As biologic drug providers endeavor to create effective protein-based medicines, immunogenicity
remains a complex challenge.
Hookipa Biotech AG, a company pioneering a new class of immunotherapies for oncology and infectious diseases, today presented the un-blinded safety and immunogenicity
data through month four from the Company's phase 1 first-in-human trial of HB-101, a vaccine against human cytomegalovirus (CMV), based on Hookipa's proprietary Vaxwave0 platform.
is now known to be one of the main causes of this loss of response.
US-based drug development decision support technology and consulting services company Certara is launching a Quantitative Systems Pharmacology Immunogenicity
Consortium, the company said.
In this Phase III, open-label study, we assessed the immunogenicity
and safety of Southern Hemisphere inactivated quadrivalent influenza vaccine (Fluarix[TM] Tetra) in Brazilian adults (NCT02369341).
The mechanisms for the development of response failure are complex; however, immunogenicity
of these protein-based TNF antagonists has been recognized as a major factor (5).
Use of an immunomodulatory agent can reduce the risk of immunogenicity
and improve clinical response.
It also brings on board IPM's immunogenicity
, pharmacokinetics, and pharmacodynamics expertise to complement BioAgilytix's capabilities in biomarkers, cell-based assays, and immunogenicity
IPM Biotech is specialised in large molecule bioanalysis, particularly in the area of immunogenicity
continues to be a major concern for the field of science, due to its impact on safety and efficacy.
PROPOSED REVISIONS TO THE GUIDELINE ON THE ASSESSMENT OF IMMUNOGENICITY
FOR BIOTECHNOLOGY DERIVED PROTEINS AND ITS RELEVANCE TO BIOSIMILARS
Antitope Limited, an Abzena company, has collaborated with Synthon Biopharmaceuticals BV (Synthon), a global pharmaceutical company with expertise in the development of complex small molecule and biosimilar drugs and new biopharmaceuticals, including antibody drug conjugates (ADC), to assess the potential immunogenicity
of candidate antibodies for Synthon's ADC programmes.