BioWorld International Correspondent

Pevion Biotech AG raised CHF35 million (US$29.3 million) in a Series A round to take forward a pipeline of virosome-based vaccine candidates for infectious disease and cancer.

The Bern, Switzerland-based company, which was established as a 50-50 joint venture in 2002 between Berna Biotech AG (now part of Leiden, the Netherlands-based Crucell NV) and Bubendorf, Switzerland-based Bachem Group AG, previously raised CHF20 million from its founders.

The new cash is earmarked for two of its three clinical stage programs, as well as several earlier-stage projects. However, its new investors passed on its most advanced project, a multi-antigen prophylactic malaria vaccine, PEV3A, which currently is undergoing a Phase IIa clinical trial in Europe.

"It's almost completed. We will start another Phase I trial in Africa this fall," Thomas Stauffer, Pevion chief operating officer, told BioWorld International. That study would represent the vaccine's first exposure in an endemic region. The company will seek an alternative funding route for the project, probably via an outlicensing deal.

Its two other clinical programs, vaccines for hepatitis C virus (HCV) and breast cancer, are in Phase I studies. The breast cancer vaccine comprises a virosome carrying synthetic peptides derived from the HER-2/NEU receptor tyrosine kinase, the target of trastuzumab (Herceptin), marketed by South San Francisco-based Genentech Inc.

The vaccine, which is intended to prevent recurrence of the cancer following treatment of the primary tumor, elicits a humoral response, Stauffer said, unlike rival HER-2-based development candidates, which evoke a cellular response.

"We're trying to mimic herceptin. It's a proven concept on the market," he said.

The Phase I study is not due for completion until around mid-2008, but a Phase II study could begin before that, "depending on what the interim data look like," Stauffer said. The interim data are expected in the fall.

The HCV vaccine trial is due to finish by the end of the year, and a Phase II clinical trial should follow in 2008. Two other preclinical candidate vaccines, against respiratory syncytial virus and Candida infection, respectively, are expected to enter the clinic during 2008 or 2009.

Several undisclosed earlier-stage projects also will be taken forward on the strength of the new cash.

Pevion's portfolio of vaccines is based on an immuneboosting virosome platform originally developed at Berna Biotech, to which it now has an exclusive license. "Pevion has almost all the rights for the virosome technology," Stauffer said.

It comprises reconstituted influenza virus envelopes containing the influenza virus antigens haemagglutinin and neuraminidase, as well as a mixture of natural and synthetic phospholipids.

"It behaves like a normal virus. It delivers antigens like a normal influenza virus would," Stauffer said. The company has two variants of the technology, PeviPRO and PeviTER, which elicit humoral and cellular antibody responses, respectively.

Crucell markets two vaccines based on the virosome platform, the influenza vaccine Inflexal V and the hepatitis A vaccine Epaxal. "We're using a technology that's already established on the market," Stauffer said.

GMP manufacturing is in place, and the technology has an entry in the European Union's pharmacopoeia.

Wilen, Switzerland-based BZ Bank AG led the funding transaction. The other participants included BB Biotech Ventures II LP, which is advised by Zurich, Switzerland-based Bellevue Asset Management AG, and CC Private Equity Partners Ltd.

Pevion will receive its new investment in three tranches, after which the combined shareholding of Crucell and Bachem will fall below 60 percent.