West Coast Editor

Boasting disposable technology that fits perfectly with the "port-a-drug" mentality of a bioterror-fearing and chicken-flu nervous world, Xcellerex Inc. raised $20 million in a Series B financing that the company said will boost efforts to commercialize its FlexFactory platform.

The Marlborough, Mass.-based firm is working on an approach that combines single-use components and production-scale disposable stirred tank bioreactor systems, allowing not only for portability - crucial in biodefense and flu situations - but for the production of multiple products at a single facility.

FlexFactory provides what Xcellerex calls a "fully integrated" approach, with potential across all cell types. Typical unit operations for a monoclonal antibody process already have been configured and used in a campaign to produce GMP-quality monoclonal antibodies for an undisclosed clinical trial, the company said.

"It allows you to get the company up and running without a huge investment," said Mike Masterson, Xcellerex's CEO. "When you're ready to pull the trigger, you can package up the manufacturing capability and ship it anywhere in the world. Wherever it lands, the infrastructure required to run it is significantly less. All you need is electricity."

Biodefense and flu preparedness efforts have been much in the news recently. Last week, PharmAthene Inc. made known its plan for a reverse merger with Healthcare Acquisition Corp., thereby gaining a public listing and up to $70 million in cash. The deal, made after another deal fell through, is designed to help Annapolis, Md.-based PharmAthene progress with its biodefense efforts. (See BioWorld Today, Jan. 23, 2007.)

Also this month, Iomai Corp., of Gaithersburg, Md., got $14.5 million from the government, as part of allocations in the pandemic-flu program. The cash comes by way of a contract that runs through March of next year with the U.S. Department of Health and Human Services, and if a product is developed through licensure over the next five years or so, Iomai could get about $128 million, plus the fixed fee. (See BioWorld Today, Jan. 18, 2007.)

Closing the first two rounds of a Series A financing this month was Juvaris BioTherapeutics Inc., of Pleasanton, Calif., and the money included a $6 million investment from Kleiner Perkins Caufield & Byers Pandemic & Biodefense Fund. The second closing, expected to occur within 120 days, would bring the total round to $12 million, with funds going for the company's flu and pneumonia vaccines, as well as immunotherapy products for hepatitis B virus and biodefense.

Xcellerex already has a customer base of what the firm describes as "top tier" pharmaceutical and biotech firms, and the new Series B funds allow for a commercial push into the vaccine and biotherapeutic markets. Flu and bioterrorism "hit our vision about 12 months ago," Masterson told BioWorld Today.

As for the flu challenge, the FlexFactory approach "mitigates stockpiling large amounts of flu antidotes, which is the model now, and having to distribute that stockpile wherever the breakouts are," he said. "That's a totally different paradigm than a large, fixed, stainless-steel infrastructure," which - due to strictures of GMP - is built to resist changeability, he added.

Xcellerex had to build a GMP facility to prove FlexFactor would work. "Nobody believed we could do it," Masterson said.

Xcellerex's contract manufacturing services include cell line creation, process development and GMP manufacturing. Along with FlexFactor, the firm has XDR stirred tank disposable bioreactor systems, XDM stirred tank mixing systems and PDMax, a high-throughput process development service platform. XDR is "the biggest piece of the FlexFactory innovation," and is already available, Masterson said.

"This has taken the traditional bioreactor and made it into almost like a baby bottle, with the outside and an inside liner that you can change as you switch drugs," he said. "You can bolt the reactors onto existing facilities, or have a totally new FlexFactory. We'll sell you the reactor and then sell you the bags as you need them, and/or we can sell you the FlexFactory system."

In December 2003, Xcellerex completed an undisclosed initial round of private financing, which the company said it would use for licensing manufacturing technology, acquiring laboratory and manufacturing equipment and hiring staff. The company recently established new corporate headquarters and the manufacturing facility in Marlborough. SCG Group, of San Diego, and Kleiner Perkins, of Menlo Park, Calif., led the latest round. Kleiner Perkins partner Thomas Monath has joined the Xcellerex board of directors.