Annie De Groot MD’s Post

Want to assess whether your monoclonal candidate will be immunogenic in the clinic? use the ADA calculator on the #ISPRI website. See figure below: Regression model for ADA prediciton: Input = Tregitope-adjusted EpiMatrix score. Y= predicted ADA. In this fugure, the initial analysis included twenty-two licensed antibodies make up the polynomial regression used for predicting T-dependent ADA responses in ISPRI (orange line). The updated regression model adds 21 new mAb examples (total of 43) with clinical immunogenicity data. Observed immunogenicity indicates the percent of exposed patients with a positive immunogenic response as defined by a positive ADA titer and reported from clinical trials identified in the FDA-approved drug product labels. The two models align despite being calculated with separate sets of ADA data. https://lnkd.in/e569CDPC

Immunogenicity assessment is a regulatory requirement that can make or break the success of your product. Recent guidelines from the FDA and EMA have both included recommendations that novel in vitro technologies, such as Octet®️ Biolayer Interferometry (BLI), be adopted. Choosing a sensitive and reliable assay method that enables rapid anti-drug antibody (ADA) evaluation is crucial for success. BLI offers multiple advantages when used in isolation or in combination with existing techniques. Download the application note to learn more: https://ow.ly/rYWP50RcpkZ #OctetBLI #Immunogenicity #AntidrugAntibody #ADA #PreclinicalTesting #FDA

A great comprehensive document on #immunogenicity evaluation utilizing state-of-the-art #OctetBLI. Download it now 👇

TiumBio plans to initiate a Phase 1b clinical trial of #TU7710, a long-acting recombinant activated factor VII, in patients with #hemophilia in Europe. Read more at https://lnkd.in/ggi24Trc

Are you interested in dose optimization for drug combinations? Here is a new, simple Bayesian design for that. https://lnkd.in/g3crvPAF

🦠 It is standard practice to test new drug molecules in vivo in two preclinical species to: - gain a more detailed understanding of how they are transported and eliminated through the kidney - mitigate risk of renal toxicity in humans What if you could predict more reliably the response in human and understand cross-species variability ahead of clinical trials? 🤔 The aProximate™ proximal tubule cells model offers a powerful tool to compare transporter activity and drug efficacy and safety across different species to improve in vitro-in vivo extrapolation (IVIVE). Find out more about cross-species comparison of drug handling with near-physiological kidney transporter model: https://lnkd.in/eWaFtAQr #Newcells #InVivo #RenalToxicity #ClinicalTrials

Dose optimization in small sample size trial faces challenges from two fronts: drug-drug combination and jointly consideration of toxicity and efficacy. Good to see this paper addresses both of them.

✅ A key milestone has been met in The Development and Validation of Technology for Time Critical Genomic Testing (“DEVOTE”) programme for the Genedrive® CYP2C19-ID kit.    ✅ The programme has now passed the patient numbers required for a subsequent submission for an in vitro diagnostics CE certification (“CE-IVD”), which is still anticipated in early 2025. ✅ The Genedrive® CYP2C19 test outperformed the laboratory test with respect to accuracy of identification of Loss of function (LoF) alleles underpinning suboptimal response to the anti-platelet drug Clopidogrel, and broader inclusion of LoF alleles. ✅ The UK’s National Institute for Health and Care Excellence (“NICE”) has recommended in draft guidance, that the Genedrive® CYP2C19-ID test should be used as the point-of-care test of choice in the NHS before clopidogrel administration in the management of IS and TIA patients (https://lnkd.in/e-JWtpzb). The draft guidance is expected to be finalised on 10 July 2024.

For ultra rare, life-threatening conditions like #BarthSyndrome where the traditional drug development paradigm doesn't quite fit, regulatory flexibility is key. https://lnkd.in/eYxPAHF4

Assess cilia function for mucociliary clearance with a new In Vitro assay 🫁 This in vitro assay helps assess cilia function for mucociliary clearance, evaluate drug efficacy, dosing, sustained effect and safety in the lung's small airway epithelium. As well as supporting confident decision-making in progressing your compound, this new assay can help to achieve: ✔️Compound evaluation for effect on ciliated cells ✔️Comprehensive, high-sensitivity cilia beating readouts for confident decision-making ✔️Mimicking of respiratory conditions for predictivity of cilia function in vivo Unlock a comprehensive, high-sensitivity set of data that accurately measures the effect of your compound, including fast-acting ones, on mucociliary clearance. Find out more: https://lnkd.in/e9CEZRUC #Newcells #LungAssay #Cilia #SAEC