Category Archives: Cell Therapy

PRINCETON, N.J.--(BUSINESS WIRE)--May 15, 2024--

Bristol Myers Squibb (NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Breyanzi is also now included in the National Comprehensive Cancer Network (NCCN ) Clinical Practice Guidelines in Oncology (NCCN Guidelines ) for B-cell Lymphomas as a Category 2A recommendation for third-line and subsequent therapy for relapsed or refractory FL.*

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Bristol Myers Squibb's CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed ... - The Bakersfield Californian

The cell therapy technologies market is consolidated, with a small number of players competing for market shares. Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany

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Here are a few key points about the cell therapy technologies market based on the information you provided:

* The global cell therapy technologies market was valued at $4.2 billion in 2023. * The market is expected to grow at a CAGR of 13.3% from 2023 to 2028. * By 2028, the market is projected to reach $7.8 billion. * Major growth drivers include the rising prevalence of chronic diseases, increasing research funding, and new product launches by key players. * The high growth rate indicates this is a rapidly expanding market, likely fueled by rising demand for cell therapies to treat diseases like cancer and diabetes. * Key companies operating in this market are developing new cell therapy technologies and expanding their product portfolios. * North America and Europe are likely leading regions in the cell therapy technologies market due to high healthcare spending, research infrastructure, and favorable regulations.

In summary, the cell therapy technologies market is in a high-growth phase and expected to see continued expansion over the next 5 years driven by key factors like chronic diseases, research investments, and new product development. The market size is projected to nearly double from 2023 to 2028.

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Key Market Players:

The cell therapy technologies market is consolidated, with a small number of players competing for market shares. Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Lonza Group (Switzerland)Danaher Corporation (US), Sartorius AG (Germany) are some of the leading players in this market. Most companies in the market focus on organic and inorganic growth strategies, such as product launches, expansions, acquisitions, partnerships, agreements, and collaborations, to increase their product offerings, cater to the unmet needs of customers, increase their profitability, and expand their presence in the global market.

Recent Developments:

* In March 2023, Thermo fisher scientific Inc. entered into collaboration with Arsenal biosciences Inc. The collaboration allows development of manufacturing process for new cancer treatments. This research and process development-focused collaboration has enabled ArsenalBio to develop a robust manufacturing process for their next-generation, programmable autologous T cells for the treatment of cancer. * In March 2023, Danaher entered into partnership with the University of pennsylvania's center for cellular immunotherapies to solve manufacturing difficulties that are affecting the adoption of cell therapies. * In March 2023, Lonza and Vertex have entered a strategic collaboration to facilitate the manufacturing of Vertex's portfolio of investigational stem cell-derived islet cell therapies. As part of the collaboration, Vertex and Lonza will establish a dedicated manufacturing facility specifically for T1D cell therapies.

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Media Contact Company Name: MarketsandMarkets Trademark Research Private Ltd. Contact Person: Mr. Aashish Mehra Email:Send Email [https://www.abnewswire.com/email_contact_us.php?pr=cell-therapy-technologies-market-a-comprehensive-guide-to-industry-trends-and-developments] Phone: 18886006441 Address:630 Dundee Road Suite 430 City: Northbrook State: IL 60062 Country: United States Website: https://www.marketsandmarkets.com/Market-Reports/cell-therapy-technologies-market-213334978.html

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Cell Therapy Technologies Market: A Comprehensive Guide to Industry Trends and Developments - openPR

Getting to Know Cells

Cells make up every living thing. Inside of each cell are genetic instructions which determine what cell type it will be, and how the cell will behave. All individuals begin with a pool of cells that are the foundation cells for every organ and tissue in the body. These cells are called stem cells which are immature cells that will divide into many different types of mature, specialized cells depending on what the body needs this is called differentiation. During this process, a set of genes in the DNA of each cell are turned on or off to determine what type of cell it will turn into and what type of proteins it will create to help the body function. For example, a stem cell may be instructed, directly or indirectly, by the genes to travel to an area of the body for muscle contraction. These will become muscle cells and continue to divide and play a role in contracting ones muscles for movement. Once a stem cell becomes a mature cell, it will stay that cell type. Throughout one's life, stem cells turn into mature cells, but certain parts of the body will keep their own supply of stem cells, such as in our bone marrow.

The processes of cell growth, division, and differentiation can be complex. When cells grow old or become damaged, they usually die, and new cells get created to divide and to take their place. However, there are times when the body is not able to recognize a cell change, and a damaged cell continues to replicate with changed DNA. A change in the DNA changes how our cells function because it affects how the proteins in our body are built. These changes can be inherited, can happen as we age, or can be caused by environmental factors.

Many human diseases are caused by our cells not functioning properly. For example, in some types of cancer, specific cells in the body get stuck somewhere along the long path of differentiation, creating a shortage of the cell type they had intended to make. The body then tries to compensate for this shortage by having these potentially damaged cells divide many times to fill the gap. This adds to the problem by filling up the tissue with non-functional cells that will take over the normal healthy cells to survive.

Cell therapy is the transfer of a specific cell type, or types, into a person to treat or prevent a disease. Many cell types have the potential to be modified and used as a therapy. Common disorders treated with cellular therapies include cancers of the blood and bone marrow, cancers of the lymphatic system, plasma cell disorders, and other conditions that affect the bodys ability to make healthy cells.

The source of the cells used for cell therapy come from one of two places:

Autologous cell therapy means the cells are collected from the individual's own body. The cells are removed, modified outside the body, then the processed cells are returned to the body. Using the person's own cells makes it less likely to cause immune responses compared to the use of donor cells but will not always be a viable option. A helpful tip to remember is that auto means self.

Allogeneic cell therapy means the cells used are from someone other than the patient, such as a healthy and compatible (or matched) donor. A helpful tip to remember this is that allo means other.

Prior to receiving a cell therapy, an individual may need to follow a pretreatment called conditioning to decrease the immune system's activity for better odds of a successful treatment. Conditioning is often a chemotherapy, which can be extremely hard on the body. It is important that all aspects of the treatment process be thoroughly explained by a healthcare professional to ensure it is well understood by the patient.

Gene modified cell therapy (or ex vivo gene therapy) is a combination of both gene and cell therapy. It first removes a persons own cells from the body. Certain cell types are then treated by either adding a working copy of the gene or modifying/editing the affected nonfunctional gene. Ideally, the body will continue to produce mature cells with the modification when administered back to the individual. CART-cell therapy is just one example of this, but other approved treatments include cells that are modified with lentivirus for disorders such as server combined immunodeficiency (SCID), and metachromatic leukodystrophy (MLD).

Learn more about gene therapy basics and various gene and cell therapy approaches.

The type of cells used for cell therapy depends on the disease being treated and the intended effect on the individual receiving treatment. Here are few commonly used types:

Hematopoietic (blood forming) stem cells also known as HSCs are versatile cells that can turn into any type of blood cell the body needs and can be retrieved from the peripheral blood, from the bone marrow or from umbilical cord blood. Treatments using these cells aim to establish healthy blood cell production in individuals whose blood cells or immune cells are not working properly. A hematopoietic stem cell transplantation (HSCT), sometimes known as a bone marrow transplant (BMT), is used to treat various blood cancers and other blood disorders. HSCs are usually from a donor (allogeneic), but in some cases may use cells collected from the persons own body (autologous).

Cells of the immune system are used because they can recognize and kill cancer cells. One type of cell therapy, called CAR T-cell therapy, modifies the individual's immune cells called T-cells by adding receptors to them. When these modified cells are delivered back to the patient, they recognize, and kill cancer cells. CAR-T typically uses a persons own cells (autologous) but in some cases, may utilize cells collected from a donor (allogenic).

Learn more about blood disorders and this treatment process in CAR T Basics.

Mesenchymal stem cells, most commonly found in bone marrow and fat, are the most versatile and can help the body heal in different ways depending on what is being targeted. They can act like stem cells and become the same type of cell as those in the surrounding area or act like a delivery system to bring medicine to the area in need.

Hope for life-limiting disease.Cell and gene therapy can help treat diseases that have limited treatment options. Without treatment many of these inherited disorders would end in severe disability or premature death. In early studies cell and gene therapy have been shown to help slow or completely stop these disorders. Cell and gene therapies make it possible to design treatments that can target any of the thousands of genes in the body.

Matched donors. Similar to human organ transplants, immune barriers exist that require the person donating the HSC and person receiving the HSC to be carefully matched to avoid life-threatening complications arising from immune system not matching. Many individuals may never find someone who is a match due to lack of recruitment, diversity, and availability.

Accuracy required.Cell and genetherapies need to ensure modified cells go to the right tissue, at the right level, for the right amount of time. This means that a lot of research goes intothe best waytodeliver the cellular material.

Immune suppression. Chemotherapy and other conditioning regimens are often administered prior to cell therapy to prevent an immune response. The medications used to suppress an individuals immune system can increase their risk for infections and can be quite hard on the body.

Informed consent. Before participating in a clinical trial or receiving a cell therapy treatment, a member of the research team should review any potential risks and benefits with the individual and/or caregiver. It is important that individuals participating in a clinical trial understand their rights during the research process and know what to expect.

Immune responses. Graft-versus-host disease (GVHD), a syndrome that arises when immune cells present in the, transplanted HSC (the graft) recognize the recipient/hosts cells/tissues as foreign and mount an immune response that leads to the destruction of multiple host tissues.

Organ toxicities. During CAR-T therapy, immune system cells become stimulated and release chemical messengers called cytokines. Too many cytokines can result in fever, trouble breathing and can be life-threatening. In the case of cytokine release syndrome, individuals may require anti-cytokine therapy.

Next, visit CAR T Basics to learn more about approved cell therapies, and cell therapy use in disease treatments for blood disorders.

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Cell Therapy Basics

Meet the new medicines, page 5

In CAR-T cell therapy, immune cells are removed from a patient, genetically modified, then put back into the patient to fight against cancer. This approach has met with substantial success against blood cancers. For example, one CAR-T cell therapy, approved in August 2017, is now being used to treat children with acute lymphoblastic leukemia.

In cell transplants, patients are given functional cells as a replacement. When patients with blood cancers undergo chemotherapy, their blood stem cells get destroyed. Afterward, they receive a transplant of blood stem cells collected either from themselves before chemotherapy or from a separate donor so that they can continue to make blood.

Examples of cell replacement therapies that are in the early stages of clinical study include:

A different type of cell therapy takes advantage of certain cell properties to deliver drugs. For example, cancer cells have a self-homing ability, moving around the body to find tumors and spread. An HSCI scientist has co-opted this ability, using cancer cells to deliver tumor-killing proteins.

Another example is mesenchymal stem cells, which are attracted by inflammation and can home to a site of injury. They can be used to deliver small-molecule or biologic drugs.

Many cell therapies that have reached the stage of clinical trials are bespoke to each patient. Because the cells come from patients themselves, this is referred to as autologous.

Because of this, manufacturing is never done in bulk quantities just one batch per patient. This process needs to be highly controlled and accurate, and the success rate extraordinarily high for a very small number of patients. However, it is currently a very expensive process, in part because each product made is the full run.

Other types of cell therapies make use of cells from another person, and are called allogeneic. The manufacturing and regulatory advantage is having a product that can cover many people. But the medical risk is that the cells will be identified as foreign and rejected by the immune system in the absence of a way to protect the them from the immune attack.

HSCI scientists are working on a couple of ways to create cell therapies that would not be rejected by the immune system:

If cell therapy is ever going to be available to large numbers of people, we will need disruptive breakthroughs in academic, commercial, and industrial research and development.

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Cell therapies | Harvard Stem Cell Institute (HSCI)

SAN DIEGO, April 13, 2023 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that two key industry opinion leaders and management will participate in Oppenheimer & Co.’s Virtual Fireside Chat: Discussion of ROR1 CAR-T Cell Therapy in Hematological Malignancies and Solid Tumors on Tuesday, April 18, 2023 at 1:30 p.m. EDT.

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Oncternal Therapeutics Participating in Oppenheimer & Co.’s Virtual Fireside Chat: Discussion of ROR1 CAR T Cell Therapy in Hematological...

Approved oral medications

Two oral medications are FDA-approved for treating adults with very rare cases of advanced BCC that are large or have penetrated the skin deeply, spread to other parts of the body or resisted multiple treatments and recurred.

Vismodegib (Erivedge)Sonidegib (Odomzo)

Both medications are targeted drugs taken by mouth. They work by blocking the hedgehog signaling pathway, a key factor in the development of BCC. In 2012, vismodegib became the first medicine ever approved by the FDA for treating advanced BCC. A second hedgehog pathway inhibitor (HHI) drug, sonidegib, was approved for advanced BCC in 2015.

Vismodegib is used for the extraordinarily rare cases of metastatic BCC or locally advanced BCC (tumors that have penetrated the skin deeply or frequently recurred) that either recur after surgery or radiation, or cannot be treated with surgery or radiation and have become dangerous or life-threatening.

Sonidegib is used in adults with BCC that is locally advanced, penetrating the skin deeply or repeatedly recurring, as well as in cases when other treatments such as surgery or radiation cannot be used.

Due to a risk of birth defects, women who are pregnant or may become pregnant should not use either drug. Couples must use birth control if the woman is capable of becoming pregnant while her partner is taking the medication.

Scientists are also investigating several other targeted hedgehog inhibitors as potential treatments for locally advanced and metastatic BCC.

In February 2021, the U.S. Food and Drug Administration (FDA) approved the intravenous immunotherapy medication,cemiplimab-rwlc(Libtayo) for treating patients with certain forms of advanced basal cell carcinoma.

Cemiplimab-rwlc(Libtayo)

Cemiplimabis a type of immunotherapy known as a checkpoint blockade therapy, which works by harnessing the power of the immune system to battle cancer. Under normal conditions, the immune system uses checkpoints, which are molecules that suppress production of T cells, the white blood cells that help protect the body from infection. These checkpoints keep T cells from overproducing and attacking normal cells in the body. However, cancer cells have the ability to keep those checkpoints active, suppressing the immune system so the cancer can grow and thrive. Cemiplimabblocks a particular checkpoint called PD-1 from working, so the immune system can releasemassive amounts of T cells to attack and kill cancer cells.

Find out more aboutcemiplimab.

Cemiplimabis used to treat patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted for patients with locally advanced BCC and accelerated approval was granted for patients with metastatic BCC.

Link:
Basal Cell Carcinoma Treatment - The Skin Cancer Foundation

How Cellular Immunotherapies Are Changing the Outlook for Cancer Patients

Reviewed By:

Philip D. Greenberg, MD.Fred Hutchinson Cancer Research Center

Some of these approaches involve directly isolating our own immune cells and simply expanding their numbers, whereas others involve genetically engineering our immune cells (via gene therapy) to enhance their cancer-fighting capabilities.

Our immune system is capable of recognizing and eliminating cells that have become infected or damaged as well as those that have become cancerous. In the case of cancer, immune cells known as killer T cells are particularly powerful against cancer, due to their ability to bind to markers known as antigens on the surface of cancer cells. Cellular immunotherapies take advantage of this natural ability and can be deployed in different ways:

Today, cell therapies are constantly evolving and improving and providing new options to cancer patients. Cell therapies are currently being evaluated, both alone and in combination with other treatments, in a variety of cancer types in clinical trials.

Cancer patients have naturally occurring T cells that are often capable of targeting their cancer cells. These T cells are some of the most powerful immune cells in our body, and come in several types. The killer T cells, especially, are capable of recognizing and eliminating cancer cells in a very precise way.

The existence of these T cells alone, however, isnt always enough to guarantee that they will be able to carry out their mission to eliminate tumors. One potential roadblock is that these T cells must first become activated before they can effectively kill cancer cells, and then they must be able to maintain that activity for a sufficiently long time to sustain an effective anti-tumor response. Another is that these T cells might not exist in sufficient numbers.

One form of adoptive cell therapy that attempts to address these issues is called tumor-infiltrating lymphocyte (TIL) therapy. This approach harvests naturally occurring T cells that have already infiltrated patients tumors, and then activates and expands them. Then, large numbers of these activated T cells are re-infused into patients, where they can then seek out and destroy tumors.

Unfortunately, not all patients have T cells that have already recognized their tumors. Others patients might, but for a number of reasons, these T cells may not be capable of being activated and expanded to sufficient numbers to enable rejection of their tumors. For these patients, doctors may employ an approach known as engineered T cell receptor (TCR) therapy.

This approach also involves taking T cells from patients, but instead of just activating and expanding the available anti-tumor T cells, the T cells can also be equipped with a new T cell receptor that enables them to target specific cancer antigens. By allowing doctors to choose an optimal target for each patients tumor and distinct types of T cell to engineer, the treatment can be further personalized to individuals and, ideally, provide patients with greater hope for relief.

The previously mentioned TIL and TCR therapies can only target and eliminate cancer cells that present their antigens in a certain context (when the antigens are bound by the major histocompatibility complex, or MHC).

Recent advances in cell-based immunotherapy have enabled doctors to overcome this limitation. Scientists equip a patients T cells with a synthetic receptor known as a CAR, which stands for chimeric antigen receptor.

A key advantage of CARs is their ability to bind to cancer cells even if their antigens arent presented on the surface via MHC, which can render more cancer cells vulnerable to their attacks. However, CAR T cells can only recognize antigens that themselves are naturally expressed on the cell surface, so the range of potential antigen targets is smaller than with TCRs. In October 2017, the U.S. Food and Drug Administration (FDA) approved the first CAR T cell therapy to treat adults with certain types of large B-cell lymphoma.

Given their power, CARs are being explored in a variety of strategies for many cancer types. One approach currently in clinical trials is using stem cells to create a limitless source of off-the-shelf CAR T cells. This may have application to only selected settings, but could allow doctors to treat patients in a timelier fashion.

More recently, adoptive cell therapy strategies have begun to incorporate other immune cells, such as Natural Killer (NK) cells. One application being explored in the clinic involves equipping these NK cells with cancer-targeting CARs.

There are currently two adoptive cell therapies that are approved by the FDA for the treatment of cancer.

Side effects may vary according to the type of adoptive cell immunotherapyand what exactly it targetsand may also be influenced by the location and type of cancer as well as a patients overall health. Potential cell therapy-related side effects often take the form of an overactive immune response and may lead to excessive inflammation via cytokine release syndrome (also known as cytokine storm), and also to neurotoxicity from inflammation in the brain. Side effects can range from mild to moderate and may become potentially life-threatening under certain circumstances.

Fortunately, in most cases, potential immunotherapy-related side effects can be managed safely as long as the potential side effects are recognized and addressed early. Therefore, its extremely important that patients inform their medical care team as soon as possible if they experience any unusual symptoms during or after treatment with cancer immunotherapy. In addition, patients should always consult their doctors and the rest of their care team to gain a better and fuller understanding of the potential risks and side effects associated with specific adoptive cell immunotherapies.

Common side effects associated with currently approved adoptive cell therapies may include but are not limited to: acute kidney injury, bleeding episodes, heart arrhythmias, chills, constipation, cough, cytokine release syndrome (cytokine storm), decreased appetite, delirium, diarrhea, dizziness, edema, encephalopathy, fatigue, febrile neutropenia, fever, headache, hypogammaglobulinemia, hypotension, hypoxia, infections, nausea, neurotoxicity, pyrexia, tachycardia, tremors, and vomiting.

Throughout its history, CRI has supported a variety of basic research projects aimed at improving our understanding of the identity and functions of our many immune cells as well as translational and clinical efforts that seek to use these insights in the development of cellular immunotherapies for cancer patients in the clinic.

Some of the most important contributions made by CRI scientists in the area of adoptive cell therapy include:

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Adoptive Cell Therapy - Cancer Research Institute (CRI)

National Medical Commission prohibits use of stem cell therapy to treat patients with autism  Hindustan Times

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National Medical Commission prohibits use of stem cell therapy to treat patients with autism - Hindustan Times

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Read the original post:
Tumor buster - where will the CAR-T cell therapy missile go?

1. Gilead lands new cell therapy for Kite in $225M Arcellx deal, providing global scale for future J&J-Legend showdown  FierceBiotech
2. Gilead buys into multiple myeloma cell therapy with Arcellx deal  BioPharma Dive
3. Gilead Sciences Gets a Shot at Next-Gen Cell Therapy With $325M Arcellx Alliance  MedCity News
4. Kite and Arcellx Announce Strategic Collaboration to Co-develop and Co-commercialize Late-stage Clinical CART-ddBCMA in Multiple Myeloma  Gilead Sciences
5. Gilead Sciences' Kite, Arcellx to Develop, Commercialize Cell Therapy Treatment for Multiple Myeloma  Marketscreener.com
6. View Full Coverage on Google News

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Gilead lands new cell therapy for Kite in $225M Arcellx deal, providing global scale for future J&J-Legend showdown - FierceBiotech