Murray Wigmore

[NEW] Database of Globally Approved Regenerative Medicine Products - https://lnkd.in/gXk9x2NA Today in 2024, there are a total of 78 globally approved regenerative medicine (RM) products that include: 1. Cell-Based Immunotherapies (14 approvals) 2. Gene Therapies (17 approvals) 3. Cell Therapies (21 approvals) 4. Cord Blood Products (8 approvals) 5. Tissue-Engineered Products (18 approvals) This product reveals the identities of these products, breaking them down into the five product categories shown above. At this time, tissue-engineered products and gene therapies are leading the regenerative medicine (RM) field with the greatest number of product approvals at 18 and 17 approvals, respectively. If you’re working within the regenerative medicine (RM) field, then you need to be in the know about these historic product approvals. It is critical that you are aware of the specific products that have achieved regulatory approval for use in human patients, as well as the identities of the companies who are commercializing them, the timing of their approvals, the agencies who approved them, the conditions they treat, and the geographies in which they are available. #regenerativemedicine #immunotherapies  #celltherapies #genetherapies #cordblood #tissueengineering

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RAPT Therapeutics Therapeutics and Shanghai Jemincare Pharmaceutical Announce Exclusive License Agreement for Novel Long-Acting anti-IgE Antibody SOUTH SAN FRANCISCO, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients with significant unmet needs in inflammatory diseases, and Shanghai Jemincare Pharmaceutical Co., Ltd (“Jemincare”), a subsidiary of Jiangxi Jemincare Group, a leading pharmaceutical company in China, today announced they have entered into an exclusive license agreement for JYB1904 (RAPT designation RPT904), a clinical-stage, half-life extended anti-immunoglobulin E (IgE) monoclonal antibody. Under the terms of the license agreement, RAPT is granted worldwide rights excluding mainland China, Hong Kong, Macau and Taiwan (together, the “Jemincare Territory”) to develop and commercialize RPT904. As consideration for the license, Jemincare receives a $35 million upfront license fee, up to $672.5 million in additional payments upon the achievement of various regulatory and commercial milestones, and royalties on future sales of RPT904 outside the Jemincare Territory. RPT904 is being developed to offer patients a potentially improved therapeutic option compared to omalizumab (marketed as Xolair®), an anti-IgE monoclonal antibody approved for several allergic disorders, including asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps and, most recently, food allergy. RAPT plans to pursue development of RPT904 initially in food allergy. Separately, Jemincare is conducting Phase 2 clinical trials of JYB1904 in China in asthma and CSU. “We’re delighted to partner with Jemincare and excited by RPT904 and its potential to be a novel best-in-class treatment option for patients with food allergy. Omalizumab’s rapid uptake in food allergy since its approval earlier this year confirms the high unmet need and large opportunity in this growing market,” commented Brian Wong M.D., Ph.D., President and CEO of RAPT. “RPT904 targets the same clinically validated epitope as omalizumab and combined with extended half-life, gives this molecule a best-in-class profile. We plan to initiate a Phase 2b clinical trial of RPT904 in food allergy in the second half of 2025.” https://lnkd.in/e92YkAmT

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Astellas Inks Second CAR-T Agreement with Poseida to Develop ‘Convertible’ Cancer Therapies Astellas Pharma on Wednesday entered into a collaboration and license agreement with Poseida Therapeutics to develop novel CAR-T therapies for solid tumors. Under the deal, Astellas will pay an upfront fee of $50 million and has pledged up to $550 million in potential development, sales and other contingent payments. Poseida will also be eligible for up to low-double digit tiered royalties on net sales. Astellas will conduct the transaction through its subsidiary Xyphos Biosciences. The collaboration is designed to combine “the innovative cell therapy platforms from each of the companies,” according to Wednesday’s announcement. Poseida will contribute its proprietary allogeneic CAR-T platform, while Xyphos will lend both its ACCEL and convertibleCAR technologies. The partnership’s goal is to produce one CAR-T construct, which in turn will yield two convertibleCAR product candidates for solid tumors. https://lnkd.in/gGZG4KKY

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[NEW] Database of Globally Approved Regenerative Medicine Products - https://lnkd.in/gXk9x2NA Today in 2024, there are a total of 78 globally approved regenerative medicine (RM) products that include: Cell-Based Immunotherapies (14 approvals) Gene Therapies (17 approvals) Cell Therapies (21 approvals) Cord Blood Products (8 approvals) Tissue-Engineered Products (18 approvals) This product reveals the identities of these products, breaking them down into the five product categories shown above. If you’re working within the regenerative medicine (RM) field, then you need to be in the know about these historic product approvals. A description of these RM product categories are below: 1. Cell-Based Immunotherapy Products: Cell-based immunotherapy involves using modified or engineered immune cells to target and destroy cancer cells or treat other diseases. These therapies often involve manipulating a patient’s own immune cells, such as T-cells, to enhance their ability to recognize and attack specific disease cells. 2. Gene Therapies: Gene therapies involve altering or replacing defective genes within a patient’s cells to treat or cure genetic disorders. This can be achieved by delivering new or modified genetic material into cells, either to correct genetic mutations or to provide a new function that helps combat the disease. 3. Cell Therapies: Cell therapies use live cells to treat diseases or injuries. These cells can be sourced from the patient (autologous) or from a donor (allogeneic) and are used to repair, replace, or regenerate damaged tissues and organs. Examples include stem cell therapies and cellular replacement therapies. 4. Cord Blood Products: Cord blood products are derived from the blood collected from the umbilical cord after childbirth. This blood is rich in stem cells, which can be used to treat a variety of conditions, including certain cancers and blood disorders. Cord blood is a valuable resource for stem cell transplantation and regenerative medicine. 5. Tissue-Engineered Products: Tissue-engineered products involve creating or regenerating tissues and organs using a combination of cells, biomaterials, and biological factors. These products aim to replace or restore function to damaged tissues or organs, and can be used in applications ranging from wound healing to organ replacement. To learn more or this claim global database, visit it: https://lnkd.in/gXk9x2NA

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[NEW] Database of Globally Approved Regenerative Medicine Products - https://lnkd.in/gXk9x2NA Today in 2024, there are a total of 78 globally approved regenerative medicine (RM) products that include: 1. Cell-Based Immunotherapies (14 approvals) 2. Gene Therapies (17 approvals) 3. Cell Therapies (21 approvals) 4. Cord Blood Products (8 approvals) 5. Tissue-Engineered Products (18 approvals) This product reveals the identities of these products, breaking them down into the five product categories shown above. At this time, tissue-engineered products and gene therapies are leading the regenerative medicine (RM) field with the greatest number of product approvals at 18 and 17 approvals, respectively. If you’re working within the regenerative medicine (RM) field, then you need to be in the know about these historic product approvals. It is critical that you are aware of the specific products that have achieved regulatory approval for use in human patients, as well as the identities of the companies who are commercializing them, the date of their approvals, the regulatory bodies who have approved them for use in human patients, and the conditions they can treat. #regenerativemedicine #immunotherapies  #celltherapies #genetherapies #cordblood #tissueengineering

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[NEW] Database of Globally Approved Regenerative Medicine Products - https://lnkd.in/gXk9x2NA Today in 2024, there are a total of 80 globally approved regenerative medicine (RM) products that include: Cell-Based Immunotherapies (15 approvals) Gene Therapies (18 approvals) Cell Therapies (21 approvals) Cord Blood Products (8 approvals) Tissue-Engineered Products (18 approvals) This product reveals the identities of these products, breaking them down into the five product categories shown above. If you’re working within the regenerative medicine (RM) field, then you need to be in the know about these historic product approvals. A description of these RM product categories are below: 1. Cell-Based Immunotherapy Products: Cell-based immunotherapy involves using modified or engineered immune cells to target and destroy cancer cells or treat other diseases. These therapies often involve manipulating a patient’s own immune cells, such as T-cells, to enhance their ability to recognize and attack specific disease cells. 2. Gene Therapies: Gene therapies involve altering or replacing defective genes within a patient’s cells to treat or cure genetic disorders. This can be achieved by delivering new or modified genetic material into cells, either to correct genetic mutations or to provide a new function that helps combat the disease. 3. Cell Therapies: Cell therapies use live cells to treat diseases or injuries. These cells can be sourced from the patient (autologous) or from a donor (allogeneic) and are used to repair, replace, or regenerate damaged tissues and organs. Examples include stem cell therapies and cellular replacement therapies. 4. Cord Blood Products: Cord blood products are derived from the blood collected from the umbilical cord after childbirth. This blood is rich in stem cells, which can be used to treat a variety of conditions, including certain cancers and blood disorders. Cord blood is a valuable resource for stem cell transplantation and regenerative medicine. 5. Tissue-Engineered Products: Tissue-engineered products involve creating or regenerating tissues and organs using a combination of cells, biomaterials, and biological factors. These products aim to replace or restore function to damaged tissues or organs, and can be used in applications ranging from wound healing to organ replacement. To learn more or this claim global database, visit it: https://lnkd.in/gXk9x2NA

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One thing I have learned over the past 2 plus years at DCN is that although lateral flow is easy to use it is highly complex to develop. DCN Dx and Patrick Vaughan ‘s team have an expertise that only time at the bench can provide. It is definitely science meets art to get it right - fit for intended use and designed for manufacture at the specificity and sensitivity required for a quality diagnostic product. Shout out to the team for being transparent and putting the patient and customer first. #lateralflow #diagnostics #lmics #ngo #rapidtests #ivd PS Stay tuned: Pat has more insights to share in the next DCN #Expertinsights podcast.

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From high-quality human biospecimens and advanced cell culture solutions to bespoke bioassays and in vitro diagnostics, we're driving scientific discovery globally. Interested in learning more? Book a meeting with me directly to explore how our cutting-edge solutions can benefit your research and healthcare projects. #LifeSciences #Diagnostics #Innovation #Healthcare #Research #BIOMEX

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[NEW] Database of Globally Approved Regenerative Medicine Products - https://lnkd.in/gXk9x2NA Today in 2024, there are a total of 78 globally approved regenerative medicine (RM) products that include: 1. Cell-Based Immunotherapies (14 approvals) 2. Gene Therapies (17 approvals) 3. Cell Therapies (21 approvals) 4. Cord Blood Products (8 approvals) 5. Tissue-Engineered Products (18 approvals) This product reveals the identities of these products, breaking them down into the five product categories shown above. At this time, tissue-engineered products and gene therapies are leading the regenerative medicine (RM) field with the greatest number of product approvals at 18 and 17 approvals, respectively. If you’re working within the regenerative medicine (RM) field, then you need to be in the know about these historic product approvals. It is critical that you are aware of the specific products that have achieved regulatory approval for use in human patients, as well as the identities of the companies who are commercializing them, the date of their approvals, the regulatory bodies who have approved them for use in human patients, and the conditions they can treat. #regenerativemedicine #immunotherapies  #celltherapies #genetherapies #cordblood #tissueengineering

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🔬 Science Corner #6: 🥇 Success Begets Success De-risked Development: Cytonics Corporation's CYT-108 Rides on the Heels of APIC’s Success 🥇 CYT-108 and the Legacy of APIC’s Success Just as the introduction of synthetic (recombinant) insulin revolutionized the treatment of diabetes by providing an improved and scalable source of insulin, Cytonics is poised to transform the field of osteoarthritis (OA) therapy with CYT-108. Building upon the clinical and commercial triumphs of our Autologous Platelet Integrated Concentrate (APIC) therapy, CYT-108 embodies the next evolution in targeted treatment for osteoarthritis. Harnessing the insights from protease inhibition and tissue regeneration mechanisms garnered through APIC’s success, CYT-108 aims to offer enhanced efficacy and precision in managing joint health. If approved by the FDA, CYT-108 may be the first and only disease-modifying pharmaceutical for OA, a remarkable leap forward in the field of regenerative medicine. Just like the development of synthetic insulin was de-risked by the clinical efficacy of the natural, purified insulin peptide, Cytonics’ CYT-108 development is de-risked by the clinical and commercial success of our first-generation APIC therapy. And here's the data to prove it: https://lnkd.in/eaKZefDP #biotech #venturecapital #healthcare #lifesciences #clinicaltrials #pharma #medicine #researchanddevelopment #innovation #FDA #genetherapy #immunotherapy #oncology #artificialintelligence #AI #biologics

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BeiGene’s Tevimbra approved by EC for first-line gastric and oesophageal cancer use BeiGene’s Tevimbra (tislelizumab) has been approved by the European Commission (EC) as part of a first-line combination treatment for adults with advanced gastric or oesophageal cancer.

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Join the 6th Exosome-Based Therapeutic Development Summit (Sept 17-29, 2024) - https://lnkd.in/ga5z-F6T Join the 6th Exosome-Based Therapeutics Development Summit in Boston, MA, this September to delve into groundbreaking advancements, access exclusive clinical data, and forge pivotal partnerships to define the future of exosome drug development. Learn from 30+ renowned speakers from across the development timeline, sharing groundbreaking insights in exosome research including Takeda, Aegle Therapeutics, RION Health, EVerZom and many more. Spanning the complete development cycle of exosome therapeutics from discovery through IND filing, this summit uniquely integrates cutting-edge research with practical commercialization strategies. It stands as a key industry meeting that bridges the gap between science and business, propelling clinical advancements. Don't miss the chance to connect with over 150 of the industry’s leading experts in exosome therapeutics, gain invaluable insights, and place your work at the forefront of pharmaceutical innovation. To learn more, download the Event Guide here: https://lnkd.in/ga5z-F6T Will I see you at this summit in September? Let me know in comments below. #exosomes #extracellularvesicles #advancedtherapies Hanson Wade Group Erin Thomas

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Every day our customers surprise us with new ways to do more advanced tests in a POC format. Please read this new blog post: Key breakthroughs in molecular POC testing Learn more about the emerging technologies used and the sample preparation techniques that are key to ensuring their success. Learn more: https://lnkd.in/e4qQB4a6

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Register for our next webinar! Learn how Vanderbilt Vaccine Center proved Beacon to be the most rapid response to COVID in discovering functional antibodies, and how Beacon represents the cutting edge for preparing for the next outbreak! Vanderbilt University Medical Center Vanderbilt Vaccine Center Bruker Cellular Analysis Bruker #Beacon #RapidResponse #PandemicPreparedness

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CARsgen Therapeutics Announces the Initiation of an Investigator-Initiated Trial for an Allogeneic CD19/CD20 CAR-T Theẻapy SHANGHAI, Dec. 31, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the initiation of an investigator-initiated trial (IIT) in China for KJ-C2219, an allogeneic CAR T-cell therapy, targeting CD19/CD20. The trial will evaluate KJ-C2219 for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). KJ-C2219 is developed based on CARsgen's THANK-u Plus platform and is designed for the treatment of hematologic malignancies and autoimmune diseases. About THANK-u Plus CARsgen has developed the THANK-u Plus platform as an enhanced version of its proprietary THANK-uCAR® allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy. THANK-u Plus demonstrates sustained expansion regardless of varying NKG2A expression levels on NK cells and exhibits significantly improved expansion compared to THANK-uCAR®. Preclinical studies show that THANK-u Plus delivers superior antitumor efficacy in the presence of NK cells compared to THANK-uCAR®. Allogeneic BCMA or dual-targeting CD19/CD20 CAR-T cells developed using this platform exhibit robust antitumor activity in the presence of NK cells, indicating that THANK-u Plus has broad potential for developing diverse allogeneic CAR-T therapies. https://lnkd.in/eysqHmpA

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The Market for Exosome Diagnostics – Leveraging Exosome-Based Diagnostics for Cancer and Beyond - https://lnkd.in/gVes2BYm To date, only two exosome-based diagnostics have gained FDA’s Fast Track Approval. One is Exosome Diagnostics/Bio-Techne’s ExoDx Prostate IntelliScore (EPI) test. The Breakthrough Device Designation was awarded on June 17, 2019. By granting the designation, FDA has acknowledged the need to avoid a painful and invasive prostate biopsy. The second diagnostic was Guardant Health’s Guardant360CDx, approved by the U.S. FDA on August 13, 2020. It is an exosome-based diagnostic that can detect metastatic non-small cell lung cancer (NSCLC). Read more at: https://lnkd.in/gVes2BYm #lungcancer #stemcell #cancer

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To compete in a regulated industry, it is imperative to go digital with a completely 21 CFR Part 11 and EU Annex 11 compliant solution. ACE is leading the market in terms of flexibility, reliability, affordability, support, and compliance for a digital solution.

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Biotherapeutics: The Shift from Commercial to Custom Antibodies 🧬💡 As biotherapeutics advance, the focus is shifting from commercial antibodies to custom-designed solutions, enabling more specific and targeted treatments. 🔍 Why the Change? Commercial Antibody Limitations: >Lack of specificity causing off-target effects. >Batch-to-batch variability impacting consistency. Custom Antibody Advantages: >Tailored for specific antigens, improving precision. >Advanced techniques (e.g., phage display, hybridoma) ensure high affinity and consistency. >Use of non-mammalian antibodies (like avian-derived IgYs) offers unique epitope targeting. This evolution improves the efficacy, safety, and reliability of biotherapeutic drugs, opening new doors for treating complex diseases. 💭 What are your thoughts on custom antibodies? Let’s discuss their future in biotherapeutics—share your insights below! 👇 #Biotherapeutics #CustomAntibodies #LifeSciences #Innovation

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