Cerulean Announces Manuscript Published in Annals of Oncology

Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), today announced the manuscript of clinical data for its lead compound, CRLX101, in the journal Annals of Oncology. The manuscript highlights results from an open-label, single arm Phase 1b/2 investigator-sponsored trial (IST) of CRLX101 in combination with Avastin® (bevacizumab) in patients with metastatic renal cell carcinoma (RCC). The trial achieved its primary endpoint of establishing a recommended Phase 2 dose and showed preliminary anti-tumor activity. The article is available online. Results from the trial also were presented at the 2015 American Society of Clinical Oncology annual meeting on June 1, 2015 and at the 2015 International Kidney Cancer Symposium on November 4, 2015.

“While new therapies, notably immunotherapies in earlier lines of treatment have improved overall survival in RCC, better defined treatment options are needed to address the growing number of patients in the relapsed or refractory setting,” stated Naomi Haas, M.D., Director, Prostate and Kidney Cancer Program and Associate Professor of Medicine at the Hospital of the University of Pennsylvania. “Of particular interest in this setting are combination therapies, such as CRLX101 and Avastin. I look forward to results from Cerulean’s ongoing randomized Phase 2 trial of CRLX101 and Avastin in this setting.”

“Combination therapies are critical to more effectively treating cancer. We believe that combining CRLX101 with a VEGF inhibitor like Avastin allows us to target multiple adaptive pathways,” said Christopher D.T. Guiffre, President and Chief Executive Officer of Cerulean. “The UPenn trial served as a foundation for our randomized Phase 2 trial, and we look forward to the results from this study.”

The article describes results from 22 evaluable patients with metastatic RCC. The trial included both clear cell and non-clear cell RCC patients, who received a median of two prior therapies, with at least one prior vascular endothelial tyrosine kinase inhibitor therapy (second to sixth line of therapy). The trial established the maximum tolerated dose and recommended Phase 2 dose of CRLX101 in combination with Avastin, a combination, which is being used in other studies in RCC patients and ovarian cancer patients. The primary endpoint for the study was to determine the recommended Phase 2 dose. No dose limiting toxicities were observed. The most common drug-related adverse events of Grade ≥3 included non-infectious cystitis, fatigue, anemia, diarrhea, and dizziness. Results for secondary endpoints included progression-free survival rate (PFS4) of ≥ 4 months (55%), median PFS (9.9 months), and overall response rate (23%).

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.

About Cerulean’s Dynamic Tumor Targeting™ Platform

Cerulean’s Dynamic Tumor Targeting Platform creates NDCs that are designed to provide safer and more effective cancer treatments. We believe our NDCs concentrate their anti-cancer payloads inside tumors while sparing normal tissue because they are small enough to pass through the “leaky” vasculature present in tumors but are too large to pass through the wall of healthy blood vessels. Once inside tumors, our NDCs enter tumor cells where they slowly release anti-cancer payloads from within the tumor cells.

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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