Vaccinex receives FDA clearance to initiate VX15/2503 Phase 1 clinical trial in advanced solid tumors

Vaccinex, Inc. announced today that it has received clearance from FDA and will initiate a Phase 1 clinical trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of therapeutic antibody candidate VX15/2503 in cancer patients with advanced solid tumors.

VX15/2503 is a novel humanized antibody that blocks the activity of semaphorin 4D (SEMA4D).  It is the first of two of the Company's therapeutic antibodies expected to begin clinical trials this year. "Advancing VX15 into the clinical stage of development is an exciting achievement for Vaccinex, and a testament to the experience and outstanding capabilities of our research and development teams," said Ray Watkins, Senior Vice President and Chief Operating Officer of the company.

"SEMA4D is an exciting therapeutic target with remarkable biological properties relevant to several disease processes," said Dr. Maurice Zauderer, President and Chief Executive Officer of Vaccinex.  As reflected in its name, semaphorin, the molecule guides the activation and movement of different cell types in different ways.  For example, SEMA4D promotes migration of tumor cells that metastasize to new locations as well as the outgrowth of cells that form new blood vessels required to provide nutrients and energy to tumors.  It is anticipated that, by blocking this signal, the anti-SEMA4D antibody will both inhibit the growth of primary tumors and limit metastases to new sites.  "This is important," Dr. Zauderer said, "because if tumors did not metastasize, then surgeons could cure cancer."  In other tissues and disease processes, for example damage to neurons in demyelinating diseases such as multiple sclerosis (MS), the same semaphorin has an opposite effect on outgrowth of cells, preventing the regeneration and remyelination of damaged neurons.  In this case, Dr. Zauderer said, "The VX15/2503 antibody has the potential to be a radical new approach to treatment of MS, acting both as an anti-inflammatory to protect against disease progression but also promoting healing of damaged tissue."  Vaccinex plans to initiate a second trial of VX15/2503 for MS later this year.