Aaron Chapman

🚀 Immunovant's strategic shift in autoimmune treatment focus! 🚀 Immunovant, a spinout of Roivant Sciences, has announced a pivotal shift in its research priorities. The company will now focus on IMVT-1402, a promising FcRn inhibitor, targeting a range of autoimmune disorders including Graves’ disease. 🧬💡 🔬 Key Highlights: - IMVT-1402: Designated as the lead asset due to positive in-class data. Planned for 4-5 registrational studies in endocrinology, neurology, and more within FY 2025. - Batoclimab: While still important, its prioritization for myasthenia gravis (MG) is being reassessed. Topline results expected within the fiscal year. - Vyvgart: With this shift, argenx’s Vyvgart, FDA-approved for MG, maintains its leading position for now. 🗣️ CEO Pete Salzmann: “We see tremendous opportunity for IMVT-1402, which we believe has a combination of potentially best-in-class features not seen with any other FcRn inhibitor.” 📈 Analyst Insights: William Blair analysts commend the decision, noting the prudence of addressing batoclimab’s LDL lowering concerns and the strategic move to bolster Immunovant’s future in autoimmune treatment. #Biotech #Pharma #AutoimmuneDisease #Research #ClinicalTrials #Innovation #Healthcare #Immunovant #RoivantSciences #FcRnInhibitor #MyastheniaGravis #GravesDisease #MedicalAdvancements #DrugDevelopment

3

1 Comment

🚀 Inocras Inc. and Watchmaker Genomics have teamed up to push the boundaries of clinical whole-genome sequencing assays! 🧬🔬 This thrilling collaboration marks a significant advancement in the field of genomic diagnostics. 🌟 🔬 Collaboration Highlights: -Adopting Advanced Technology: Inocras has integrated Watchmaker’s DNA library prep kits with fragmentation into its CancerVision assay. -Target-Enhanced Sequencing: The CancerVision assay is a state-of-the-art, target-enhanced whole-genome sequencing test designed specifically for solid tumors. -Driving Genomic Innovation: This partnership is set to revolutionize whole-genome sequencing and analytics, paving the way for more precise and advanced diagnostic products. 🗣 Stephanie Ferguson, Chief Clinical Operations Officer at Inocras, says: "We’re proud to demonstrate the power of whole-genome sequencing and analytics through our diagnostics products. Our collaboration with Watchmaker has been important in driving this innovation, and we are excited to continue our partnership on upcoming laboratory-developed assays." 📍 About Inocras: Formerly Genome Insight, Inocras is a San Diego-based spinout from the Korea Advanced Institute of Science and Technology (KAIST). The company excels in developing whole-genome sequencing assays and data curation pipelines focused on cancer and rare diseases. #Genomics #WholeGenomeSequencing #Inocras #WatchmakerGenomics #CancerResearch #BiotechInnovation #HealthcareAdvancements #GenomicAssays #PrecisionMedicine #Biotechnology

3

1 Comment

📢 Breaking News: Watchmaker Genomics and SPT Labtech Partner to Automate NGS Library Prep 📢 📅 May 28, 2024 New York – Watchmaker Genomics and SPT Labtech have announced a strategic partnership to automate library preparation for next-generation sequencing (NGS). Partnership Details: Integration: Watchmaker's sample prep assays will be integrated with SPT Labtech's automated instruments. Focus: The integration has already been achieved with Watchmaker's mRNA Library Prep Kit and DNA Library Prep Kit with Fragmentation using SPT Labtech's Firefly liquid handler. Key Quotes: Sandra Rowe, VP of Marketing at Watchmaker, stated that the mRNA library prep solution "lowers the energy barrier to accessing meaningful gene expression information while ensuring robust and reproducible performance." Background: SPT Labtech has recently entered into several deals to automate genomics workflows, partnering with Parse Biosciences, Roche, and Scale Biosciences. The firm was acquired by Battery Ventures' EQT IX Fund in 2022. Watchmaker Genomics has also collaborated with automation providers, including Beckman Coulter Life Sciences and Volta Labs, Inc.. Impact: This partnership aims to enhance the efficiency and accessibility of genomic sequencing, paving the way for advancements in genetic research and diagnostics. #WatchmakerGenomics #SPTLabtech #NGS #LibraryPrep #Genomics #Automation #BiotechNews #LifeSciences #ResearchInnovation

31

2 Comments

Progress on ATE2024 is going so well we are adding an extra two tracks to the agenda! Our Web agenda will go live May 1st! #ATE #Advancedtherapieseurope #cellandgenetherapy #ATMPs #Advancedtherapies #celltherapy #genetherapy

This would be a great opportunity to get a jump on your Clinical Trial planning. If your planning or even just thinking about a trial in 2025, it is not too early to talk to potential Clinical Trial CRO partners. All we do at Translational Drug Development (TD2) is Oncology. Parris is your goto to learn about the TD2 difference. Curious what that is? Stop by and talk with Parris! #oncology #clinicaltrial #cro #clinicalcro #oncologytrial #oncologycro #cancertherapeuticdevelopment

1

Scientists and researchers involved in drug discovery are deeply committed to utilizing innovation to create hope and inspiration globally. At Diamond Age Data Science, we support them in using their commitment to knowledge and learning to develop tools that make our lives better. This Blog by Eleanor Howe provides a few examples of the celebration and positive impact that comes from what we do, it is a really good read. #drugdiscovery #sciencematters #bioinformatics

7

Merck has signed an exclusive licensing deal with Orion Corporation, potentially worth over $1.6 billion, to develop and commercialize Orion's hormone-dependent cancer treatments, particularly targeting the CYP11A1 enzyme. This enzyme is crucial in steroid production and its inhibition could offer new avenues for treating hormone-dependent cancers such as prostate cancer. 𝐶ℎ𝑎𝑛𝑔𝑒𝑠 𝑆𝑖𝑛𝑐𝑒 𝑡ℎ𝑒 𝐿𝑎𝑠𝑡 𝐷𝑒𝑎𝑙: In the initial 2022 agreement, Merck and Orion engaged in a co-development and co-commercialization strategy for opevesostat, with Merck paying $290 million upfront. At that time, both companies shared development costs and responsibilities, with Orion actively participating in the development process​​. 𝑁𝑒𝑤 𝐷𝑒𝑣𝑒𝑙𝑜𝑝𝑚𝑒𝑛𝑡𝑠: The new deal marks a transition to an exclusive licensing arrangement, granting Merck full global rights to develop and commercialize the CYP11A1 program. Under this arrangement, Merck assumes all past and future development and commercialization costs, while Orion receives significant financial support through milestone payments and royalties without bearing the development burden​​. 𝐃𝐞𝐚𝐥 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬: Total Value: Upfront Payment: $290 million Development Milestones: Up to $30 million Regulatory Milestones: Up to $625 million Sales-based Payments: Up to $975 million Royalties: Tiered annual royalties on sales Orion's Responsibilities: Repay 60 million euros (~$64 million) to Merck, which was part of the initial $290 million for development. Continue to manufacture clinical and commercial supplies for Merck. 𝐀𝐬𝐬𝐞𝐭: 𝐎𝐩𝐞𝐯𝐞𝐬𝐨𝐬𝐭𝐚𝐭 Opevesostat, the focal point of this deal, is a CYP11A1 inhibitor currently in phase 3 trials for metastatic castration-resistant prostate cancer. It works by suppressing the production of steroid hormones that activate the androgen receptor signaling pathway, a critical driver in certain cancers. 𝐁𝐞𝐧𝐞𝐟𝐢𝐭𝐬 𝐭𝐨 𝐁𝐨𝐭𝐡 𝐏𝐚𝐫𝐭𝐢𝐞𝐬: 𝑀𝑒𝑟𝑐𝑘: Gains global rights to a promising cancer treatment. Enhances its oncology portfolio, potentially leading to substantial sales and market share. 𝑂𝑟𝑖𝑜𝑛: Receives significant financial support, reducing its risk. Can focus on other development candidates while benefiting from Merck's expertise and resources in commercialization. Secures a steady stream of potential milestone payments and royalties, aligning with its financial objectives. 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐒𝐲𝐧𝐞𝐫𝐠𝐲: This agreement exemplifies strategic alliances in biotech where companies leverage each other’s strengths. Orion provides innovative research and Merck brings extensive development and commercialization capabilities. This partnership minimizes Orion's financial risk and development burden while positioning Merck to potentially capitalize on a lucrative new cancer therapy.

27

BMS is poised to enter the Eosinophilic Esophagitis (EoE) market. Buried in the BMS Q2 2024 earnings call was news that company's eosinophilic esophagitis (EoE) treatment, cendakimab, successfully met Phase 3 clinical endpoints. Similar to already-approved, Dupixent, cendakimab is a biologic with subcutaneous injections every other week. Specifics on the data have yet to be released, this new agent could pose some competitive pressure for Dupixent in EoE. #gastroenterology #clinicaldata https://lnkd.in/g_2a2MWv

7

Ipsen and Skyhawk Therapeutics Announce Groundbreaking $1.8B Deal to Target RNA in Rare Neurological Diseases The Key Takeaways from BioSpace Article: 1. Ipsen and Skyhawk Therapeutics have entered into an exclusive worldwide collaboration agreement to develop novel small molecule drugs against RNA targets in rare neurological conditions. 2. The deal is worth up to $1.8 billion, including upfront payments, development, regulatory, and commercial milestones, as well as tiered royalties on future products. 3. Skyhawk's proprietary platform combines four complementary data sets (SKYSTAR, SKYSEQ, SKYLIBRARY, and SKYAI) to discover and design small molecule drugs against RNA molecules that are upstream of disease-causing proteins. 4. This approach has the potential to yield treatments for thousands of previously undruggable targets, particularly in rare neurological diseases for which there are no approved therapeutics. 5. The collaboration will leverage Ipsen's expertise in movement disorders and Skyhawk's cutting-edge technology to explore the potential for modifying RNA expression across rare and debilitating neurological conditions. #RNATargeting #RareNeurologicalDiseases #DrugDiscovery #Collaboration #BiotechInnovation

3

🚀 Registration Now Open for the Oligonucleotide Therapeutics Xchange - Maryland 2024! 🚀 We are thrilled to share that registration is now open for hubXchange's Oligonucleotide Therapeutics Xchange Maryland 2024! This event will convene leading executives from the pharma and biotech sectors to tackle and find solutions for the critical challenges in Oligonucleotide Therapeutics. 📅 Date: Wednesday, October 30, 2024 🕗 Time: 8:00 AM - 6:15 PM 📍 Location: Maryland Join us to stay at the forefront of Oligonucleotide Therapeutics innovation and connect with fellow industry leaders. Don’t miss out—register today and get your Complimentary Pass! https://lnkd.in/eyChA_wt 🔎 Why Attend hubXchange? Take advantage of a unique platform that promotes knowledge exchange and industry connections. 🗣🔬 Featuring Industry Experts: Weiguo Zhai, Senior Director, R&D Analytical Sciences, BioPharmaceutical Development, AstraZeneca Xiaoyong Lu, M.S. Ph.D., Director of Oligonucleotide and Genetic Medicine, Eli Lilly and Company Antonio DiGiandomenico, Senior Director, AstraZeneca Jimmy Weterings, VP, Research RNA Therapeutics & Delivery, Sirnaomics Jeremy Little, Director of Custom Oligonucleotides, ChemGenes Trishul Shah, Director Business Development, Head of Sales North America, PolyPeptide Group Jeremy Little, Director of Custom Oligonucleotides, ChemGenes David Brown, Director, RNAimmune David Blackmon, Director, Alcyone Therapeutics Inc. Our Partners: 🤝 ChemGenes 🤝 PolyPeptide Group 💊 Only available for Senior Scientists and above, from Bio and Pharma companies, with a drug pipeline. 💊 #OligonucleotideTherapeutics #Pharma #Biotech #hubXchange #Networking #Innovation #MarylandEvent #DrugDevelopment #RNAtherapeutics #GeneticMedicine #Biopharma #Pharmaceuticals #Biotechnology #LifeSciences #MedicalResearch #HealthcareInnovation #BiotechCommunity #ScientificConference #Therapeutics #BiotechInnovation #PharmaConference #ClinicalResearch #DrugDelivery #NewModalities #OligonucleotideDiscovery #PharmaNetworking #PharmaEvents #Xchanges #Roundtable #FreePass #RegisterNow #ComplimentaryPass

5

🔬 Biopharma Layoffs: Navigating Challenges in a Shifting Landscape Recent trends in biopharma layoffs have left many scientists reeling. Here are key takeaways from a recent STAT article: 67% of life science layoffs in H1 2024 were at large biopharma companies (>$1B annual sales), up from 47% in 2021-2023. Job postings in biotech dropped from 21,366 to 12,300 between early 2021 and 2024. Scientists face unique challenges in job searches, including maintaining confidentiality about previous work. Visa constraints add pressure for international workers, limiting job search time. Networking remains crucial: Some successful companies are hiring primarily through personal connections. The industry sees this as part of a cyclical pattern, influenced by patent expirations and acquisitions. Despite these challenges, opportunities still exist. Adaptability, networking, and a broader job search approach are key for scientists navigating this evolving landscape. What strategies have you found effective in weathering industry changes? Share your thoughts below! #BiopharmaJobs #CareerTransition #LifeSciences #Networking

3

𝗗𝗮𝗶𝗹𝘆 𝗡𝗲𝘂𝗿𝗼-𝗯𝗶𝘁𝗲𝘀 🧠: 💵𝘾𝙤𝙣𝙜𝙧𝙖𝙩𝙪𝙡𝙖𝙩𝙞𝙤𝙣𝙨 to CereVasc who secures $70 million series B financing, following FDA approval of STRIDE study 𝗦𝗼, 𝘄𝗵𝗮𝘁 𝗮𝗿𝗲 𝘁𝗵𝗲𝘆 𝗴𝗼𝗶𝗻𝗴 𝘁𝗼 𝘂𝘀𝗲 𝘁𝗵𝗶𝘀 𝗳𝘂𝗻𝗱𝗶𝗻𝗴 𝗳𝗼𝗿? 🧑‍💻Support the clinical and regulatory development of the company’s novel eShunt system ⚕️Fund their upcoming STRIDE pivotal study involving patients with normal-pressure hydrocephalus. 🤔𝗪𝗵𝗮𝘁 𝗱𝗼𝗲𝘀 𝘁𝗵𝗲𝗶𝗿 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗱𝗼? Their eShunt System is a minimally invasive approach to treating hydrocephalus. The System comprises an endovascularly implantable CSF shunt and associated delivery component. This is designed to avoid the need for: ⭐Invasive surgery ⭐General anesthesia ⭐Extended hospitalization ⭐Post-procedure pain management. #hydrocephalus #brainhealth #minimallyinvasive #patientoutcomes #neurovascular https://lnkd.in/e-R5wkkQ https://lnkd.in/enfjKs_E

10

Poseida Therapeutics, Inc. Therapeutics Announces FDA Orphan Drug Designation Granted to P-BCMA-ALLO1 for the Treatment of Multiple Myeloma Data Describing Activity of P-BCMA-ALLO1 in BCMA-Experienced Patients to be Presented at Upcoming AACR Meeting SAN DIEGO, March 13, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the treatment of multiple myeloma to P-BCMA-ALLO1, a novel BCMA-targeted allogeneic, T stem cell memory (TSCM)-rich chimeric antigen receptor (CAR)-T therapy candidate. The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM). "The Orphan Drug Designation for P-BCMA-ALLO1 underscores the high unmet medical need for a rapid and accessible off-the-shelf allogeneic CAR-T therapy for patients with multiple myeloma," said Kristin Yarema, Ph.D., President and Chief Executive Officer of the Company. "This designation further validates our belief that TSCM-rich allogeneic CAR-T therapies may potentially offer the optimal combination of clinical results, on-demand availability, and high-volume production, while supporting broader access to CAR-T therapies. We look forward to continuing our work on the Phase 1 study of P-BCMA-ALLO1 and plan to share further clinical updates in 2024." The Company is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and recently shared positive early safety and preliminary efficacy data at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in December 2023. Data highlighted at the meeting showed that P-BCMA-ALLO1 was a well-tolerated off-the-shelf therapy with a favorable emerging safety profile, delivered to 100% of patients in the intent-to-treat population with no use of bridging chemotherapy or other anti-myeloma bridging therapies. Preliminary data presented at ASH also showed allogeneic TSCM-rich CAR-T cells trafficking to bone marrow, differentiating to cell-killing effector T cells and persisting at least 6 weeks after treatment, which support the hypothesis of cell persistence at tumor-relevant sites.

54

📰 In Brief This Week 📰 -Bionano Genomics closes a $10M direct offering with potential for $20M more from milestone-linked warrants. Funds to be used for R&D, working capital, and more. 💰🔬 #Biotech #Funding #R&D -Thermo Fisher Scientific announces a quarterly dividend of $.39 per share, payable on Oct. 15, 2024. 📈💵 #Dividends #Investments #ThermoFisher -Helio Genomics completes separation from Laboratory for Advanced Medicine. Now an independent entity, Helio focuses on commercializing its liver cancer test, HelioLiver Dx. 🧬🩸 #CancerDiagnostics #Genomics -Volition Rx partners with PharmaVentures to outlicense its oncology portfolio, including Nu.Q Cancer assays and Capture-PCR detection method. 🤝🔍 #Oncology #StrategicPartnership #Biotech -Mainz Biomed submits next-gen colorectal cancer test for FDA breakthrough device designation. Assay shows 97% sensitivity for colorectal cancer. 📑🧫 #CancerScreening #FDA #Innovation - Parse Biosciences launches CSP program with SeqMatic and Eurofins Clinical Enterprise offering single-cell products as a service. 🌐🔬 #SingleCell #BiotechServices #ParseBiosciences -MGI Australia partners with University of Queensland's CEAStAR for antimicrobial resistance testing and surveillance using DNBSeq technology. 🌊🦠 #AMR #Collaboration #MGI #BiotechNews #HealthcareInnovation #LifeSciences #MedicalResearch #TechInMedicine #InnovationInHealthcare #ScientificBreakthroughs

6

1 Comment

📢 Check out our report on the explosive growth of the Cell and Gene Therapy (CGT) industry in Greater Philadelphia! 🌟 #LeadingLifeSciences! The region is now the nation’s #2 CGT hub, serving as home to 60 of the estimated 500 CGT companies worldwide. Dive into the report here: https://lnkd.in/edNneij9

8

Hello Boston. Translational Drug Development (TD2) is at Clinical Trials in Oncology East Coast. Visit our booth and learn how TD2 can help advance your cancer therapeutic program (from bench to bedside). While I won't be there (why did I hear a huge sigh of relief 😉), my colleague Parris Johnson is the man you want to speak with anyway. Don't worry, I'll be back for Tumor Models Boston in a couple weeks. #clinicaltrials #cancertherapeutic #oncology #tumormodelsboston #tumormodels #clinicaldevelopment #preclinical

1

PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza™ WARREN, N.J., May 14, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the FDA has accepted for filing the Biologics License Application (BLA) for Upstaza™ (eladocagene exuparvovec), a gene therapy for the treatment of AADC deficiency. The application has been granted Priority Review with a target regulatory action date of November 13, 2024. "We are excited to be one step closer to bringing an approved therapy to patients with AADC deficiency in the United States," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. "The data collected to date continue to support the transformative benefit of Upstaza, this highly innovative gene therapy directly infused into the brain." About Upstaza™ (eladocagene exuparvovec) Upstaza is a one-time gene replacement therapy indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic L–amino acid decarboxylase (AADC) deficiency with a severe phenotype. It is a recombinant adeno-associated virus serotype 2 (AAV2) https://lnkd.in/e5EvQp7D

31