Preclinical development and first-in-human study of 68Ga-MLN6907

Invicro developed and optimized the radiosynthesis of 68Ga-DOTA-MLN6907, a peptide containing three disulfide bonds and specific to guanyl cyclase C (GCC), a cell surface target that is highly expressed in colorectal cancer. The optimized radiolabeling procedure was used to support a variety of preclinical in vivo imaging studies and supported subsequent GMP labeling method development. In addition, Invicro used a combination of in vitro, ex vivo and in vitro studies and mathematical modeling to simulate clinical list-mode data for 68Ga-DOTA-MLN6907. This simulated data was analyzed to assess the expected impact of clinical image protocol design on the resulting clinical image data. The analysis was then used to guide the design of a Phase 1, first-in-human single-dose PET imaging study of 68Ga-MLN6907 in patients with metastatic colorectal carcinoma.

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Figure 1: Cvet et al. 2015 AACR/SNMMI Poster