Cerulean has developed a novel class of tumor-targeted therapy, nanopharmaceuticals, designed to penetrate tumor tissues, enter cancer cells, and deploy durable therapeutic effects. Clinical and preclinical product candidates have been developed with two broadly applicable technologies, namely CDP and PNP. CRLX101 is a CDP-based Phase 2 development candidate containing the anticancer drug camptothecin. It is currently being evaluated for the 2nd/3rd line treatment of non-small cell lung cancer (NSCLC) in a 150-patient randomized study.  CRLX101 has previously shown a median progression-free survival (mPFS) of 4.4 months in 21 NSCLC patients, exceeding the 2.5 to 2.9 months mPFS observed with approved agents erlotinib, docetaxel, and pemetrexed.  CRLX301 is a CDP-based preclinical development candidate containing docetaxel. CRLX301 possesses superior pharmacokinetic and biodistribution profiles compared to docetaxel, achieving a 10-fold increase in drug concentration in tumor tissue, which is correlated with superior efficacy, as measured by tumor growth delay and cure rate, across multiple xenograft models. Additionally, we have developed a PNP-based siRNA nanopharmaceutical that has shown a 70% tumor-specific protein level knockdown at 5 days after a single intravenous dose in an orthotopic breast tumor xenograft.  The siRNA PNP has also been shown to be well tolerated and non-immunogenic.

Cerulean Pharma's nanopharmaceuticals: From bench to bedside

243rd National Meeting (2012)

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