Cerulean Announces Publication in Cancer Research

Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), today announced the publication of preclinical proof of concept data for its lead compound, CRLX101, in the journal Cancer Research. The publication highlights that CRLX101 demonstrated strong antitumor activity, as monotherapy and in combination with Avastin® (bevacizumab), leading to complete tumor regression, reduced metastasis, and extended survival of mice with metastatic disease. These preclinical results were derived from mouse models of orthotropic primary triple-negative breast tumor xenografts, including a patient-derived xenograft and a model of post-surgical, advanced metastatic breast cancer. The article was published online.

“CRLX101 in combination with Avastin is a promising combination that has shown compelling antitumor activity in renal cell carcinoma and ovarian cancer, and we are eager to further explore its potential utility in this aggressive and difficult-to-treat form of breast cancer in which patients are at very high risk of recurrence and metastasis,” said Christopher D.T. Guiffre, President and Chief Executive Officer of Cerulean. “Consistent with what we observed in previous studies, these preclinical data show that CRLX101 complements and improves concurrent antiangiogenic therapy, and provides strong rationale for continued development in this indication.”

In primary xenograft and patient-derived xenograft models, mice on therapy for five to six months of CRLX101 showed tumor growth suppression or regression and reduced lung metastasis. Additionally, Avastin improved both median survival and reduced lung metastasis. Long-term antitumor activity of CRLX101 monotherapy and combination with Avastin was also demonstrated to prevent the emergence of new metastases and caused regression of existing metastases in a model of post-surgical, advanced metastatic breast cancer. Finally, CRLX101 led to improved tumor perfusion and reduced hypoxia, as measured by contrast-enhanced ultrasound and photoacoustic imaging. This improvement in tumor perfusion may contribute to the ability of CRLX101 to effectively and durably suppress HIF-1α.

About CRLX101

CRLX101 is a nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is involved in cellular replication, and also inhibits hypoxia-inducible factor-1α (HIF-1α), which research suggests is a master regulator of cancer cell survival mechanisms. CRLX101 has shown activity in four different tumor types, both as monotherapy and in combination with other cancer treatments. CRLX101 is in Phase 2 clinical development and has been dosed in more than 350 patients. The U.S. FDA has granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma.

About Cerulean Pharma

The Cerulean team is committed to improving treatment for people living with cancer. We apply our Dynamic Tumor Targeting™ Platform to create a portfolio of NDCs designed to selectively attack tumor cells, reduce toxicity by sparing the body’s normal cells, and enable therapeutic combinations. Our first platform-generated NDC clinical candidate, CRLX101, is in multiple clinical trials in combination with other cancer treatments, all of which aim to unlock the power of combination therapy. Our second platform-generated NDC clinical candidate, CRLX301, is in a Phase 1/2a clinical trial. For more information, please visit www.ceruleanrx.com.

Cautionary Note on Forward Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about the clinical development of our product candidates, statements about the sufficiency of cash and cash equivalents to fund our operations, debt service and other scheduled expenditures and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and completion of clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 2, 2016, and in other filings that we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.

Avastin is a registered trademark of Genentech, Inc.

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