On December 10, 2014 Immunovaccine reported that DPX-Survivac, the Company’s lead cancer vaccine candidate, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) as maintenance therapy in subjects with advanced ovarian, fallopian tube, and peritoneal cancer who have no measureable disease following surgery and front-line platinum/taxane chemotherapy to improve their progression-free survival (Press release Immunovaccine, DEC 10, 2014, View Source [SID:1234501175]). Ovarian cancer patients who have no measurable disease following their initial standard surgery and chemotherapy treatments have an unmet need that may be served by the DPX-Survivac therapy. DPX-Survivac is designed to activate T cells of the immune system that are expected to recognize and eliminate cancer cells in an attempt to keep patients in remission longer.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs with the potential to treat serious or life-threatening conditions and address an unmet medical need. This designation provides companies the opportunity for more frequent interactions with FDA during clinical development and the “rolling” submission of individual sections of a Biologics License Application (BLA) as they are completed for review by FDA. Additionally, therapies with Fast Track designation are eligible for priority review and/or accelerated approval, which have the potential to reduce the time required for FDA review and make a therapy available to patients earlier than would be traditionally possible.

“This Fast Track designation highlights the urgent need for new, innovative ovarian cancer treatments that can maintain patients in remission longer and ultimately increase survival,” said Dr. Marc Mansour, chief executive officer of Immunovaccine.

Immunovaccine has previously reported positive results from DPX-Survivac clinical studies in ovarian cancer patients. In these studies, robust and durable CD8 T cell responses were observed in almost all patients receiving a specified regimen of the vaccine. The vast majority of ovarian cancer patients enrolled in these studies were in remission with no evidence of disease. Notably, a patient with stable but measurable disease achieved a partial response (PR) as measured by Response Evaluation Criteria In Solid Tumors (RECIST 1.1). The PR, which persisted following discontinuation of treatment, was accompanied by reduction in levels of a commonly used ovarian cancer biomarker (CA125) and a significant increase in vaccine-induced immune responses. The patient benefited from the DPX-Survivac therapy for more than 8 months demonstrating a potentially durable effect of the therapy.

Immunovaccine is finalizing the design of a large randomized Phase II trial in ovarian cancer to be sponsored and conducted by Canada’s NCIC Clinical Trials Group (NCIC CTG).

The company also recently announced that it has received clearance from Health Canada to conduct a Phase II clinical study of DPX-Survivac in patients with diffuse large B cell lymphoma (DLBCL). The Company-sponsored trial, expected to begin in early 2015, will evaluate DPX-Survivac in combination with oral cyclophosphamide, an immune modulating agent, in patients with recurrent DLBCL. Immunovaccine expects initial data from this study in the second half of 2015. Positive trial results could provide rationale for the initiation of a pivotal trial in recurrent DLBCL which could lead to the approval of DPX-Survivac for the treatment of DLBCL.