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Scooped by
Gilbert C FAURE
April 2, 12:22 PM
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🏭 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐞𝐬 𝐟𝐨𝐫 𝐂𝐀𝐑 𝐍𝐊 𝐂𝐞𝐥𝐥 𝐓𝐡𝐞𝐫𝐚𝐩𝐢𝐞𝐬: 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬 & 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧𝐬
Manufacturing CAR NK cells at sufficient scale and quality for clinical use is no easy feat. Robust GMP-compliant protocols are essential, but strategies vary depending on the starting material and proprietary technologies.
Here’s a look at how different companies are tackling this challenge:
🩸 𝐏𝐁-𝐍𝐊 (𝐏𝐞𝐫𝐢𝐩𝐡𝐞𝐫𝐚𝐥 𝐁𝐥𝐨𝐨𝐝-𝐃𝐞𝐫𝐢𝐯𝐞𝐝 𝐍𝐊 𝐂𝐞𝐥𝐥𝐬)
Companies like Nkarta, Inc. use healthy donor NK cells, activated with feeder cells and genetically modified using γ-retrovirus to introduce a CAR and IL-15. Cells are expanded and cryopreserved for off-the-shelf use.
🧬 𝐂𝐁-𝐍𝐊 (𝐂𝐨𝐫𝐝 𝐁𝐥𝐨𝐨𝐝-𝐃𝐞𝐫𝐢𝐯𝐞𝐝 𝐍𝐊 𝐂𝐞𝐥𝐥𝐬)
Artiva Biotherapeutics and Takeda leverage donor CB units, selecting for high-affinity CD16 variants or KIR ligand mismatches to enhance anti-tumor activity. Genetic engineering (via lentivirus/retrovirus) introduces CAR and IL-15, followed by expansion and storage.
🦠 𝐢𝐏𝐒𝐂-𝐍𝐊 (𝐈𝐧𝐝𝐮𝐜𝐞𝐝 𝐏𝐥𝐮𝐫𝐢𝐩𝐨𝐭𝐞𝐧𝐭 𝐒𝐭𝐞𝐦 𝐂𝐞𝐥𝐥-𝐃𝐞𝐫𝐢𝐯𝐞𝐝 𝐍𝐊 𝐂𝐞𝐥𝐥𝐬)
Fate Therapeutics Inc. uses a clonal iPSC master bank to generate NK cells, incorporating genetic modifications such as IL-15RF expression and CD38 knockout, enabling high-scale production.
⚡ 𝐍𝐊-𝟗𝟐 (𝐈𝐦𝐦𝐨𝐫𝐭𝐚𝐥𝐢𝐳𝐞𝐝 𝐍𝐊 𝐂𝐞𝐥𝐥 𝐋𝐢𝐧𝐞)
Trials like NCT03383978 explore NK-92-based CAR NK cells, expanded under GMP conditions. Due to their tumorigenic nature, γ-irradiation is applied before infusion to prevent proliferation while maintaining potency.
Each approach presents unique advantages and challenges, shaping the future of off-the-shelf cell therapy. As technology advances, optimizing manufacturing efficiency and scalability will be key to ensuring broader patient access.
💬 What do you think is the most promising approach for CAR NK therapies ? Let’s discuss !
#CellTherapy #CellandGeneTherapy #CARNK #GMP #Manufacturing #Immunotherapy #Oncology
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Scooped by
Gilbert C FAURE
March 28, 4:50 AM
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📚🔬Innovation médicale et prix des médicaments : un équilibre économique à trouver
Nouveaux traitements, thérapies géniques, accès aux soins… Derrière chaque…
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Scooped by
Gilbert C FAURE
March 27, 5:00 AM
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Vaccines are one of the most effective #PublicHealth tools in our toolbox. Combination vaccines, where one vaccine covers multiple diseases or strains, could…
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Scooped by
Gilbert C FAURE
March 14, 4:35 AM
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Un médicament administré par injection une fois par an a la possibilité de prévenir l'infection par le VIH.
Ceci pourrait changer complétement la donne en…
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Scooped by
Gilbert C FAURE
March 9, 5:36 AM
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CAR-T vs CAR-NK therapies:
How do they compare?
Let's break it down:
1. Relative Abundance in the Body
- CAR-T: T cells = ~30-60% of lymphocytes (easier… | 80 comments on LinkedIn
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Scooped by
Gilbert C FAURE
February 5, 5:01 AM
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Interesting mini symposium
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Scooped by
Gilbert C FAURE
February 4, 5:49 AM
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Organ and tissue damage, particularly of the musculoskeletal system, is commonly encountered in the clinic and can impact patient quality of life. Reconstructive operations can be necessary to restore form and function to damaged tissues; however, available off-the-shelf products fail to meet the needs of individual patients. Personalized regenerative treatments to restore damaged tissues could potentially bring benefits to both clinicians and patients. For example, resorbable implant scaffolds can be bioengineered and customized using technologies such as 3D printing to address the specific needs of patients while offering improved clinical outcomes along with reduced surgical time and complexity. For this purpose, appropriate medical-grade materials, advanced multiscale fabrication techniques and regulatory compliance are required. In this Review, we summarize the key considerations for developing personalized bioengineered implant scaffolds, emphasizing good manufacturing practice and clinical translatability. We discuss the status of clinical translation for personalized bioengineered implants and the lessons learned from existing phase I clinical trials using craniofacial reconstruction as a model system. Additionally, we provide a framework to inform wider clinical translation with recommendations on rational biomaterial choice and design, biofabrication strategies, biofunctionalization, standardized workflow, compliance with regulatory requirements, and evaluation of benefits. Finally, we discuss the remaining challenges and provide an outlook for the translation of personalized bioengineered implant scaffolds into routine clinical practice. Personalized bioengineered implant scaffolds offer customizable medical solutions for tissue and organ regeneration. This Review provides a framework for navigating the regulatory process and addressing challenges in technical development and biofabrication to ensure clinical translation of personalized devices.
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Scooped by
Gilbert C FAURE
February 1, 11:43 AM
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Vaccines and treatments are up for approval in early to mid-2025, including a chikungunya vaccine, a meningococcal vaccine, a monoclonal antibody for RSV, and more.
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Scooped by
Gilbert C FAURE
January 27, 4:09 AM
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Norovirus Vaccines: Unlocking the Next Frontier in Global Health
Did you know norovirus causes over 677 million cases of gastroenteritis annually, costing $60…
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Scooped by
Gilbert C FAURE
January 23, 4:36 AM
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mRNA Vaccines: What’s Inside and How They Work
Have you ever wondered what makes mRNA vaccines so groundbreaking? Beyond their life-saving capabilities, these…
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Scooped by
Gilbert C FAURE
January 21, 12:15 PM
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A comprehensive review: Bispecific antibodies: advancing precision oncology
Bispecific antibodies (bsAbs) offer a novel approach to anticancer therapy by… | 15 comments on LinkedIn
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Scooped by
Gilbert C FAURE
January 17, 9:39 AM
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Breaking: China’s NMPA Approves Country’s First MSC-Based Cell Therapy Ever, Ruibosheng!
On January 2, 2025, China’s National Medical Products Administration…
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Scooped by
Gilbert C FAURE
January 14, 1:46 PM
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The first day of the J.P.
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Scooped by
Gilbert C FAURE
March 28, 6:50 AM
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Scooped by
Gilbert C FAURE
March 27, 5:10 AM
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🧬 𝗡𝗲𝘄 𝗦𝘁𝘂𝗱𝘆 𝗥𝗲𝘃𝗲𝗮𝗹𝘀 𝗛𝗼𝘄 𝗺𝗥𝗡𝗔 𝗖𝗢𝗩𝗜𝗗-𝟭𝟵 𝗩𝗮𝗰𝗰𝗶𝗻𝗲𝘀 𝗧𝗿𝗮𝗶𝗻 𝘁𝗵𝗲 𝗜𝗺𝗺𝘂𝗻𝗲 𝗦𝘆𝘀𝘁𝗲𝗺’𝘀 '𝗟𝗼𝗻𝗴-𝗧𝗲𝗿𝗺…
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Scooped by
Gilbert C FAURE
March 18, 5:52 AM
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I'm pleased to share with you the first of two publications with Arti Rai on the legal and regulatory landscape around biologics manufacturing patents. Using…
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Scooped by
Gilbert C FAURE
March 10, 5:06 AM
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𝐂𝐀𝐑 𝐓 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐢𝐧 𝐍𝐨𝐧-𝐎𝐧𝐜𝐨𝐥𝐨𝐠𝐲 👇
CAR T cell therapy has transformed cancer treatment, but its potential extends far beyond oncology.… | 24 comments on LinkedIn
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Scooped by
Gilbert C FAURE
February 20, 6:40 AM
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A fundamental challenge for cancer vaccines is to generate long-lived functional T cells that are specific for tumour antigens. Here we find that mRNA–lipoplex vaccines against somatic mutation-derived neoantigens may solve this challenge in pancreatic ductal adenocarcinoma (PDAC), a lethal cancer with few mutations. At an extended 3.2-year median follow-up from a phase 1 trial of surgery, atezolizumab (PD-L1 inhibitory antibody), autogene cevumeran1 (individualized neoantigen vaccine with backbone-optimized uridine mRNA–lipoplex nanoparticles) and modified (m) FOLFIRINOX (chemotherapy) in patients with PDAC, we find that responders with vaccine-induced T cells (n = 8) have prolonged recurrence-free survival (RFS; median not reached) compared with non-responders without vaccine-induced T cells (n = 8; median RFS 13.4 months; P = 0.007). In responders, autogene cevumeran induces CD8+ T cell clones with an average estimated lifespan of 7.7 years (range 1.5 to roughly 100 years), with approximately 20% of clones having latent multi-decade lifespans that may outlive hosts. Eighty-six percent of clones per patient persist at substantial frequencies approximately 3 years post-vaccination, including clones with high avidity to PDAC neoepitopes. Using PhenoTrack, a novel computational strategy to trace single T cell phenotypes, we uncover that vaccine-induced clones are undetectable in pre-vaccination tissues, and assume a cytotoxic, tissue-resident memory-like T cell state up to three years post-vaccination with preserved neoantigen-specific effector function. Two responders recurred and evidenced fewer vaccine-induced T cells. Furthermore, recurrent PDACs were pruned of vaccine-targeted cancer clones. Thus, in PDAC, autogene cevumeran induces de novo CD8+ T cells with multiyear longevity, substantial magnitude and durable effector functions that may delay PDAC recurrence. Adjuvant mRNA–lipoplex neoantigen vaccines may thus solve a pivotal obstacle for cancer vaccination. In a phase 1 trial, patients with pancreatic ductal adenocarcinoma who were treated with surgery and bespoke neoantigen mRNA vaccines combined with anti-PD-L1 and chemotherapy exhibited marked long-lived persistence of neoantigen-specific CD8+ T cell clones, which correlated with prolonged recurrence-free survival at a 3.2-year follow-up.
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Scooped by
Gilbert C FAURE
February 4, 1:28 PM
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The immune-related adverse events associated with chimeric antigen receptor (CAR)-T cell therapy result in substantial morbidity as well as considerable cost to the health-care system, and can limit the use of these treatments. Current therapeutic strategies to manage immune-related adverse events include interleukin-6 receptor (IL-6R) blockade and corticosteroids. However, because these interventions do not always address the side effects, nor prevent progression to higher grades of adverse events, new approaches are needed. A deeper understanding of the cell types involved, and their associated signalling pathways, cellular metabolism and differentiation states, should provide the basis for alternative strategies. To preserve treatment efficacy, cytokine-mediated toxicity needs to be uncoupled from CAR-T cell function, expansion, long-term persistence and memory formation. This may be achieved by targeting CAR or independent cytokine signalling axes transiently, and through novel T cell engineering strategies, such as low-affinity CAR-T cells, reversible on–off switches and versatile adaptor systems. We summarize the current management of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, and review T cell- and myeloid cell-intrinsic druggable targets and cellular engineering strategies to develop safer CAR-T cells. Treatment with chimeric antigen receptor (CAR)-T cell therapies is associated with important immune-related adverse events. In this Review, the authors discuss the standard-of-care management for cytokine release and immune effector cell-associated neurotoxicity syndromes, and the potential of other T cell druggable targets as well as cellular engineering strategies to develop safer CAR-T cells.
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Scooped by
Gilbert C FAURE
February 4, 5:09 AM
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#Immunotherapy | #Cancer | In Case Anyone has Missed this PHENOMENAL Study / Resource posted last week : "A pan-Cancer #Atlas of #Tcell #Targets" | OPEN ACCESS…
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Scooped by
Gilbert C FAURE
February 1, 3:00 AM
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🚀 Anti-CTLA-4 Induces Stronger Immune Memory Than Anti-PD-1
Immune checkpoint blockade (ICB) has transformed cancer therapy, and anti-CTLA-4 and anti-PD1… | 15 comments on LinkedIn
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Scooped by
Gilbert C FAURE
January 26, 7:17 AM
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ADCs in Lung Cancer 👇
Approved ADCs for Lung Cancer
1. HER2 (7.7–23%)
Trastuzumab deruxtecan (Enhertu): Approved for HER2-mutant lung cancer.
2. TROP2…
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Scooped by
Gilbert C FAURE
January 21, 1:48 PM
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Nenään annettavaa koronarokotetta kehittävä yhtiö on saanut luvan aloittaa rokotekokeet ihmisillä.
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Scooped by
Gilbert C FAURE
January 21, 5:04 AM
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LYTGOBI 4 mg comprimé pelliculé est une nouvelle spécialité indiquée dans certaines formes de cholangiocarcinome, ou cancer des voies biliaires.
Il con
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Scooped by
Gilbert C FAURE
January 16, 4:15 AM
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Opportunities and limitations of B cell depletion approaches in SLE
In this Review, the authors consider evidence gathered from over two decades of using…
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