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Stem Cell Therapy Market to Observe Exponential Growth By 2022 to 2030 | Smith, Nephew (UK), MEDIPOST Co Ltd. (South Korea) – Digital Journal

Posted: June 22, 2022 at 2:50 am

New Jersey, United States-Stem Cell Therapy Market 2022 2030, Size, Share, and Trends Analysis Research Report Segmented with Type, Component, Application, Region, and Forecast

The mesenchymal stem cells infiltrate and incorporate into different organs, fix cardiovascular, lung, and spinal line wounds, and work on the condition of immune system infections, liver, and bone and ligament illnesses. Stem cells are a powerful instrument for the treatment of diseases brought about by irritation, insusceptible system disappointment, and, or tissue degeneration.

The drivers answerable for the development of the worldwide stem cell therapy market are the expanded occurrence of ongoing illnesses, ascend in GMP-confirmation endorsements for cell therapy creation offices, development of biotechnology area, and ascend in clinical preliminaries for stem-cell-based treatments. Notwithstanding, factors that are supposed to control the market development are the ascent in the expense of stem cell-based research, and the dangers looked at while going through stem cell therapy, and the accessibility of options.

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Division segment

In view of type, the worldwide stem cell therapy market is extensively divided into allogeneic stem cell therapy and autologous stem cell therapy. In 2022, the allogeneic portion represented the biggest portion of the stem cell therapy market. The development of the allogeneic portion is credited to the simplicity of assembling and creation processes and the rising accessibility of novel stem cell items across significant geologies.

In light of restorative application, the worldwide stem cell therapy market is divided into outer muscle problems, wounds and wounds, cardiovascular illnesses, medical procedures, provocative and immune system sicknesses, neurological problems, and other remedial applications (which incorporate visual infections, fat misfortune, and fringe blood vessel infections). The neurological problems portion is supposed to develop at the most noteworthy CAGR during the gauge time frame inferable from the rising commonness of neurological problems and the significant expense of therapy.

Regional Analysis

Topographically, the stem cell therapy market is divided into North America, Europe, Asia Pacific, RoW. In 2022, North America represented the biggest portion of the stem cell therapy market, trailed by Asia Pacific and Europe. The huge portion of this territorial fragment in the worldwide market can fundamentally be ascribed. The enormous portion of North America in the worldwide market can be credited to the rising public-private financing and examination awards for creating safe and compelling stem cell therapy items and the developing number of clinical preliminaries.

Competitive Analysis

Central participants in the stem cell therapy market incorporate Smith and Nephew (UK), MEDIPOST Co., Ltd. (South Korea), Anterogen Co., Ltd. (South Korea), PHARMICELL Co., Ltd. (South Korea), JCR Pharmaceuticals Co., Ltd. (Japan), and NuVasive, Inc. (US).

The following are some of the reasons why you should take a Stem Cell Therapy market report:

Explore the Full Index of the Stem Cell Therapy Market Research Report 2022

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Stem Cell Therapy Market to Observe Exponential Growth By 2022 to 2030 | Smith, Nephew (UK), MEDIPOST Co Ltd. (South Korea) - Digital Journal

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Teclison Announces Publication of Phase 1 Data Demonstrating the Safety and Therapeutic Potential of Tirapazamine Chemoembolization for Patients with…

Posted: June 22, 2022 at 2:50 am

Tirapazamine (TPZ) with conventional trans-arterial chemoembolization had a good safety profile and promising efficacy signals in early- and intermediate-stage liver cancer, including in patients who had progression or recurrence after standard therapy

Of the 17 evaluable patients, including 10 who progressed despite prior therapy, 47% achieved complete response, with a median time to progression of 12.6 months and a median overall survival of 29.3 months

Results are consistent with the response rates seen in previous treatment-naive patient cohort, and support the theory that TPZ chemoembolization could induce complete tumor necrosis

The dose was selected for a randomized Phase 2 study to compare TPZ with doxorubicin, a current therapy, using the same embolization protocol

PRINCETON, N.J., and TAIPEI, Taiwan, June 21, 2022 (GLOBE NEWSWIRE) -- Teclison, a clinical-stage biotechnology company developing innovative cancer therapeutics to induce tumor necrosis and enhance anti-tumor immunity, today announced the peer-reviewed publication of a study demonstrating the safety, tolerability and preliminary efficacy of its trans-arterial tirapazamine chemoembolization (TATE) therapy in patients with unresectable early- and intermediate-stage hepatocellular carcinoma (HCC), also known as liver cancer. The clinical data, published in The Journal of Vascular and Interventional Radiology titled Phase I Dose-Escalation Study of Tirapazamine Chemoembolization for Unresectable Early- and Intermediate-Stage Hepatocellular Carcinoma, establishes tirapazamine, a hypoxia-activated anti-cancer drug, as safe when administered in conjunction with trans-arterial embolization with promising efficacy in patients with liver cancer, including those with progression or recurrence after treatment with conventional trans-arterial chemoembolization (TACE).

The current standard of care for unresectable liver cancer is conventional trans-arterial chemoembolization with the chemotherapeutic agent doxorubicin. Though well established, TACE with doxorubicin has limited efficacy because chemotherapy does not effectively kill cancer stem cells, a root cause for tumor recurrence after TACE. Additionally, embolization-induced tumor hypoxia is thought to dampen the cytotoxic effects of doxorubicin, said Chang-Hsien Liu, MD, principal investigator of the study. The results of this study support tirapazamine as an alternative to doxorubicin in trans-arterial chemoembolization. A future randomized study is warranted to compare tirapazamine and doxorubicin under embolization.

Ray Lee, MD, PhD, Founder and CEO of Teclison, added, We are encouraged by the potential of trans-arterial tirapazamine chemoembolization to improve the clinical response and extend overall survival when administered to patients with liver cancer. This data reinforces findings from our previous first-in-human study published in the Journal of Hepatocellular Carcinoma and establishes the tirapazamine dose for subsequent Phase 2 clinical trials.

Seventeen patients with unresectable early-stage HCC or unresectable intermediate-stage HCC were enrolled in this non-randomized, open-label Phase 1 study. Prior treatment such as surgery, radiofrequency ablation, and TACE, was permitted. Following a 3 + 3 dose escalation design, patients were assigned to three cohorts with a tirapazamine dose of 5mg/m2, 10mg/mg2 and 20mg/m2, respectively. As no dose-limiting toxicity was observed, the 20mg/m2 dose was converted to a fixed 35mg dose in the expansion cohort. The primary outcomes of the study were safety and tolerability. No serious adverse side effect was reported during the study. Most common adverse effects included transiently elevated liver enzymes, abdominal pain, fever, elevated bilirubin level, and transient ECG abnormality. The secondary endpoint was efficacy of TATE therapy. Of the 17 enrolled patients, 8 achieved complete response (CR 47.1%) as measured radiographically. Three patients achieved a partial response (PR 17.6%) for an overall response rate of 65%. CR rates were comparable between subgroups with and without prior TACE. The six-month progression-free survival rate was 72.6% and the median overall survival (OS) was 29.3 months.

Trans arterial chemoembolization (TACE) is the common therapeutic modality recommended by the Barcelona Clinic Liver Cancer (BCLC) staging system for patients with intermediate or advanced HCC. The overall response rate of TACE is 52% and median OS of about 20 months in a recent systemic review of 10,000 patients. A Phase 2 randomized study comparing efficacy of TATE vs TACE in patients with intermediate liver cancer is underway.

About TeclisonTeclison is a clinical-stage pharmaceutical company developing novel cancer therapeutics to induce targeted necrosis of solid tumors and convert the tumor into a therapeutic vaccine to enhance cancer remission. The Companys portfolio is comprised of new approaches aimed at enhancing the therapeutic benefit of immunotherapy to treat nearly all solid tumors. Its lead product candidate, TEC-001, a first-in-class therapeutic agent, and Trans-Arterial TEC-001 Embolization (TATE) therapy, are being evaluated in combination with FDA-approved immune checkpoint inhibitors in Phase 2 clinical trials for the treatment of liver, colorectal and lung cancer. Teclison is headquartered in Princeton, New Jersey. For more information, please visitwww.teclison.com.

Forward-Looking StatementsThis press release contains statements that are forward-looking statements that are based upon managements current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated herein.

Media contact:Gloria GasaaturaLifeSci CommunicationsTel: (646) 970-4688ggasaatura@lifescicomms.com

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The Future of Parkinson Disease Therapies and the Challenges With Stem Cell Therapies – Neurology Live

Posted: June 22, 2022 at 2:49 am

The future of therapeutics for Parkinson disease (PD) appears to be bright, with the pipeline of clinical development featuring a vast number of investigational and varied approaches to treating the condition. This is notable because although levodopaa gold standard therapyhas provided many patients with relief from PD symptoms, there are still limitations to its abilities, and there are several needs that remain unaddressed.

In a presentation given by Rajesh Pahwa, MD, FANA, FAAN, on these emerging therapies at the2022 Advanced Therapeutics in Movement and Related Disorders (ATMRD) Congressin Washington, DC, June 17-19, four specific therapies on the horizon were highlighted that might be able to address, at least in part, some of the shortcomings of the available options.1 Pahwa, the Laverne and Joyce Rider Professor of Neurology; chief, Parkinsons Disease and Movement Disorders Division; and director, Parkinsons Foundation Center of Excellence, University of Kansas Medical Center, shared that IPX-203, apomorphine subcutaneous infusion, continuous foslevodopa/foscarbidopa infusion (also known as ABBV-591), and continuous subcutaneous liquid levodopa/carbidopa (also known as ND0612) could all enter the market within the next couple years.

If I were to predict, I would say the next four of them would definitely be in the market in the next 3 to 4 years, Pahwa said. We have had levodopa which is the gold standard for the treatment of Parkinson disease. We have had different extended forms of levodopawe had the sustained release carbidopa-levodopa that came out 30 years ago. We had the extended-release capsules that came out, about 4 to 5 years ago now. The next generation, so to speak, is IPX-203.

He said that likely, the next therapy that will become available will be subcutaneous apomorphine infusion, closely followed by foslevodopa/foscarbidopa, and then IPX-203. The Neuroderm subcutaneous liquid levodopa [ND0612] will be another few years later. The rest of themwe do not know where they'll end up with phase 3 studies, he said.

The thing is, we still don't have that perfect carbidopa-levodopa where we can say OK, we have reached the stage that this is the best one out there. But every extended-release formulation, we have made some degree of improvement over the past. The extended-release capsules were better than the sustained release because we could get immediate action. And the same thing, I think, with IPX-203. We will, hopefully, have a better improvement than we saw with the previous one, he continued.

After running through the available clinical data on these therapies, Pahwa began to look further into the future of treatment. Touching briefly on the gene therapies that have been assessedmostly unsuccessfullyin PD, he then turned to stem cell-based therapies. Speaking to the hope that patients often carry when talking about the potential of stem cell approaches, he shared that this approach can often come with difficulties, and the progress has been slow.

READ MORE: The Importance of Treatment Nuance and Novel Options in Treating Parkinson Disease

We are very early in the journey of stem cell therapies. The challenges with Parkinson are multiple. You have to figure out the source of this stem cell, the quality of stem cell, age of the patient, stage of the patient, surgical techniques used, the need to use immunosuppression therapy or not use immunosuppression therapy, Pahwa explained. We are looking at a lot of challenges that we have not completely eliminated when we talk about stem cells. But like I said, every patient really feels that the stem cell is going to be an answer to their Parkinson's disease. The challenge is, as far as being a clinician is that Parkinson's is a progressive disorder that affects multiple areas in the brain. Using stem cell therapy, can we stop this progression? Can we actually slow down the disease or cure it? Or is it really going to only focus on dopaminergic replacement? And I think those are our challenges.

These challenges as well as the promises, he explained, can also be unique to each source of stem cells that is taken with this approach. For fetal ventral mesencephalic cells or embryonic stem cells, there are a few trials ongoingthe TRANSEURO (NCT01898390), STEM-PD (NCT02452723), and NYSTEM (NCT03119636), specificallyand there have been positives with these cells, including good long-term graft survival and their indefinite expandability. But they do carry ethical concerns and can be both unpredictable and limited in terms of their supply. Additionally, tissue rejection and tumorigenesis are possible risks.

Induced pluripotent stem cells are another approach in an ongoing trial at the Center for iPS Cell Research and Application, in Kyoto, Japan. These cells, similar to the aforementioned ones, also come with the benefit of indefinite expandability, and unlike the prior mentioned, have an easily accessible source and lack the need for immunosuppressive therapy. Although, they have a high operative cost, can be time consuming to develop, and require complex procedures.

The final option, neural progenitor cells, are also being assessed in two clinical trials (NCT03309514 and NCT01329926), and offer an easy expansion and differentiation protocol, as well as a large quantity source and multipotency. But, again, they carry risks such as low graft survivability and limited proliferation, and they require invasive tissue collection.

People are surprised that we are so slow with stem cells, Pahwa said. Seven years ago, I used to say, Oh, it's going to be 5 to 10 years, and everyone was led to believe that it was all the federal governments fault that we were going so slow. But really, it takes a long time, looking at the safety of it, because all you need is one patient who have a significant complication, and this is going to be put on the backburner for a long time.

Pahwa stressed the importance of being honest with patients about the progress being made in this area, given the significant interest from the general population in stem cell approaches. He warned about patients seeking out unapproved, unregulated treatment by either traveling out of the United States, or within.

What I tell my patients is don't spend the money because a lot of people out there [are selling this idea], not only if you're talking about going to a different country, even in the US, he said. I have a patient who was walking and doing well, who had stem cells injected in her spine, and could not walk after that. It is very likely she had, some form of fibrosing meningitis or something that that affected her gait significantly. Not only there is no efficacy data, there is no safety data. So, I strongly try to discourage my patients.

But the challenge is, people who are interested in stem cells, they often don't believe you, they want to go because the person who's doing the stem cells is doing a very good job selling this product for them. I don't know how to say we can stop this from happening, and that's why I always talk about how there are very few studies going on, Pahwa said.

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How to Self-Administer Testosterone Injections

Posted: June 22, 2022 at 2:48 am

Testosterone injections are prescribed on a very individualized basis. Therefore there can be a lot of variation in the dosages of injectable testosterone prescribed. The most common form of injectable testosterone therapy contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. This is commonly referred to as DEPO-Testosterone or merely DEPO.

DEPO testosterone injections are usually prescribed in vials of 100 mg/mL solution or 200 mg/mL solution. But, no matter what brand or dosage of injectable testosterone you are prescribed, it is vitally important that you learn how to safely and properlyadminister testosterone injections.

Testosterone injections are given into the muscles, therefore, a testosterone injection is known as an intramuscular injection, or IM injection. IM injections are easy to self-administer, and relatively safe and pain-free, once you know all of the steps and procedures to properly administer testosterone injections.

No matter what brand or dosage of injectable testosterone you are prescribed, it is vitally important that you learn how to safely and properly administer testosterone injections.

The first step in learning how to administer testosterone injections correctly, is to choose your injections site. IMs are given into thick muscular areas to effectively enter the bloodstream, while minimizing pain and discomfort. This is because the thick muscles of your forearm, buttocks, or outer thigh, are very vascular, and also can accommodate the relatively thick needles of testosterone injections with little discomfort. Once you have selected your injection site, the most important thing to learn about how to self-administer your testosterone injections, is how to maintain sterile conditions through the various steps of the process. The rare problems that occur with testosterone injections, such as pain, inflammation, or an infection at the site of injection, are almost always caused by failing to observe sterile protocols, and/or using improper injection techniques.

Testosterone injections are given into the muscles. They can be easy to self-administer, and relatively safe and pain-free, once you know all of the steps and procedures to properly administer testosterone injections.

Testosterone injections are given much like any other IM. You may receive specific instructions from your doctor, or from the package insert of your particular prescription. Always follow your prescribers instruction on how to inject your particular dose of testosterone. The following should be taken only as an overview of the 10 basic steps to administering a testosterone injection, simply to give you an idea of the process. These steps to injecting testosterone, should not be taken as specific instructions on how to give a testosterone injection.

Gather all the supplies needed for your testosterone injection, and place them on a clean and sterile staging area. Be sure you are well aware of your prescribed dose of testosterone. Taking additional injections, or more than your prescribed dose of testosterone, will not improve your results, and in fact, can be dangerous. Carefully check the expiration date on the vial of testosterone. Never use testosterone that is expired.

Make sure your hands are clean, and that you are wearing rubber gloves. Now clean the top of the vial with one of the alcohol swabs that came with your testosterone injection kit. Pull back on the needles plunger to draw air to the graduated number line on the syringe that corresponds to your prescribed dose.

With the vial still on the table in the upright position, insert the needle through the top of the vial and inject the air into the solution. Now, with the needle still in the vial, invert and lift the vial, so you can draw the testosterone down, into the syringe.

Pull back the plunger of the syringe, again to your desired dose, this time drawing the liquid testosterone into the syringe.

Remove the needle from the vial. Flick the side of the needle with your finger to make sure there are no air bubbles. Injecting air into your body, can cause a serious complication known as an air embolism. Squirt a tiny bit of the testosterone out of the tip of the needle. This will further ensure that you have removed all of the air bubbles, and also lubricate the tip of the needle, making injection of the testosterone a little easier.

Clean your selected injection site with another alcohol wipe. Most users of testosterone injections find that the heavy muscle of the outer part of the upper thigh is the easiest injection site to access, and to administer the IM.

Squeeze about 1 inch of muscular tissue between your forefinger and thumb, as seen above.

In a firm swift motion press the needle into the injection site.

Pull up slightly on the plunger and check for blood in the syringe. If you draw up any blood you have stuck the needle into a vein, and not muscle tissue. Remove and try again in another area, until you are sure there is no blood.

In a steady push, trying to keep the needle at a 90 degree angle, inject the testosterone into the muscle.

Withdraw the needle. Clean the injection site with another alcohol wipe, discard the needle appropriately, and properly store your testosterone vial for the next injection.

If you are correctly following this basic outline, and your testosterone prescribers specific self-injection instructions, you should be able to give yourself your testosterone shots with little or no pain. If you are experiencing pain on a regular basis, try alternating your injection sites. If discomfort continues, contact your prescriber. You may have to have your testosterone injection dosage adjusted, or be retrained on how to take your testosterone injections, or perhaps switch to another brand of injectable testosterone.

When learning how to administer your testosterone injections, there are a few other things to consider, such as:

Once you are comfortable in correctly knowing how to give yourself testosterone injections, and start taking them, you will be on your way to achieving some remarkable benefits. The many benefits of testosterone injections include:

Do not expect to see these benefits immediately after you first testosterone injection. It takes time for your body to get used to the impact of increased testosterone in the blood. You will start to feel all of the above benefits, cumulatively, over the course of the weeks and months of your testosterone injection therapy.

So, now that you know how simple, safe and easy administering testosterone replacement shots can be, why dont you contact us today and see of testosterone therapy is right for you!

The rare problems that occur with testosterone injections, such as pain, inflammation, or an infection at the site of injection, are almost always caused by failing to observe sterile protocols, and/or using improper injection techniques.

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Alumni Entrepreneurs Pitch Startups to Impact the World – Princeton Alumni Weekly

Posted: June 22, 2022 at 2:46 am

Participants at the 2022 Tiger Entrepreneurs Conference and Pitch Competition: (from left) Tom Meyer 87, Cornelia Huellstrunk, Mayra Ceja 03, Joyce Zhang Gray *15, Eli Kalfaian 22, Julia Macalaster 12, Bayo Okusanya 20.

Wright Seneres

Participants at the 2022 conference had ideas for curbing noise pollution, harnessing fusion for zero-emission energy, and more

Before the blast of fireworks displays and Abba cover bands at Reunions, a group of alumni shared their startup dreams at the 2022 Tiger Entrepreneurs Conference and Pitch Competition.

Organized by the Princeton Entrepreneurship Counciland thePrinceton Entrepreneurs Network, the conference consisted of panel discussions, fireside chats, and networking opportunities, all of which culminated in a pitch competition adjudicated by conference attendees and a panel of investors.

Anne-Marie Maman 84, executive director of the Princeton Entrepreneurship Council, set the tone for the day during the opening panel.

We dont care if youre from the arts or the sciences, if youre for-profit or nonprofit, if youre business-to-business or business-to-consumer, Maman said, referring to the councils mission. What we care about is impact, the potential for your idea to make change.

The showcase floor displayed a strong sense of this impact-driven motivation, with startups that includedGetNoisy, which seeks seeking to curb noise pollution caused by aircraft traffic;Nucleos, an online learning platform designed to educate those in the carceral system; andPrinceton Stellarators Inc., which aims to use seeks to use fusion to create sustainable, zero-emission energy.

While individual startups were diverse in focus, each entrepreneur had strong, often personal motivation for getting their idea off the ground.

ConsiderConcarlo Therapeutics, which seeks to provide transformative therapies for drug-resistant cancers. The founder, Stacy Blain 89, said she decided to name the company by combining the names of her three kids, Connor, Carly, and Logan.

I do what I do because I want to make the world a better place for the next generation, Blain explained. Being reminded that Im doing this for the world that [my kids] are going to live in, thats what keeps me going.

Many of the founders were far removed from the business world while studying at Princeton. A majority of their paths to entrepreneurship are rooted in other interests microbiology, politics, computer tech, food science. Instead of being drawn to entrepreneurship for its own sake, these founders motivations are anchored by the conviction that they have something that the world needs, something that can drive positive change.

When we were first starting up, we called up 10 friends who we thought would be interested, Lauren Imparato 02, founder of health and wellness companyI.AM.YOU., recalled. The first thing they said was, What? Werent you SPIA [School of Public and International Affairs]?

Of the 16 varied startups on the showcase floor, three reached the final round:Alariss Global, an international business development service;Piggyback Network Inc., a carpooling app for families; andExpressCells, a genetic engineering company.

After a final pitch round and Q&A, ExpressCells was chosen as the competitions winner. ExpressCells promises to provide genetically edited cell lines months faster, which can help speed up scientific research and discovery. Matthew Handel 87, the companys CEO, accepted the $5,000 prize and will be given the opportunity to pitch ExpressCells to a variety of investors.

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Gene edited foods back on the menu – what are they and what’s changed? – ABC News

Posted: June 22, 2022 at 2:46 am

Scientists Jonathan Napier and Cathie Martin remember when they needed armed guards and high fences to protect their research sites.

Genetically modified (GM) food crops were the target of activists concerned about genetic engineering.

But the strict laws governing their crops are now rapidly changing.

So are the definitions of what gets called a GM food and what doesn't.

What could this mean for your dinner plate? And have scientists learnt anything from the heated debates around GM about better involving citizens in decisions around their research?

GUESTS

Simon BurallSenior associate, InvolveMember, Nuffield Council on Bioethics

Professor Michael JonesProfessor of agricultural biotechnologyFoundation of the WA State Agricultural Biotechnology Centre

Professor Cathie MartinPlant scientistJohn Innes Centre, UK

Professor Jonathan NapierPlant scientist and metabolic engineerRothamsted Research, UK@johnathannapie1

FURTHER INFORMATION

Biofortified tomatoes provide a new route to vitamin D sufficiency (Nature, 2022)

CRISPR editing of plants and animals gets green light in Australia. Now what? (2019)

Genetic Technology (Precision Breeding) Bill (UK)

Nuffield Council commentary on the UK's Genetic Technology (Precision Breeding) Bill

Australia's gene technology regulatory system

CRISPR co-inventor Jennifer Doudna, and debating the ethics of gene editing (Science Friction, 2018)

Making happier animals? Gene editing in the farm-yard (Science Friction, 2017)

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CRISPR Therapeutics to Host Innovation Day on June 21, 2022 – GuruFocus.com

Posted: June 22, 2022 at 2:46 am

ZUG, Switzerland and CAMBRIDGE, Mass., May 31, 2022 (GLOBE NEWSWIRE) -- CRISPR Therapeutics ( CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced that it will host an Innovation Day focused on early research and development on Tuesday, June 21, 2022 at 2:00 PM ET.

CRISPR Therapeutics Innovation Day will focus on the Company's differentiated genetic engineering platform technologies, novel approach to cell and gene therapy, and emerging discovery programs.

A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company's website at https://crisprtx.gcs-web.com/events. A replay of the webcast will be archived on the Company's website for 30 days following the presentation. Please contact [emailprotected] for any questions regarding the event.

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

CRISPR THERAPEUTICS word mark and design logo are trademarks and registered trademarks of CRISPR Therapeutics AG. All other trademarks and registered trademarks are the property of their respective owners.

Investor Contact:Susan Kim+1-617-307-7503[emailprotected]

Media Contact:Rachel Eides+1-617-315-4493[emailprotected]

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Global Therapeutic Proteins Market Research Report 2022: Focus on Insulin; Fusion Protein; Erythropoietin; Interferon; Human Growth Hormone; Follicle…

Posted: June 22, 2022 at 2:46 am

DUBLIN--(BUSINESS WIRE)--The "Therapeutic Proteins Global Market Report 2022: By Product, By Application, By Function" report has been added to ResearchAndMarkets.com's offering.

The global therapeutic proteins market is expected to grow from $100.06 billion in 2021 to $112.17 billion in 2022 at a compound annual growth rate (CAGR) of 12.1%. The market is expected to reach $177.30 billion in 2026 at a CAGR of 12.1%.

The therapeutic proteins market consists of sales of therapeutic proteins. Therapeutic proteins provide important therapies for diseases such as diabetes, cancer, infectious diseases, hemophilia, and anemia.

The main types of products in therapeutic proteins are insulin, fusion protein, erythropoietin, interferon, human growth hormone and follicle stimulating hormone. Insulin is a peptide hormone produced by beta cells in the pancreatic cells that serves as the individual 's primary anabolic hormone. It affects fat, carbohydrate and protein metabolism by boosting glucose uptake from the blood into the fat, liver and skeletal muscle cells.

The different functions include enzymatic and regulatory activity, special targeting activity, vaccines, protein diagnostics and is used in various applications such as metabolic disorders, immunologic disorders, hematological disorders, cancer, hormonal disorders, genetic disorders, others.

Advance technologies for protein-based drug development drives the therapeutic proteins market. Therapeutic proteins cannot be synthesized chemically, they need to be produced by genetic engineering and recombinant DNA technology in living cells or organisms.

Protein-engineering platform technologies such as glycoengineering, pegylation, Fc-fusion, albumin fusion, albumin drug conjugation help to increase the production yield, product purity, circulating half-life, targeting, and functionality of therapeutic protein drugs. Belimumab, ipilimumab, taliglucerase alfa, albiglutide, coagulation factor IX recombinant human are some therapeutic protein drugs developed using protein engineering technologies approved by FDA in the past five years.

Increasing biosimilar drugs in global market decline the growth of the therapeutic proteins market. Patent expiry of therapeutic proteins such as monoclonal antibodies give space for entry of biosimilar. In EU, AbbVie evidenced patent expiration of Humira (adalimumab) in 2018, five biosimilar of Humira from Mylan, Amgen, Sandoz, Samsung Bioepis received drug approvals from European commission to enter the EU market. These cost-effective treatments similar to original biologics decline the revenue and sales of therapeutic proteins.

Monoclonal antibody drug approvals are increasing in the protein therapeutic segment. Chronic diseases such as cancer, immunological disorders are well treated with monoclonal antibodies. Monoclonal antibodies are dominant and well-established product class in the protein therapeutic segment with more safety and immunogenicity than antibodies.

Cell-based expression systems such as Chinese hamster ovary (CHO) mammalian cell expression system with latest technologies increased the productivity of monoclonal antibodies by overcoming the problems associated with earlier antibody drugs. In last five years, FDA approved 213 drugs, among them 44 are monoclonal antibodies. For instance, twelve monoclonal antibodies were approved by FDA for the treatment of cancer and immunological disorders.

In the United States, therapeutic protein drug manufacturers file therapeutic biologics application (BLA) to FDA for the product approvals. The drug approved through BLA should be proved as safe, pure and potent. FDA consolidated review of most therapeutic proteins in Center for Drug Evaluation and Research (CDER). In European Union, biologics are regulated by Committee for Medicinal Products for Human Use (CHMP) for marketing authorization.

In July 2021, Eli Lilly and Company, a US-based pharmaceutical company acquired Protomer Technologies Inc. for $1 billion. Lilly is delighted to add protomer's breakthrough technology to its diabetes pipeline through this acquisition, since the company's glucose-sensing insulin programme, which is based on its proprietary molecular engineering of protein sensors (MEPS) platform, is exhibiting great potential.

Major players in the therapeutic proteins market are

Key Topics Covered:

1. Executive Summary

2. Therapeutic Proteins Market Characteristics

3. Therapeutic Proteins Market Trends And Strategies

4. Impact Of COVID-19 On Therapeutic Proteins

5. Therapeutic Proteins Market Size And Growth

5.1. Global Therapeutic Proteins Historic Market, 2016-2021, $ Billion

5.1.1. Drivers Of The Market

5.1.2. Restraints On The Market

5.2. Global Therapeutic Proteins Forecast Market, 2021-2026F, 2031F, $ Billion

5.2.1. Drivers Of The Market

5.2.2. Restraints On the Market

6. Therapeutic Proteins Market Segmentation

6.1. Global Therapeutic Proteins Market, Segmentation By Product Type, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

6.2. Global Therapeutic Proteins Market, Segmentation By Application, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

6.3. Global Therapeutic Proteins Market, Segmentation By Function, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

7. Therapeutic Proteins Market Regional And Country Analysis

7.1. Global Therapeutic Proteins Market, Split By Region, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

7.2. Global Therapeutic Proteins Market, Split By Country, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

For more information about this report visit https://www.researchandmarkets.com/r/ktb394

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Global Therapeutic Proteins Market Research Report 2022: Focus on Insulin; Fusion Protein; Erythropoietin; Interferon; Human Growth Hormone; Follicle...

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An Experimental Treatment Failed in Mice, and Researchers Did the Right Thing: They Published About It – UConn Today – UConn

Posted: June 22, 2022 at 2:45 am

Blocking the mutant protein with an antibody didnt stop the strange, abnormal bone growths in mice. But the knowledge gained could steer scientists toward more promising approaches, report researchers from UConn and Alexion Pharmaceuticals in the 15 June issue of The Journal of Clinical Investigation.

Fewer than 4,000 people worldwide are afflicted with fibrodysplasia ossificans progressiva (FOP), an inherited disease in which small injuries or bruises to skeletal muscle provoke the growth of massive, abnormal bone and cartilage. Gradually much of the bodys soft tissue turns to bone. Now, researchers at UConn and Alexion Pharmaceuticals who were investigating a potential cure instead found a concerning surpriseblocking the protein responsible for the disease with a monoclonal antibody made the abnormal bone growth worse in mice .

Normally, stem cells help repair muscle damaged by injury or disease. But in people with FOP, certain stem cells get the wrong message from a mutant receptor on their surface. Instead of promoting muscle regeneration, the stem cells develop into bone.

UConn Professor of Molecular and Cell Biology David Goldhamer, Alexion Pharmaceuticals researcher Jeffrey Hunter, and colleagues worked for years to discover a potential antibody therapy for FOP using accurate genetic mouse models of the disease developed by the two groups. The idea was that the antibody would block the mutant receptor and prevent the responsible stem cells from making new bone. But the results were exactly the opposite.

The unexpected result: injecting the antibody into FOP mice caused a dramatic increase in inappropriate bone formation, instead of protecting them as wed hoped, Goldhamer says.

Goldhamer, Hunter and their teams worked with an antibody discovered by Alexion that interferes with the specific cell-surface receptor involved in FOP called Activin A receptor type 1, or ACVR1. The researchers thought that if they blocked ACVR1, the abnormal bone growth would stop. But instead, it was exacerbated.

The antibody appears to lower the injury threshold needed to stimulate bone growth within muscle tissue. Mild injuries that normally dont make bone in FOP mice suddenly make lots of bone. Additionally, the antibody increases and prolongs the immune response to the injury, Goldhamer says.

Another team working on antibody-based therapies for FOP ran into the same effect. Regeneron Pharmaceuticals used different antibodies they derived independently, as well as a different strain of FOP mice, but got the same adverse result. Their paper also appears in the JCI this week.

The teams dont yet know precisely why the antibodies dramatically worsen the disease in mice, but their work raises serious safety and efficacy concerns for the clinical application of this approach, which has not yet been tested in humans. Neither team has plans to pursue this clinically.

This work was funded by a grant from the National Institutes of Health (R01AR072052) and a sponsored research agreement between Alexion Pharmaceuticals and the University of Connecticut.

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An Experimental Treatment Failed in Mice, and Researchers Did the Right Thing: They Published About It - UConn Today - UConn

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Gamida Cell Submits Biologics License Application for Omidubicel to the FDA – Pharmacy Times

Posted: June 22, 2022 at 2:43 am

The drug is being evaluated as the first potential allogeneic advanced cell therapy donor source for patients with blood cancers in need of a transplant.

Gamida Cell has completed the rolling biologics license application (BLA) submission to the FDA for omidubicel for the treatment of individuals with blood cancer who need an allogenic hematopoietic stem cell transplant, the company said in a statement.1

Omidubicel is an advanced cell therapy candidate that was developed as an allogeneic hematopoietic stem cell transplant for individuals with blood cancer. It is the first stem cell transplant donor source to receive breakthrough therapy designation from the FDA.1

Additionally, it has received orphan drug designation in the European Union and the United States.1

The BLA submission marks an important milestone for both Gamida and the transplant community, as omidubicel has the potential to be the first approved advanced cell therapy product for allogeneic stem cell transplantation, Julian Adams, PhD, CEO of Gamida Cell, said in the statement.1

Completion of this BLA submission is a key inflection point in our mission to deliver a new treatment option for patients with blood cancers. We look forward to working closely with the FDA to bring this potentially important therapy to patients, Adams said.1

The FDA has 60 days to determine whether the BLA for omidubicel is acceptable for filing.1

The BLA is supported by the results of a phase 3 study published in Blood, the journal of the American Society of Hematology. The study met its primary endpoint of the median time to neutrophil engraftment in individuals with hematologic malignancies undergoing allogeneic bone marrow transplant, with patients receiving omidubicel having a median time of 12 days compared with 22 days for the umbilical cord blood graft group.1

In the key secondary endpoints of the study, approximately 55% of individuals receiving omidubicel achieved platelet engraftment by day 42 compared with approximately 35% for the comparator.1

Additionally, the rate of infection was significantly reduced, with the cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for individuals randomized to omidubicel being 37% compared with 57% for the comparator.1

Hospitalization in the first 100 days after transplant was significantly reduced with a median number of days alive and out of hospital for individuals randomized to omidubicel was 61 days compared with 48 days for the comparator.1

Furthermore, 1-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by a significant reduction in infectious complications and reduced non-relapse mortality. There was no significant increase in increases in graft-versus-host-disease rates or the relapse rate.1

The results showed that transplantation after an individual received omidubicel had fewer bacterial and viral infections and less time in the hospital, investigators said.2

Omidubicel was generally well tolerated in the phase 3 study.1

Investigators reported that the incidence of treatment-emergent serious adverse events were similar in both arms, with approximately 40% in the omidubicel group and 41% for the comparator.2

References

1. Omidubicel has orphan drug designation and breakthrough therapy designation. Gamida Cell. News release. June 2, 2022. Accessed June 3, 2022. https://investors.gamida-cell.com/news-events/press-releases/news-release-details/gamida-cell-completes-rolling-biologics-license

2. Horwitz ME, Stiff PJ, Cutler C, Brunstein C, et al; Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021;138(16):1429-1440. doi: 10.1182/blood.2021011719

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