Shreeyashi Ojha’s Post

A big step in realizing our strategy towards on integrated offering for viral vector manufacturing!

Demand for #advancedtherapies, such as cell and gene therapies, is growing and won’t stop anytime soon. To get these innovative treatments to patients as quickly as possible, it is critical for #CDMOs to evolve to meet the needs of #pharma and #biotech customers as they work to move medicines from #clinicaltrials to commercialization.   I recently had the opportunity to sit down with [@Clinical Trials Arena] to discuss how our newly opened cold and ultra-cold facility in the #Netherlands will enable our partners in the EU to advance medicines.    Read more from our conversation here: https://lnkd.in/e9j3Rs2e

Synergies between automated cell expansion systems and real-time analyzers creates a powerful combination for monitoring and optimizing cell expansion processes, transforming cell and gene therapy manufacturing to provide improved scalability, reproducibility, and tighter process controls. See how 908 Devices and Terumo BCT are collaborating to do just that. #celltherapy #manufacturing #processdevelopment

Vertex Pharmaceuticals lifts sales guidance as launch of gene therapy Casgevy picks up steam As growth in Vertex's cystic fibrosis portfolio buoys the company amid the launch of gene therapy Casgevy, the company is feeling confident enough to boost its revenue outlook for the year. After collecting $2.65 billion in second-quarter revenues, representing a 6% uptick from last year’s second quarter, Vertex lifted its full-year sales guidance to a range of $10.65 billion to $10.85 billion. The new forecast adds $100 million on either end of the company's prior guidance. The new numbers reflect expectations for continued cystic fibrosis growth and Casgevy’s uptake in its approved indications and markets, the company said in a release. After Casgevy's approval in sickle cell disease in December and subsequent FDA nod in beta thalassemia in January, it's still early days in the groundbreaking launch. But Vertex is steadily expanding its patient base and continues to predict a “potential multi-billion opportunity,” according to its earnings presentation (PDF). So far, around 20 patients have begun their treatment journey with the cell collection process, Vertex reported. https://lnkd.in/eUmxy9CN

Gene&Cell Therapy >> Taysha’s $75M offering; Augustine raises €17M: Plus, news about Agile Therapeutics, Insud, Werewolf Therapeutics and Allakos: Taysha Gene Therapies sells $75M in shares: The biotech is issuing more than 14 million shares of common stock for $2.25 apiece and offering pre-funded warrants to certain investors. The company’s shares $TSHA dropped 36% last week after it unveiled Phase 1/2 data for its Rett syndrome gene therapy candidate. — Ayisha Sharma Augustine raises $18.5M in Series A: The Belgian biotech brought in €17 million in the first close of its Series A. Its investors include Eli Lilly, Asabys Partners and V-Bio Ventures, among others. The biotech is focused on neurodegenerative and cardiometabolic diseases, both of which are familiar categories to Lilly. — Kyle LaHucik Agile Therapeutics merges with Insud: Agile, a women’s health company, will be acquired by Exeltis Project, a subsidiary of Spain-based Insud, at an enterprise value of $45 million. — Kyle LaHucik Werewolf Therapeutics unveils initial Ph1 cancer data: The company’s WTX-330 achieved “therapeutically relevant exposure levels” in subjects with locally advanced or metastatic solid tumors or non-Hodgkin lymphoma. The selectively activated IL-12 prodrug was linked with one unconfirmed partial response in a metastatic melanoma patient. — Ayisha Sharma Allakos teases derm drug data in healthy subjects: The biotech’s monoclonal antibody candidate, AK006, reached serum concentrations consistent with mast cell inhibition in preclinical models. Allakos’ Phase 1 trial is also enrolling people with chronic spontaneous urticaria. The company’s shares $ALLK were down around 7% when the market opened. — Ayisha Sharma #lucidquest #genetherapy #celltherapy

An insightful post shared below:

🚨 Roche to acquire Poseida Therapeutics, Inc. for up to $1.5B! 🚨 Roche is acquiring Poseida Therapeutics for approximately $1.0 billion upfront + $0.5 billion in contingent value rights. Roche will absorb Poseida's platform of proprietary non-viral delivery capabilities and pipeline of gene therapy, gene editing and donor-derived cell therapy programs, as well as GMP manufacturing capabilities. The acquisition builds on the existing partnership between Roche and Poseida, established in 2022. Poseida's lead programs include P-BCMA-ALLO1 for multiple myeloma and P-CD19CD20-ALLO1 for B-cell malignancies, both already partnered with Roche, with potential applications in autoimmune diseases including multiple sclerosis and systemic lupus erythematosus. That marks three >$1B innovative modality early biotech acquisitions in November, including Novartis' acquisition of Kate Therapeutics (AAV gene therapy, $1.1B) and AbbVie's acquisition of Aliada Therapeutics (antibody-oligo brain shuttles, $1.4B). The clearest sign yet of a healthier financial environment for biotech innovation? 🤞 Subscribe to my newsletter for a weekly summary of all the good news in biotech: https://lnkd.in/gH5e-nhN

🌟 Exploring the Future of #RareDisease Treatment: Cell and Gene Therapies Market 🌟 DelveInsight Business Research LLP's latest report dives into the transformative landscape of Cell and Gene Therapies in Rare Disorders Market. With groundbreaking innovations in gene editing, cell-based treatments, and personalized #medicine, this report sheds light on emerging therapies aimed at revolutionizing rare disease management. The leading Cell and Gene Therapies in Rare Disorders Companies such as Pfizer, Sangamo Therapeutics, Inc., Roche (Spark Therapeutics, Inc.), Freeline Therapeutics, 4D Molecular Therapeutics, Astellas Pharma Gene Therapies, Actus Therapeutics (Acquired by Bayer), GenSight Biologics, Coave Therapeutics, Johnson & Johnson/MeiraGTx, Applied Genetic Technologies Corporation, Nanoscope Therapeutics Inc. jCyte, Inc., ReNeuron Group Plc, REGENXBIO, Amicus Therapeutics, Sarepta Therapeutics, Capricor Therapeutics, Inc./Nippon Shinyaku, BrainStorm Inc. Cell Therapeutics, CRISPR Therapeutics/Vertex Pharmaceuticals, Editas Medicine, Krystal Biotech, Inc., Abeona Therapeutics, Castle Creek Biosciences, Inc., Holostem Terapie Avanzate S.r.l., RHEACELL GmbH & Co. KG, Ishin Pharma, Anterogen, Ultragenyx Pharmaceutical, and others. 🔬 Uncover how novel therapies are opening doors to improved outcomes and hope for patients worldwide @ https://lnkd.in/djeg783R #CellAndGeneTherapy #RareDisorders #GeneTherapy #MarketResearch #HealthcareInnovation #DelveInsight

Are you designing an early-phase clinical trial for your cell & gene therapy (CGT) product? Unsure of how to approach the trial design? Early phase trial designs for CGT products depend on the product's distinctive features, previous clinical experience and manufacturing logistics. Inevitably, these are significantly different (and may be more complex） than those of small molecules. It is important for sponsors to consider clinical safety issues, preclinical issues, and CMC related issues for CGT products. Read our blog that covers the key considerations when designing early-phase clinical trials for CGT products https://lnkd.in/dRzXEzcx Discuss your regulatory requirements for designing CGT clinical trials 🤝 Meet us at BIO International 2024: https://lnkd.in/gJt7Vxwv 🤝 Meet us at DIA Global 2024: https://lnkd.in/grrwWGU6 #cell #gene #therapy #clinical #trial #regulatory #BIO2024 #DIAGlobal #pharma #biologic #CMC #preclinical #safety

this is a really great summary of the challenges faced by companies developing novel cell and gene therapies (CGTs). Cost is a major hurdle, with biomanufacturing making up a large portion of that cost due to scale (small-batch production), media (recombinant growth factors and expensive proprietary formulations) and yield. This marks such a huge opportunity for B2B companies working to support cultured meat (or cellular agriculture in general). #biotech #cultivatedmeat #cellularagriculture #cellandgenetherapy #partnership