What does 2024 hold for #biopharma? Garuda Therapeutics’ Co-founder, President & CEO Dhvanit Shah expects an increased appetite for off-the-shelf blood stem cell therapies due to their ability to bypass many challenges associated with current treatment options. Check it out: bit.ly/49BZlfA
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🔴 The availability of stem cell transplantation and novel immunochemotherapies have improved the outcomes of multiple myeloma therapies. However, it is not clear in a big picture how multiple myeloma treatment patterns have changed longitudinally and what what the estimated treatment costs are in multiple myeloma in Finland. 💡 Read our latest multiple myeloma (MM) publication and see how complex MM treatment patterns were assembled from data available in the Helsinki University Hospital data lake, Finland, how the patterns have changed in 2013–2019, and what are the estimated treatment costs in multiple myeloma. 🔍 The study was carried out by the experts Kristiina Uusi-Rauva and Johanna Vikkula at Medaffcon, Sanofi, and Helsinki University Hospital, Finland, and was published online on 13 October 2023, explained Kristiina Uusi-Rauva. ➡ Read the whole article here: https://lnkd.in/d9EbsK8G ➡ Link to publication: https://lnkd.in/dFfnUFsf #RWE #researchreport #myeloma #RWD #pharma #research
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Empowering the fight against multiple myeloma with a multi-faceted approach: chemotherapy, immunomodulatory drugs, stem cell transplants, and targeted therapies. Each bullet point represents a step towards victory. . . . . . #MyelomaTreatment #FightMyeloma #CancerTherapy #MyelomaWarrior #Chemotherapy #Immunotherapy #StemCellTransplant #TargetedTherapy #CancerResearch #HopeForMyeloma
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Case study: becoming the first #GMP-certified cell and #genetherapy manufacturing facility in Thailand In this article, Kitipong Uaesoontrachoon explores how Genepeutic Bio Co., Ltd. is increasing the accessibility of #CARTcelltherapies to people in Southeast Asia through their production of an anti-CD19 CAR-T cell therapy Read this article to learn about: • How Genepeutic Bio became the first GMP-certified manufacturing facility in Thailand to provide services for CAR-T cell production • Challenges involved in improving CAR-T cell therapy accessibility in Thailand • Anti-CD19 CAR-T cell therapy #clinicaltrial progress Read below:
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Last December, we have successfully completed Type-C meeting with FDA regarding on going phase 3 clinical trial of “Neuronata-R”, stem cell therapy for ALS. We have received feedback that the ongoing Phase 3 clinical trial is deemed appropriate by the FDA as a supplementary study to provide evidence of the efficacy and safety of the drug for future BLA approval. Additionally, there were no specific issues confirmed by the FDA regarding the selection of primary and secondary efficacy evaluation variables, as well as exploratory variables. read more at: https://lnkd.in/g2cQmscE #als #alsresearch #neurodegenerative #clinicaltrial
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📢 Cellino is proud to announce the publication of this collaborative white paper on considerations for the development of iPSC-derived cell therapies in Cytotherapy! Co-authored by Marinna Madrid, PhD, our Co-Founder & Chief Product Officer, Bar Makovoz, PhD, our Principal Product Manager, and the The Japanese Society for Regenerative Medicine (JSRM)-ISCT iPSC Committee, this piece focuses on critical considerations for scaling iPSC production. iPSC-derived cell therapies hold immense promise for patients by treating and potentially curing a wide range of chronic degenerative conditions. Scaling up these therapies involves overcoming challenges such as complex manufacturing processes, meticulous QA measures, high production costs, and a patchwork of regulatory standards. This white paper explores these key topics and more: 🔹 Overview of required elements for developing autologous and allogeneic iPSC-derived cell therapies 🔹 Global regulatory guidance and development of iPSC-derived cell therapies across the US, UK, Japan, Australia, and the EU 🔹 Challenges to widespread adoption and opportunities to automate cell therapy manufacturing to expand patient access 📰 Learn more about the Committee’s findings at https://lnkd.in/grHmxF84 Reinforcing our commitment to continuous innovation, this work focuses on strategies to make these transformative treatments more accessible. We extend our appreciation to ISCT, International Society for Cell & Gene Therapy, Uma Lakshmipathy, Xiaokui Zhang, Kapil Bharti, Dominic Wall, Yoji Sato, George Muschler, Anthony Ting, Nathan Smith, Shuhei Deguchi, Shin Kawamata, Jen Moore, Stephen Sullivan, Arwa Z. Al-Riyami, Veronica Falco
Considerations for the development of iPSC-derived cell therapies: a review of key challenges by the JSRM-ISCT iPSC Committee
sciencedirect.com
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Exciting results from Poseida in the allogenic cell therapy space. Posting an 82% overall response rate qualifies as a breakthrough, but posting 100% ORR in treatment naive patients is practically unheard of. With this being an "off the shelf" CAR-T therapy, it has the potential to revolutionize the space. Questions do remain regarding durability (which has historically been a challenge for allogenic cell therapies), but the potential is definitely there in the myeloma space. It's definitely a step in the right direction. https://lnkd.in/gCm6tNSa
Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting
prnewswire.com
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As seen at #ASH23 - BRL-101 (BRL Medicine 邦耀生物) CRISPR/Cas9-edited cell therapy increased Hb and HbF in patients with transfusion-dependent β-thalassemia (TDT) regardless of β0/β0 or non-β0/β0 genotype. https://lnkd.in/eeT_ssUJ
CRISPR/Cas9 Cell Therapy Increases Hemoglobin in Transfusion-Dependent β-Thalassemia Across HBB Genotypes
cgtlive.com
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Neurodegeneration - More hope for Motor Neurone Disease (MND) sufferers (also known as ALS and Lou Gehrig's) via stem cell therapy? - An initially disappointing set of phase III trial results have turned out, after a slightly lost post-hoc analysis, to be a lot more promising than the 'doom and gloom' headline discussion conclusions of the peer-reviewed paper would lead a reader to conclude. Post-hoc analysis revealed a bright chink of light. On analysis of the cohort, it was found to have an unexpected tilt towards late-stage patients, which may sadly be too late to help, or for which the test available is not sensitive enough, a phenomenon known as the floor effect. When the pre-defined sub-groups of patients were analysed, early-stage sufferers showed a positive clinical response. Also, for participants in the trial on the placebo, the functional responses (a measure of disease progression) deteriorated faster than for participants receiving the therapy. Finally, a range of biomarkers thought to be indicative of, or related to, disease progression responded positively in treated participants (concentrations fell or rose depending on whether the biomarker is deemed 'good' or 'bad'). As a result, the FDA has committed to a PIIIb trial - the central key to which will be that the design selects for a cohort dominated by earlier-stage sufferers. The marketing licence is not quite yet a home run but it looks pretty hopeful and certainly a lot more hopeful than the PIII top-line analysis suggested. For investors, positive PIIIb results will bring high multiple returns over a relatively short timeframe, all things being reasonably equal. If you want to read more two places you could go are our recent thematic on regenerative medicine Neurodegenerative diseases - MND/ALS/Stem Cells - here https://lnkd.in/e-5V6Hfz or our recent initiation on $BCLI Brainstorm Therapeutics here https://lnkd.in/e2UZVkmw Brainstorm Cell Therapeutics The ALS Association
#StemCelltherapies $BCLI $AZN $AMGN $SNY $GILD $VRTX $ABBV $AMRX $ROG.SW $MRK $PFE $TEVA $NVS $BIIB. $BCLI PIII post hoc analysis revealed the clinical effectiveness of its NurOwn stem cell Motor Neuron Disease therapy. Biomarker data supports the clinical results. BCLI's PIIIb has FDA approval. Success will create a 10x catalyst effect. Download our initiation note here https://lnkd.in/e2UZVkmw. Brainstorm Cell Therapeutics First indication - Motor Neurone Disease #MND #ALS, Lou Gehrig's.
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#BrainStormTherapeutics #BCLI has made a significant stride by aligning with the FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of their PIII3b #NurOwn® clinical trial for ALS. This follows the FDA's Special Protocol Assessment (SPA) agreement commitment, providing clear guidance on the trial's design and endpoints. Aligning with the FDA is a critical step in addressing the complexities of manufacturing cell therapies, ensuring all CMC-related questions are resolved before the pivotal PIIIb trial. In the meantime BCLI prepared its executive readiness for registrational PIIIb #ALS study launch, as of 18 Jun 24 when BCLI announced it had secured the appointment of #HaroHartounian (previously CEO at #BioCentriq) as its new EVP & COO. This progress brings hope to many in the ALS community. $AZN $AMGN $SNY $GILD $VRTX $ABBV $AMRX $ROG.SW $MRK $PFE $TEVA $NVS $BIIB Download our #ACFResearch initiation https://lnkd.in/em-Pk929 Brainstorm Cell Therapeutics IceCure Medical Pfizer AbbVie
#StemCelltherapies $BCLI $AZN $AMGN $SNY $GILD $VRTX $ABBV $AMRX $ROG.SW $MRK $PFE $TEVA $NVS $BIIB. $BCLI PIII post hoc analysis revealed the clinical effectiveness of its NurOwn stem cell Motor Neuron Disease therapy. Biomarker data supports the clinical results. BCLI's PIIIb has FDA approval. Success will create a 10x catalyst effect. Download our initiation note here https://lnkd.in/e2UZVkmw. Brainstorm Cell Therapeutics First indication - Motor Neurone Disease #MND #ALS, Lou Gehrig's.
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🦠 While non-viral cell therapy manufacturing has seen a "natural" slowdown in terms of #funding and adoption, the hunger for viral alternatives is at an all-time high. Indee Labs has released findings showcasing their Hydropore platform's ability to enhance CAR-T cell motility and resistance to activation-induced cell death (AICD). The study compared the Hydropore platform to Nucleofection and electroporation 📖 Background: Indee Labs's Hydropore utilizes microfluidic vortex shedding for efficient delivery of small molecules, nucleic acids, proteins, and gene-editing complexes to immune cells, overcoming viral and traditional transfection limitations 🔦 Study highlights: 🔹Hydroporation processes 5 x 10^8 cells in less than 10 seconds 🔹 Hy-CAR-T cells exhibit superior growth, division, and IL-10 secretion compared to Nuc-CAR-T cells, enhancing CAR-T function 🔹Hy-CAR-T cells outperform Nuc-CAR-T cells in terms of T cell subsets, activation, and pro-inflammatory cytokine secretion 🔹Hy-CAR-T cells exhibit robust target-seeking, contact dynamics, and target killing efficacy. They also maintain significantly more motility than donor-matched Nuc-CAR-T cells, crucial for strong CAR-T potency and patient response 📜 Dive into the full manuscript for more insights: https://lnkd.in/gY6zd-9x Congrats ryan pawell, University of California, San Francisco!! I am curious to hear: how do you see the demand for viral alternatives evolving in the next few years, and what implications do you think these advancements in cell therapy could have for future treatments? Let's discuss👇 #celltherapy #precisionmedicine #biotechnews
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ROP (Return on Potential) is my favorite acronym although I’m an MD, PhD, MBA, CFA & a bunch of other acronyms people think matters. 4x’ing ROP @ Harvard, MIT, & Stanford & Founder/CEO of a multibillion dollar VC firm.
7moOne of the greatest value propositions we can deliver to patients. Excited for what is ahead for team Garuda.