Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), located in Cambridge Massachusetts, has announced the execution of an exclusive licensing deal with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (SIX: ROG; OTCQX: RHHBY, Basel, Switzerland) for the transfer of rights for their IL-6 antibody technology, including EBI-031 for the treatment of diabetic macular edema. Under the terms of the commercial deal Eleven is understood to receive $30 million in payments from Roche, including a $7.5 million upfront payment and a $22.5 million milestone payment based on completing the submission of an Investigational New Drug application (IND) for EBI-031. The total value of the transaction could be in the region of $270M, subject to milestones, approvals and sales.
According to Eleven Bio, their most advanced preclinical product candidate is EBI-031 for the treatment of diabetic macular edema (DME) and uveitis. The experimental drug was designed and engineered for intravitreal delivery using a platform technology, known as “AMP-RX”, also under development at the company. AMP-Rx uses a yeast display system to design and engineer proteins capable of modulating the effects of cellular effects of cytokines. The EBI-031 drug is understood to block both free interleukin-6 (IL-6) and IL-6 complexed to the soluble IL-6 receptor (IL-6R). An IND for the drug was filed with the FDA in June 2016 to conduct clinical trials of the drug in patients with DME and uveitis. In addition to the $30M in payments, the company stated that it may also receive up to an additional $240 million dependent on the achievement of certain future regulatory, development and commercialization milestones. Eleven Bio also stated that, subject to clinical success and approval, it may be eligible to receive royalties on net sales of any future products that comprise EBI-031 or other Eleven IL-6 compounds that form part of the transaction.
The announcement of the ocular deal with Roche comes after a disappointing start to FY2016 for Eleven Bio which saw the company announce plans to terminate development of its then lead compound, isunakinra (also known as EBI-005), following its failure to meet its primary end-point in a Phase III clinical study. Commenting on the completion of the deal with Roche, Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Bio stated, “With the completion of this licensing deal and the IND being effective, we look forward to the future clinical advancement of EBI-031 by Roche as they explore its potential use for ocular diseases, including diabetic macular edema”.