If the normal clinical development trial approach is used then there would be at least two trials, a phase II and then a phase III.
These data demonstrate the prophylactic and therapeutic efficacy of this new class of human monoclonal antibodies in a highly stringent and clinically relevant animal model of influenza and justify clinical development of this approach as intervention for both seasonal and pandemic influenza.
Here, we review the evidence that genetically engineered Tregs can effectively dampen pathogenic immune responses and critically evaluate the prospects for clinical development of this approach.
The treatment of metastatic kidney cancer has rapidly evolved during the last few years, and a large number of targeted molecules have either already shown efficacy in phase III trials or are in advanced stage of clinical development, replacing former immunotherapeutic approaches (Schrader and Hofmann, 2008).
However, only a fraction of potential blood-stage vaccine antigens have been evaluated as targets, and a number of new promising candidate antigen formulations and delivery platforms are approaching clinical development.
Given that only a fraction of potential blood-stage antigens have been evaluated as vaccine targets and new candidate vaccines will continue to approach clinical development, it remains essential that robust, sensitive and reliable methods of detecting even modest clinical efficacy of BSV be established.
Importantly, the valuable information that we have learned from this study, in terms of safety, immune response and patient profile, provides Immunovaccine with critical insight into how best to proceed with the clinical development of this novel approach to cancer immunotherapy," said Dr Marc Mansour, Immunovaccine's chief scientific officer.
Additional approaches under clinical development include therapeutics that target cytokines, such as interleukin-12/23 interleukin-12/23 thas block T-cell signaling.
Novel approaches for clinical development and trial design could have a key role in overcoming some of these challenges by improving efficiency and reducing attrition rates.
Immatics and BioNTech will jointly take this personalized immunotherapy approach into clinical development.
