IAVI ReportImportant note: Information in this article was accurate in September/ November 2000. The state of the art may have changed since the publication date.
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Industry Insider

IAVI Report - September / November 2000
 

SmithKline Bio Aiming For Phase III Vaccine Trials in Three Years
The president of SmithKline Biologicals, Jean Stephenne, reported that his company hopes to have vaccines for both HIV and malaria in Phase III trials within three years. Stephenne made these comments at the European Commission (EC)-sponsored "Roundtable on HIV/AIDS, Malaria, Tuberculosis and Poverty Reduction" on 28 September in Brussels. The Roundtable included representatives from the EC and its member states, and from a number of developing countries, multilateral agencies, research institutions, NGO's and industry.

SmithKline Herpes Vaccine May Work in Women Only
Two Phase III trials suggest that a vaccine developed by SmithKline Biologicals protects women, but not men, against genital herpes. According to data released at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) on 17-21 September in Toronto, the vaccine protected about 73% of women against genital herpes but did not appear to protect men or women who had previously been infected with HSV-1. The vaccine contains a recombinant glyocoprotein of herpes simplex virus-2 (HSV-2) and SmithKline's new SBAS4 adjuvant. These unexpected results highlight the need to enroll sufficient numbers of women in AIDS vaccine trials so that potential gender differences can be detected.

Targeted Genetics Announces New Deals
In August, Targeted Genetics Corp. announced that it would buy Genovo, a privately-held Pennsylvania-based gene therapy company. According to the Seattle-based Targeted, the acquisition will provide it with four new gene therapy candidates as well as valuable patents on the production and use of adeno-associated virus (AAV) vectors for gene therapy. The company is conducting human studies of gene therapy for cystic fibrosis and cancer and is working with IAVI and researcher Phil Johnson of the University of Ohio (Cincinnati) to develop an AAV vaccine for HIV.

Targeted also announced a collaboration with biotech company Biogen that will enable it to develop additional gene therapy products. Genovo collaborated with the University of Pennsylvania's Institute for Human Gene Therapy (Philadelphia) in a gene therapy study that led to the death of 18-year old participant Jesse Gelsinger last year, and which is now the subject of controversy and litigation.

AlphaVax Gets New Financing
AlphaVax announced that it has raised US$11 million in financing from U.S. and European-based investors. The North Carolina-based biotech company is developing an AIDS vaccine based on a Venezuelan equine encephalitis (VEE) vector, with backing from IAVI, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the Walter Reed Army Institute for Research. AlphaVax hopes to begin human trials of its first HIV-VEE prototype vaccine in the first half of 2001. "With these funds, we can initiate new product programs, as well as begin taking up second-generation systems and new technologies," said Peter Young, the company's president.

ProdiGene to develop plant-based HIV vaccine
ProdiGene, a Texas-based biotechnology company that is developing a number of edible plant vaccines, has received an NIH grant to develop a plant-based HIV vaccine. The HIV grant will allow the company to engineer maize seed (corn) that expresses HIV gp120. According to ProdiGene's president John Howard, the corn seeds could also be designed to express codon-optimized genes and DNA vaccines and to be part of any corn product (cooked or uncooked), including cornmeal. Plant vaccines offer several potential advantages: they are cheap to produce, do not need refrigeration; can be grown in virtually every country and require no needles to administer.

Howard also presented data at the Millennium Second World Congress on Vaccines and Immunization, held on 29 August -1 September 2000 in Liege, Belgium, showing that a corn vaccine against porcine gastroenteritis virus seemed to offer some protection (measured as longer survival) in immunized pigs. At the same meeting, researchers from Cornell University (New York) reported that edible potato vaccines for E. coli, Norwalk virus and hepatitis B have entered human trials, and that all three generated measurable immune responses.

Four Companies Get NIAID Team Grants
Four companies were awarded HIV Vaccine Design and Development Team contracts by the U.S. NIAID to pursue different strategies for developing DNA vaccines. The contracts, totalling US$70 million over five years, were awarded to: Advanced BioScience Laboratories (for vaccines containing envelope proteins from multiple HIV strains); Chiron Corporation (to combine DNA vaccines with a protein or an alphavirus vector boost); the University of New South Wales (Sydney) and Virax (an Australian company developing a DNA vaccine to use with a fowlpox vector); and Wyeth Lederle Vaccines (for DNA vaccines that also containing a cytokine or other immunomodulatory protein, and for an HIV peptide vaccine).

NIAID also awarded a two year, US$4 million grant to Progenics (Tarrytown, New York) to develop novel envelope antigens.

In related news, Virax expects to begin trials of its fowlpox vaccine in HIV-infected volunteers by the end of this year.

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