NurOwn is being developed for the treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (PMS) and other neurodegenerative diseases.

Catalent, a biopharma focused CDMO, entered into a partnership with Brainstorm in 2020 to provide CGMP clinical supply of NurOwn, in anticipation of the product candidate's potential regulatory approval.

Chaim Lebovits, CEO, BrainStorm Cell Therapeutics, said the manufacturing of cellular therapies such as NurOwn is complex and requires careful planning and very specific expertise. He acknowledged the progress made to date through the alliance with Catalent, which it noted has industry-leading capabilities in the field.

The NurOwn technology platform - autologous MSC-NTF cells - represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders, according to BrainStorm.

MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo, it explained.

The MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

Since 2020, Catalent has invested in its cell therapy capabilities.

Alongside its facility in Texas, it has a site in Maryland, and runs its European Center of Excellence for cell and gene therapy out of its campus in Gosselies, Belgium.

The organization continues to increase its clinical and commercial-scale manufacturing capabilities across the full range of cell and gene therapy activity, with it finalizing a deal to acquire Dusseldorf-based human induced pluripotent stem cells (iPSCs) developer, RheinCell Therapeutics.

John Chiminski, CEO, Catalent, on a conference call with analysts in August, noted that the dynamics in the cell and gene therapy space continue to be extremely robust.

Over the last two years, we've added critical pieces to our portfolio, in the cell therapy space giving additional manufacturing facilities and capacity, we entered into the plasmid DNA space, and now, obviously, with the acquisition of RheinCell, we have our hands on a kind of iPSC cell bank. So, we really think that we have a strong portfolio.

The company, he said, has a strong footprint for cell therapy. And we have a huge capability in viral vector manufacturing in the Baltimore area. But if we were able to get our hands on the right asset from a viral vector manufacturing standpoint in Europe, that would also be a priority for us,added Chiminski.

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Tech transfer box ticked in Catalent and BrainStorm cell therapy alliance - BioPharma-Reporter.com

The Automated And Closed Cell Therapy Processing Systems 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.

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Automated And Closed Cell Therapy Processing Systems Market: 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.

Automated And Closed Cell Therapy Processing Systems Market: 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.

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

Automated And Closed Cell Therapy Processing Systems Market: 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.

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Automated And Closed Cell Therapy Processing Systems Market is predicted to grow at a noteworthy speed to 2030 | TMR Research Study - BioSpace

CAR-T cell therapy, which modifies a patients own T cells to recognize specific antigens on tumors, has proven effective in treating blood cancers. But the engineered immune cells have precious little time to proliferate in the body, which often limits their anti-tumor efficacy. Now, scientists at the Curie Institute in France have identified a potential mechanism that could be targeted to improve T-cell therapies.

By using genomewide CRISPR-Cas9 screen in mice, the Curie Institute team pinpointed the protein SOCS1 as an important brake that inhibits the expansion and survival of CD4+ T cells, according to results published in Science Immunology.

Crippling SOCS1 in human CD19-targeted CAR-T cells markedly improved the persistence of CD4+ CAR-T cells and the function of CD8 CAR-T cells in a mouse model. Thus SOCS1 inhibition could boost the efficacy of T-cell therapies against cancer, the team suggested.

When cancer relapses or progresses after patients initially respond well to CAR-T treatments, the culprit is thought to be poor persistence of the engineered cells. One of the key components of CAR-T cell therapy, CD8+ T cells, can continuously self-proliferate after stimulation. But another critical element, CD4+ T cells, require repeated antigen stimulation to continue growing.

RELATED:Enhancing CAR-T therapy by leveraging its communication with the immune system

To understand the inhibitory mechanism of CD4+ T cells, the Curie Institute team used CRISPR screening to search for genes that, when inactivated, would restore the proliferation of antigen-experienced CD4+ T cells.

The gene encoding for SOSC1 emerged as a hit. In two different TCR CD4+ T-cell models, inactivating the gene helped the T cells expand, while the the proliferation of untreated cells quickly stopped, the researchers reported.

The researchers challenged mice with a type of bladder tumor and treated them with anti-tumor CD4+ T cells. Treatment with T cells that had SOCS1 inactivated rejected the tumors, as the T cells proliferated. The researchers also found that the SOCS1-deleted T cells infiltrated tumors more efficiently than control cells by nearly tenfold.

SOCS1 also played a role in regulating CD8+ T cells, the study found. In mice with melanoma, the scientists observed a significant and durable rejection of tumors in animals that received SOCS1-deleted, tumor-specific CD8+T cells as compared with control T cells.In SOCS1-inactivated T cells that entered tumors, the researchers found higher numbers of cytotoxic molecules and effector T cells, likely explaining the strong anti-tumor effect, they said.

The French team validated their findings with human CD4+ and CD8+ CAR-T cells, reporting that in mouse models of lymphoblastic leukemia, treatment with SOCS1-inactivated CAR-T cells produced better tumor control, and the number of CAR-T cells accumulating in bone marrow was twofold higher than it was with unmodified CAR-T cells.

The promise that engineered T-cell therapy holds against various cancers has prompted scientists across the globe to explore ways to enhance its efficacy. A team at the University of Pennsylvania recently proposed inhibiting BET proteins to prevent T-cell exhaustion in CAR-T cell treatment of chronic lymphocytic leukemia, for example.

Scientists at Frances Pasteur Institute foundthat the interaction between interferon gamma by CAR-T cells and interleukin 12 by host cells is critical to the cancer-killing activity of CAR-T cells. And a team at the Fred Hutchinson Cancer Research Center has designed new CARs with fragments involved in T-cell signaling to increase their ability to recognize tumor antigens.

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Improving CAR-T cell therapies for cancer by targeting a protein 'brake' - FierceBiotech

REGULATED INFORMATION

Article 14 of the Law of 2 May 2007 on disclosure of major holdings

Gosselies, Belgium, 10 December 2021, 7am CET BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces that it has received a transparency notification dated 8 December 2021 indicating that the shareholdings held by Nyenburgh Holding NV have crossed above the threshold of 5% following the issuance of new shares of Bone Therapeutics via a private placement on 2 December 2021. The new shares were delivered to the participating investors on 7 December 2021.

The notification dated 8 December 2021 contains the following information:

The notification can be consulted on the website of Bone Therapeutics, under the heading Shareholder Information.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a diversified portfolio of cell therapies at different stages ranging from pre-clinical programs in immunomodulation to mid stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell and gene therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerLieve Creten, Chief Financial Officer ad interimTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Bone Therapeutics SA: Transparency notification received - GlobeNewswire

Full TitleA Phase 1 Study to Evaluate the Safety, Proliferation and Persistence of GEN-011, an Autologous Adoptive Cell Therapy Targeting Neoantigens in Solid Tumors (TITAN)Purpose

The purpose of this study is to assess the safety of an investigational cellular immunotherapy called GEN-011 in people with advanced cancers of the bladder and kidney. Researchers will also see how the cancer responds to this treatment. GEN-011 is made in a laboratory using a patients own white blood cells (lymphocytes). The treatment is designed to attack cancer cells without harming healthy cells. It is given intravenously (by vein).

To be eligible for this study, patients must meet several requirements, including:

For more information about this study and to ask about eligibility, please contact the office of Dr. David Aggen at 646-422-4679.

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A Phase I Study of GEN-011 Cellular Therapy in People with Advanced Cancers of the Bladder and Kidney - On Cancer - Memorial Sloan Kettering

Immune checkpoint inhibitors, a type of immunotherapy drug, work well for a specific type of mesothelioma patient.

Another type of immunotherapy treatment, CAR T-cell therapy, seems to cause remission as well.

CAR T-cell therapy, a type of immunotherapy-gene therapy combination, enhances the immune system by modifying T cells to recognize cancer tumors. Those who cant have surgery and people who dont respond to or want chemotherapy are routinely being offered immunotherapy drugs Opdivo and Yervoy, which are approved for mesothelioma officially. CAR T-cell therapy for mesothelioma is still in testing.

Scientists add RNA to T cells removed from the patient. This RNA strand helps T cells connect with a specific protein receptor associated with proteins for a specific cancer, which vary based on the type of malignancy. The added RNA is what makes them CAR T cells.

At the Society for Immunotherapy of Cancer conference, a cell therapy manufacturing company reported disease response in mice with mesothelioma or pancreatic cancer. The manufacturer, Cellectis, hopes the study leads to an off-the-shelf therapy for mesothelin-expressing tumors.

Mesothelin, a protein found in malignant mesothelioma, is a target for specific types of therapy. CAR T cells can be programmed to go link with mesothelin tumors via protein receptors. Cellectis therapy is called UCARTMESO. It also disrupts three genes: TRAC, CD52 and TGFBR2.

The preclinical data demonstrated potent activity of UCARTMESO against mesothelin-expressing cell lines in pancreatic and pleural mesothelioma mouse models, the manufacturers press release reads.

CAR T-cell therapy is already approved for specific blood cancers, such as myeloma and lymphoma. Its currently in testing for solid tumor cancers, such as malignant mesothelioma and others.

Working in mouse models means the next step is running a first-in-patient phase 1 clinical trial. A few studies are already in the works for CAR T-cell therapy for mesothelioma.

Some trials pair T-cell therapy with immune checkpoint inhibitors. Gavo-cel was featured in an MD Anderson Cancer Center clinical trial, which also hunts mesothelin-expressing tumors for mesothelioma cancer. Both proved successful in small sample sizes of patients.

Sources & Author

Devin Golden is the content writer for Mesothelioma Guide. He produces mesothelioma-related content on various mediums, including the Mesothelioma Guide website and social media channels. Devin's objective is to translate complex information regarding mesothelioma into informative, easily absorbable content to help patients and their loved ones.

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CAR T-cell Therapy Shows Signs of Remission for Mesothelioma - Mesothelioma Guide

Despite advances in novel therapies, survival rates remain poor for patients with relapsed/refractory aggressive B-cell lymphoma who develop progressive disease following CD19-directed chimeric antigen receptor (CAR) T-cell therapy, according to a study conducted by Joanna C. Zurko, MD, and colleagues, and presented at the 2021 American Society of Hematology Annual Meeting.

This study consisted of 400 patients who received anti-CD19 CAR T-cell therapy between 2015 and 2020 across 12 U.S. academic medical centers. The investigators collated demographic and clinical characteristics of the study population along with CAR T-cell therapy toxicities and response. Univariate analyses were performed to determine the impact of demographic and clinical variables on survival outcomes, the researchers noted.

According to the results, in the entire cohort, median progression-free survival (PFS) and overall survival (OS) from time of CAR T-cell infusion were 11 months and 27 months, respectively. Analyses showed that patients who received three or more lines of therapy before CAR T-cell infusion and those with refractory disease pre-infusion had both markedly worse PFS (p = 0.004 and p = 0.001) and OS (both p < 0.001).

Results showed that at 22.4 months follow-up, almost half (48%) of patients had progressive disease following CAR T-cell therapy. The investigators noted that, of patients with progressive disease, median PFS and OS from time of disease progression was just 83 days in patients who received salvage therapy and 174 days for all patients, respectively.

Furthermore, the results showed that median PFS was highest for in patients treated with polatuzumab vedotin plus bendamustine-rituximab (4.5 months; n = 14), followed by bispecific antibodies (2.5 months; n = 8), lenalidomide with or without an anti-CD20 antibody (1.8 months; n = 13), checkpoint inhibitors (1.6 months; n = 10), BTK inhibitors (1.2 months; n = 8), radiation alone (1.2 months; n = 17), chemotherapy (1.1 months; n = 12), and tafasitamab plus lenalidomide (0.9 months; n = 5). The median PFS for all treated patients was 1.8 months.

Twelve patients in the study (6.3%) later received an allogeneic hematopoietic cell transplant (alloHCT), and 10 were evaluated for response. The results showed that seven achieved CR and five remain in CR.

AlloHCT remains a potential curative therapy for select patients with over half with durable remission; however, few ultimately received alloHCT, the researchers concluded. Despite increased use of novel therapies, survival in patients who progress after CAR T-cell therapy is still dismal warranting more effective therapies.

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Outcomes in Patients With Aggressive B-Cell Lymphoma With Progressive Disease Following CAR T-Cell Therapy - DocWire News

DISCUSSION QUESTION

What are the key factors that influence yourdecision making for third-line therapy?

PAOLO CAIMI, MD: What are the key factors that influence your decision in choice of regimen for patients who are in the third-line therapy? Any comments about the things that you use when youre thinking about how to salvage a patient with DLBCL who has relapsed after the first salvage treatment?

DEVA NATHAN, MD: The most important thing for third-linefor [patients around] 75 years old, I want to see what their performance status is going to be like.

CAIMI: I think the capacity to tolerate treatment [is an important factor], and particularly with the treatments weve had so far. If you want to give them a lot of chemotherapy, its a bit tough. I think my first consideration is: Is the patient going to tolerate what Im going to throw at them?

PRIYA KUMAR, MD: I think convenience and logistics are important, too.

CAIMI: At any age, but I think [especially] for older patients, I agree with you. I think thats becoming more and more important. A lot of our patients ask us to be close to home.

JULIE CHANG, MD: I really like tafasitamab [Monjuvi] and lenalidomide [Revlimid], but its not very convenient for patients, so thats been a big barrier for that as an option.

CAIMI: Because it has the weekly dosing, and then they go on to continue treatment for a long period of time, I think the other thing isat least in my experiencedoing 25 mg of lenalidomide makes it tough for patients who are over 70. I end up dose reducing for a significant number of patients.

LYLE GOLDMAN, MD: I think all therapy is very important, whether or not you are looking to do something aggressive, like CAR [chimeric antigen receptor] T-cell therapy, with a reasonably good chance of having complete response [CR], as opposed to just a palliative mode. So, I think that eligibility for CAR T-cell therapy is really important in this space.

CAIMI: Yes, I think thats a good point for discussion. Are you going to give them something that at least has more data indicating that you have long-term remissions, and potential for cure? The Kaplan-Meier curves in CAR T-cell therapy seem to flatten, although we see with some of the newer agents the durations of the responses are getting longer and longer. But, if you can be aggressive in a patient, almost regardless of age, depending on their functional status, that is something to bring up to the table. In a patient with poor functional status, which you worry about the adverse events [AEs], you worry about the logistics of CAR T cells; for them, the options and the discussion changes.

DIVIS KHAIRA, MD: I think that with the CAR T cells, the neurological AEs can be pretty significant. I think with the rest of the treatmentsfor example, lenalidomidethats a big wallet biopsy for some patients, not always covered. The intravenous therapies are always covered; the oral medications depend on the patients insurance, and with Medicare and secondary [insurance], it doesnt adequately cover a lot of the oral medications.

CAIMI: Its a great point, because we tend to be sold on oral therapies [as opposed to intravenous therapies] for patients. But, if its $10,000 a month, and they really dont have coverage, they dont want an oral therapy. They want something that they can come to the infusion center and get. The coverage is so much more beneficial to their side. So, even though the convenience of taking something at home is good, if you have to pay for it, its much harder. If it was cheaper, it would be easier.

KHAIRA: What we find is a lot of patients are too proud to say that they cant afford it, so they just decline the treatment.

CAIMI: Yes, its a good point. So, we talked about performance status, tolerability, cost, the convenience as well. I think that these regimens can be complex, in terms of how we administer them. I think tafasitamab/lenalidomide has that issue that it is so frequent, and actually never ends, at least with 1 of the components of it.

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Part 1: Choosing a Third-Line Treatment for Refractory DLBCL - Targeted Oncology