Could a Long-Acting Prodrug of SN-38 be Efficacious in Sacituzumab Govitecan-Resistant Tumors?
AbstractWe previously proposed that sacituzumab govitecan (SG, Trodelvy ®) likely acts as a simple prodrug of systemic SN-38 as well as an antibody drug conjugate (ADC). In the present commentary, we assess whether a long-acting SN-38 prodrug, such as PLX038, might be efficacious in SG-resistant patients. We first describe possible mechanisms of action of SG, with new insights on pharmacokinetics and TROP2 receptor occupancy. We argue that SG is not an optimal conventional ADC and that the amount of systemic SN-38 spontaneously hydrolyzed from the ADC is so high it must have activity. Then, we describe the concept of time...
Source: BioDrugs - January 18, 2024 Category: Drugs & Pharmacology Source Type: research
Unveiling the Biosimilar Paradox of Oncologists ’ Perceptions and Hesitations in South Korea: A Web-Based Survey Study
ConclusionKorean oncologists perceived biosimilars to be as safe and effective as originators. However, there is a notable mismatch between this perception and their prescribing practices, particularly among those who have not prescribed biosimilars before. The financial burden of patients served as a significant driver for prescribing biosimilars, yet marginal price differences between originators and biosimilars may be associated with the low adoption rate of biosimilars in Korea. Active price competition may enhance market penetration of biosimilars. (Source: BioDrugs)
Source: BioDrugs - January 12, 2024 Category: Drugs & Pharmacology Source Type: research
Safety, Tolerability, and Preliminary Efficacy of Serplulimab, a Novel Anti-PD-1 Antibody, in Patients with Metastatic or Recurrent Solid Tumors: A Phase I Study
ConclusionsSerplulimab was well tolerated and demonstrated antitumor activity. These data support further study of serplulimab in larger patient populations.Clinical Trial RegistrationClinicalTrials.gov NCT03468751 (19 March, 2018). (Source: BioDrugs)
Source: BioDrugs - January 9, 2024 Category: Drugs & Pharmacology Source Type: research
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Anti-IFNAR1 Monoclonal Antibody QX006N: A First-in-Human Single Ascending Dose Study in Healthy Chinese Volunteers
ConclusionsQX006N demonstrated acceptable safety, tolerability, and pharmacokinetic characteristics in healthy subjects when administered as a single intravenous infusion at doses that ranged from 0.3 mg/kg to 10.0 mg/kg. Based on the pharmacokinetic and safety outcomes, a recommended effective dose of 300 mg is proposed for future phase Ib studies.Clinical Trial RegistrationThis study has been registered athttp://www.chinadrugtrials.org.cn/ under identifier CTR20212834. (Source: BioDrugs)
Source: BioDrugs - December 27, 2023 Category: Drugs & Pharmacology Source Type: research
Acknowledgement to Referees
(Source: BioDrugs)
Source: BioDrugs - December 18, 2023 Category: Drugs & Pharmacology Source Type: research
Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries
ConclusionThe availability of biosimilars was associated with a decrease in adalimumab expenditure without compromising the consumption of adalimumab. (Source: BioDrugs)
Source: BioDrugs - December 8, 2023 Category: Drugs & Pharmacology Source Type: research
Molecular Engineering of Interleukin-2 for Enhanced Therapeutic Activity in Autoimmune Diseases
We describe the structural mechanisms of IL-2 signaling, explore current applications of IL-2-based compounds as immunoregulatory interventions, and detail the progress and challenges associated with clinical adoption of IL-2 therapies. In particular, we focus on protein engineering approaches that have been employed to optimize the regulatory T-cell bias of IL-2, including structure-guided or computational design of cytokine mutants, conjugation to polyethylene glycol, and the development of IL-2 fusion proteins. We also consider future research directions for enhancing the translational potential of engineered IL-2-based...
Source: BioDrugs - November 24, 2023 Category: Drugs & Pharmacology Source Type: research
Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study
ConclusionsCT-P43 demonstrated equivalent efficacy to originator ustekinumab in patients with moderate to severe plaque psoriasis, with comparable pharmacokinetic, safety and immunogenicity profiles.Clinical Trial RegistrationClinicalTrials.gov Identifier: NCT04673786; date of registration: 17 December, 2020 (Source: BioDrugs)
Source: BioDrugs - November 22, 2023 Category: Drugs & Pharmacology Source Type: research
