BioWorld International Correspondent

LONDON - BioVex Ltd. raised £17 million in a third-round funding, giving it the means to start a U.S. Phase II trial of its lead cancer vaccine, OncoVEX, and move ImmunoVEX into Phase I work.

Gareth Beynon, CEO, told BioWorld International, "We went out for £15 million, and while it is never easy raising money, the level of interest meant we exceeded that amount."

The £17 million (US$28.3 million) round was led by Scottish Equity Partners, with new participants being ABN Amro Capital, Avalon Ventures, Credit Lyonnais Private Equity and Sitka Health Fund VCT. All the existing investors participated, including GeneChem Management Inc., Lloyds Development Capital, Merlin Biosciences Fund LP, Temasek Holdings, Technomark Medical Ventures and West Deutsche Landesbank Girozentrale.

Going forward, BioVex is looking for merger and acquisition activity to expand its size and reach and is interested in finding a U.S. partner. Beynon said, "I think a lot of companies will be interested in us because we have strong technology in immunotherapy, an area where the data are now looking strong, with products in Phase III."

Abingdon,UK-based BioVex's product OncoVEX is a modified herpes simplex virus (HSV). The virus has a single gene deletion that renders it harmless to normal cells, but is designed to still be capable of growing in and killing cancer cells. Also, it is engineered to provoke an antitumor immune response to destroy metastases through the deletion of HSV immune suppressor genes and the insertion of the gene for granulocyte macrophage colony-stimulating factor.

The product has completed Phase I work in multiple tumor types in patients with advanced cancer.

"Overall it was well tolerated and we saw evidence of activity," Beynon said. "This was not just occurring at the site of the injection, though it is too early to say if this is due to an immune response."

An investigator has been chosen for the multisite Phase II study in the U.S., which is due to start in the second quarter of 2004. That will involve 50 patients with melanoma who have relapsed.

BioVex also is planning two small clinical trials of OncoVEX as a combination with chemotherapy and radiotherapy, to start in the third quarter of 2004. Beynon said the company has generated animal data indicating improved efficacy when chemotherapy is given with OncoVEX.

"We think the chemotherapy per se is more effective in combination, though we don't know the mechanism as yet," he said.

ImmunoVEX is a multi-antigen vaccine platform for delivering antigens to dendritic cells without inactivating them, as is the case with native HSV. BioVex has just been granted a U.S. patent for that platform.

The lead product based on the technology is ImmunoVEX (tri-melan), which contains three melanoma-associated antigens. That is due to start a 50-patient Phase I trial in the UK and Canada next year.

ImmunoVEX also is being developed as a prophylactic vaccine platform. In collaboration with the National Institutes of Health in Bethesda, Md., BioVex has produced a vaccine containing three AIDS antigens engineered at NIH to make them more immunogenic. The product is in preclinical evaluation at NIH.

Following behind is an ImmunoVEX vaccine against HSV2, due to enter preclinical development next year.

BioVex was spun out of University College London in 1999, and has raised £13 million in previous rounds.

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