WFU And IntraVec To Develop Innovative Cancer And HIV Treatments

November 20, 1998

WINSTON-SALEM, N.C. -- Leading edge cancer and HIV treatment and prevention strategies may soon be available to patients as the result of the efforts of a new company, IntraVec, Inc., formed by Wake Forest University, where the basic research was done. IntraVec will manage the development process.

IntraVec will build on research done at Wake Forest University School of Medicine by Si-Yi Chen, M.D., Ph.D., a former assistant professor of cancer biology. In developing the new treatments and therapies for trial and use in humans, IntraVec will work with Chen and Malcolm Brenner, M.D., Ph.D., director of the Center for Cell and Gene Therapy at Baylor College of Medicine, where Chen is now an associate professor.

The cancer treatments will use "toxic cell" technology in which Chen and his colleagues genetically modified normal cells to produce and secrete a toxin, or poison, that attacks and kills cancer cells but does not harm the carrier cell or other normal cells.

Scientists see this treatment as a major advantage over traditional approaches in which a drug is injected into the bloodstream but only a small amount of it finds its way to the tumor cells. And most cancer drugs also damage other dividing cells, including normal cells.

In human patients, the scientists hope that the altered toxic cells will serve a continuing surveillance function, going after remaining cancer cells that otherwise would multiply again and restart the cancer.

IntraVec's HIV treatments will be based on Chen's discovery of a method for genetically altering white blood cells (lymphocytes) to make them impervious to entry by the HIV virus. During infection by HIV the lymphocytes -- the body's main disease-fighters -- are taken over by the virus, which multiplies there, resulting in AIDS and susceptibility to a variety of potentially deadly illnesses.

Ordinarily, the HIV binds to the host cell through interaction with chemokine (protein) coreceptor on the surface of the cell. But some people with certain "defective" genes do not produce the chemokine that permits "docking" by the HIV.

Chen and his colleagues designed a novel approach called intracellular chemokine -- or intrakine -- that mimics that natural HIV resistance. In the process, lymphocytes would be removed from the infected patient, genetically modified with intrakine, then periodically reinfused back into the patient. The modified cells would prevent the necessary protein from reaching the surface of the host cells, thus preventing HIV infection from entering that cell.

IntraVec also plans to develop a process discovered by Chen that masks the docking sites for HIV on both macrophages and lymphocytes. Taken together, the new processes address both early and later stage HIV infections.

When the research was first reported last year, Chen said that the technology was revolutionary in that it focused on preventing HIV infection of cells, rather than on inhibiting HIV replication in already-infected cells, as does most current treatment. Also, he said, the new technology is less likely than current drug therapies to have toxic side effects and generate drug-resistant HIV mutants.

Recent data indicate that the lifetime treatment cost for an AIDS patient is about $100,000. IntraVec's approach to genetic therapy could significantly reduce those treatment costs. The major advantage, however, could be that the therapy leaves the patient's immune system intact and functioning. This responds to opinions expressed at a recent International AIDS Conference that new therapies should focus on strengthening patients' immune response to HIV.

Annette M. Tobia, J.D., Ph.D., IntraVec's president and CEO, said that the HIV-targeted technology could have far broader applications. "The cellular engineering principles discovered by Dr. Chen are applicable not only for HIV infection, but also for any disease where prevention of the cell surface expression of a protein would have therapeutic significance," she said.

Tobia added that she expected Chen and Brenner, working together, to take the technology to the next generation and produce "breakthrough" vectors, to be developed by IntraVec, that will be able to affect stem cells, the body's nonspecific "mother" cells that later differentiate into cells for specific body functions.

It may be possible to change the stem cells in a way that causes them to differentiate into more HIV-resistant lymphocytes and macrophages.

"This would truly be a new age vaccine for the prevention of HIV infection," Tobia said, adding that "the knowledge gained from the project could also be used for creating a cancer vaccine."

IntraVec also plans to produce unique therapeutic proteins for the treatment and prevention of Hepatitis B, certain cancers, and HIV-AIDS. To help fund that research, the company plans to develop a "gene screen" used to identify genes coding for proteins that elicit an immune response. The company will license the screen to pharmaceutical companies and pharmaceutical contract service providers.

Tobia said that IntraVec's development process begins with clinical trials early next year at Baylor, and that once human efficacy is established, more intensive development will follow. She said that the company presents an exciting investment opportunity, and she encouraged potential investors to contact the company directly for additional information.

Beth Fordham-Meier, director of Technology Transfer for Wake Forest University, said the partnership with IntraVec is unique in that the school is a founder, licensor, and investor in the company, having contributed seed capital to the startup venture.

She said that she is excited also about the relationship with Baylor. "Dr. Brenner is a nationally recognized expert in gene therapy, and the Center for Cell and Gene Therapy already has the necessary federal approval to produce and administer clinical-grade vectors," she said.

"Once the effectiveness of the technology is proven in humans, we expect Wake Forest University Baptist Medical Center to become one of the clinical sites where the therapy can be carried out," Fordham-Meier said.

Chen's research was among about 100 projects included in last spring's Connectivity Expo, which showcased for investors and venture capitalists some of the technology created at the medical school and other Winston-Salem institutions that is ready to be developed and marketed.

"We anticipate more announcements of startup ventures in the coming months and years," said Fordham-Meier.

IntraVec is the second collaborative arrangement between Wake Forest and a new technology company announced in the past month.

Investors seeking information about IntraVec should call Tobia at 610-695-2079. For more information about technology available for license through Wake Forest University School of Medicine, call Fordham-Meier at 336-716-2846.

Media Contact: Mark Wright, Bob Conn, or Jim Steele, at 336-716-4587.
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Wake Forest Baptist Medical Center

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