A5078192251- Monoclonal and Polyclonal Antibodies Research
- Biosimilars and Bioanalytical Methods
- HER2/EGFR in Cancer Research
- Head and Neck Cancer Studies
- Cancer Treatment and Pharmacology
- Cancer, Hypoxia, and Metabolism
- Nanoparticle-Based Drug Delivery
- Nanoplatforms for cancer theranostics
- Lung Cancer Treatments and Mutations
- Radiopharmaceutical Chemistry and Applications
- Microfluidic and Capillary Electrophoresis Applications
- Protein purification and stability
- COVID-19 Clinical Research Studies
- Medical Imaging Techniques and Applications
- Radiation Dose and Imaging
- Diabetes Management and Research
- Breast Cancer Treatment Studies
- Dialysis and Renal Disease Management
- Metal-Catalyzed Oxygenation Mechanisms
- Saffron Plant Research Studies
- Graphene and Nanomaterials Applications
- Fibroblast Growth Factor Research
- Brain Metastases and Treatment
- Lipid Membrane Structure and Behavior
- Bee Products Chemical Analysis
Institut de Cancérologie Strasbourg
2020-2025
Inserm
2018-2019
Université de Strasbourg
2015-2019
Levi Strauss (United States)
2018-2019
Eurométropole de Strasbourg
2018
Interface (United States)
2018
Hôpital d'Hautepierre
2016
The high cost of trastuzumab (Herceptin®) limits its accessibility for patients worldwide. Biosimilars, such as Tuznue® (HD201), represent a promising alternative to improve access this essential therapy HER2-positive breast cancer. This study aims assess the similarity with reference product Herceptin® through comprehensive analytical and biofunctional evaluations, ensuring similar quality, safety, efficacy profiles. Multiple methods were performed key quality attributes Herceptin®....
Abstract Ultrasmall nanoparticles (USNs) (nanoparticles with hydrodynamic diameter <10 nm) are being widely developed pre‐clinically and started to emerge in clinical trials over the last decade. Most of these USNs display same features including short retention time blood, rapid renal clearance, relie on passive targeting strategy reach tumor. Through this review, development AGuIX is focused because their usages as passively targeted USN but also possible biofunctionalizations peptides...
Current therapeutic treatments improving the impaired transportation of oxygen in acute respiratory distress syndrome (ARDS) have been found to be relevant and beneficial for treatment COVID-19 patients suffering from severe complications. Hence, we report preclinical preliminary results Phase I/II clinical trial LEAF-4L6715, a liposomal nanocarrier encapsulating kosmotropic agent trans-crocetin (TC), which, once injected, enhance oxygenation vascular tissue therefore has potential improve...
Background: Native mass spectrometry (nMS) approaches appear attractive to complement bottom-up strategies traditionally used in biopharmaceutical industries thanks their quite straightforward and rapid workflows, especially through online hyphenation of non-denaturing liquid chromatography (LC) nMS. The present work provides an overview the state-of-the-art chromatographic tools available for detailed characterization monoclonal antibody (mAb) formats, exemplified on antibody-drug conjugate...
management of head and neck squamous cell carcinomas (HNSCC) include anti-Epidermal Growth Factor Receptor (EGFR) antibodies radiotherapy, but resistance emerges in most patients. RAS mutations lead to primary EGFR blockade metastatic colorectal cancer are infrequent HNSCC, suggesting that other mechanisms implicated. Since hypoxia Hypoxia Inducible Factor-1 (HIF-1) have been associated with treatment failure tumor progression, we hypothesized EGFR/mammalian Target Of Rapamycin (mTOR)/HIF-1...
Abstract Pneumatic transportation systems (PTS) were recently proposed as a method to carry ready-for-injection diluted monoclonal antibodies (mAbs) from the pharmacy bedside of patients. This reduces time and improves efficiency drug distribution process. However, mAbs are highly sensitive molecules for which subtle alterations may lead deleterious clinical effects. These can be caused by various external factors such temperature, pH, pressure, mechanical forces that occur during...
For most patients suffering from recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC), chemotherapy is the main option after considering surgery reirradiation. Cetuximab combined with a platinum-fluorouracil regimen (EXTREME) has been standard of care for over decade. Nevertheless, significant number remain unfit this because age, severe comorbidities, or poor performance status. The aim study to investigate an alternative sufficient efficacy safety.We reviewed...
The EXTREME protocol is the standard of care for recurrent or metastatic head and neck squamous-cell carcinoma (R/M HNSCC) in first line. Beyond first-line except immunotherapy, poor efficacy was reported by second-line chemotherapy. Re-challenge strategies based on a repetition line with platinum cetuximab regimens might have been an option to consider.We performed retrospective study order assess plus doublet-based chemotherapy regimen patients R/M HNSCC progressing after at least 3 months...
Abstract Prestige Biopharma Ltd (Singapore) has developed HD201, a proposed biosimilar to reference product trastuzumab. As part of the stepwise approach ensure comparability between candidate and medicinal product, phase I study in healthy subjects was conducted demonstrate pharmacokinetic (PK) equivalence (NCT03776240). The primary objective EU‐Herceptin ® , US‐Herceptin given at 6 mg/kg as 90‐min i.v. infusion male subjects. A pairwise comparisons based on endpoint AUC 0–inf secondary PK...
e18018 Background: Since the results of KN-048 trial, combination platinum/5FU plus PMB has become standard care (SOC) for R/M HNSCC pts. The KN-B10 study shows that 5FU can be replaced by P with a favorable response rate and toxicity profile. Weekly use reduces hematologic increases dose-intensity. Methods: We retrospectively reviewed all records patients or LVA (T4b and/or N3b) HNSCC, ECOG-PS 0 to 2, PDL1 CPS ≥ 1, treated in first-line weekly (80 mg/m2) CP (AUC 2: maximum total dose 250 mg...
Abstract Improving the tumor reoxygenation to sensitize radiation therapy is a cornerstone in oncology. Here, pre‐clinical development of clinically transferable liposomal formulation encapsulating trans sodium crocetinate (NP TSC) reported improve oxygen diffusion through environment. Early pharmacokinetic analysis clinical trial this molecule performed on 37 patients orient define optimal fixed dosage use triple‐negative breast cancer model validate therapeutic combination and NP TSC....
Abstract Pneumatic transportation systems (PTS) were recently proposed as a method to carry ready-for-injection diluted monoclonal antibodies (mAbs) from the pharmacy bedside of patients. This reduces time and improves efficiency drug distribution process. However, mAbs are highly sensitive molecules for which subtle alterations may lead deleterious clinical effects. These can be caused by various external factors such temperature, pH, pressure, mechanical forces that occur during...
Purpose This first-in-human study was designed to evaluate the pharmacokinetic (PK) equivalence between HD204 and European Union (EU)-sourced bevacizumab, United States of America (US)-sourced EU-sourced US-sourced bevacizumab (NCT 03390673). Methods In this randomized, double-blind, 3-way parallel group, single-dose comparative PK study, healthy male subjects were randomized receive a single 1 mg/kg intravenous dose HD204, or bevacizumab. parameters calculated using non-compartmental...
579 Background: Trastuzumab, an approved prescription drug by EMA and FDA under the name Herceptin has become key treatment in patients with HER2 − positive breast cancer. HD201, developed Prestige Biopharma Pte Ltd is a biosimilar candidate to Herceptin. The biosimilarity of HD201 was established based on systematic stepwise comparisons between reference product, In order confirm clinical similarity two studies were undertaken. Methods: First, double-blind, randomised parallel group study,...