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Wednesday, July 9, 2008
Chasing cancer
Vaccine may target deadly threats
By Lisa Eckelbecker TELEGRAM & GAZETTE STAFF
leckelbecker@telegram.comwww.telegram.com/article/20080709/NEW... WORCESTER— A technology developed by Antigen Express Inc. to bolster therapeutic vaccines has shown early signs of progress in breast cancer and is also being tested in early studies of avian flu and prostate cancer.
The technology, which depends on peptides that focus the body’s immune system against deadly threats, seemed so efficient in an early breast cancer study that researchers were able to test their vaccine without adding a component usually needed in peptide vaccines.
“That indicates by its nature it was more immunogenic than other peptides,” said Eric von Hofe, president of Antigen Express. “It’s a little unprecedented.”
A subsidiary of Toronto-based Generex Biotechnology Corp., Antigen Express employs 10 people in a small suite of offices and two laboratories in the Massachusetts Biotechnology Research Park. The group contracts out the manufacture of peptides, which are fragments of proteins, and focuses on research and development.
Dr. Robert E. Humphreys formed Antigen Express in the mid-1990s, spinning it out of the University of Massachusetts Medical School. Nearly $2 million in federal research grants kept it alive during lean years when venture capitalists and other financiers were uninterested in the company’s technology.
Generex bought Antigen Express in 2003. The company, which is developing a way to deliver insulin to diabetic patients through a mouth spray, is not yet profitable and posted a loss of $10.2 million, or 9 cents per share, in the first quarter ended April 30. Generex boosted its cash cushion in the spring with the sale of nearly $20.7 million in convertible notes and warrants to existing institutional investors.
Its Antigen Express subsidiary remains close to UMass. After years in a Massachusetts Biomedical Initiatives business incubator in Worcester, it moved to Worcester’s life sciences park partly to be close to the medical school’s animal research facilities, according to Dr. von Hofe, who has a doctorate in experimental pathology and has worked for several life sciences companies.
The company’s most advanced peptide vaccine, known as AE37, was created from a fragment of the HER-2/neu gene, which the body pumps out in certain tumors, including many breast cancers. AE37 was designed to act as a warning system: Show the body a peptide fragment and the immune system should muster CD4+ T helper cells to attack cancerous cells related to the peptide fragment, wherever they may be.
The goal is to seek and destroy cancer cells even after patients have undergone other treatments, such as surgery.
“You’ve got these little policemen running around all the time looking for it,” Dr. von Hofe said.
A small trial of 15 healthy breast cancer patients led by Dr. George E. Peoples of the Brooke Army Medical Center in Texas found that patients tolerated the six monthly injections, according to a report on the trial at the American Society of Clinical Oncology in June. After some patients showed a strong response to the immunizations, researchers gave some of the treatments without an adjuvant, which is an irritant used in vaccines to provoke the immune system.
The researchers wrote, “to our knowledge, AE37 is the first peptide-based cancer vaccine to show potency in the absence of an immunoadjuvant.”
Antigen Express has begun the second phase of testing for AE37 in breast cancer at 10 medical centers, a process that could take three years. A third and final phase of studies after that could extend another four years, according to Dr. von Hofe.
Antigen Express’ technology appears promising, although Generex has released little data about it and is best known for its oral insulin program, said Vernon T. Bernardino, senior biotechnology analyst with Rodman & Renshaw, who has a “market outperform” rating on Generex stock. Rodman & Renshaw makes a market in Generex stock, but Mr. Bernardino does not own any Generex shares.
“Antigen Express is sort of extra and unrecognized by investors,” Mr. Bernardino said. “The parent company often does not highlight that part of it. It is unrecognized value.”
The company’s collaborators are studying the use of Antigen Express peptide vaccines to treat a number of diseases. Researchers at St. Savas Cancer Center in Athens, Greece, began a 30-patient prostate cancer study of AE37 late last year. Earlier in 2007, Antigen Express collaborators began human studies of a peptide vaccine against H5N1 avian flu, and in March the company extended a partnership with researchers in Lebanon to test peptides for an avian flu vaccine.
More recently, Antigen Express signed a second agreement to work with Mayo Clinic researchers to move a therapeutic vaccine against melanoma into human studies. Mr. Bernardino of Rodman & Renshaw called the agreement “further validation of the value of the immunogenicity enhancing properties” of Antigen Express’ technology in a recent note to clients.
Dr. von Hofe said Antigen Express researchers are also studying whether the company’s technology could be used in reverse to turn down immune system reactions and treat disorders such as Type-1 diabetes, or even to create a diagnostic kit that would help doctors diagnose diabetes early.
Antigen Express will likely remain small, managing its research with collaborators around the world, Dr. von Hofe said.
“We do not need to grow a lot now,” he said. “I think so far we’re in pretty good shape.”