A week after acknowledging the failure of its lead candidate in a Phase III trial, Vical has ended development of the DNA vaccine candidate and eliminated more than half its staff.
Vical has shrunk its workforce from 74 to 34 staffers in a restructuring intended to conserve cash. The job cuts were completed Tuesday, Vical said in a regulatory filing. The company will take approximately $1.1 million in first-quarter charges related to the cuts.
Vical shrunk its workforce after disclosing January 22 that its lead candidate ASP0113—a DNA vaccine being co-developed with Astellas Pharma for cytomegalovirus (CMV)-seropositive hematopoietic stem cell transplant recipients—missed its primary or secondary endpoints in the Phase III HELIOS trial.
HELIOS was designed to assess the efficacy of ASP0113 compared with placebo in 514 CMV-seropositive participants undergoing hematopoietic stem cell transplantation. Efficacy was assessed using a primary composite endpoint of overall mortality and CMV end-organ disease through the first year following the transplant.
That primary endpoint was not met, Vical acknowledged. Also missed were secondary endpoints of time to first protocol-defined CMV viremia and time to first use of adjudicated CMV-specific antiviral therapy.
Vical said it will focus on VL-2397, its antifungal drug product candidate set to enter a pivotal Phase II trial in the first quarter, and VCL-HB01, a herpes simplex virus 2 (HSV-2) vaccine for patients with symptomatic genital herpes infection, now in a Phase II study.
VL-2397 is being developed for patients with invasive fungal infections. The vaccine is eligible for an FDA Limited Use Indication approval for the treatment of invasive aspergillosis, contingent on a single successful Phase II trial.
Vical expects to generate topline results for VCL-HB01 from an ongoing Phase II study. The HSV-2 vaccine candidate is being assessed in 261 healthy adults ages 18 to 50, randomized 2:1 to vaccine or placebo. A four-dose vaccination series was completed in July 2017, followed by a 12-month surveillance period during which each new lesion recurrence is assessed. After 9 months or more of surveillance, the primary endpoint of annualized recurrence rate will be calculated.
Vical has yet to report Q4 results. When that happens, Vical said, it expects currently available cash and investments to be sufficient to fund operations at least through 2019, based on a 2017 burn rate projected to be at the low end of the company’s guidance of $8 million to $11 million. Vical also expects to have finished 2017 with cash and investments of approximately $60 million to $65 million.
