Assistant Managing Editor

A major pipeline reprioritization at Sanofi-Aventis left Oxford BioMedica plc without a partner for its late-stage cancer vaccine TroVax, but the UK company made up for it by signing an earlier-stage deal with Sanofi to develop gene-based therapies for ocular diseases.

Those two actions help shore up the firm's cash reserves by adding an immediate £29 million (US$42.8 million) - £11 million in termination fees related to the ended TroVax alliance plus £18 million in up-front payments for the new eye disease collaboration. When combined with its £22 million in cash as of Dec. 31, Oxford BioMedica should have enough to support operations into 2012, CEO John Dawson told investors during an analyst briefing.

The new Sanofi deal also calls for committed funding of up to an additional £16 million over the next three years, which will be used to take the four identified ocular programs, all of which stem from Oxford BioMedica's LentiVector gene delivery technology, though Phase I/II studies, after which time Sanofi will have the option of taking those programs into later-stage development and potential commercialization.

If Sanofi elects to move those programs forward, Oxford BioMedica will be entitled to additional license fees, milestones and royalties on any product sales. Specific financial terms were not disclosed, though Oxford BioMedica described them as "consistent with other deals of this size and scope."

The company's shares (LSE:OXB) jumped 16 percent, or 1.50 pence, to close Wednesday at 10.75 pence.

In addition to providing a healthy cash infusion, the new deal also puts a spotlight on the company's LentiVector technology, which has taken a backseat as TroVax has ridden the roller coaster that has been the cancer vaccine space over the past couple of years.

In early 2007, Oxford BioMedica signed Sanofi to a potential $690 million deal for TroVax, but that collaboration hit a stumbling block last summer after investigators reported that an interim analysis showed the Phase III TRIST (TroVax Renal Immunotherapy Survival Trial) would fall short of its endpoints in renal cancer patients. Hopes rebounded a few months later when the companies said further analysis into dosing, background standard of care and individual prognostic factors could warrant further study of the drug, and they are awaiting word from the FDA on whether TroVax can move forward. (See BioWorld Today, July 14, 2008, and Oct. 8, 2008.)

The company asked investors not to read too much into the fact that Sanofi opted to drop TroVax, given that the product was one of 14 programs stricken from the Paris-based big pharma's clinical pipeline in a sweeping reprioritization and cost-cutting move.

"They were also looking at terminating a Phase II melanoma vaccine," said Stuart Naylor, chief scientific officer. That decision, combined with the TroVax news, led Oxford BioMedica to "believe that it was a product area decision" and not a "reflection on TroVax itself."

"We believe there are routes forward with TroVax," he added.

Dawson said Sanofi will continue helping out with TroVax during the pending FDA review, which is expected to be resolved by the end of this quarter. Should the agency's review "go in our favor, we plan to re-partner TroVax for future development," he said.

If that's the case, then Oxford BioMedica could benefit from some good timing, since the cancer vaccine space got a considerable lift recently when Seattle-based Dendreon Corp. reported much-anticipated Phase III data showing that its cancer vaccine Provenge met its primary endpoint of overall survival. Specific data released at the American Urology Association meeting this week showed that Provenge reduced the overall risk of death by 22.5 percent compared to placebo, marking a clear win for a cancer vaccine. (See BioWorld Today, April 29, 2009.)

"I think there remains a lot of interest, at least, in cancer immunotherapies," Dawson said, which likely will grow as Dendreon's Provenge moves through the expected regulatory process and, hopefully, "drive interest from prospective partners [for TroVax]," he added. "We hope to ride on the back of this."

Oxford BioMedica, however, has no plans to pursue a possible confirmatory Phase III TroVax trial without a partner, Dawson stressed. "We won't be starting Phase III at our own cost."

Instead, the firm intends to focus its cash resources on advancing LentiVector programs, including those in the Sanofi deal, as well as its Parkinson's product ProSavin, which is in Phase I/II testing, with data expected later this year. ProSavin is designed to deliver genes for three enzymes needed for dopamine synthesis directly into the brain.

Products covered under the Sanofi agreement include RetinoStat, which aims to deliver antiangiogenic genes endostatin and angiostatin to the retina to treat age-related macular degeneration.

Unlike existing therapies, such as Genentech Inc.'s Lucentis (ranibizumab), which requires repeated injections directly into the eye, Oxford BioMedica said RetinoStat could end up requiring only a single administration.

The firms also will work on StarGen, a product designed to deliver a corrected version of the ABCR gene to treat Stargardt disease; UshStat, which aims to deliver a corrected version of the MYO7A gene to treat usher syndrome; and EncorStat, which is similar to RetinoStat but designed to prevent corneal graft rejection.

The goal is to get through Phase I/II studies with "all three programs within three years," Naylor said.

He added, however, that those first indications are "merely springboards," and that Sanofi also has rights to develop those products in other potential ophthalmic indications.