Therion Biologics Corp. is holding a rather grand ribbon-cutting ceremony today.
The Cambridge, Mass.-based business is hosting top brass from the Bay State's government offices, including Gov. Mitt Romney, as it opens the doors to its manufacturing facility. A fresh round of funding, worth $39 million, will allow Therion to fill the building with additional personnel as it looks to move its two lead cancer vaccine candidates toward registration and commercialization.
"I think it's always good when you have something to celebrate, like jobs being created and staying in Massachusetts," Therion President and CEO Mark Leuchtenberger told BioWorld Today. "I think a string of clinical successes in the last 18 months have built confidence in the company."
He was referring to positive data found in clinical studies of Panvac-VF and Prostvac-VF, its vaccine candidates to treat pancreatic and prostate cancer, respectively. Therion plans to use the funds to advance their clinical development.
More specifically, the company plans to begin a Phase II trial of Prostvac-VF late this year, followed soon after by the initiation of a Phase II trial of Panvac-VF early next year.
"The prostate cancer trial results that we presented at ASCO in 2002 showed that we had stabilized 60 percent of patients in the lead therapeutic arm for up to 30 months," Leuchtenberger said. "For Panvac-VF, we reported results at this year's ASCO showing a 40 percent stabilization rate for late-stage, treatment-refractory patients with CEA-bearing cancers - colorectal, mostly, and some breast and some pancreatic."
CEA, or carcinogenic embryonic antigen, is found on the surface of more than 90 percent of pancreatic and colorectal cancer tumor cells. Panvac-VF also includes another tumor antigen called MUC-1. Therion's products include the genes for the proteins inside their vectors, which are injected and absorbed by the immune system. As it ingests the tumor protein genes, the system expresses them on their surface and looks to extinguish the tumor proteins.
Since 1991, Therion has raised between $100 million and $110 million, Leuchtenberger said, adding that the latest cash infusion would sustain operations through the middle of 2005.
"We expect to be able to complete these two randomized, controlled, large Phase IIs in pancreatic and prostate cancer by the first quarter of 2005," he added. "So we'll have funds to spare as we look for the next monetization option at that point, which could be an M&A transaction, an IPO or another round of financing to get us through pivotal trials."
Leuchtenberger said the company plans to maintain autonomy over the two vaccines at least through registration, after which Therion would be in an optimal position to explore various commercialization options. He said his experience at Biogen Inc. overseeing the Avonex program, which the Cambridge, Mass.-based company built into a $1 billion product under his watch, would play into Therion's plans in creating first-time commercial franchise opportunities with Panvac-VF and Prostvac-VF. For example, beyond the lead pancreatic cancer indication for Panvac-VF, the company may look to partner limited rights for other CEA indications such as breast, lung and colorectal cancers.
Therion also expects to use the funds to expand manufacturing capabilities at the newly completed, 11,000-square-foot facility, which was built to good manufacturing practice specifications. The company plans to grow its manufacturing and related operations to 25 employees over the next year to support the production of trial- and commercial-sized quantities of its lead cancer vaccines.
"We intend for this to be a launch facility, and obviously we still need to validate it and undergo inspections," Leuchtenberger said. "But it was designed to GMP specifications, and the intent is to use this to produce pivotal trial product and to produce product to take us through the first couple of years of launch. It has capacity of up to 400,000 doses per year."
He said that Panvac-VF could grow into a blockbuster product, while Prostvac-VF eventually could enter a market that produces 200,000 new diagnoses annually in the U.S.
Beyond its lead programs, Therion is developing products through direct tumor modification. The program, which is supported through a partnership with the National Cancer Institute in Bethesda, Md., could result in therapies for melanoma, head and neck and bladder cancer.
With Aventis Pasteur Ltd., the vaccines business of Lyon, France-based Aventis SA, Therion has cross-licensed patents as both pursue cancer vaccine technologies. Aventis is developing Alvac-CEA/B7.1 for colon cancer as a result of the relationship.
The most recent financing includes terms similar to Therion's third round, which closed two years ago. The latest internal financing, which Leuchtenberger labeled a C II round, included lead investor Hans-Werner Hector, a founder of software firm SAP AG, of Walldorf, Germany, and also included Hambrecht and Quist Capital Management LLC, of Boston, and S.R. One Ltd., of West Conshohocken, Pa.