Nicola Beltraminelli

[Clinical] 09/12 Innovent Biologics: Mazdutide Showed Improved Glycemic Control and Weight Reduction in phase 3 Trials for Type 2 Diabetes 09/12 Fulcrum Therapeutics Stops phase 3 REACH Trial for FSHD Drug Losmapimod After Failing to Meet Primary and Secondary Endpoints same day : ( ↓ NASDAQ: FULC | -61.19% ) 09/12 Aura Biosciences Completes phase 2 Trial of AU-011 with 80% Tumor Control and 90% Visual Acuity Preservation in Early-Stage Choroidal Melanoma same day : ( ↑ NASDAQ: AURA | +9.48% ) 09/12 CureVac Advances to phase 3 Trials for Seasonal Influenza mRNA Vaccine after Demonstrating Immune Responses in Phase 2 same day : ( ↓ NASDAQ: CVAC | -2.81% ) 09/12 Oncternal Therapeutics Halts Clinical Trials for ONCT-534 Due to Insignificant Patient Improvements and High Dose Toxicity same day : ( ↓ NASDAQ: ONCT | -59.36% ) 09/12 Gilead Sciences' phase 3 Trial Shows Lenacapavir Reduces HIV Infections by 96% same day : ( ↑ NASDAQ: GILD | +1.72% ) 09/11 BriaCell Therapeutics Corp. reports 15.6 months median overall survival in phase 2 breast cancer trial with Bria-IMT™ same day : ( ↑ NASDAQ: BCTX | +3.23% ) 09/11 Skyhawk Therapeutics Presents phase 1 Data for SKY-0515, Reports 72% HTT mRNA Reduction in Healthy Volunteers Trial 09/10 Eli Lilly and Company's phase 3 Trial Shows Efsitora Alfa Achieves Non-Inferior A1C Reduction at Week 26 Compared to Insulin Degludec in Type 1 Diabetes same day : ( ↓ NYSE: LLY | -0.77% ) [Deals] 09/12 Sanofi Lands Exclusive Licensing Deal with Radiomedix, Inc. and Orano Med for €100M Upfront and up to €220M Sales Milestones for AlphaMedix's Commercialization and Production same day : ( ↓ NASDAQ: SNY | -1.24% ) 09/12 Organon China Strikes $12M License Agreement with BaoPharma and Centergene for Exclusive Rights to Potential First Long-Acting Fertility Drug SJ02 same day : ( ↑ NYSE: OGN | +0.47% ) 09/12 Oncopeptides AB (publ) AB and SCbio Inc. Sign $15-30M Deal for Pepaxti Commercialization in South Korea 09/12 Onconic Therapeutics enters Central and South American pharmaceutical market through License agreement with Laboratorios Sanfer for gastroesophageal reflux drug 'Jakyubo' 09/12 Encellin and Lucy Biotech sign USD 19.5M licensing agreement for stem cell therapy EN001 development in Asia 09/11 Contraline Secures Exclusive Licensing Agreement with Population Council for Potential Male Contraceptive NES/T [VC] 09/12 F2G secures $100 million for late-stage development of antifungal therapy olorofim, a candidate for invasive aspergillosis treatment 09/11 Safi Biotherapeutics Inc secures $5M seed funding to boost clinical trials of manufactured red blood cell transfusion product [Regulatory] 09/11 FDA approves Johnson & Johnson's TREMFYA for treatment of active ulcerative colitis in adults based on QUASAR study data same day : ( ↓ NYSE: JNJ | -0.99% ) 09/11 FDA grants Ascendis Pharma Orphan Drug exclusivity for YORVIPATH in hypoparathyroidism same day : ( ↓ NASDAQ: ASND | -0.76% )

4

1 commentaire

An exciting talk is on the way from Jérôme Caron, Head of the Orakl Oncology Lab 🙌 The development of new biologics is accelerated by technological innovation, and Medicen Paris Region, together with ACROBiosystems, has brought together some key players in the field. Anticipating drug efficacy and clinical benefits remains a significant bottleneck in drug development, especially for cancer—a highly heterogeneous disease. Jérôme will share how we are addressing this challenge by leveraging our tumor avatars and drug screening techniques to better predict patient responses to therapies in the clinic 🔮 #drugscreening #drugdevelopment

11

Congratulations to our partners KisoJi, who announced today a mAb partnership with Cancer Research UK’s Centre for Drug Development (CDD) who will sponsor, design and deliver a Phase 1/2a clinical trial of KJ-103, in selected TROP2 expressing solid tumours. This is the first non-ADC approach to targeting TROP2, a promising solid tumour target. This mAb, which was humanised by LifeArc, directs macrophage activation and phagocytosis of tumour cells and may bring advantages over TROP2-ADC approaches. https://lnkd.in/eNpsjS6d

59

Knock knock ! Who’s there? BGene ! BGene who? BGene Genetics’ new website ! Come take a look and explore the synergistic interplay between biotechnology and computer modelling for sustainable innovations: https://bgene.fr/en #BGene #Innovation #yourRDpartner #synbio #biotechnology #sustainability

17

1 commentaire

🚨 Another (BIG) piece of Canadian news today in the #celltherapy field: ExCellThera's Market Authorization Application was accepted for review by the #EMA under accelerated assessment. 🔬 Their #UM171 molecule allows for undifferentiated expansion of hematopoietic stem cells. This cell therapy showed successful results in several clinical trials in blood cancers (including #leukemias and #myelodysplasias) in Canada, the US and Europe. ✅ Following last week's C3i's DEL, we now have back-to-back wins for the Canadian #advancedtherapies industry!

40

6 commentaires

Dear Ts/Dr/Sir/Madam, Warm Greetings from ALS Technichem (M) Sdn Bhd   Webinar Invite – Laboratory Testing Services   Topic: GLP vs. Non-GLP Studies – What are the Key Differences ? When: 12:00pm, 30th July 2024 Duration : 60 minutes Join us for this complimentary webinar on GLP vs. Non-GLP Studies – What are the Key Differences ?   • What is OECD GLP? • Benefits and Importance of OECD GLP-compliant data for pesticide registration • Flow of OECD GLP study on physical-chemical testing and field trial • Responsibilities of personnel involved in OECD GLP physical-chemical and field trial studies   This webinar will be presented by Mr Teem Chin Mean, Study Director and Ms Hafizah Abdul Latib, QA Manager of ALS Malaysia.   Register in advance for this exciting webinar: Registration Link : https://lnkd.in/gZfjhCaG After registering, you will receive a confirmation email containing information about joining the webinar. Kindly contact us if there are any enquiries at [email protected]   Thank you. #OECD #GLP #ALSTraining #LabTest

🚨📢I’m thrilled to announce the publication of this long-awaited white paper in Cytotherapy on considerations for the development of iPSC-derived cell therapies!! A huge thanks to Bar Makovoz, PhD of the Cellino team and the fabulous JSRM-ISCT iPSC Committee for the extensive collaboration in developing this piece. iPSC-derived cell therapies have incredible potential for treating and potentially curing a wide range of chronic degenerative conditions, but to reach patients at scale, the modality must overcome challenges like complex manufacturing processes, meticulous QA measures, high production costs, and a patchwork of regulatory standards. In this white paper, we explore: 🔹An overview of the required elements to develop autologous and allogeneic iPSC-derived cell therapies 🔹 Global regulatory guidance for development of iPSC-derived cell therapies across the US, UK, Japan, Australia, and the EU  🔹 Challenges facing widespread adoption of cell therapies, along with opportunities to automate iPSC manufacturing to expand access for patients  🔹 And much more! 📰Check out the article at https://lnkd.in/ef94AQiP Let’s keep moving personalized cell therapies forward to benefit patients! cc ISCT, International Society for Cell & Gene Therapy, Uma Lakshmipathy, Xiaokui Zhang, PhD, Kapil Bharti, Dominic Wall, Yoji Sato, George Muschler, Anthony Ting, Nathan Smith, Shin Kawamata, Stephen Sullivan, PhD, MBA, FRSM, Arwa Z. Al-Riyami FRCPC, MD, BSc, Veronica Falco #RegenerativeMedicine #CellTherapies #Patients #Biomanufacturing #Manufacturing #Autologous #Automation #Regulatory #Innovation #YourCellsYourCure

88

6 commentaires

This is one of the questions that always comes up when I talk about #continuousmanufacturing....don't miss this webinar to hear about our experience in converting a fed-batch process to our Intensified Continuous Biomanufacturing platform!

13

Bold and brave by Jubilant Biosys Limited ! 🇮🇳 Perhaps a little misplaced, but ever since the Eli Lilly/Covance Greenfield site deal (can you believe that was 16 years ago?!) I have a certain fondness for this type of agreement, where significant site and domain expertise is not lost in the name of cost control, but instead pivoted from serving the internal needs of a pharma company to face the broader external market as part of a CRO.... ....maybe I'm being idealistic, but beyond the jobs being secured I think I like the sense of parity such deals suggests, that both sponsor and CRO are genuine piers/partners with the shared goal of improving human health driving both sides of the relationship....i.e. in the end, does it really matter which side of the fence you're on?.....(or am I just being a bit romantic....these deals seem to be very popular in France... 🇫🇷 🥂 ) In any case, this seems to me to be a significant deal in that: 1) It brings a serious Indian based Integrated Drug Discovery (IDD) player to the heart of Europe and with a scaled and mature offering. 2) It brings Jubilant straight into the ADC/biologics space, complimenting traditional small molecule expertise. 3) At the flick of a switch it brings new capacity, expertise and capabilities to the European CRO market. In the longer run I guess the challenge will be ensuring that there is sufficient revenue coming to the site if/when Pierre Fabre (inevitably?) scale back once their initial commitment has run down... (as a comparison, GSK committed to $40M over 4 years to Oncodesign Services as part of the deal transferring the Les Ulis site....certainly helps cover the costs for a while...!) But that's a question for tomorrow....for today, congratulations to Giuliano Perfetti and the Jubilant team!

7

Identifying and Controlling Antibody Charge Variants: Unlocking the Intricacies  Dive into how charge variations in monoclonal antibodies impact stability, pharmacokinetics, and functionality. With advanced techniques like iCIEF and IEC, we can systematically analyze these variants to enhance therapeutic development. Explore our comprehensive guide: https://lnkd.in/gSnggjcv #AntibodyResearch #Biopharmaceuticals

1

[D-3 Flow Chemistry Webinar] 📅 Join us next Monday 𝐀𝐩𝐫𝐢𝐥 𝟐𝟐𝐧𝐝 𝐚𝐭 𝟓𝐏𝐌 𝐂𝐄𝐓 / 𝟏𝟏𝐀𝐌 𝐄𝐓 for our SEQENS Pharmaceutical Solutions 𝐰𝐞𝐛𝐢𝐧𝐚𝐫!   ⏳It is still time to register! Connect with jean-baptiste Rouchet, Ph.D. and Jean-Yves LENOIR and 𝐥𝐞𝐚𝐫𝐧 𝐡𝐨𝐰 𝐭𝐨 𝐢𝐦𝐩𝐫𝐨𝐯𝐞 𝐭𝐡𝐞 𝐬𝐚𝐟𝐞𝐭𝐲 𝐚𝐧𝐝 𝐜𝐨𝐦𝐩𝐞𝐭𝐢𝐭𝐢𝐯𝐞𝐧𝐞𝐬𝐬 𝐨𝐟 𝐲𝐨𝐮𝐫 𝐩𝐫𝐨𝐜𝐞𝐬𝐬 𝐮𝐬𝐢𝐧𝐠 𝐅𝐥𝐨𝐰 𝐂𝐡𝐞𝐦𝐢𝐬𝐭𝐫𝐲.   𝐃𝐮𝐫𝐢𝐧𝐠 𝐭𝐡𝐢𝐬 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐥𝐞𝐚𝐫𝐧: ✔️How to assess whether a Flow chemistry process should be studied as an alternative for your API synthesis, ✔️Insights on ICH Q13 guidance and how reproducibility and quality can be improved using continuous processes, ✔️Strategies to optimize a continuous process for an easier upscaling   𝐓𝐨 𝐫𝐞𝐠𝐢𝐬𝐭𝐞𝐫 ➡ https://lnkd.in/e2sUgA2X

38

1 commentaire

Meet SynapCell’s experts at Neuroscience 2024 and let’s talk about science and #preclinical #EEG!

11

If someone you love is 𝗯𝗮𝘁𝘁𝗹𝗶𝗻𝗴 𝗔𝗹𝘇𝗵𝗲𝗶𝗺𝗲𝗿'𝘀, here's something you should know: 🧠 𝙏𝙝𝙚 𝙟𝙤𝙪𝙧𝙣𝙚𝙮 𝙩𝙤 𝙖 𝙘𝙪𝙧𝙚 𝙨𝙩𝙖𝙧𝙩𝙨 𝙬𝙞𝙩𝙝 𝙖𝙘𝙘𝙪𝙧𝙖𝙩𝙚 𝙙𝙞𝙖𝙜𝙣𝙤𝙨𝙩𝙞𝙘𝙨. New lab tests are set to revolutionize how we detect and treat this disease, offering fresh hope for early intervention. 🌟

52

Great discussions at my ASCO 2024 poster presentation! Special thanks to Vassili Soumelis for interesting insights. Let's connect if you're interested in learning more! #ASCO24 #posterpresentation #oncology

117

4 commentaires

🚀 𝗔𝗱𝘃𝗮𝗻𝗰𝗶𝗻𝗴 𝗶𝗣𝗦𝗖-𝗗𝗲𝗿𝗶𝘃𝗲𝗱 𝗖𝗲𝗹𝗹 𝗧𝗵𝗲𝗿𝗮𝗽𝗶𝗲𝘀: 𝗞𝗲𝘆 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗟𝗮𝘁𝗲𝘀𝘁 𝗜𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗥𝗲𝘃𝗶𝗲𝘄! 🌿 The recent review by the JSRM-ISCT, International Society for Cell & Gene Therapy iPSC Committee delves into the critical 𝘤𝘩𝘢𝘭𝘭𝘦𝘯𝘨𝘦𝘴 𝘢𝘯𝘥 𝘰𝘱𝘱𝘰𝘳𝘵𝘶𝘯𝘪𝘵𝘪𝘦𝘴 𝘧𝘰𝘳 𝘪𝘗𝘚𝘊-𝘣𝘢𝘴𝘦𝘥 𝘵𝘩𝘦𝘳𝘢𝘱𝘪𝘦𝘴. Here are 3 take-home messages: 𝟭- 𝗛𝗮𝗿𝗺𝗼𝗻𝗶𝘇𝗶𝗻𝗴 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 🌍: Navigating the diverse global regulatory frameworks is essential for ensuring the safe and efficient development of iPSC-derived therapies. Early engagement with regulatory bodies can help streamline product approval. 𝟮- 𝗙𝗼𝗰𝘂𝘀 𝗼𝗻 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗖𝗼𝗻𝘁𝗿𝗼𝗹 & 𝗖𝗼𝘀𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 💡: The path to commercialization requires rigorous quality control and thoughtful cost-of-goods (COGs) strategies. Optimizing manufacturing processes through advanced automation can significantly reduce expenses, making therapies more accessible. 𝟯- 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵𝗲𝘀 𝘁𝗼 𝗧𝘂𝗺𝗼𝗿𝗶𝗴𝗲𝗻𝗶𝗰𝗶𝘁𝘆 𝗥𝗶𝘀𝗸𝘀 🔬: Addressing the risks of genomic instability and tumorigenicity remains a major challenge. Collaborative efforts and new assay developments are key to ensuring the safety and efficacy of these transformative treatments. #CellTherapy #iPSC #RegenerativeMedicine #BiotechInnovation #QualityControl #GlobalHealth https://lnkd.in/eHXRz7e2 Stephen Sullivan, PhD, MBA, FRSM iPSirius Lindville Bio Veronica Falco Dominic Wall Cell Therapies Pty Ltd Nathan Smith

4

Pharma pipelines can vary significantly by modality across different geographies. Building on a strong legacy of iPSC-based research, Japanese pharma has a larger proportion of cell therapies in their pipelines compared to other global players. Moreover, small molecules still represent the most common modality in Japan compared to a clear preference for monoclonal antibodies within Global pharma. In a related development this week, BlueRock Therapeutics has received clearance for its induced pluripotent stem cell (iPSC)-derived cell therapy IND application for the treatment of primary photoreceptor diseases. This is the first drug candidate spawned through the collaboration between FUJIFILM Cellular Dynamics, Opsis Tx and BlueRock Tx to discover and develop off-the-shelf iPSC-derived cell therapies for ocular diseases. https://lnkd.in/gty39Yfg

9

[D-3 Flow Chemistry Webinar] 📅 Join us next Monday 𝐀𝐩𝐫𝐢𝐥 𝟐𝟐𝐧𝐝 𝐚𝐭 𝟓𝐏𝐌 𝐂𝐄𝐓 / 𝟏𝟏𝐀𝐌 𝐄𝐓 for our SEQENS Pharmaceutical Solutions 𝐰𝐞𝐛𝐢𝐧𝐚𝐫!   ⏳It is still time to register! Connect with jean-baptiste Rouchet, Ph.D. and Jean-Yves LENOIR and 𝐥𝐞𝐚𝐫𝐧 𝐡𝐨𝐰 𝐭𝐨 𝐢𝐦𝐩𝐫𝐨𝐯𝐞 𝐭𝐡𝐞 𝐬𝐚𝐟𝐞𝐭𝐲 𝐚𝐧𝐝 𝐜𝐨𝐦𝐩𝐞𝐭𝐢𝐭𝐢𝐯𝐞𝐧𝐞𝐬𝐬 𝐨𝐟 𝐲𝐨𝐮𝐫 𝐩𝐫𝐨𝐜𝐞𝐬𝐬 𝐮𝐬𝐢𝐧𝐠 𝐅𝐥𝐨𝐰 𝐂𝐡𝐞𝐦𝐢𝐬𝐭𝐫𝐲.   𝐃𝐮𝐫𝐢𝐧𝐠 𝐭𝐡𝐢𝐬 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐥𝐞𝐚𝐫𝐧: ✔️How to assess whether a Flow chemistry process should be studied as an alternative for your API synthesis, ✔️Insights on ICH Q13 guidance and how reproducibility and quality can be improved using continuous processes, ✔️Strategies to optimize a continuous process for an easier upscaling   𝐓𝐨 𝐫𝐞𝐠𝐢𝐬𝐭𝐞𝐫 ➡ https://lnkd.in/e2sUgA2X

25

For meeting the needs of scientists..

8