over USD 12900 Million in the year 2020.

Cell therapy technologies facilitate the transplantation of human cells to replace or repair damaged tissue and cells. The global cell therapy technologies market is anticipated to grow with a CAGR of 13.6% over the forecast period, i.e., 2021 - 2030.

Factors such as the growing incidences of chronic diseases around the globe, followed by the rising geriatric population, and therefore the concern for diseases amongst this age groups, are some of the major factors anticipated to drive the market growth.

Moreover, factors such as the growing research and developments in the field of cell-based immunotherapies, such as CAR-T therapy, and the rising need for newer, better therapies for diseases, such as cancer and cardiovascular diseases (CVDs) among others, are also expected to drive the market growth during the forecast period.

The global cell therapy technologies market is segmented into numerous segments, which include segmentation by product, process, cell type, end-user, and by region. By product, the market is segmented into consumables, system & software, and equipment.

Amongst these, the consumables segment is anticipated to garner the largest revenue of near to USD 17890 Million by the end of 2030. Additionally, the segment generated a revenue of close to USD 5160 Million in the year 2020.

Geographically, the global cell therapy technologies market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Amongst these, the market in North America region is anticipated to garner the largest revenue of more than USD 19950 Million by the end of 2030, up from a revenue of around USD 5800 Million in the year 2020.

Some of the prominent industry leaders in the global cell therapy technologies market that are included in our report are Lonza Group Ltd., Sartorius AG, Danaher Corporation, Becton, Dickinson and Company, Thermo Fisher Scientific Inc., Avantor, Inc., Eppendorf SE, Miltenyi Biotec B.V. & Co. KG, and others.

Key Topics Covered:

1. Introduction1.1. Market Definition1.2. Market Segmentation

2. Assumptions

3. Research Methodology3.1. Research Process3.2. Primary Research3.3. Secondary Research

4. Executive Summary - Global Cell Therapy Technologies Market

5. Market Dynamics5.1. Market Drivers5.2. Market Trends

6. Key Market Opportunities

7. Major Roadblocks for the Market Growth

8. Regulatory and Standards Landscape

9. Industry Risk Analysis

10. Pricing Analysis of Cell therapy Technologies Market

11. Value Chain Analysis

12. Impact of COVID-19 on the Cell Therapy Technologies Market

13. Market Share Analysis Based on Therapy

14. Competitive Positioning

15. Competitive Landscape15.1. Market Share Analysis, 202015.2. Competitive Benchmarking15.3. Company Profiles15.3.1. Lonza Group Ltd.15.3.2. Sartorius AG15.3.3. Danaher Corporation15.3.4. Becton15.3.5. Dickinson and Company15.3.6. Thermo Fisher Scientific Inc.15.3.7. Avantor, Inc.15.3.8. Eppendorf SE15.3.9. Miltenyi Biotec B.V. & Co. KG

16. KOL Mapping

17. Bioreactors Market Analysis w.r.t. Product, Region, and Year

18. Future Forecast of the Manufactures and Startup Companies

19. Global Cell Therapy Technologies Market 2020-203019.1. Market Overview19.2. By Value (USD Million)

For more information about this report visit https://www.researchandmarkets.com/r/esfcow

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Global Cell Therapy Technologies Market Outlook, 2020-2021 & 2030 - Growing Research and Developments in the Field of Cell-based Immunotherapies -...

Stem Cell and Gene Therapy Biological Testing Market report is an excellent report that makes it possible to the healthcare industry to take strategic decisions and achieve growth objectives. This report also provides the company profile, product specifications, production value, contact information of manufacturer and market shares for company. The analysis of this industry report has been used to examine various segments that are relied upon to witness the quickest development based on the estimated forecast frame. The credible Stem Cell and Gene Therapy Biological Testing market research report helps healthcare industry to divulge the best market opportunities and look after proficient information to efficiently climb the ladder of success.

For a better understanding of the market and leading business growth, Stem Cell and Gene Therapy Biological Testing marketing report is an ideal solution. This market analysis report gives clear idea on various segments that are relied upon to observe the quickest business development amid the estimate forecast frame. SWOT analysis and Porters Five Forces analysis are the two well-established tools that are preferred by the businesses due to their potential in generating market research report are also used while preparing this market report. It is the necessity of this rapidly changing market place to adopt such winning Stem Cell and Gene Therapy Biological Testing market document that makes aware about the market conditions around.

Download Sample of this Report to understand structure of the complete report (Including Full TOC, Table & Figures) @ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-stem-cell-and-gene-therapy-biological-testing-market

Key Market Players mentioned in this report:MEDIPOSTSmith & NephewANTEROGEN.CO.,LTDPHARMICELL Co., LtdJCR Pharmaceuticals Co., LtdNuVasive, IncGilead Sciences, IncDendreon Pharmaceuticals LLCOrganogenesis IncOsirisSTEMCELL Technologies

Stem Cell and Gene Therapy Biological Testing Market Segmentation:-

By Types:Cell Therapy and Gene Therapy

By Application:Hospitals, Wound Care Centres, Cancer Care Centres, Ambulatory Surgical Centres and Others

Market Analysis and Insights: Global Stem Cell and Gene Therapy Biological Testing Market

Data Bridge Market Research analyses that the stem cell and gene therapy biological testing market will exhibit a CAGR of around 14.87% for the forecast period of 2021-2028. Rising approvals of GMP-certified facilities to manufacture stem cells, rising stem cell research activities and increasing public and private expenditure for the development ofhealthcareinfrastructure especially in emerging economies are the major factors attributable to the growth of stem cell and gene therapy biological testing market. This signifies that the stem cell and gene therapy biological testing market value, which was USD 1,497.03 million in 2020, will rocket up to USD 4,538.22 million by the year 2028.

Browse Full Report Along With Facts and Figures @ https://www.databridgemarketresearch.com/reports/global-stem-cell-and-gene-therapy-biological-testing-market

Global Stem Cell and Gene Therapy Biological Testing Market Scope and Market Size

The stem cell and gene therapy biological testing market is segmented on the basis of product type and end users. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

By product type, the global stem cell and gene therapy biological testing market is segmented into cell therapy and gene therapy.

Stem Cell and Gene Therapy Biological Testing Market, By Region:

Stem Cell and Gene Therapy Biological Testing market is analysed and market size insights and trends are provided by country, type, application and end-user as referenced above.

The countries covered in the Stem Cell and Gene Therapy Biological Testing market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates the Stem Cell and Gene Therapy Biological Testing market due to rise in the surgical procedures, increase in the R&D activities initiated by government and rise in the geriatric population in this region. Europe is the expected region in terms of growth in Stem Cell and Gene Therapy Biological Testing market due to also rise in the surgical procedures, increase in the R&D activities initiated by government and rise in the geriatric population in this region.

Table of Contents: Global Stem Cell and Gene Therapy Biological Testing Market

1 Introduction2 Market Segmentation3 Executive Summary4 Premium Insight5 Market Overview6 Covid-19 Impact on Stem Cell and Gene Therapy Biological Testing in Healthcare Industry7 Global Stem Cell and Gene Therapy Biological Testing Market, by Product Type8 Global Stem Cell and Gene Therapy Biological Testing Market, by Modality9 Global Stem Cell and Gene Therapy Biological Testing Market, by Type10 Global Stem Cell and Gene Therapy Biological Testing Market, by Mode11 Global Stem Cell and Gene Therapy Biological Testing Market, by End User12 Global Stem Cell and Gene Therapy Biological Testing Market, by Geography13 Global Stem Cell and Gene Therapy Biological Testing Market, Company Landscape14 Swot Analysis15 Company Profiles16 Questionnaire17 Related Reports

Get Full Table of Contents with Charts, Figures & Tables @ https://www.databridgemarketresearch.com/toc/?dbmr=global-stem-cell-and-gene-therapy-biological-testing-market

The research provides answers to the following key questions:

What is the estimated growth rate of the market for the forecast period 20222028? What will be the market size during the estimated period? What are the key driving forces responsible for shaping the fate of the Energy Harvesting System market during the forecast period? Who are the major market vendors and what are the winning strategies that have helped them occupy a strong foothold in the Energy Harvesting System market? What are the prominent market trends influencing the development of the Energy Harvesting System market across different regions? What are the major threats and challenges likely to act as a barrier in the growth of the Energy Harvesting System market? What are the major opportunities the market leaders can rely on to gain success and profitability?

The key questions answered in Stem Cell and Gene Therapy Biological Testing Market report are:

What are the market opportunities, market risks, and market overviews of the Stem Cell and Gene Therapy Biological Testing Market?

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Stem Cell and Gene Therapy Biological Testing Market Trends, Share, Industry Size, Growth, Opportunities and Forecast by 2028 - Digital Journal

Osaka, JapanOsaka University and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that Osaka University and Otsuka entered into an exclusive, worldwide license agreement for Otsuka to use R8H283, a novel antibody that recognizes the CD98 heavy chain identified by Osaka University, in its pharmaceutical and medical products.

R8H283 is an anti-CD98 heavy-chain antibody that was identified by a research group led by Professor Naoki Hosen (Department of Hematology and Oncology, Osaka University Graduate School of Medicine). CD98 heavy chain is a protein expressed in a wide range of tissues. However, R8H283 binds specifically to multiple myeloma. In February 2022, Osaka University announced that R8H283 showed significant anti-tumor effects in an animal model study.

(February 2022, Science Translational Medicine, Osaka University press release)

Upon consummation of this agreement, Otsuka will make an up-front payment to Osaka University, as well as development and sales-milestone payments and sales royalties. Otsuka will exclusively perform non-clinical research, clinical development, manufacturing, and commercialization of products utilizing R8H283, including ethical drugs as well as regenerative medicine products such as CAR-T cell therapy products.

Dr. Toshiki Sudo, board member for Research and Intellectual Property at Otsuka Pharmaceutical noted, "We are very pleased to in-license this promising new antibody from Osaka University. MMG49 CAR-T (development code: OPC-415), in-licensed from Osaka University in August 2018, has currently advanced to Phase I/II clinical trials. We hope that this agreement will lead to the development of new therapeutic agents and regenerative medicine products for malignant tumors."

Professor Naoki Hosen (Graduate School of Medicine, Osaka University) commented, "R8H283, a unique multiple myeloma-specific antibody, has the potential to be applied not only to antibody drugs but also to various other medical products, including CAR-T cells. In addition, this antibody could be applicable to other types of cancer. We believe that this agreement is very important in bringing these products to patients as soon as possible. We will continue our efforts to conduct research that will be useful in the treatment of patients suffering from cancer."

R8H283

The Osaka University research group identified R8H283, an antibody that binds to the CD98 heavy chain expressed in myeloma. The results of the study suggest that the difference in glycosylation of the CD98 heavy chain expressed on myeloma cells and normal blood cells may be responsible for its myeloma specificity. Furthermore, in experiments using mice, they showed that administration of R8H283 specifically eliminated only myeloma cells without damaging normal cells.

The results of this research were published in the U.S. scientific journal Science Translational Medicine on February 16, 2022. (Title: Selective targeting of multiple myeloma cells with a monoclonal antibody recognizing the ubiquitous protein CD98 heavy chain

(February 2022, Osaka University press release)

https://resou.osaka-u.ac.jp/en/research/2022/20220228_1

CD98 Heavy Chains

CD98 heavy chains are expressed in various tissues and function as amino acid transporters by forming heterodimers with CD98 light chains on the cell membrane. In addition, CD98 heavy chain is known to be highly expressed in several cancer types.

Multiple myeloma

Multiple myeloma is a hematological cancer in which plasma cells producing antibodies in the bone marrow become malignant, undergo unregulated proliferation, and eventually accumulate. In recent years, its treatment options have increased and the lifespans of many patients with multiple myeloma have been extended. While treatable, it is generally not yet curable.

CAR-T cell therapy

CAR- (chimeric antigen receptor) T cell therapy is a type of treatment in which a patient's T cells (a type of white blood cell with a key role in immune defenses) are altered so they will attack cancer cells. A gene for a special receptor that binds to a certain protein on the patient's cancer cells is introduced to the T cells. The special receptor is called a chimeric antigen receptor.

About Osaka University

Osaka University was founded in 1931 as one of the seven imperial universities of Japan and is now one of Japan's leading comprehensive universities with a broad disciplinary spectrum. This strength is coupled with a singular drive for innovation that extends throughout the scientific process, from fundamental research to the creation of applied technology with positive economic impacts. Its commitment to innovation has been recognized in Japan and around the world, being named Japan's most innovative university in 2015 (Reuters 2015 Top 100) and one of the most innovative institutions in the world in 2017 (Innovative Universities and the Nature Index Innovation 2017). Now, Osaka University is leveraging its role as a Designated National University Corporation selected by the Ministry of Education, Culture, Sports, Science and Technology to contribute to innovation for human welfare, sustainable development of society, and social transformation.

Website: https://resou.osaka-u.ac.jp/en

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Osaka University and Otsuka Pharmaceutical to enter into an exclusive license agreement on new anti-tumor antibody - EurekAlert

DUBLIN--(BUSINESS WIRE)--The "Dry Eye Products Market Forecast to 2028- COVID-19 Impact and Global Analysis - by Product; Type" report has been added to ResearchAndMarkets.com's offering.

The dry eye products market is projected to reach US$ 9,681.73 million by 2028 from US$ 6,837.26 million in 2021; it is estimated to grow at a CAGR of 5.1% from 2021 to 2028.

Factors such as rising incidences of dry eye and growing geriatric population are drive the growth of the market. However, the side effects caused due to eye drops hamper the market growth.

The Asia Pacific region is a highly affected region in the world as the outbreak of COVID-19 has come from China. Countries such as China, India, and South Korea have registered the highest number of COVID-19 positive patients. The countries have imposed lockdowns for several months.

Few countries such as South Korea and China have recovered from the pandemic. However, India is still struggling to fight against COVID-19. Therefore, there has been a great economic drop in the country, which is trying to recover. The fast recovery from the situation was seen due to the shift of focus of various companies operating in the ophthalmic division.

Companies have shifted their focus towards supplying reliefs to these countries as corporate social responsibility (CSR) activity. Also, governments are seeking help from the private sectors to contribute during the tough situation. Therefore, market players have strengthened their efforts to supply personal protective equipment.

For instance, in January 2020, Allergan plc has donated US$ 9,514 million (one million yen) to the Chinese Red Cross Foundation to provide medical masks, robes, gloves, eyewear, and other protective equipment for medical providers in Wuhan.

The incidence of dry eye is commonly seen in older people of age 65 and above. The number of geriatric population is increasing rapidly across the world. The older population is becoming a significant social transformation such as depending on the other for financial needs and wellness on the younger people in the present century.

Older people are significantly contributing to the development of the medical sector as it is helps by offering various innovative techniques to treat older people. Various healthcare companies design their products by focusing on geriatric population. As the degeneration process among older people is much faster, they are highly prevalent to dry eye conditions.

Therefore, the high prevalence of dry eye among older population is likely to promote manufacturers to introduce new dry eye products in the market, which, in turn, contributes to the growth of the market. For instance, according to the Department of Economic and Social Affairs, the United Nations report for 2019, there were 703 million individuals of age 65 years and above and is estimated to grow double to 1.5 billion by 2050.

Product Insights

The dry eye products market is segmented on the basis of product and type. Based on the product, the market is segmented into artificial tears, antibiotic drops, hormone drops, and others. The artificial tears segment held the largest share of the market in 2021, and the hormone drops segment is estimated to register the highest CAGR of 5.9% in the market during the forecast period.

World Health Organization, Royal Society of Medicine, Brazilian Research Association for Vision and Ophthalmology, Canadian Dry Eye Summit, International Dacryology Society, National Health Service, Royal Society of Medicine are among the primary and secondary sources referred to while preparing the report on the dry eye products market.

Key Market Dynamics

Market Driver

Market Restraints

Market Opportunities

Future Trends

Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/osg3y6

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Global Dry Eye Products Markets Report 2022-2028: Ongoing Research and Growing Pipeline & Opportunities in Stem Cell Therapy -...

The phase 1 ADVANCED-1 trial of the biologic immunopotentiator agent TARA-002 began dosing patients with non-muscular invasive bladder cancer.

A clinical trial investigating the safety and toxicity of TARA-002, a cell therapy agent, for non-muscular invasive bladder cancer (NMIBC), has started dosing, according to a press release from Protara Therapeutics.1

The new immunopotentiator agent phase 1 ADVANCED-1 trial (NCT05085977) is now investigating a single-arm, open-label, dose-finding trial of TARA-002 for treatment-naive and previously treated patients with NMIBC with high-grade carcinoma in situ (CIS) and high-grade papillary tumors.

NMIBC is one of the most recurrent and difficult to treat cancers with very limited treatment options, Jesse Shefferman, chief executive officer of Protara Therapeutics, said in a statement. We are thrilled to have dosed the first patient in our phase 1 study in NMIBC and look forward to exploring TARA-002s full potential in this pressing area of high unmet need.

TARA-002 is an immunopotentiator cell therapy based on group A Streptococcus pyogenes that cause immune cells to produce a local inflammatory cytokine reaction that destroys abnormal cells in a cyst or tumor. It was developed from the same genetic cell bank as OK-432 (Picibanil), a broad immunopotentiator that is approved in Japan and Taiwan.

The phase 1a of the ADVANCED-1 trial is enrolling an estimated 18 patients with NMIBC to receive 6 weekly intravesical doses of TARA-002. Patients are eligible if they are unable to receive intravesical Bacillus Calmette-Gurin (BCG), have received at least 1 dose of BCG, or have received at least 1 dose of intravesical chemotherapy.

Patients will receive up to 3 dose levels: 10 KE, 20 KE, and 40 KE, which will be tested sequentially starting with the lowest dose. The goal of the study is to determine the agents safety and tolerability as well as observe for preliminary signs of antitumor activity. The primary end points for the dose escalation phase are dose-limiting toxicities, maximum tolerated dose, and recommended phase 2 dose (RP2D).

The phase 1b dose expansion part of the trial (NCT05085990) is planned to enroll patients with CIS NMIBC in 2023 to receive 6 weekly doses of the RP2D. Its primary end point is the incidence of adverse events in these patients.

In 2021, TARA-002 was granted a rare prediatric disease designation by the FDA for lymphatic malformations, a rare condition affecting young children.2 Protara stated its intention to begin a clinical trial of TARA-002 in a clinical trial in this setting. While OK-432 is the standard-of-care agent to treat lymphatic malformations in Japan and Taiwan, there is no FDA-approved agent for this disease.

While bladder cancer is the 6th most common cancer in the United States today, with NMIBC representing approximately 80% of diagnoses, treatment options for these patients remain limited, Edward M. Messing, MD, a principal investigator of the ADVANCED-1 study and a professor of urology, oncology, and pathology at the University of Rochester said in a statement.1 There is an urgent need for new therapeutic interventions for these patients, as there continues to be an increase in recurrence, progression and an escalated number of patients needing cystectomies.

References:

1. Protara Therapeutics doses first patient in ADVANCED-1 phase 1 study of TARA-002 in non-muscle invasive bladder cancer. Protara Therapeutics. March 24, 2022. Accessed April 1, 2022. https://bit.ly/376E9TY

2. Protara Therapeutics provides regulatory update for TARA-002 for the treatment of lymphatic malformations. Protara Therapeutics. April 23, 2021. Accessed April 1, 2022. https://bit.ly/37cE5lG

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Phase 1 Trial Begins Dosing of TARA-002 Cell Therapy for NMIBC - Targeted Oncology

SAN FRANCISCO, April 05, 2022 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq:NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs, today announced that the first patient has been dosed in its Phase 1 clinical trial of DeTIL-0255, a drug-enhanced tumor infiltrating lymphocyte therapy and the lead candidate in its cellular therapy portfolio. The trial is designed to evaluate the safety and efficacy of DeTIL-0255 in patients with advanced gynecological malignancies including ovarian cancer, cervical cancer, and endometrial cancer.

DeTIL-0255 is a cell therapy derived via ex-vivo treatment of patient-derived tumor infiltrating lymphocytes (TILs) with a potent, small-molecule inhibitor of Casitas B-lineage lymphoma proto-oncogene-B (CBL-B) called NX-0255, which was identified using Nurixs proprietary DELigase platform.

The initiation of our first cell therapy study is a major milestone for Nurix and the culmination of significant efforts across our clinical, regulatory and manufacturing teams. It is also the first time targeted protein modulation has been combined with cell therapy, marking the beginning of what we believe will be an important step forward in the treatment of solid tumors, said Robert J. Brown, M.D., executive vice president of clinical development of Nurix. Within the rubric of targeted protein modulation, Nurix has now moved three treatment modalities into the clinic including oral targeted protein degraders, an oral CBL-B inhibitor, and now a drug-enhanced cell therapy.

CBL-B is an E3 ligase that is expressed in immune cells, and in the context of cancer functions as an intracellular checkpoint that negatively regulates T cell activation, NK cell activity, and immune response through the degradation of specific intracellular signalling proteins. Inhibition of CBL-B with NX-0255 increases those protein levels and is used to generate a drug-enhanced cell therapy product with superior anti-tumor activity in animal models of adoptive cell therapy. Nurix expects to provide a clinical update from the safety run-in portion of the Phase 1 study in the second half of 2022.

Our preclinical models of adoptive T-cell therapy demonstrate that NX-0255 treatment of cells provides improved characteristics that have the potential to increase the success of manufacturing durable cells that can deliver significant anti-tumor effects, said Michael T. Lotze, M.D., chief cellular therapy officer of Nurix. DeTIL-0255 is an autologous TIL product that is designed to overcome the major limitations of current TIL therapy which include T cell exhaustion post expansion, suboptimal manufacturing success rates, and poor persistence of anti-tumor cells in the patient.

About DeTIL-0255The DeTIL-0255 investigational product under development is an autologous cell therapy consisting of T cells derived from a patients tumor expanded in culture with recombinant interleukin-2 and the small molecule CBL-B inhibitor NX-0255. DeTIL-0255 is designed to be a single administration autologous TIL therapy infused following non-myeloablative chemotherapy. Given the improved phenotypes of T cells produced with CBL-B inhibition, DeTIL-0255 could allow a broader application of TIL therapy, potentially providing long term benefit to patients with multiple types of cancer. Nurix is conducting the open label Phase 1 trial of DeTIL-0255 at multiple sites in the United States. Additional information on the clinical trial can be accessed at http://www.clinicaltrials.gov (NCT05107739).

About Nurix Therapeutics, Inc.Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of small molecule and cell therapies based on the modulation of cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging Nurixs extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurixs drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels. Nurixs wholly owned pipeline includes targeted protein degraders of Brutons tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California. For more information, please visit http://www.nurixtx.com/.

Forward Looking StatementThis press release contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this press release, the words anticipate, believe, could, estimate, expect, intend, may, outlook, plan, predict, should, will, and similar expressions and their variants, as they relate to Nurix, may identify forward-looking statements. All statements that reflect Nurixs expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding our future financial or business performance, conditions, plans, prospects, trends or strategies and other financial and business matters; our current and prospective drug candidates; the planned timing and conduct of our clinical trial programs for our drug candidates; the planned timing for the provision of clinical updates and initial findings from our clinical studies; the potential advantages of our DELigase platform and drug candidates; and the extent to which our scientific approach and DELigase platform may potentially address a broad range of diseases. Forward-looking statements reflect Nurixs current beliefs, expectations, and assumptions regarding the future of Nurixs business, future plans and strategies, its development plans, its preclinical and clinical results, future conditions and other factors Nurix believes are appropriate in the circumstances. Although Nurix believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Nurix can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Nurixs actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and uncertainties include, but are not limited to: (i) risks and uncertainties related to Nurixs ability to advance its drug candidates, obtain regulatory approval of and ultimately commercialize its drug candidates; (ii) the timing and results of preclinical studies and clinical trials; (iii) Nurixs ability to fund development activities and achieve development goals; (iv) the impact of the COVID-19 pandemic on Nurixs business, clinical trials, financial condition, liquidity and results of operations; (v) Nurixs ability to protect intellectual property and (vi) other risks and uncertainties described under the heading Risk Factors in Nurixs Annual Report on Form 10-K for the fiscal year ended November 30, 2021 and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. The statements in this press release speak only as of the date of this press release, even if subsequently made available by Nurix on its website or otherwise. Nurix disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law.

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Nurix Therapeutics Doses First Patient in Phase 1 Clinical Trial of DeTIL-0255, a Drug-Enhanced Cell Therapy for the Treatment of Patients with Solid...

UAB has been awarded for its superior CAR-T therapy program services and leadership.

UAB has been awarded for its superior CAR-T therapy program services and leadership. Photography: Steve WoodThe University of Alabama at Birmingham has been identified by Emerging Therapy Solutions as a Program of Experience for Chimeric antigen receptor T cell therapy.

According to the American Cancer Society, CAR-T therapy is a path for immune cells called T cells a type of white blood cell to fight cancer by changing them in the lab so they can find and destroy cancer cells. This form of treatment can be helpful for patients with various cancer types even when other types of treatments are no longer available.

CAR-T therapy is becoming an essential pillar of cancer care, joining the ranks of surgery, chemotherapy, radiation and other targeted treatments.

The UAB-BMT and Cell Therapy Program is the only state-of-the-art program in Alabama to offer CAR-T therapy for patients with some cancers, said Amitkumar Mehta, M.D., associate scientist in the ONeal Comprehensive Cancer Center at UAB, assistant professor in the UAB Division of Hematology and Oncology, Director of CAR-T Program and Medical Director of Clinical Trial Office. The program is certified for all commercial FDA-approved CAR-T products. The program also supports next generation cell therapy treatment through clinical trials. The CAR-T team is a highly specialized and experienced team that supports the patients who are on this treatment. This recognition is an appreciation of the dedicated and patient-centered cell therapy team at UAB-BMT. I am very proud to be part of the program.

ETS created this designation after evaluating centers across the United States that provide CAR-T services and identifying the leading CAR-T programs with the essential experience and resources, including volume of CAR-Ts administered.

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UAB has been recognized as a Program of Experience for CAR-T therapy - University of Alabama at Birmingham