WisTechnology.com – FluGen Fighting Flaws in Flu Vaccine Industry

November 16, 2009
By Lynn Welch For WisTechnology.com

A Madison biotech startup is among those in the race to improve the efficiency of flu vaccine production and delivery.

FluGen Inc., founded in 2007, hopes to net first-round financing following its presentation last week at the MidAmerica Healthcare Venture forum at the Monona Terrace Community & Convention Center. Company President & CEO Paul V. Radspinner said the company is seeking $7 to $10 million to bring to clinical trial its newly proven CHO-cell-based vaccine production system, as well as a patented vaccine delivery patch said to be more effective and painless.

“This year, the pandemic has really exposed the flaws in the (current) system. The reality is this has to change,” Radspinner said of the current vaccine production method. “We have a cost proposition that we know will be better than the egg-based production method.”

According to the World Health Organization (WHO), it takes five to six months for approved vaccine to become available following the discovery of a new flu strain. The standard egg-based process of producing vaccine involves “many sequential steps and each of these steps require a certain amount of time to complete,” the WHO Web site explains.

Current production delays for H1N1 vaccine doses have put a spotlight on the limits of the standard egg-based vaccine production. According to a recent report in The Lancet, a number of companies are moving toward a cell-based production solution to solve the problem.

Last month, FluGen announced that its CHO-cell (Chinese hamster ovary) system had, indeed, generated the 2009 H1N1 influenza virus without using eggs. The 10-employee company is ramping up its capability to type and bank cells next year in advance of seeking a clinical trial for its cell-based system, licensed last year to the company last year by the Wisconsin Alumni Research Foundation (WARF).

In the near future, the company anticipates that its cell-based, egg-free method will result in vaccine production. While it will take a while for the trial and approval process to occur before the technology is commercialized, Radspinner doesn’t see the issue of vaccine production urgency fading.

“In the middle of this pandemic, it gives the government an incentive to find a method,” Radspinner said. “They’ve been talking about this since the avian flu in 1997.”

Meanwhile, FluGen is ready next year to take to clinical trial a micro-needle patch aimed at achieving a greater vaccine efficacy rate. The company last spring announced that it had acquired exclusive rights to this technology, developed by Madison-based Ratio Inc., a small medical device company specializing on pain-free delivery of large molecule drugs through the skin.

This system uses an inexpensive, non-electronic pump with a micro-needle array on a small poker-chip sized patch applied to the skin to the skin like a Band-Aid. The small, hollow needles then administer vaccine through the skin. For flu vaccine delivery, Radspinner said this device has the potential to increase vaccine effectiveness significantly.

“Even if people do get the (flu) vaccine, they’re not immediately protected,” said Radspinner of the 20 percent to 40 percent efficacy rate of current vaccine delivery. “This is critical, particularly in the elderly with influenza and pneumonia related illness from flu as the number one cause of death in people age 65 and older.”

FluGen is in pre-clinical testing of this device and in the second half of 2010 expects to submit an investigational new drug application to the U.S. Food and Drug Administration for approval to enter a Phase I clinical trial by the end of 2010.

Radspinner said the cell-based vaccine production and micro-needle patch address the two fundamental problems currently plaguing the influenza industry. They will also lay the groundwork for FluGen’s future growth, and development of its longer term projects aimed at making flu vaccines more efficient, and building its vaccine booster, or adjuvant.

“This exciting vaccine-delivery technology from Ratio is an important expansion of FluGen`s product pipeline,” according to Radspinner. “It will allow the company to offer the $6-billion influenza vaccine market not only superior vaccines, but an easy-to-use, painless delivery technology that increases vaccine effectiveness.”

FluGen was founded with technology created by University of Wisconsin-Madison Veterinary Medicine Professor Yoshihiro Kawaoka, described as a leading influenza expert, and Gabrielle Neumann, a virologist at UW-Madison. Radspinner, a former WARF licensing manager whose industry experience includes more than 15 years in leadership positions with Eli Lilly and Deltanoid Pharmaceuticals, leads the company’s business operations.