Stripped-down Vical ‘considering options’ after pipeline woes

After a string of pipeline failures, Vical has called in advisers to help decide the future of the company.

The San Diego company says it has appointed financial consultancy MTS Health Partners to explore its options. It won’t be going into any more detail for now, but presumably that could involve the sale of the company or its assets, which include antifungal drug VL-2397 in phase 2 and a preclinical hepatitis B virus (HBV) program.

The move comes just over a month after Vical abandoned work on a genital herpes vaccine after a negative phase 2 trial which management blamed on a lower-than-expected relapse rate in the placebo group, and after earlier failures for a cytomegalovirus vaccine for kidney and hematopoietic stem cell transplant (HSCT) recipients, licensed from Astellas, and a cancer immunotherapy.

The failure of the CMV program prompted a big reduction in headcount, with Vical eliminating half of its workforce in January in order to conserve cash for its remaining pipeline projects, and it now says it will end the year with around $40 million in cash—enough to keep going until its phase 2 antifungal data comes through in 2020.

The big question is whether there is enough value in Vical to attract a partner or purchaser, and given that its HBV program is still in the very early stages, its options will hinge on VL-2397, which is also licensed from Astellas.

The antifungal is being studied for invasive aspergillosis, a serious fungal infection that mainly affects people with compromised immune systems, such as leukemia patients and those who undergo HSCT. It’s being compared to three standard antifungals in the two-year trial with the aim of showing it's noninferior to them on all-cause mortality at four and six weeks.

Vical is hoping that the trial could support a filing under the FDA’s limited use indication pathway, which can be used for early approval of drugs that treat serious diseases in patients for whom alternative therapies are not available. A phase 3 program would be need for use in the wider aspergillosis patient population, for example tackling the infection in people with chronic obstructive pulmonary disease (COPD).

The HBV program has arisen out of Vical’s in-house R&D and focuses on compounds designed to inactivate the covalently closed circular (CCC) viral DNA reservoir, which is a source of persistent infection. The company is working on screening lead candidates that will move into animal testing later this year.

"There is no set timetable for the review process and there can be no assurance that the process will result in a transaction," says Vical in its statement, adding: "There will be no further disclosures regarding the evaluation process unless a transaction is approved by the board of directors, or is otherwise deemed appropriate."