Dive Brief:
- In a move to "conserve capital," Vical Inc. is axing its failed Phase 3 cytomegalovirus vaccine ASP0113 and cutting 40 jobs, more than half of its workforce. Personnel restructuring charges will be around $1.1 million in the first quarter of 2018.
- The San Diego-based biotech will terminate all activities relating to the ASP0113 program, which it licensed to Astellas Pharma Inc. in 2015, and will move its focus to its Phase 2-ready antifungal VL-2397 and to its HSV-2 vaccine candidate VCL-HB01, which is already in mid-stage testing.
- Vical, which expects to finish 2017 with between $60 million and $65 million in cash, believes that these moves will allow it to fund itself at least through 2019.
Dive Insight:
The news comes after the failure of the vaccine in a Phase 3 trial of post-stem cell transplant patients and the subsequent 21% fall in Vical's share value. That wasn't the first time the vaccine had fallen short either: a prior Phase 2 study in kidney transplant patients also failed to meet its primary endpoints.
"We have carefully evaluated our organization and priorities and are restructuring to extend our cash runway to ensure that our promising HSV-2 vaccine candidate and VL-2397 antifungal drug product candidate is adequately resourced to maximize shareholder value," said company CEO Vijay Samant.
In July 2011, Vical granted Astellas an exclusive global license to develop and commercialize ASP0113 for the control and prevention of CMV infection in immunocompromised patients, including transplant recipients and transplant donors. It isn't yet clear whether the Japanese company Astellas will continue development.
"At this point Astellas cannot comment on future plans for ASP0113. The assessment of detailed data is currently ongoing. Astellas is committed to turning innovative science into value for patients and we will continue to pursue therapies that aim to help people lead healthier lives," the company said in a statement.
This leaves Vical with just two clinical candidates. Its HSV-2 vaccine, VCL-HB01, is in a Phase 2 trial in patients with symptomatic genital herpes infection, and top-line results are expected in the second quarter of 2018.
VL-2397 is in development for patients with invasive fungal infections, and a Phase 2 trial in invasive aspergillosis is planned for the first quarter of 2018. Provided Phase 2 results are positive, VL-2397 will be eligible for a limited use indication approval from the Food and Drug Administration for invasive aspergillosis. The agent also has qualified infectious disease product, orphan drug and fast track designations for this indication.