ISPE’s Post

Don’t miss this webinar: It could really change your drug development projects! #celltherapy #drugdevelopment

BlueRock Therapeutics LP, the pioneering clinical stage cell therapy company under Bayer (Schweiz) AG, and bit.bio, the visionary team coding human cells for groundbreaking cures, have joined forces. Witness the cutting-edge progress and potential of this extraordinary collaboration by clicking the link below to read the full news: https://lnkd.in/dTXkJy-K #celltherapy #innovativemedicine #therapeutics #media7 #biotechnologyreport

Poseida Therapeutics, Inc.'s Mark Gergen and Kristin Yarema, Ph.D. detail why #allogeneic is not #autologous with extra #geneediting, and why Allo should not be considered inferior to Auto. Here, they share why that realization is starting to take hold. #cellandgenetherapy #celltherapy https://lnkd.in/eD5rwCGi

Accelerating development of engineered T cell therapies in the EU: current regulatory framework for studying multiple product versions and T2EVOLVE recommendations https://lnkd.in/gzGUtk2t

Reposting Erin Harris Approaching The Allogeneic Tipping Point: The Emergence Of Allogeneic Cell Therapy For Oncology, Cell & Gene, Guest Column | November 1, 2023 By Mark Gergen, CEO, and Kristin Yarema, Ph.D., President, Cell Therapy, Poseida Therapeutics https://lnkd.in/dGwyeYtP "As we envision an ideal allogeneic product, we think about a product that: (i) is immediately available; (ii) is dramatically cheaper than autologous approaches; (iii) will deliver equivalent or better efficacy than autologous products; (iv) has a better safety and tolerability profile to improve the patient experience and allow for combination therapies that are the clinical norm in oncology; and (v) can explore and enable redosing and other treatment options. Is an allogeneic product with all those characteristics truly possible? We should be aspiring to an allogeneic cell therapy that has the advantages of other modalities including first generation cell therapy, biologics and antibodies, and even small molecules. There is no good reason that one cannot create an allogeneic product that is equivalent or better than what the autologous programs have delivered to date. When one thinks about what will make an exciting allogeneic product, one should focus on the patient experience. Can we get a patient into a deep response with limited toxicities and a reasonable treatment experience and keep them in response for a long period – all at a reasonable cost? The many benefits of an allogeneic product will open many paths to get to those outcomes that are not possible with autologous products – we just need to keep an open mind and not limit our thinking."

Developing cell therapies comes with its own unique set of challenges - creating tailored analytical approaches, navigating an ever-evolving regulatory landscape and ensuring patient safety/optimising therapeutic efficacy. In our latest blog by Caroline Beltran, we discuss the above considerations and bioanalytical strategies for cell therapy clinical trials. For a further deep-dive into bioanalytical strategies for cell therapy clinical trials, watch our latest on-demand webinar: https://lnkd.in/eprjixEX #Synexa #lifesciences #celltherapy #clinicaltrials

MD Anderson plans to focus on using the CaspaCIDe technology as a safety feature of cell therapies in development. The safety switch incorporates an inducible enzyme known as caspase-9, which initiates the first step of the apoptosis programmed cell death pathway. The switch can be triggered by rimiducid, leading to rapid elimination of cells containing the CaspaCIDe switch. MD Anderson's Therapeutics Discovery division also plans to continue the clinical development of rimiducid in order to seek future approval from the Food and Drug Administration. https://lnkd.in/eU4A8r7K

LucidQuest Strategic Insights (lqventures.com) >>> Gene&Cell Therapy >> FDA offers more clarity on safety testing for cell therapies: The FDA is providing sponsors of cell therapies with a new draft guidance document on the kinds of safety testing they should perform. The 14-page guidance, published late last month, provides sponsors with clarity on how to carry out cell safety testing when submitting an investigational new drug application or a biologics application. The guidance lays out how allogeneic cell therapies do carry some risk, including contamination, or genome changes that can potentially lead to cells developing into tumors. The FDA says sponsors should base safety testing on the potential the cells have to expand, the reagents used to expand the cells and the number of patients capable of being treated. Patrick Hanley Patrick Hanley, chief and director of cell therapy at Children’s National Hospital, told Endpoints News in an interview that the guidance is a sign the FDA is listening to cell therapy sponsors who have been asking the agency for more clarity in this area. He said focusing on allogeneic cell therapies, which involve using cells from a donor to treat the patient, is particularly helpful. He said there wasn’t previously much clarity on the kind of testing that should be done based on the number patients being treated with the therapy. “That’s what this guidance tries to address is what testing needs to be acquired based on the specific properties and treatment potential of the therapy,” he said. Hanley added that it would be helpful if the FDA laid out benchmarks for testing based on the the specific number of patients being treated with a cell therapy, but acknowledged that would be difficult given that each therapy is different. Comments on the guidance are due July 29. The guidance lays out considerations for sponsors using highly expanded cells, as well as cells with limited potential to expand. It also includes a table with a description of types of cell therapies and their corresponding testing recommendations. #lucidquest #genetherapy #celltherapy

Please take a look at a complete picture of the industry environment of the Cell Therapy Industry, its clinical researches, and other elements of pharmaceutical research and development. In the infographic you’ll find out the following: 🔹 400 BioTech companies that develop Cell Therapy Technologies 🔹 Comprehensive overview of existing Cell Therapy Technologies 🔹 Mindmaps with companies are developing Stem Cell Therapy, Non-Stem Cell Therapy and Gene-based cell therapy 🔹Overview of platforms and methods that famous companies use #celltherapy #overview #industry #onlinecourses #symmetrictraining

Lisa Ricciardi of Cognition Therapeutics, Inc., one of our Cowtown Angels portfolio companies, was recently featured in BioSpace talking about their trial candidate, CT1812, that prevents the binding of toxic oligomers to synapses in a neuroprotective approach that acts earlier in the amyloid cascade to slow cognitive decline and disease progression. Their Phase II trial is underway with 540 early-to-mild Alzheimer’s patients. Results from an earlier Phase II trial are expected mid-summer. Are you an accredited investor looking for quality investment opportunities from top emerging companies? Learn more about Cowtown Angels here: https://lnkd.in/eF8x7_VX