|
Avant, Pfizer Sign $50M Deal for GBM Cancer Vaccine
(BioWorld Today Via Thomson Dialog NewsEdge) $440M Potential
Avant Immunotherapeutics is well on its way to advancing its therapeutic cancer vaccine CDX-110, thanks to a $50 million deal with Pfizer Inc. The Needham, Mass.-based firm will receive $40 million in up-front payments and $10 million in equity investments as part of an exclusive worldwide licensing agreement with the New York pharma giant.
Under terms of the agreement, Avant also is eligible for milestone payments in excess of $390 million if the vaccine or products related to its technology are commercialized. In addition, the company projects double-digit royalties if CDX-110 or other EGFR-vIII vaccines make it to market.
The deal was enacted through Celldex Therapeutics, which merged with Avant March 7.
The company's stock (NASDAQ:AVAN) jumped 16.6 percent, or $1.67, on the news to close at $11.72. The deal prompted analysts at Needham & Company LLC to issue a buy rating for Avant and to upgrade their price target of Avant shares to $18. According to Needham's estimates, Avant has $70 million in cash and sufficient resources to operate into 2010.
Avant's Senior Vice President of Business Development Ron Newbold said the company is anticipating sizable revenues from the deal, both in the short term and in years to come. "We expect that there will be some near-term milestones, and upon commercialization, some very significant milestones paid to AVANT," he said.
The deal centers on CDX-110, Avant's lead compound for glioblastoma (GBM), an aggressive form of brain cancer. The vaccine targets EGFR-vIII, a variant of the epidermal growth factor receptor that commonly is overexpressed in tumor cells. EGFRvIII contributes to cancer cell growth in about 40 percent of GBM tumors.
There are an estimated 10,000 people affected annually by glioblastoma in the U.S. First-stage treatment for glioblastoma is surgical resection, followed by a regiment of radiotherapy and chemotherapy with temozolomide.
Avant's vaccine is a novel approach to treating glioblastoma, and CDX-110 has been granted both fast-track and orphan drug designations by the FDA in that indication.
CDX-110 has shown marked success in the clinic. Data from a 43-patient Phase IIa study showed that the vaccine doubled survival rates in glioblastoma patients. The product currently is in Phase IIb/III trials in GBM. Interim efficacy data from those trials could be available by year-end. Final data are expected in 2010 or 2011.
Newbold said the company is upbeat about the potential the vaccine has shown in clinical studies. "We're hopeful that the data will continue to be as promising for CDX-110 for glioblastoma as they have been," he said.
Avant Chief Medical Officer Thomas Davis said that Pfizer's involvement could expedite the vaccine's development, since Pfizer will be funding all further development of CDX-110. Newbold echoed those sentiments. "We think this has been a nice timing of events for us that will enable us to advance the program with the help and support of Pfizer resources," he said.
However, Davis pointed out the collaborative nature of the agreement between Avant and Pfizer. "An important feature is that it is a collaborative deal, so we'll be working with Pfizer in developing the product. There's a joint steering committee, and we're still involved with running the current study."
That kind of partnership could pave the way for new indications for the vaccine. Under terms of the agreement, Pfizer has the option to explore other avenues for CDX-110's EGFRvIII-targeting technology.
"Pfizer has licensed rights to that program, as well as the use of the same molecule in any other cancer indication, as well as any other future vaccines that they could develop with the vIII target," Newbold said. "There's the potential for multiple product opportunities."
For Avant, having its lead product financed by Pfizer could enable the development of other products in its own pipeline.
"We don't have that burn on our books any longer," Newbold said. "And we can use the $50 million in funding to more aggressively advance our antibody program."
Avant has several products in that portfolio, including CDX-1307-01 and 02, vaccines based on its Antigen Presenting Cell (APC) Targeting Technology.
Those products, which target the beta chain of human chorionic gonadotropin, are in Phase I trials in patients with advanced pancreatic, bladder, breast and colon cancer. Data from those trials are expected in the second quarter of this year.
The company also has the compound CDX-1401, another APC-targeted antigen product, in preclinical trials. That therapeutic is being studied for treatment of solid tumors in breast, colon, lung and prostate cancers.
Davis said that the company is looking to build on its APC platform. "We are looking for several [investigational new drug applications] in the next few years," he said. "We are looking to create a comprehensive vaccine around that technology."
And Davis reiterated the effect that the Pfizer deal will have on the Avant's APC candidates. "This money really makes a huge difference for us to be able to advance those programs as efficiently and aggressively as we can," he said.
On a more general level, Newbold said that Avant will dip into the up-front payment to further other candidates in its vaccine program. "The payment will help us to continue to build Avant into a more significant vaccine player," he said.
The company has four other vaccine candidates in its portfolio. Choleragarde, a single-dose oral vaccine for cholera, is in Phase II trials. Ty800, its oral vaccine candidate that protects against Salmonella typhi, the cause of typhoid fever, is in Phase II studies as well. ETEC/Cholera, a combination travelers' vaccine that offers protection against cholera and enteric disease, is in Phase I trials. Avant also has CDX-2401, a prophylactic vaccine for HIV, in Phase I trials.
And the company is not ruling out future collaborations to further its vaccine program. "We're also interested in continuing to build out our pipeline of products through relationships with other partners, so we're going after targets and components that will be helpful to vaccine development," Newbold said. "That's part of our strategy to continue to in-license and support our portfolio of products." n
?
?
Copyright ? 2008 Thomson BioWorld, All Rights Reserved.
[ Back To TMCnet.com's Homepage ]
|
Find Solutions for Enterprises, SMBs & Service Providers at the INTERNET TELEPHONY Conference and EXPO West, September 16-18, 2008. Los Angeles, California.
