In a recent Phase I trial with healthy volunteers, Richmond Pharmacology were pleased to provide our sponsor, Codiak BioSciences, with positive results of its exosome therapeutic exoIL-12.
In this randomized, placebo controlled, double-blind study, exoIL-12 demonstrated a favourable safety and tolerability profile in healthy volunteers. This is an important breakthrough as previous trials by other drug development companies showed detectable systemic exposure using IL-12.
Benny Sorensen, Senior Vice President and Head of Clinical Development at Codiak BioSciences commented: “This is an important milestone, as these results show that exoIL-12 acts in humans as we had expected, based on our preclinical evaluations. The safety and tolerability profile observed here support the target profile that we are hoping to achieve with this candidate.”
The gene IL-12 is an anti-tumour cyotine, which has been found to have significant systemic exposure in previous clinical trials. ExoIL-12 was created to control the dose of IL-12 and target the tumour micro-environment. This enables safe application in patients and highly accurate targeting to the affected area.
Dr Jorg Tabel, CEO of Richmond Pharmacology stated: “We are pleased to work with Benny Sorensen and his team at Codiak BioSciences to assess this novel therapy. We were able to quickly recruit during the pandemic and deliver the study results within stringent timeframes to enable Codiak to progress to the next phase of research. The development of Codiak’s engEx platform realises the potential to treat many conditions, bringing hope to patients and their families.”
Richmond Pharmacology is celebrating 20 years of clinical excellence. We have been supporting pharmaceutical and biotechnology companies to study the tolerability and safety of novel therapies since 2001 and specialise in FIH and patient studies.