Category Archives: Cell Therapy

More of these treatments have been approved, but supply chain issues and cost remain obstacles.

CAR-T therapies are a new and promising treatment for cancer. The global market for CAR-T therapies is projected to increase from $2.9 billion in 2020 to $11.8 billion by 2025, according to MarketsandMarkets.

But some major obstacles loom ahead, cost being one of them. A single CAR-T treatment can run into the hundreds of thousands of dollars. Although CAR-T therapy is a relative rarity now and therefore not a huge burden on payers, as the number of patients receiving it increases, so will the cost and payer scrutiny. The enthusiasm about the promise of CAR-T is also tempered somewhat by the risk of cytokine release syndrome, an adverse effect that can be life threatening.

Approvals

CAR-T therapies involve genetically engineering a patients own T cells so they recognize and kill tumor cells.

Approved by the FDA in 2017, Kymriah (tisagenlecleucel) was the first CAR-T therapy to get the agencys OK. Yescarta (axicabtagene ciloleucel) was next, approved a few months later as a treatment for large B-cell lymphoma in adults after at least two other kinds of treatment failed.

In 2021, the agency approved Abecma (idecabtagene vicleucel), the first CAR-T for multiple myeloma. And in February 2022, the FDA approved a second CAR-T therapy for multiple myeloma, Carvykti (ciltacabtagene autoleucel).

Sankalp Sethi, the cell and gene therapy practice lead at ZS Associates, has helped more than 25 oncology manufacturers commercialize cancer innovations and notes that this approval marks a strong gain in efficacy outcome.

Nearly all patients (98%) in the study of Carvykti achieved a clinical response, and 78% achieved a stringent complete response, he says. Time is needed to determine how the product impacts overall survival, though many say that these results represent a new gold standard in CAR-T efficacy.

Abhinav Deol, M.D., a hematologist-oncologist at Karmanos Cancer Institute in Detroit, says the recent spate of CART-T approvals is notable. In addition to Carvykti, the FDA approved Yescarta as a treatment for a broader group of patients with large B-cell lymphoma, Kymriah as a treatment for relapsed or refractory follicular lymphoma and Breyanzi (lisocabtagene maraleucel) as a treatment of patients with large B-cell lymphoma.

Deol also points to the ongoing trials evaluating allogeneic CAR-T cells, which would be available off the shelf, replacing the complicated process that involves using the patients own T cells. Additionally, he says, there are ongoing studies looking at rapid manufacturing of autologous CAR-T cell product, thereby shortening the time it takes to have the product ready for infusion.

Deol explains that CAR-T therapy provides another option for an increasing number of patients with cancers that have come back despite multiple rounds of other types of treatment.

Long-term data in diffuse large B-cell lymphoma in the third-line setting shows that about 30% to 40% of patients can have sustained remission after CAR-T cell therapy, Deol says. Heavily treated (patients with multiple myeloma) can have disease control for over a year after one infusion of CAR-T cell therapy.

Limited availability

For many patients, CAR-T represents their best potential option at a key moment of treatment eligibility. However, availability has been limited.

These advancements mean these products can be more safely administered, more patients will be able to receive them and patients will be able to receive them earlier, Sethi says.

Remember, when CAR-Ts first came out, only a select number of centers of excellence were certified to administer. Given the complex nature of the products as well as the serious potential (adverse) effects, there was a need for providers to build more experience with the products before allowing for wider distribution.

Progress has been made in overcoming some of the chief barriers to access to CAR-T, says Sethi, which include traveling distance for patients, management of adverse effects and financial viability of the administering centers.

We are now reaching a stage where access is much more widespread at this time, 70% of the U.S. population lives within 50 miles of a center that administers a CD19 CAR-T, he says. Geographic access to these products will no longer be a major barrier for most patients.

Additionally, providers have become more comfortable handling the adverse events that come with CAR-T, he says. This means that for the right patients, outpatient administration is possible. Patients can stay with their families and caregivers while being monitored, improving their quality of life.

A recent study by ZS Associates also found that around 90% of CAR-T providers today are profitable overall with CAR-T administration.

When first approved, CAR-Ts negatively impacted treatment centers finances, as reimbursement rates and mechanisms were still being sorted out, Sethi says. But we are now seeing that these centers have been able to become profitable through better management of (adverse) effects, applying markups and manufacturer discounts, and where applicable, receiving hospital-specific Medicare reimbursement adjustments. As a result, we expect more providers to be able to scale their capacity over time and offer CAR-Ts to more patients in the future.

Supply chain issues

The supply chain and manufacturing challenges of CAR-T are center stage in discussion today.

Maria Whitman, global head of the pharmaceutical and biotech practice at ZS Associates, notes that Carvykti launched with a more limited number of certified centers (32) and limited manufacturing slots. This means that although patients and providers are eager for these products, the benefit is limited to a very small proportion of patients deemed eligible.

Looking forward, it is also a source of budding innovation in support of patients, she says. Limited capacity and commercial availability are not only a challenge for meeting demand, but for scaling accessibility.

For instance, Novartis recently unveiled T-Charge, a next-generation CAR-T platform that is expected to develop the cancer-finding T cells in the patients body instead of in a cell culture, reducing manufacturing time.

Gracell Biotechnologies Inc.s proprietary FasTCAR platform is currently being evaluated in trials in China, and the company claims it has next-day manufacturing capabilities.

Manufacturing turnaround times have long been a barrier to broader accessibility of CAR-T, and these developments are a strong sign that we are moving toward a future where patients are no longer waiting weeks to receive product, Whitman says.

The high cost of CAR-T is another obstacle. CMS announced in 2019 that Medicare would cover CAR-T, but some provider groups have expressed discontent with what they say are low rates.

One important thing to note is the cost for these advanced therapies can lead to sticker shock, says Deol. But the cumulative cost of other cancer therapies over a period of time is very high too, and CAR-T therapy is generally a one-time cost.

Keith Loria is a writer in the Washington, D.C., area who covers healthcare.

See the rest here:
The Latest on CAR-T Therapy - Managed Healthcare Executive

SOUTH SAN FRANCISCO, Calif. & SEATTLE--(BUSINESS WIRE)--Sonoma Biotherapeutics, Inc., a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases, today announced that it has entered into a lease agreement to develop an approximately 83,000 square-foot Research and Development (R&D) and Manufacturing Center to expand its operations in Seattle and complement its existing R&D enterprise in South San Francisco. The state-of-the-art Center will support the R&D and manufacturing of Sonoma Bios pipeline of gene-modified Treg therapies for autoimmune and inflammatory diseases at scale.

Sonoma Bio is at the forefront of developing Treg therapies to treat autoimmune and inflammatory diseases by restoring balance to the immune system, and we are establishing robust and nimble infrastructure from end-to-end to deliver these cellular products, said Heidi Hagen, Chief Technical Officer of Sonoma Biotherapeutics. Through the integration of our R&D engine with next-generation process development and cell therapy production tools, we will have the ability to quickly and efficiently deliver potentially transformative therapies to patients in need.

This R&D and Manufacturing Center will include the development and use of cutting-edge technologies and capabilities from cell selection and genetic modification to intelligent manufacturing automation and information technology systems. The integration of this infrastructure and scientific expertise will enable Sonoma Bio to move efficiently from molecular target identification to in-house full-scale production for multiple product candidates and indications in Phase 2 clinical trials and beyond. The Center will be located on the Seattle waterfront at 501 Elliott Avenue West, a property owned by Office Properties Income Trust and being redeveloped by The RMR Group into Unison Elliott Bay.

Seattle has an established legacy of delivering many firsts in the cell therapy field for cancer, and we are building upon those insights to advance our pipeline of engineered Treg therapies for autoimmune and inflammatory diseases, said Jeff Bluestone, Ph.D., Co-Founder and CEO of Sonoma Biotherapeutics. This Center will create highly-skilled scientific, engineering and manufacturing jobs in the Seattle area, taking advantage of the deep local capabilities and expertise. As we move into the next phase of growth at Sonoma Bio, we want to unite talent across the thriving life science communities of Seattle and San Francisco.

About Sonoma Biotherapeutics

Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Treg biology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted and durable Treg cell therapies designed to cure autoimmune and inflammatory diseases. Sonoma Biotherapeutics is based in South San Francisco and Seattle. For more information visit sonomabio.com and follow on Twitter and LinkedIn.

See the original post here:
Sonoma Biotherapeutics Enters Long-Term Lease Agreement to Establish a Treg Cell Therapy R&D and Manufacturing Center - Business Wire

The automated and closed cell therapy processing systems market is predicted to grow at a noteworthy speed in the upcoming years. The market growth is on the back of the increasing popularity of regenerative medicines and cell therapies. In addition to this, various benefits that are provided by the automation technologies for the comprehensive development of therapies are also adding to the market growth.

The rising integration of advanced therapy development procedures and software technologies is also estimated to bring lucrative opportunities to the market. Further, bio manufacturers are investing at a high rate for the development of cellular therapy products with the help of series funding that is anticipated to drive growth impetus in the market in the years to come.

Rising partnerships among different market players for the adoption and application of these systems and increasing product count are also bolstering growth impetus in the market.

Automated And Closed Cell Therapy Processing SystemsMarket: Key Trends

Recent years have encountered a massive growth in the clinical trials that are associated with advanced therapies. This market growth has been attributed to the rising demand for advanced and automated technologies. These technologies are used for the achievement of high throughput. This increased growth is possible with various benefits provided by these automated and closed systems. Reduced possibility of errors at the time of bioprocessing and better cell handling abilities are some of the most prominent benefits of these systems. Thus, owing to these factors, the automated and closed cell therapy processing systems market has been expected to grow at a noticeable speed in the forthcoming years.

There has been increased availability of a wide range of systems in the global market. These systems provide automated integrated workflow solutions along with partial automation. In addition to this, these systems also enable constant monitoring of the controlled therapy processing. These initiatives are helpful for the development of various novel therapeutics platforms. Thus, based on these factors, the automated and closed cell therapy processing systems market is experiencing various growth avenues.

GET BROCHURE OF THE REPORT

Automated And Closed Cell Therapy Processing SystemsMarket: Competitive Dynamics and Key Developments

The key players serving in the automated and closed cell therapy processing systems market are using different development strategies to drive the growth avenues in the upcoming years. The strategies include mergers and acquisitions, technological partnerships and collaborations, product introductions and approvals, strategic initiatives, and regional expansion that are adopted by these market players to fuel lucrative opportunities in the market.

For instance, Brooks Life Sciences and Cytiva have agreed in order to extend their capabilities of automated cold chain in February 2021. These companies have been working together for the enhancement of capabilities of the automated cold chain system of Cytiva.

Some key players in the automated and closed cell therapy processing systems market are:

GET TABLE OF CONTENT OF THE REPORT

Automated And Closed Cell Therapy Processing SystemsMarket: Regional Assessment

The automated and closed cell therapy processing systems market has been spread across different geographical locations such as Europe, the Middle East & Africa, North America, Latin America, and Asia Pacific. Out of these areas, the North America region is expected to hold a significant share in the market revenue. The market dominance has been on the back of the rising adoption of the technology for cell therapy processing. In addition to this, rising emphasis on production and high precision is also fueling growth avenues in the market. Furthermore, rising demand for regenerative medicines and growing investments for R & D activities are also bolstering growth impetus in the automated and closed cell therapy processing systems market.

GET DISCOUNT ON THE LATEST REPORT

TMR Research has rich experience in developing state-of-the-art reports for a wide array of markets and sectors. The brilliance of the experts at TMR Research and their alacrity to conduct thorough research and create phenomenal reports makes TMR Research better than others.

5-Point Growth Formula

The 5-point growth formula developed by TMR Research provides an insight to the stakeholders and CXOs about the current situation in the market. The growth formula makes the report a perfect companion for the stakeholders and CXOs.

The 5-point growth formula includes the following points:

Current and Future Threats

Along with studying the opportunities necessary for growth, threats are also an important aspect to look upon for the companies and stakeholders in a specific sector. TMR Research studies every negative aspect that will hinder the growth of a specific area of business and includes it in the report. The stakeholders and CXOs will have the benefit of assessing the threat and take the necessary steps to prevent the hindrance caused due to the threats.

Accurate Trend Analysis

Keeping up with the latest trends is crucial in any business or sector. While stakeholders are aware of the trends that are on the surface, TMR Researchers find trends that are deeply entrenched in the particular market or sector. The reports are constantly updated with the latest trends so that the stakeholders and CXOs can derive benefits from the trends and generate good revenues.

Regional Assessment

Demography forms an important part of the growth pattern of all the markets. Diving deep into the demographics enables maximum output from specific areas. The TMR Research team assesses every region and picks out the vital points that have a large impact on the growth of a market.

Industrial Analogy

The analysts at TMR Research conduct an all-round analysis on the competitive landscape of the market. The observations recorded by the analysts are added to the reports so that every stakeholder gets a glimpse of the competitive scenario and frame their business plans according to the situation.

COVID-19 Impact

The COVID-19 outbreak has changed the growth projections of numerous sectors and businesses. The analysts at TMR Research have conducted a conscientious survey on the markets after the pandemic struck. The analysts have put forth their brilliant and well-researched opinions in the report. The opinions will help the stakeholders to plan their strategy accordingly.

The reports offer answers to the top 7 questions that revolve around the growth of the market

About TMR Research

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

Contact:

Rohit Bhisey

TMR Research,

3739 Balboa St # 1097,

San Francisco, CA 94121

United States

Tel: +1-415-520-1050

Visit Site: https://www.tmrresearch.com/

More here:
Automated and Closed Cell Therapy Processing Systems Market, 2031| Key Drivers | Current Trends | Industry Analysis - BioSpace

Elected officials, community members and University and industry leaders gathered on Hazelwood Green Thursday to celebrate a major step forward for the regional life sciences industry: an agreement to form a 30-year strategic partnership between Pitt and biotech company ElevateBio to accelerate the development of highly innovative cell and gene therapies at Pitt BioForge.

Through this agreement, ElevateBio will collaborate with Pitt to locate one of its next BaseCamp process development and Good Manufacturing Practice manufacturing facilities in Pittsburgh continuing the movement toward positioning Pittsburgh as a hub for the life sciences.

This announcement supports the regions rise as a leader in cell and gene therapy and advances our vision of bringing an entirely new commercial manufacturing sector to the area, said Pitt Chancellor Patrick Gallagher. The University of Pittsburgh is proud to partner with ElevateBio in this work, which will see us leveraging lessons from the lab in new and exciting ways for the benefit ofhuman health.

To realize our vision of transforming the cell and gene therapy field for decades to come, broadening our footprint across metropolitan areas is a key priority for us, and we are thrilled that the University of Pittsburgh will be home to one of our BaseCamp facilities, said David Hallal, chair and CEO of ElevateBio. Weve identified Pittsburgh as an ideal location to extend our BaseCamp presence as it sits at the intersection of science, technology and talent. We are grateful for the support of the governor and county executive as we bring the first-of-its-kind offering we have built at ElevateBio BaseCamp to advance the work of the entire biopharmaceutical industry.

The announcement was held Aug. 25 outside the Roundhouse at Hazelwood Green a building created to service trains delivering materials for the steel industry that now houses coworking space for startups. Speakers included Pennsylvania Governor Tom Wolf sporting a blue-and-gold tie, Pittsburgh Mayor Ed Gainey, Pennsylvania Rep. Aerion Andrew Abney and County Executive Rich Fitzgerald, along with key players from Pitt and ElevateBio and other leaders. The theme of the event: creating jobs and saving lives.

We have some exceptional emerging research coming out of the University of Pittsburgh. However, the missing ingredient has been access to high-quality process science and manufacturing capabilities, said Pitt Senior Vice Chancellor for the Health Sciences Anantha Shekhar. As we position ourselves to become the next global hub for life sciences and biotech, we were in search of the right partner to help us realize our vision, and ElevateBios expertise and reputation in cell and gene therapy made them the perfect partner to accelerate our ability to build our biomanufacturing center of excellence.

The partnership is expected to generate more than 170 permanent full-time jobs, 900 construction jobs and 360 off-site support jobs.

ElevateBio plans to lease 80,000 square feet of space from Pitt, expanding from its first site in Waltham, Massachusetts. The facility will include gene editing, induced pluripotent stem cell and cell, vector and protein engineering capabilities, with the company investing $35 million in the sites operation, including equipment and training.

ElevateBio is targeted to move into the facility in 2026, and in total the partnership is expected to generate more than 170 permanent full-time jobs, 900 construction jobs and 360 off-site support jobs along with lifesaving advances in the life sciences.

We are excited that Pitt, working with UPMC Enterprises, has attracted ElevateBio to this region, said Leslie Davis, president and CEO of UPMC. The companys expertise and manufacturing capabilities, combined with Pitt research and UPMCs clinical excellence, are essential to delivering the life-changing therapies that people depend on UPMC to deliver.

The Pitt BioForge Biomanufacturing Center was first announced with a $100 million grant from the Richard King Mellon Foundation to the University of Pittsburgh in November 2021, the largest single-project grant in the foundations 75-year history. The proposed facility will host advanced manufacturing for therapeutics, currently a key bottleneck in the process of bringing lifesaving therapies to clinical trials.

This partnership between two national life-science powerhouses the University of Pittsburgh and ElevateBio is a consequential step forward in realizing our shared vision to make Pittsburgh a national and international biomanufacturing destination, said Sam Reiman, Director of the Richard King Mellon Foundation. Pitt BioForge is a generational opportunity to bring extraordinary economic-development benefits to our region and life-changing cell and gene therapies to patients distribution that will be accelerated and enhanced by Pitts partnership with UPMC. ElevateBio could have chosen to locate its next biomanufacturing hub anywhere in the world; the fact they are choosing to come to Pittsburgh is another powerful validation of our region and the Pitt BioForge project at Hazelwood Green.

In addition, the commonwealth and Allegheny County have provided incentive grants to ElevateBio in support of this partnership to build a biomanufacturing center and establish Pittsburgh as a premier biomanufacturing destination.

This announcement is continued verification of Pittsburghs ability to attract new and emerging companies that provide economic opportunities in the life sciences field. The University of Pittsburgh and its medical school are a magnet for that ecosystem and along with this regions quality of life and investment in innovation, we continue to see businesses choosing Pittsburgh, said County Executive Rich Fitzgerald. The creation of the Innovation District, and the many companies that call it home, continue to provide great opportunities for talent to fill jobs across the ecosystems pipeline. We welcome ElevateBio to our region and look forward to all that you will do here as part of this great ecosystem.

Go here to see the original:
Pitt and ElevateBio are partnering to bring cell and gene therapy manufacturing to Pittsburgh - University of Pittsburgh

Treatment Is a Safe and Effective Alternative to Surgery and Laser Therapies

HACKENSACK, N.J., Aug. 29, 2022 /PRNewswire/ -- Urologists at Hackensack University Medical Centerhave become the first in northern New Jersey to offer an innovative treatment for benign prostatic hyperplasia (BPH) that uses a high-intensity waterjet to destroy (ablate) excess prostate tissue that causes uncomfortable urinary symptoms for many older men. Aquablationtherapy is an option for men whose prostate enlargement cannot be effectively treated using prostate-shrinking medications. Aquablation therapy is performed using the AquaBeam Robotic System, guided by real-time imaging to deliver treatment with extraordinary precision.

BPH is the most common reason men see a urologist. About half of all men aged 51-60 develop BPH, and the incidence rises with each decade of life. It causes symptoms that impair quality of life, such as trouble urinating, feeling like they cannot fully empty the bladder, and needing to urinate frequently including multiple overnight trips to the bathroom that can impact sleep.

Some 30-50 million men in the United States have BPH, 10-15 million of whom are actively managing their condition with medications (such as Flomax or Proscar) or other treatment. In more than one million men each year, BPH medications are not effective enough and patients need surgery. Most urologists counsel their patients to try medication for at least 4 weeks before resorting to surgery.

The most common surgical approaches are transurethral resection of the prostate (TURP), in which the prostate tissue is removed through the urethra, and GreenLightlaser surgery, which vaporizes prostate tissue. Both treatments may cause sexual side effects such as retrograde ejaculation, in which semen backs up into the bladder when a man ejaculates; in the case of laser treatment, as many as 90% of patients may experience this side effect. Flomax is also associated with this side effect, while Proscar can reduce sex drive and cause erectile dysfunction and hot flashes.

Aquablation therapy is indicated for any man whose prostate is causing an obstruction, and who cannot achieve relief with medication or does not want to take these drugs. "Aquablation therapy is as effective as these other minimally invasive treatments but with fewer side effects, including only a 10-15% risk of retrograde ejaculation," explained Ravi Munver, M.D., vice chair of Urology and division director of Minimally Invasive and Robotic Urologic Surgery at Hackensack University Medical Center. "Aquablation is performed using a robotic system with ultrasound guidance. As a result, the procedure can be completed rapidly and with a higher level of precision that is reproducible from surgeon to surgeon. The advantage of real-time ultrasound imaging is that a surgeon can see where the prostate tissue ends, which allows removal of more of the excess tissue. Aquablation therapy is the only heat-free and image-guided waterjet ablation approach that is available to treat BPH."

Here's how it works: The patient is asleep under anesthesia. An ultrasound probe is inserted into the patient's rectum to produce clear images of the prostate. The addition of ultrasound imaging enables the surgeon to map the parts of the prostate to remove and the parts to avoid. The Aquablation scope is inserted into the urethra. When ready to begin, the surgeon presses on a foot pedal and the Aquablation system advances throughthe prostate, delivering a heat-free waterjet so intense that it can remove the prostate tissue that has been mapped out. See a video of Aquablation in action.

"Depending on the size of the prostate, the resection time may take as little as 5 minutes," said Michael D. Esposito, M.D., Hackensack University Medical Center. Dr. Esposito explained that the patient stays in the hospital overnight with a urinary catheter and typically goes home as soon as the next day. Patients report feeling a reduction in BPH symptoms right away and are able to go off their BPH medications. "Aquablation achieves years of prostate relief, and we're thrilled to offer this new option to our patients."

High-tech treatments such as Aquablation therapy are best suited to centers with expertise and high volumes in the field of robotic surgery. "For years, Hackensack University Medical Center has been a national leader in the use of robotic surgery, especially for urologic procedures, and we have trained many other surgeons in its use," noted Michael Stifelman, M.D., chair of Urology. "We are proud to be the first in northern New Jersey to offer this innovative treatment to restore comfort and quality of life to men with BPH."

ABOUT HACKENSACK UNIVERSITY MEDICAL CENTER

Hackensack University Medical Center, a 781-bed nonprofit teaching and research hospital, was Bergen County's first hospital founded in 1888. It was also the first hospital in New Jersey and second in the nation to become a Magnet-recognized hospital for nursing excellence, receiving its sixth consecutive designation from the American Nurses Credentialing Center.The academic flagship of the Hackensack MeridianHealth network, Hackensack University Medical Center is Nationally-Ranked by U.S. News & World Report 2022-2023 in four specialties, more than any other hospital in New Jersey. The hospital is home to the state's only nationally-ranked Urology and Neurology & Neurosurgery programs, as well as the best Cardiology & Heart Surgery program. It also offers patients nationally-ranked Orthopedic care and one of the state's premier Cancer Centers (John Theurer Cancer Center at Hackensack University Medical Center). Hackensack University Medical Center also ranked as High-Performing in conditions such as Acute Kidney Failure, Heart Attack (AMI), Heart Failure, Pneumonia, chronic obstructive pulmonary disease (COPD), Diabetes and Stroke. As well as High Performing in procedures like Aortic Valve Surgery, Heart Bypass Surgery (CABG), Colon Cancer Surgery, Lung Cancer Surgery, Prostate Cancer Surgery, Hip Replacement and Knee Replacement. This award-winning care is provided on a campus that is home to facilities such as the Heart & Vascular Hospital; and the Sarkis and Siran Gabrellian Women's and Children's Pavilion, which houses the Donna A. Sanzari Women's Hospital and the Joseph M. Sanzari Children's Hospital, ranked #1 in the state and top 20 in the Mid-Atlantic Region in the U.S. News & World Report's 2022-23 Best Children's Hospital Report. Additionally, the children's nephrology program ranks in the top 50 in the United States. Hackensack University Medical Center is also home to the Deirdre Imus Environmental Health Center and is listed on the Green Guide's list of Top 10 Green Hospitals in the U.S. Our comprehensive clinical research portfolio includes studies focused on precision medicine, translational medicine, immunotherapy, cell therapy, and vaccine development. The hospital has embarked on the largest healthcare expansion project ever approved by the state: Construction of the Helena Theurer Pavilion, a 530,000-sq.-ft., nine-story building, which began in 2019. A $714.2 million endeavor, the pavilion is one the largest healthcare capital projects in New Jersey and will house 24 state-of-the-art operating rooms with intraoperative MRI capability, 50 ICU beds, and 175 medical/surgical beds including a 50 room Musculoskeletal Institute.

SOURCE Hackensack University Medical Center

Read the rest here:
Hackensack University Medical Center Becomes First in North Jersey to Offer Aquablation Therapy to Treat Enlarged Prostates - PR Newswire

OverviewMan seated in chair for CAR T-cell cancer treatment.What is CAR-T cell therapy?

Chimeric antigen receptor (CAR) T-cell therapy treats certain cancers by turning your T lymphocytes or T cells into more efficient cancer-fighting machines. While researchers are still collecting long-term data, CAR T-cell therapy is proving to be a very effective way of treating certain blood cancers.

Your T cells are white blood cells in your immune system. Your immune system monitors your body for intruders, including cancer (and also infected or other abnormal cells), by tracking proteins called antigens. Antigens are located on intruder cells surfaces. Your T cells have their own proteins called receptors. Receptors are like the anti-virus software on your computer. When your T cell security team senses intruder antigens, they use their receptors to catch and block the intruders. More than that, your T cells can kill the intruder cells.

But intruder antigens have their own form of protection. They can disguise themselves to hide from your T cells. CAR T-cell therapy ensures your T cells can get past intruder antigen disguises or defenses.

The U.S. Food and Drug Administration (FDA) has approved several CAR-T cell therapies for people who have certain blood cancers that dont respond to chemotherapy and other treatments. This therapy is also used to treat people who have blood cancer that returns after other successful treatments.

CAR-T cell therapy is offered through special programs called risk evaluation and mitigation strategies (REMS). REMS ensure healthcare providers are certified to provide the therapy and have the know-how to manage any serious side effects.

Here is information on the cancers now treated with CAR-T cell therapy:

B-cell non-Hodgkin lymphoma, including:

Diffuse large B-cell lymphoma (DLBCL).

Follicular lymphoma with DLBCL.

High-grade B-cell lymphoma.

These conditions are usually treated with chemotherapy, monoclonal antibodies and stem cell transplant.

Tisagenlecleucel.

Axicabtagene Ciloleucel (pronounced AK-see-KAB-tuh-jeen sy-lo-LOO-sel). Brand name: Yescarta.

Researchers are investigating whether CAR-T cell therapy can help people who have other cancers like breast cancer, brain cancer and lung cancer.

CAR-T cell therapy is a relatively new treatment. As of 2019, 130 U.S.-based medical centers were authorized to provide it. All told, those centers had treated fewer than 2,000 people with CAR-T cell therapy.

The CAR-T cell process starts with collecting your blood. Heres a step-by-step explanation:

Most people need to stay in the hospital for a week to 10 days so their healthcare providers can monitor their response to the treatment and treat any side effects. You may be able to receive your CAR-T cells without staying in the hospital. If thats your situation, your healthcare providers will still monitor your progress and the process. If you have side effects, you may need to return to the hospital to complete your treatment.

Healthcare providers and regulatory agencies evaluate CAR-T cell therapy on a case-by-case basis. Generally speaking, the U.S. Food and Drug Administration (FDA) approves these therapies after clinical trials show significant success in treating specific cancers.

For example, the FDA recently approved CAR-T cell drug idecabtagene vicleucel (Abecma) to treat multiple myeloma after a clinical trial showed this treatment partially or completely shrank tumors in 72% of people participating in the trial. The treatment effect lasted about 11 months.

CAR-T cell therapy isnt perfect. Sometimes, CAR-T cell therapy doesnt kill cancer cells as expected. Sometimes, the treatment works, but the cancer comes back. Some reasons why CAR-T cell therapy may not work include:

Like most cancer treatments, CAR-T cell therapy has side effects that can, at times, cause serious life-threatening problems. The two most common side effects are cytokine release syndrome and neurological problems.

Cytokine release syndrome (CRS) can happen after youve received your CAR-T cells and they start multiplying and attacking cancer cells. Cytokines are chemicals that trigger your immune system. When your CAR-T cells start to work, your immune system may respond by releasing large amounts of cytokines into your bloodstream. Most of the time, CRS happens in the first week or two after treatment.

If you have this syndrome, you may feel as if you have the flu. CRS symptoms include:

CAR-T cell therapy can affect your nervous system, causing symptoms that happen in the first few weeks after your treatment. Some symptoms can affect your ability to drive or operate machinery, so you should plan to avoid those activities for eight weeks after your treatment. Neurological symptoms include:

CAR-T cell therapy can cause significant or life-threatening side effects. Thats why healthcare providers usually require people who have this treatment to stay in the hospital for several days so healthcare providers can monitor and manage any side effects.

For the first month after treatment, you should plan on having someone with you 24 hours a day. You should also plan on staying within driving distance of your treatment location. And you should plan on having someone drive you where you need to go for two months after treatment.

Its still early days for CAR-T cell therapy, but studies continue showing positive results. For example, a 2020 study tracked children who had acute lymphoblastic leukemia (ALL). More than 85% of the children with ALL had complete remission right after treatment and 60% of those children remained free of cancer 12 months after treatment.

And, researchers are aggressively pursuing new insight into CAR-T cell therapy. As of March 2020, CAR-T cell was the focus of more than 800 studies. Examples of current research include:

CAR-T cell therapy has significant side effects. Once youre home from the hospital, you should monitor changes in your body and contact your healthcare provider if you develop side effects.

CAR-T cell therapy is expensive. It can cost healthcare providers up to $1 million to treat one person. The amount you may need to pay for treatment depends on your individual circumstance, such as your insurance coverage and whether you qualify for Medicare. If your healthcare provider recommends CAR-T cell therapy, theyll probably suggest that you work with hospital financial advocates to understand your specific situation.

A note from Cleveland Clinic

CAR-T cell therapy is breaking new ground and bringing new hope for some people who have certain blood cancers that dont respond to chemotherapy or other initial treatments. Its also used for people whose blood cancer has come back. But CAR-T cell therapy has potentially life-threatening side effects. And while it helps many people, its too soon to say if CAR-T cell therapy can cure the blood cancers that it targets. If you have blood cancer, ask your healthcare provider if your cancer might be treated with CAR-T cell therapy.

Read more from the original source:
CAR T-Cell Therapy: Procedure, Prognosis & Side Effects - Cleveland Clinic

Chimeric Antigen Receptor T-cell (CAR T-cell) therapy is a new approach to fighting cancer using the patients own immune system.

Certain immune system cells, called T-cells or T-lymphocytes, are normally able to identify abnormal cells, like cancer cells, and destroy them before they multiply and cause disease. Sometimes, however, T-cells have trouble detecting cancer cells.

CAR T-cell therapy removes T-cells from the blood and inserts a new gene into them to make it easier for the T-cells to fight cancer. The new cells are called CAR T-cells.These CAR T-cells arethen infused into the patient to fight cancer.

As of August, 2022 the FDA has approved the following CART-cell therapies for patients who relapsed, or did not respond totreatment, after several rounds of chemotherapy:

The specific CAR T-therapy available to you will vary dependingon the medical center where you are receiving treatment. Your insurance plan may limit coverage to specific CAR T-therapies.

Your treatment center mayoffer you an opportunity to participate in a clinical trial testing anew type of CAR T-cell therapy.Research is underway to determine if patients with other typesof cancer such as chronic lymphocytic leukemia (CLL), acutemyeloid leukemia (AML), Hodgkin lymphoma andsome solidtumors can also benefit from CAR T-cell therapy.

NEXT: Steps Involved in CAR T-cell Therapy

Updated August, 2022

Language English

Read more from the original source:
What is CAR T-cell Therapy? | BMT Infonet - BMT Infonet |

Editors note: BioPharma Dive, as part of its newly launched Emerging Biotech Weekly, is taking a closer look at competitive areas of startup activity. We aim to give an overview of the companies developing a new technology and what their goals are. This, on regulatory T cell therapy, is our second.

Twelve years ago, Bill Ludwig and Doug Olson were running out of options when they enrolled in a clinical trial at the University of Pennsylvania.

They had chronic lymphocytic leukemia, a type of blood cancer, and their disease had progressed despite several treatments. They became the first volunteers to receive what would become known as CAR-T therapy, a cutting-edge treatment that turned their own immune cells into cancer killers.

CAR-T therapy drove both Ludwigs and Olsons tumors into remission, a finding that opened a new frontier in cancer drug research. More than a decade later, Olson remains cancer free, and Ludwig was, too, when he died from COVID-19 last year, researchers reported in February. Over that time, CAR-T therapy has gone from an academic research project to a growing class of medicines, with multiple products approved to treat several blood cancers.

Researchers and drugmakers now aim to test whether cell therapy can similarly impact other diseases. One strategy now reaching clinical testing could lead to a new way to attack autoimmune conditions like rheumatoid arthritis and Type 1 diabetes. The approach involves genetically modifying a different type of immune cell than the ones at the heart of CAR-T therapy, but holds a similar goal: a treatment with powerful and potentially curative benefit.

Over the past four years, a group of biotechnology companies have formed to develop these treatments, known as regulatory T cell, or Treg, therapies. Several have raised substantial funding. Larger drugmakers have begun to show interest, too. Heres where things stand:

Regulatory T cells are a specialized type of immune cell. They guard the body from attacking itself and prevent the malfunctions that lead to inflammatory conditions.

Those characteristics make Tregs an intriguing option for cell therapy, where, in theory, they could be harnessed to restore order to the immune systems of patients whose internal defenders have gone rogue.

The idea has intrigued researchers for decades. Academic studies of Treg cells trials in which a persons cells were removed, multiplied and re-infused date back to 2004, according to Nature. But in those early studies, the experimental treatments werent very effective for patients receiving organ transplants or with autoimmune diseases.

Drug researchers and biotechnology companies now have more tools at their disposal, however. CAR-T therapy showed an effective treatment could be made by genetically manipulating a patients T cells to add a receptor that binds to a protein flag, or antigen, on the surface of tumors. That blueprint, along with advances in gene editing technologies and manufacturing capabilities, has made it possible for researchers to envision similar medicines being made with Treg cells.

In theory, these therapies would train Treg cells to seek out antigens on inflamed tissue and then use their multifaceted capabilities to suppress wayward immune responses. One Sangamo Therapeutics treatment in early human testing, for instance, engineers the cells to target an antigen on the surface of cells in a newly implanted kidney.

But there are challenges awaiting Treg cell therapy developers, among them identifying the right antigens and ensuring the new cells dont start causing damage themselves. For example, CAR-T treatments are associated with a potentially fatal immune reaction, but theyre being used to treat deadly cancers, not chronic health conditions.

Its also unclear how long the effects of a Treg cell therapy would last, as some research has shown transplanted cells have trouble persisting.

Autoimmune diseases like multiple sclerosis, rheumatoid arthritis and Type 1 diabetes are treated with a variety of medicines meant to help slow their progression or ease symptoms. Patients who receive organ transplants, meanwhile, typically take a lifelong regimen of immunosuppressive drugs.

In each case, there is room for improvement. Drugs like Humira that are used to treat a range of inflammatory diseases can leave patients vulnerable to infections and may increase the risk of certain malignancies.

Long-term use of immunosuppressive drugs to thwart organ rejection can also lead to heart disease or cancer. A 2018 paper published in the Journal of Nephrology found that, between 1996 and 2014, heart disease was the leading cause of death among U.S. kidney transplant recipients.

Safety concerns involving cardiovascular and cancer risk have also been linked to a newer class of oral drugs for inflammatory diseases, leading the Food and Drug Administration to limit their use last year.

By comparison, Treg cell therapies are meant to help the body return to normal, potentially permanently, and without leaving its defenses compromised. For a kidney transplant recipient, treatment could train the immune system to accept the new organ rather than fight it. In autoimmune disease, a Treg cell therapy might reprogram the immune system to stop its attack without simultaneously compromising its ability to fight infections.

At least five biotech companies have launched in recent years, raising hundreds of millions of dollars in funding. Other more established companies are in the mix, too.

The first was Kyverna Therapeutics, which was formed in 2018 and backed by Westlake Village BioPartners, Vida Ventures and Gilead Sciences, one of the industrys top cell therapy developers. The company was co-founded by Jeffrey Greve, who started another biotech focused on autoimmune diseases, Delinia, that was acquired by Celgene in 2017.

Kyverna was joined next by Quell Therapeutics, a U.K.-based biotech formed by immunology experts at three universities in England and seeded by healthcare company creator Syncona.

SOURCE: Company press releases

The most richly funded so far is Sonoma Biotherapeutics, a startup launched by prominent immunologist Jeffrey Bluestone, who in 2019 left the Parker Institute for Cancer Immunotherapy to run the company. The startup has raised more than $335 million from a wide range of investors including Arch Venture Partners, the venture arm of Eli Lilly and the cell therapy biotech Lyell Immunopharma.

GentiBio was seeded by OrbiMed, RA Capital Management, Novartiss venture fund and Seattle Childrens Research Institute in 2020. The startup emerged publicly with a $157 million Series A round one year later and is steered by Adel Nada, the former head of clinical development at gene editing specialist Intellia Therapeutics.

More recently, in 2021, Abata Therapeutics was launched by Third Rock Ventures and ElevateBio. Co-founded by Diane Mathis, a Harvard Medical School immunology professor and expert on Treg biology, the company is headed by Samantha Singer, a former executive with the Broad Institute of MIT and Harvard and Biogen.

Sangamo Therapeutics, a publicly traded biotech best known for its zinc finger gene editing technology, has pursued Treg cell therapy since 2018, when it acquired French biotech TxCell. A Maryland startup named TeraImmune and AZTherapies, an Alzheimers disease-focused company with a cell therapy platform, are also pursuing Treg cell therapy.

Sangamos kidney transplant treatment is the first of the new group of Treg cell therapies to reach clinical testing, with a Phase 1 trial that began in late March.

Others involved in the field are still in preclinical testing, but have started to make their development plans clear.

Quell is working on a treatment for patients whove undergone a liver transplant, while Sonoma is developing a cell therapy for rheumatoid arthritis. Kyverna is eyeing autoimmune diseases such as lupus nephritis and systemic sclerosis, and has deals in place with both Gilead and Intellia. It aims to start clinical development of one candidate this year.

GentiBio is targeting diabetes with its most advanced program and this month struck a partnership with Bristol Myers Squibb to develop a treatment for inflammatory bowel disease.

Abata aims to have candidates for multiple sclerosis, Type 1 diabetes and an inflammatory condition called inclusion body myositis in human trials by 2025.

Originally posted here:
'Treg' cell therapy: bringing CAR-T to autoimmune disease - BioPharma Dive

After receiving CD19 chimeric antigen receptor T-cell therapy (CART19), patients with relapsed or refractory large B-cell lymphomas (rrLBCL) can have long-term remission. But more than 50% of patients do not respond to therapy. In order to identify high-risk patients who could benefit from alternative or consolidative therapy, methods were required.

Prior to CART19, researchers assessed low-pass whole-genome sequencing (lpWGS) of cell-free DNA (cfDNA) as a fresh method for risk categorization. In order to identify DNA copy number alterations (CNAs), they conducted lpWGS on pretreatment plasma samples from 122 patients at the time of leukapheresis who received standard-of-care CART19 for rrLBCL. High focal CNA scores (FCS), which indicated genomic instability, were the most important pretreatment factor in the multivariable selection and were negatively correlated with 3-month complete response rates (28% vs. 56%, P=.0029), progression-free survival (PFS; P=.0007; hazard ratio, 2.11), and overall survival (OS; P=.0026; hazard ratio, 2.10).

In 108 (89%) patients, they found 34 distinct focal CNAs; the deletion of 10q23.3, which results in the loss of the FAS death receptor, was most strongly related to poor outcomes, resulting in worse PFS (P<.0001; hazard ratio, 3.49) and OS (P=.0027; hazard ratio, 2.68) in both patients. They developed a straightforward risk model that could accurately risk stratifying patients by integrating FCS with conventional indicators of increasing tumor mass (elevated lactate dehydrogenase and >1 extranodal site).

As a result, lpWGS of cfDNA was a minimally invasive assay that might quickly identify high-risk patients and help determine which patients to choose from and which targeted medicines to test in upcoming clinical trials.

Reference: ashpublications.org/blood/article/140/5/504/485178/Risk-assessment-with-low-pass-whole-genome

Go here to see the original:
Risk Assessment with lpWGS of cfDNA Before CD19 CAR T-cell Therapy for LBCL - Physician's Weekly

Seasoned pharmaceutical industry executive to lead Tessas corporate and development strategy built around its proprietary autologous and allogeneic CAR-T platforms

Appointment follows Tessas recent US$126 million financing and precedes several clinical and data milestones expected during the second half of 2022 and early 2023

SINGAPORE, Aug. 22, 2022 (GLOBE NEWSWIRE) -- Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, today announced the appointment of Thomas Willemsen as its President and Chief Executive Officer effective October 1, 2022. Mr. Willemsen has also been named as a member of Tessas Board of Directors.

Mr. Willemsen brings more than 25 years of experience to Tessa with extensive international management and leadership experience in the pharmaceutical industry. He joins Tessa from Takeda Pharmaceuticals, where he served as Senior Vice President, Asia Pacific, leading the transformation of Takeda across 10 markets and enhancing its focus on rare and genetic diseases, oncology, and vaccines.

As President and CEO, Mr. Willemsen will lead Tessas corporate, business and development strategy focused on maximizing the value potential of the companys proprietary autologous and allogeneic CAR-T platforms, including ongoing clinical programs involving its autologous CD30-CAR-T therapy (TT11) and allogeneic CD30.CAR EBVST therapy (TT11X). Mr. Willemsen will lead Tessa from its global headquarters in Singapore. John Ng, who had served as Tessas acting CEO since November 2021, will continue as the companys Chief Technical Officer.

Tessa is extremely pleased to add an executive of Thomas caliber as our new President and CEO, coming at a time of significant optimism at the company as we pursue a multi-tier development strategy built around our proprietary CAR-T technologies and fueled by the recently completed US$126 million financing, stated Gran Ando, M.D., Chairman of the Board of Tessa Therapeutics. Thomas career is highlighted by senior leadership positions at several global pharmaceutical companies, including Takeda, GlaxoSmithKline and Merck KGaA. His combination of executive experience at global pharma companies and deep understanding of commercialization and oncology makes Thomas an ideal executive to lead Tessas next stage of growth.

Prior to Takeda, Mr. Willemsen held the position of Vice President, Oncology, at GlaxoSmithKline (GSK) for its Intercontinental & Emerging Markets business, where he was assigned to develop the business strategy for Asia & Emerging Markets, including Access Strategy and Commercial Structure design. Prior to that, Mr. Willemsen served as Chairman and General Manager for GSK in China, and as General Manager of GSK Taiwan. He also spent 12 years with Merck KGaA in various commercial and regional roles in the Asia Pacific region, and as the Head of its German Oncology business unit.

Mr. Willemsen graduated with an MBA from Trier University, Germany, and attained a Chinese Language Degree from Sun Yat-Sen University, Guangzhou, China. He speaks German, English, and Mandarin.

Tessa is at the forefront of developing the next generation of CAR-T therapies, including our allogeneic off-the-shelf EBVST technology, which has demonstrated very encouraging safety and efficacy data in the ongoing Phase 1/2 clinical trial in CD30 positive lymphomas, said Mr. Willemsen. I look forward to working with the entire Tessa team and continuing the positive progress with our CAR-T programs as we strive to ultimately bring these important therapies to patients with high unmet medical needs.

Dr. Ando concluded, On behalf of Tessa, I would like to commend John Ng for serving as our acting CEO during the past several months. Under Johns leadership, Tessa achieved numerous clinical and business successes, including the close of the Series A financing and the recent initiation of a clinical trial of TT11 in combination with nivolumab, which has the potential to introduce TT11 as a second-line therapy for relapsed and refractory CD30+ classical Hodgkin lymphoma patients.

About Tessa Therapeutics

Tessa Therapeutics is a clinical-stage biotechnology company developing next-generation cell therapies for the treatment of hematological cancers and solid tumors. Tessas lead clinical asset, TT11, is an autologous CD30-CAR-T therapy currently being investigated as a potential treatment for relapsed or refractory classical Hodgkin lymphoma as both a monotherapy (Phase 2) and combination therapy (Phase 1b). TT11 has been granted RMAT designation by the FDA and access to the PRIME scheme by European Medicine Agency. Tessa is also advancing an allogeneic off-the- shelf cell therapy platform targeting a broad range of cancers in which Epstein Barr Virus Specific T Cells (EBVSTs) are augmented with CD30-CAR. A therapy using this platform is currently the subject of a Phase 1 clinical trial in CD30-positive lymphomas. Tessa has its global headquarters in Singapore, where the company has built a state of the art, commercial cell therapy manufacturing facility. For more information on Tessa, visit http://www.tessacell.com.

Cautionary Note on Forward Looking Statements

This press release contains forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, to the fullest extent applicable) including, without limitation, with respect to various regulatory filings or clinical study developments of the Company. You can identify these statements by the fact that they use words such as anticipate, estimate, expect, project, intend, plan, believe, target, may, assume or similar expressions. Any forward-looking statements in this press release are based on managements current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the Companys financial results, the ability to raise capital, dependence on strategic partnerships and licensees, the applicability of patents and proprietary technology, the timing for completion of the clinical trials of its product candidates, whether and when, if at all, the Companys product candidates will receive marketing approval, and competition from other biopharmaceutical companies. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made, and disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Companys views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The Companys products are expressly for investigational use pursuant to a relevant investigational device exemption granted by the U.S. Food & Drug Administration, or equivalent competent body.

Tessa Therapeutics Investor Contact

Wilson W. CheungChief Financial Officerwcheung@tessacell.com

Tessa Therapeutics Media Contact

Tiberend Strategic Advisors, Inc.Bill Borden+1-732-910-1620bborden@tiberend.com

Dave Schemelia+1-609-468-9325dschemelia@tiberend.com

Excerpt from:
Tessa Therapeutics Appoints Thomas Willemsen as President and CEO - GlobeNewswire