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Category Archives: Cell Therapy

Can This Cell Therapy Help Fight the NASH… – Labiotech.eu

Posted: November 7, 2019 at 11:46 am

Nonalcoholic steatohepatitis (NASH) is the most severe form of nonalcoholic fatty liver disease (NAFLD) and is characterized by a fatty liver, inflammation, and liver cell damage. If left untreated, NASH can further develop into liver fibrosis, the formation of scar tissue in the liver, and liver cirrhosis. To date, a patients only option at the final stage of liver disease is a liver transplant. There is no alternative available yet.

This year alone has already seen a number of disappointments within the NASH clinical trial landscape. In April, Gilead announced that its anti-fibrosis compound selonsertib failed to reach the endpoint in phase III. In June, Conatus and Novartis NASH cirrhosis treatment emricasan also missed its primary endpoint in a phase IIb trial. And although Intercepts Ocaliva showed an effect on fibrosis in phase III, the results were overshadowed by strong side effects.

The therapy landscape for NASH is currently dominated by small molecules that address defined targets. Many of the currently ongoing trials are focusing on the earlier stages of NASH, covering the fibrotic stages F1 and F2. The later stages of NASH, F3 and F4, on the other hand, are receiving attention at the clinical stage but are difficult to treat.

If you look at the number of therapies in development for cirrhotic NASH F4 and indications further down the disease progression path, you will find a blue ocean, says Henrik Luessen, CBO at Promethera. There is not much competition to be found in that space. NASH is a spectrum disease in which many factors play a role, including inflammation, immune activation, stellate cell activation, lipid metabolism, and fibrosis. Most molecules can only target one of these factors and the action is therefore very limited. In later stages, where many more factors are involved, there is a need for an approach that addresses more than one target. That is the key challenge in NASH.

Promethera has taken a leap into the blue ocean and has developed a cell therapy in which liver-derived cells can address several factors of the disease. These cells have a potent paracrine effect and are able to respond to the cause of the disease by secreting or expressing various molecules, including hepatic growth factor (HGF), indoleamine 2,3-dioxygenase (IDO), and prostaglandin E2 (PGE2), to reduce inflammation, inhibit stellate cell activation, and to further interrupt the fibrotic or cirrhotic process and restore liver function.

Based on the behavior of our cells observed over more than six years of intense clinical research following the inception of Promethera, we decided to focus on end-stage NASH and acute-on-chronic liver failure (ACLF), the end-stages of the disease where patients are suffering from at least one organ failure and have a very low prognosis to survive the next three months, Luessen explains. When we found promising signs of efficacy and safety in ACLF we decided to move further into the NASH field and focus on the late stages of the disease where there is a strong unmet medical need. In both cases, we are positioning our cells as an alternative to liver transplantation.

The data of the completed HEP101 study in ACLF patients will be published at the upcoming American Association for the Study of Liver Diseases (AASLD) meeting in Boston on 10th November 2019, for the first time.

Moreover, in May 2019, Promethera started the PANASH study, which is evaluating the safety of HepaStem in NASH F3 and F4 patients at different dosages. Efficacy markers will also be investigated as a study outcome.

Prometheras pipeline is comprised of two allogeneic cell therapies and one antibody. Designed to target the tumor necrosis factor receptor 1 (TNF-R1), the companys antibody Atrosimab is currently in preclinical development. TNF is known to interact with receptors one (R1) and two (R2). While R1 is responsible for triggering inflammatory responses and apoptosis, R2 is actually a type of regenerative receptor.

Classical TNF inhibitors inhibit all systemic TNF, including all interactions with R2, Luessen says. Atrosimab only inhibits R1, which allows the regenerative properties of R2 to be maintained. It can also be potentially used in combination with our HepaStem technology.

HepaStem, currently in phase II, is a cell therapy that addresses different components of the NASH disease progression. Consisting of liver-derived mesenchymal stem cells (MSC), HepaStem is administered intravenously without the need for immunosuppressants and enters the liver via the bloodstream, where it then targets multiple changed pathways. HepaStem can reduce tissue fibrosis and promote the restoration of liver function by lowering inflammation, deactivating stellate cells, and reducing fibrosis.

Prometheras second cell therapy, H2Stem, is currently at a preclinical stage. H2Stem are liver-derived progenitor cells from the hepatobiliary tract that can express various markers, can differentiate into hepatocyte-like cells in vitro and have been observed to home and repopulate the liver of humanized mice. H2Stem has shown good signs of engraftment in mice, which allows us to assume that it might have strong regenerative or repair properties, but we are still collecting evidence, says Luessen.

Prometheras allogeneic cell line is unique in that it also has the potential for liver homing, meaning the cells have a liver imprint and remain in the liver where they can fight the cause of the disease. Moreover, the cells do not provoke immunogenic responses, which enables the intravenous injection of the therapy without needing immune suppression. Even a second injection, triggers no acute immunogenicity or toxicity.

Our product has undergone the chemistry, manufacturing, and controls (CMC) part of development, Luessen explains. This means that we have a very scalable product. We are now moving to bioreactors, which will allow us to treat thousands of patients with only one liver. We are confident that we can meet global demand with our new in-house process, in particular when we move to our state-of-the-art facilities in Gosselies, Belgium, in 2020. At the moment, the only option for end-stage liver disease patients is a liver transplant, so with one liver we could avoid a very high number of liver transplants, at least exceeding the currently recorded global numbers of transplants. Thats what makes our technology unique and very promising.

Many companies are now becoming increasingly aware that addressing only one target in early-stage NASH does not add many benefits to patients, Luessen says. In fact, patients often have to take several medications continuously, which can come with unpleasant side effects. Furthermore, early-stage NASH patients can greatly benefit from lifestyle changes, including dietary measures and physical exercise.

In the early stages of NASH, during F1 and F2, many patients are not aware of their disease because they do not show any symptoms. Once the disease is felt, patients are often already in the later stages, F3 and F4, and here, the medicinal landscape becomes very poor, Luessen explains. Looking at the future, I think this will be recognized and there will be a greater focus on the fibrotic and cirrhotic stages of NASH. We can already see different pharma companies, who are usually competitors, working together. They are combining their compounds to have a more efficient treatment. This will be the only way to address the disease outside of cell therapy.

Do you want to discover more about how Prometheras cell therapy could revolutionize NASH treatments? Check out Prometheras website for more information or get in touch with their experienced team!

Images via Promethera and Shutterstock.com

Author: Larissa Warneck, Science Journalist, Labiotech.eu

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Can This Cell Therapy Help Fight the NASH... - Labiotech.eu

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Vertex invests in gene therapy manufacturing – BioPharma-Reporter.com

Posted: November 7, 2019 at 11:46 am

Across 2019, Vertex has struck deals intended to yield a new generation of breakthrough medicines.

In June, Vertex agreed to pay $245m (220m) upfront to acquire Exonics Therapeutics for its gene editing technology and pipeline of programs targeting diseases including Duchenne muscular dystrophy (DMD). Months later, Vertex put up another $950m to buy Semma Therapeutics and its cell therapy treatment for type I diabetes.

The acquisitions moved Vertex, which started out in small molecules, into new areas, and building out capabilities in those areas will cost money.

In recent years, Vertex has grown its annual operating expenses by 10% to 14%. Talking on a recent quarterly results conference call, Vertex CFO Charles Wagner warned investors to expect costs to rise faster in 2020.

Wagner said, Our current expectation is that the rate of growth will be somewhat higher in 2020 as we invest in research and preclinical manufacturing for selling genetic therapies in support of our programs in type I diabetes, DMD and other diseases.

The move into type I diabetes also takes Vertex into territory that, to some observers, looks different than the areas the company has targeted historically.

Asked by an analyst about the shift in focus, Vertex CEO Jeff Leiden downplayed the differences, noting that type I diabetes is treated in the US in a relatively small number ofcenters that can be targeted by a speciality sales force.

Researchers have achieved positive, long-term outcomes by transplanting cadaveric islets into patients but two barriers have stopped companies from industrialising that approach.

Firstly, there are too few cadaveric islets to treat all type I diabetics. Secondly, immunosuppression is needed to stop patients from rejecting the transplanted cells.

Semma is trying to tackle the problems by differentiating stem cells and using a device to protect them from the immune system. Vertex thinks these technologies are the breakthroughs the field needs to industrialize the concept.

Leiden said, We were watching companies who are addressing those two problems for the last two, three years. And over the last six to eight months, we were convinced that Semma has actually solved both of those problems.

Vertex reached that conclusion on the strength of preclinical data. Now, Vertex is set to invest to find out whether the idea works in the clinic.

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Cellular Biomedicine Group Reports Third Quarter of 2019 Financial Results and Business Highlights – P&T Community

Posted: November 7, 2019 at 11:46 am

NEW YORK and SHANGHAI, Nov. 6, 2019 /PRNewswire/ --Cellular Biomedicine Group Inc.(NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today reported its financial results and business highlights for the third quarter of 2019.

"During the third quarter of 2019, we made great strides in both corporate and clinical progress. We started our U.S. expansion for research and clinical development in a new 22,000 square foot facility in Rockville, Maryland in October 2019. This milestone will allow us to foster strategic partnerships, develop new innovations and support continued development of CBMG's cell therapy-based immune-oncology assets that have shown promise in early proof-of-concept trials in China," said Tony (Bizuo) Liu, Chief Executive Officer for the Company.

"We also had continued progress on the clinical side, with the initiation of our Phase II clinical trial in China of AlloJoin therapy for knee osteoarthritis (KOA). Additionally, our autologous stem cell therapy program for KOA, ReJoin, was accepted by the NMPA in China to begin a Phase II clinical trial. We are excited about our regenerative medicine programs as we are currently the only company that has received two clinical trial acceptances for any stem cell program in China."

Mr. Liu continued, "Presentations of our pre-clinical and clinical data at upcoming medical conferences later this year will demonstrate continued focus on our immune-oncology pipeline and we are proud to provide an update of our commitment to cancer immunotherapy."

Third Quarter 2019 and Other Recent Corporate Developments

Upcoming Clinical and Preclinical Presentations:

Financial Results for the Third Quarter of 2019

Conference Call and Webcast InformationThe Company will host a conference call and webcast with the investment community on Wednesday, November 6th at 4:30 p.m. Eastern Time featuring remarks by Tony Liu, Executive Director, CEO and CFO of CBMG.

Live Call:

Toll-Free: 1-855-327-6838

International: 1-604-235-2082

Webcast:

http://public.viavid.com/index.php?id=136796

Replay:

Toll-Free: 1-844-512-2921

International: 1-412-317-6671

Conference ID: 10007976

(Available approximately two hours after the completion of the live call until 11:59 p.m. ET on November 20, 2019)

About Cellular Biomedicine GroupCellular Biomedicine Group, Inc. (NASDAQ: CBMG) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. It conducts immuno-oncology and stem cell clinical trials in China using products from its integrated GMP laboratory. The Company's GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. Its Shanghai facility includes a "Joint Laboratory of Cell Therapy" with GE Healthcare and a "Joint Cell Therapy Technology Innovation and Application Center" with Thermo Fisher Scientific, which partnerships focus on improving manufacturing processes for cell therapies. CBMG currently has ongoing CAR-T Phase I clinical trials in China. The China NMPA (formerly CFDA) accepted the Company's IND application for a Phase II trial for AlloJoin, CBMG's "Off-the-Shelf" allogenic haMPC therapy for the treatment of Knee Osteoarthritis (KOA), and the Company's IND application for a Phase II trial for ReJoin autologous haMPC therapy for the treatment of KOA. CBMG is included in the broad-market Russell 3000 Index and the small-cap Russell 2000 Index, and the Loncar China BioPharma index. To learn more about CBMG, please visit http://www.cellbiomedgroup.com.

Forward-Looking StatementsStatements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts and may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include those regarding our ability to implement our plans, strategies and objectives for future operations, including regulatory approval of our IND applications, our plan to configure part of our Shanghai facility with GE Healthcare's FlexFactory platform, our ability to execute on our obligations under the terms of our licensing and collaboration arrangement with Novartis, our ability to execute on proposed new products, services or development thereof, results of our clinical research and development, regulatory infrastructure governing cell therapy and cellular biopharmaceuticals, our ability to enter into agreements with any necessary manufacturing, marketing and/or distribution partners for purposes of commercialization, our ability to seek intellectual property rights for our product candidates, competition in the industry in which we operate, overall market conditions, any statements or assumptions underlying any of the foregoing and other risks detailed from time to time in CBMG's reports filed with the Securities and Exchange Commission, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although CBMG believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. CBMG does not have any obligation to update these forward-looking statements other than as required by law.

For more information, please contact:

Company Contact:Derrick C. LiHead of Strategy and Investor Relations, CBMGPhone: 917-717-0994Email: derrick.li@cellbiomedgroup.com

Investor Contact:Valter Pinto / Allison SossKCSA Strategic CommunicationsPhone: 212-896-1254 / 212-896-1267Email: cellbiomed@kcsa.com

CELLULAR BIOMEDICINE GROUP, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

September 30,

December 31,

2019

2018

Assets

Cash and cash equivalents

$29,035,677

$52,812,880

Restricted cash

17,000,000

-

Accounts receivable, less allowance for doubtful accounts of nil and $94,868 as of September 30, 2019 and December 31, 2018, respectively

-

787

Other receivables

591,271

101,909

Prepaid expenses

1,589,479

1,692,135

Total current assets

48,216,427

54,607,711

Investments

240,000

240,000

Property, plant and equipment, net

19,856,287

15,193,761

Right of use

14,298,613

15,938,203

Goodwill

7,678,789

7,678,789

Intangibles, net

7,521,523

7,970,692

Long-term prepaid expenses and other assets

7,640,535

5,952,193

Total assets

$105,452,174

$107,581,349

Liabilities and Stockholders' Equity

Liabilities:

Short-term debt

$14,138,419

$-

Accounts payable

5,686,023

422,752

Accrued expenses

1,477,174

1,878,926

Taxes payable

28,625

28,950

Other current liabilities

4,526,594

5,710,578

Total current liabilities

25,856,835

8,041,206

Other non-current liabilities

12,545,245

14,321,751

Total liabilities

38,402,080

22,362,957

Stockholders' equity:

Preferred stock, par value $.001, 50,000,000 shares authorized; none issued and outstanding as of September 30, 2019 and December 31, 2018, respectively

-

-

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Cellular Biomedicine Group Reports Third Quarter of 2019 Financial Results and Business Highlights - P&T Community

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UPDATED: Andy Plump teams with MD Anderson on the race to cell therapy 2.0 and they’re already planning a pivotal – Endpoints News

Posted: November 7, 2019 at 11:46 am

Anyone who specializes in neurosciences R&D has to prepare themselves for some frustration along the way. And the team at Arkuda Therapeutics can tell you all about it.

The CEO and co-founder is Gerhard Koenig, who you may recall headed up the team at Quartet Medicines, which worked on neuronal and inflammatory cells, until they folded the shop after running into a blind alley. Before that, he was CSO at Forum, which Deborah Dunsire now CEO at Lundbeck had helmed as it tried to break new ground in Alzheimers and schizophrenia.

It didnt work out either.

But even though Atlas closed the checkbook on Quartet, Bruce Booth never blamed the crew. You want to try something cutting edge here, you pay your money and you take your chances. And sometimes you write off your losses.

Thats biotech.

So now Koenig and some of the execs hes known along the way are back, knocking the door on a new approach to neurodegeneration, another high-risk, high-reward play where they are looking to break new ground. And Booth has been bankrolling the incubator work in hopes of seeing a new venture fly.

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UPDATED: Andy Plump teams with MD Anderson on the race to cell therapy 2.0 and they're already planning a pivotal - Endpoints News

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Sangamo to Present Gene Therapy and Ex Vivo Gene-Edited Cell Therapy Data | INN – Investing News Network

Posted: November 7, 2019 at 11:46 am

The company will present data at the 61st Annual Meeting of the American Society of Hematology in Orlando, Florida between December 7 and 10.

Sangamo Therapeutics (NASDAQ:SGMO) has announced that data from its hemophilia A gene therapy clinical data and hemoglobinopathies ex vivo gene-edited cell therapy will be featured on a poster at the Annual Meeting of the American Society of Hematology (ASH).

As quoted in the press release:

Gene Therapy

The SB-525 poster will show updated Alta study data including durability of Factor VIII (FVIII) levels, bleeding rate, factor usage, and safety, for all five patients in the high dose cohort of 3e13 vg/kg, with approximately 4 months to 11 months of follow-up after treatment with SB-525.

As of the abstract submission date, four patients in the 3e13 vg/kg cohort achieved FVIII levels within the normal range with no bleeding events reported up to 24 weeks post-administration. These patients did not require FVIII replacement therapy following the initial prophylactic period of up to approximately 3 weeks post-SB-525 administration. The fifth patient in the 3e13 vg/kg cohort had only recently undergone treatment with SB-525 at the time of the abstract submission. As previously reported, one patient had treatment-related serious adverse events (SAEs) of hypotension and fever, which occurred approximately 6 hours after completion of the vector infusion and resolved with treatment within 24 hours, with no loss of FVIII expression. SB-525 is being developed as part of a global collaboration between Sangamo and Pfizer.

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Sangamo to Present Gene Therapy and Ex Vivo Gene-Edited Cell Therapy Data | INN - Investing News Network

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Data suggest gene, cell therapy trial initiations in Europe lag behind North America here’s why – Endpoints News

Posted: November 7, 2019 at 11:46 am

No new drug has been approved for Alzheimers since 2003, and researchers endeavoring to change that have been greeted with a graveyard of failed therapies. So when Chinese regulators waved a treatment developed by an obscure biotech through to the market albeit a conditional approval contingent upon confirmatory data it makes sense that scientists who woke up to the news were more in doubt than in awe.

While several prominent Alzheimers experts threw their weight behind the seaweed-derived therapy, oligomannate (GV-971), others contacted by Endpoints News were much more skeptical. As Green Valley Pharma has yet to release full data of the single Phase III trial on which the decision was based, most are taking a wait-and-see stance while the company prepares to launch a second, global trial in early 2020.

Among the deluge of questions surrounding the surprise approval, two seem particularly crucial: Did Green Valley offer enough credible evidence to warrant an OK? And did the drug really work as the biotech claimed?

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Talaris Therapeutics Presents Data Supporting Potential of FCR001 to Prevent Recurrence of Kidney-Related Autoimmune Disease in Kidney Transplant…

Posted: November 7, 2019 at 11:46 am

BOSTON & LOUISVILLE, Ky.--(BUSINESS WIRE)--

Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, today presented data demonstrating the potential of its cell therapy to resolve certain auto-immune diseases of the kidney.

The data, presented in a late-breaking poster at the 2019 American Society of Nephrology (ASN) Kidney Week conference, reflect an analysis of living donor kidney transplant recipients with auto-immune diseases of the kidney who underwent kidney transplant and treatment with Talaris cell therapy, FCR001, in the companys Phase 2 trial.

Various auto-immune diseases including IgA nephropathy, focal segmental glomerulosclerosis (FSGS) and Alport syndrome degrade kidney function and can necessitate a kidney transplant. These conditions recur in a high percentage of cases post-transplant, potentially leading to an accelerated decline of the transplanted kidney. Therefore, repeated kidney transplants are often necessary for patients with these diseases.

Twelve subjects in Talaris Phase 2 trial experienced kidney failure as a result of an auto-immune disease. Within this cohort, seven patients were successfully tolerized with FCR001, including two with FSGS, which is a particularly aggressive kidney-related auto-immune condition. None of the seven successfully tolerized patients has to date had a detectable recurrence of their underlying auto-immune disease. Of the five other patients who displayed either transient or no immune chimerism, recurrence of the prior auto-immune disease was observed in two cases.

Were very excited by this demonstration of the potential of FCR001 to durably reset the immune system and halt auto-immune disease in patients in our Phase 2 trial. Many auto-immune diseases of the kidney are not resolved by a conventional kidney transplant, and therefore patients may require multiple transplants over the course of their lives. Were hopeful that our cell therapy could interrupt this cycle of repeat transplants, said Chief Executive Officer Scott Requadt. Talaris plans to build upon these promising findings in an upcoming Phase 2 trial, in which we will evaluate the potential of FCR001 to treat certain severe auto-immune or immune-mediated disorders.

About FCR001 FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics to induce or restore patients immune tolerance. FCR001 builds on over 30 years of research by the companys founder, Dr. Suzanne Ildstad, into the means by which durable immune tolerance can be induced in a patient who receives a transplanted organ or can be restored in patients with certain immune-mediated or blood disorders. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. A Phase 3 trial of FCR001 in living donor kidney transplant recipients is now enrolling patients. More information about the FREEDOM-1 trial can be found at: https://www.clinicaltrials.gov/ct2/show/NCT03995901

About Talaris Therapeutics Talaris Therapeutics, Inc. is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe autoimmune and immune-mediated disorders. Talaris operates its own cell processing facility in Louisville, KY and maintains corporate offices in Boston, MA and Louisville, KY. Talaris is backed by leading life sciences investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA. http://www.TalarisTx.com.

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Talaris Therapeutics Presents Data Supporting Potential of FCR001 to Prevent Recurrence of Kidney-Related Autoimmune Disease in Kidney Transplant...

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Sigilon Therapeutics to Present Preclinical Data Showing Six Months Durability for Cell Therapies in Rare Blood Disorders – Business Wire

Posted: November 7, 2019 at 11:46 am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sigilon Therapeutics announced today that it will present data at the American Society of Hematology Annual Meeting demonstrating that its novel Shielded Living TherapeuticsTM platform for rare bleeding disorders remains viable in animal models for at least six months. The data also demonstrate dose-responsive in vivo expression of human coagulation factor VIII (hFVIII) and correction of the bleeding phenotype in immunocompetent hemophilia A mice.

The data we will be sharing at ASH are another important validation of our Shielded Living Therapeutics platform and our ability to deliver sustained production of crucial proteins, such as factor VIII, with a single treatment, said David Moller, M.D., Sigilons Chief Scientific Officer.

The ASH abstract details Sigilons novel approach to developing durable cellular therapies. The process starts with engineering human cell lines to express high levels of hFVIII without the use of viral vectors. These cells are then encapsulated inside dual-compartment spheres. The inner compartment is designed to maximize cell viability and protein production in vivo. The outer layer of the spheres contains proprietary small molecules conjugated to alginate which avoids fibrosis and immune system attack.

In the latest studies, the therapeutic cells remained viable and continued producing stable levels of hFVIII six months after implantation in mice, after which the study was terminated. If these data are replicated in the clinic, the implanted cells could potentially eliminate the need for patients to get regular factor or non-factor injections.

These data are unprecedented in demonstrating sustained expression of therapeutic proteins for the treatment of hemophilia, said Deya Corzo, M.D., Sigilons Chief Medical Officer. The results bolster our confidence in our Shielded Living Therapeutics platform, which enables a modular approach to harnessing the bodys most powerful machine the human cell to express therapeutic proteins for a wide array of indications.

Sigilon recently received Orphan Drug Designation for SIG-001, its investigational therapy for hemophilia A. Clinical trials of SIG-001 are expected to begin in 2020. We are looking forward to moving SIG-001 into the clinic as we advance our mission to replace fear with hope in patients living with chronic disease, Dr. Corzo said.

The ASH abstract 2065 is entitled: Correcting Rare Blood Disorders Using Coagulation Factors Produced in vivo by Shielded Living Therapeutics Products and will be presented on Saturday, Dec. 7 from 5:30 7:30 p.m. ET during the Gene Therapy and Transfer: Poster I Session in Hall B of the Orange County Convention Center.

About Sigilon Therapeutics

Sigilon Therapeutics is developing functional cures for chronic diseases through its Shielded Living Therapeutics platform. Sigilons therapeutics consist of novel human cells engineered to produce the crucial proteins, enzymes or factors needed by patients living with chronic diseases such as hemophilia, diabetes and lysosomal storage disorders. The engineered cells are protected by Sigilons Afibromer biomaterials matrix, which shields them from immune rejection and fibrosis. Sigilon was founded by Flagship Pioneering in conjunction with Daniel Anderson, Ph.D., and Robert Langer, Sc.D., of the Massachusetts Institute of Technology.

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Canine Stem Cell Therapy Market Trends and Analysis to (2019-2025) – Pledge Times

Posted: November 7, 2019 at 11:46 am

Canine Stem Cell Therapy market report includes the estimation of market size for value and volume. Further, the report explains statistical forecasts, major trends, regional marketing analysis, and Canine Stem Cell Therapy industry based on Strengths, Weaknesses, industry internal and external environments. Those data are further broken down with manufacturing base distribution, Canine Stem Cell Therapy production area and product type. Major points like market situation and trends, concentration rate mergers, expansion which is basic Canine Stem Cell Therapy information to grow/establish a business is also provided.

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Sorrento to Present New Data on Advanced Immunotherapies at Multiple Upcoming Scientific Conferences – GlobeNewswire

Posted: November 7, 2019 at 11:46 am

SAN DIEGO, Nov. 06, 2019 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), announced today that Dr. Henry Ji, Chairman and CEO, and members of Sorrentos research team will participate in upcoming industry conferences in the 4th quarter 2019.

Sorrento will provide new data on recent advances in allogeneic cellular therapy research, including but not limited to 3 clinical areas Sorrento has been focusing on:

Examples from the CD38 and BCMA programs will illustrate current progress in key development areas.

Several scientific posters will be presented at the upcoming Society of Immunotherapy of Cancer and American Society of Hematology conferences and will be available following the event.

Zhangjiang International Summit on Cell Therapy 2019

Date: November 14thTime: 11:15 AM China TimeLocation: ShanghaiNext-generation off-the-shelf CAR-T cell therapy Keynote Speaker, Dr. Henry Ji

American Society of Hematology (ASH Scientific Conference)

Date: December 7th through 10thLocation: Orange County Convention Center (OCCC), Orlando, Fl

ASH online (following scientific conference)

Longwood Annual Winter Meeting at Harvard Medical School 2019

Date: December 10thTime: 8:30 AM Eastern TimeLocation: Harvard Medical School, Joseph B. Martin Conference Center, Boston, MAIdentifying Novel Technologies and Therapeutic AreasExpert panel discussion with Dr. Henry Ji

About Sorrento Therapeutics, Inc.

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (G-MAB library), antibody-drug conjugates (ADC) as well CAR-T and oncolytic virus (Seprehvir).

Sorrento's commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) RTX and ZTlido. RTX is completing a phase IB trial in terminal cancer patients. ZTlido was approved by US FDA on February 28, 2018.

For more information visit http://www.sorrentotherapeutics.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward looking statements include statements regarding the developments of and prospects for Sorrento's and its subsidiaries and affiliates products and technologies, expected research and development and clinical trials. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's, its subsidiaries', affiliates and partners technologies and prospects; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks related to seeking regulatory approvals and conducting clinical trials; risks of supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its strategies; risks related to Sorrentos debt obligations; and other matters that are described in Sorrento's Annual Report on Form 10-K for the year ended December 31, 2018, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Media and Investor Relations

Alexis Nahama, DVM (SVP Corporate Development)

Telephone: 1.858.203.4120

Email: mediarelations@sorrentotherapeutics.com

ZTlido and G-MAB are trademarks owned by Scilex Pharmaceuticals Inc. and Sorrento, respectively.

Seprehvir, is a registered trademark of VirttuBiologics Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.

All other trademarks are the property of their respective owners.

2019 Sorrento Therapeutics, Inc. All Rights Reserved.

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