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.
Immunogenicity 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 and pharmacokinetics.
IPM Biotech is specialised in large molecule bioanalysis, particularly in the area of
immunogenicity.
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.
