Eleven Biotherapeutics signed a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) to evaluate its late-clinical-stage fusion protein Vicinium™ (VB4-845) combined with AstraZeneca’s immune checkpoint inhibitor Imfinzi™ (durvalumab) for treating nonmuscle invasive bladder cancer (NMIBC).

Under terms of the CRADA, the NCI will carry out a Phase I study to evaluate the safety and efficacy of combination therapy in patients with high-grade NMIBC.

Vicinium comprises a single-chain anti-epithelial cell adhesion molecule (anti-EpCAM) antibody fragment fused with a cytotoxic payload, Pseudomonas exotoxin A (ETA). Developed using Eleven’s Targeted Protein Therapeutics (TPT) platform, the anticancer candidate is currently being assessed in a Phase III study as monotherapy for high-grade NMIBC in patients who have previously received two courses of Bacillus Calmette–Guérin (BCG) and whose disease has become BCG-unresponsive. Topline data from the study are expected in 2018.

“While we remain internally focused on advancing our Phase III registration trial of Vicinium as a monotherapy, preclinical data suggests that Vicinium also has the ability to potentiate the activity of immuno-oncology agents,” commented Stephen Hurly, president and CEO at Eleven Biotherapeutics. “We are pleased to enter into this collaboration with the NCI and AstraZeneca, which broadens the scope of our ongoing clinical program and enables us to evaluate Vicinium together with Imfinzi, a programmed death-ligand 1 (PD-L1) checkpoint inhibitor.

Eleven acquired its two lead candidates Vicinium and Proxinium (VB4-847) through its acquisition of Viventia in September 2016. Proxinium is an EpCAM-targeting fusion protein in mid-stage development for the potential treatment of squamous cell carcinoma of the head and neck. A month prior to the Viventia announcement, Eleven inked a potentially $300 million licensing deal with Roche to develop its interleukin-6 (IL-6) antagonist antibody technology. 

Just last month, Imfinzi was granted accelerated approval by the FDA as therapy for locally advanced metastatic urothelial carcinoma (mUC) in previously platinum chemotherapy-treated patients. The drug is also undergoing Phase III development as monotherapy and in combination with tremelimumab as first-line therapy for patients with unresectable and metastatic bladder cancer.

Within the last couple of days, AstraZeneca reported positive data from a Phase III study evaluating its poly(ADP-ribose) polymerase (PARP) inhibitor Lynparza™ (olaparib) in patients with BRCA-mutated metastatic breast cancer








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