A run of upbeat news is continuing at Dynavax Technologies Corp., which said a pivotal study of its lead allergy product began just a week after the company priced its initial public offering.
The Berkeley, Calif.-based company said a Phase II/III trial is under way to study its ragweed allergy immunotherapy product, AIC. The two-year trial will enroll 462 subjects at 30 midwest and eastern U.S. allergy clinics to evaluate the product's safety and efficacy.
The late-stage trial is being managed in collaboration with UCB Pharma, which will provide financial support through a partnership signed earlier this month. Even more recently, Dynavax's IPO netted $45 million. (See BioWorld Today, Feb. 20, 2004.)
"We have been active," Dynavax President and CEO Dino Dina told BioWorld Today. "We wanted to secure the outcome of our lead program in ragweed and make it independent of the vagaries of financing. The UCB deal allowed us to do so, in that it contractually commits UCB to fund the program both in ragweed and grasses through completion. So it's not subject to reprioritization or a link to a specific timeline."
The pharmaceuticals division of Brussels, Belgium-based UCB Group, UCB Pharma is funding continued research and development, as well as costs related to regulatory filings and potential product launch, sales and marketing.
UCB Pharma gained an exclusive worldwide license to AIC in exchange for an undisclosed up-front fee and potential milestone payments. UCB Pharma also acquired access to Dynavax's grass allergy immunotherapy program and an option to license its peanut allergy program.
Dynavax, which would receive royalties on sales, retained an option to co-promote products in the U.S. under certain unspecified circumstances.
The trial will be conducted by Quintiles Transnational Corp., a pharmaceutical services organization based in Research Triangle Park, N.C.
"That puts it on the map in terms of seeing it through all the way to completion of the two-year study, without spending any additional money on our side, or very limited amounts," Dina said. "We thought that was a very good deal, combined with royalties that come close to a profit split."
The study's protocol calls for subjects to receive a six-week regimen of either placebo or escalating doses of up to 30 micrograms of AIC prior to the 2004 ragweed season. Some subjects will receive two additional booster shots of AIC prior to the 2005 season.
"This is mainly designed to confirm what we have seen in Phase II - that a single course of therapy can provide a long-term benefit for at least two years, and hopefully we will find out for more," Dina said. "We will also look at the potential role of a short booster with just two injections in year two, to compare that to a single year and placebo. It will allow us to come closer to final definition of the optimal regimen."
The trial's primary endpoint will be the change in nasal symptoms relative to placebo following the 2005 ragweed season. Secondary endpoints will be comparative medication use and quality-of-life parameters between AIC-treated subjects and those receiving placebo. An interim analysis will be performed at the end of the 2004 ragweed season.
The program and its others are based on immunostimulatory sequences, or ISS, short DNA sequences that reprogram the immune system's response to infectious pathogens to control chronic inflammation and fight disease.
"We have shown across the board with all allergens that when we link an allergen to ISS, they no longer behave as allergens but instead become therapeutic drugs," Dina explained.
With its lead programs partnered, Dynavax soon after completed the IPO for which it registered in the fall. The company priced 6 million shares at $7.50 each, about a month after setting its price range at $12 to $14. Dynavax later added $6.3 million in net proceeds after the underwriters fully exercised their 900,000-share overallotment option.
And since then, the company's stock has traded up. On Wednesday, the shares (NASDAQ:DVAX) gained 5 cents to close at $8.60.
"The IPO opens the door to liquidity for our investors, who provided us with a very significant amount of money, in spite of the adjustment in price," Dina said. "And given our burn rate and the size of the company, which today is about 45 people, it gives us a good shot at not having to refinance the company except under circumstances that are favorable to us."
He said the cushion provides Dynavax the opportunity to continue to advance its other programs.
Later this year, the company expects to begin a Phase III trial of a hepatitis B virus vaccine. Dina said the investigational product allows for an accelerated schedule, cutting the number of administrations to two over as many months, rather than three over six months. Dynavax has an agreement with Bern, Switzerland-based Berna Biotech AG, which will supply the vaccine and with which Dynavax has a commercialization option in countries where Berna has a presence.
A third clinical-stage product is in a Phase II study for mild asthmatics. Dina said the product relies on the presence of allergen in the lung, adding that the trial is expected to yield data this summer.
The company also receives full funding from the U.S. government for preclinical programs directed at developing vaccines for anthrax and influenza.