Preparing to file a biologics license application in 2006 for its lead pancreatic cancer product, Therion Biologics Corp. secured a $50 million line of credit.

The Cambridge, Mass.-based company expects to hit two milestones in the near-term, completing patient enrollment in each of its late-stage trials - a Phase II of Prostvac-VF to treat prostate cancer and a pivotal Phase III of Panvac-VF to treat pancreatic cancer.

Data from those trials should follow in the first half of 2006, and the BLA filing of Panvac-VF is expected before the end of the second quarter.

Clinical trials and regulatory filings cost money - a lot of it - and the line of credit gives Therion the flexibility to continue to advance its unpartnered lead products.

"It couldn't be more significant, coming when it does - the timing of it and the amount," said Mark Leuchtenberger, president and CEO of Therion. "Basically, the $50 million allows us to complete both of our two controlled trials, and it gives us funding into 2007."

The credit was provided by Therion's investor Hans-Werner Hector, a founder of the enterprise software company, SAP AG, of Walldorf, Germany, who led a $30 million financing round completed in June. That money was expected to last the company through the end of 2005. (See BioWorld Today, June 20, 2005.)

Leuchtenberger said that once clinical data of its lead products are released, lead investor Hector likely would "drive [the company] to a liquidity solution." A partner or an acquirer could gain rights to Therion's products, potentially giving investors an exit "with or without a public financing," he said.

Therion expects to move Prostvac-VF into Phase III trials in 2006. One of a possible two Phase III trials would be fully funded by the National Institutes of Health. The product entered the Phase II trial for prostate cancer in late 2003.

Therion also is evaluating its targeted therapeutics in colorectal, ovarian, breast and lung cancers. Its therapies are designed to selectively seek out and destroy malignant cells without the serious side effects associated with cytotoxic chemotherapy. The technology has been evaluated for 13 years in more than 30 clinical trials involving about 1,000 patients.

If approved, Panvac-VF would address a market of 25,000 second-line pancreatic cancer patients. The drug's pricing "would be consistent with an oncology breakthrough" product, such as Avastin, Leuchtenberger said. South San Francisco-based Genentech Inc.'s drug for colorectal cancer, Avastin, costs about $4,400 a month.

"The big breakthrough here would be that [Panvac-VF] would be the first second-line pancreatic cancer therapy approved by the FDA, if we're successful," Leuchtenberger told BioWorld Today.

Front-line therapy consists of surgery, radiation and chemotherapy with gemcitabine. When that fails, patients are treated with other single-agent chemotherapies to address symptoms. The hope is that Panvac-VF will take the treatment one step further by extending survival. Panvac-VF entered its pivotal Phase III trial in mid-2004 under a special protocol assessment with the FDA. With a primary endpoint of overall survival, the trial was designed to enroll 250 advanced pancreatic cancer patients who would be randomized to receive the vaccine or a control treatment, such as capcitabine, irinotecan or 5-fluorouracil. (See BioWorld Today, May 24, 2004.)

Panvac-VF stimulates the immune system to target and destroy cancer cells expressing carcinoembryonic antigen and mucin-1, which are found on more than 90 percent of pancreatic tumor cells. The vaccine incorporates Therion's triad of co-stimulatory molecules (B7.1, ICAM-1 and LFA-3) to enhance and sustain a targeted immune response.

Therion's second vaccine candidate, Prostvac-VF, is based on the same technology platform as Panvac-VF, but it uses a gene for prostate-specific antigen inside its vectors. With a primary endpoint of progression-free survival at 24 weeks, the Phase II trial is enrolling 120 men with metastatic prostate cancer who are hormone refractory.

Founded in 1991, Therion has raised more than $160 million since inception.