Transgene presents encouraging Phase II cancer vaccine data at 22nd Annual San Antonio Breast Cancer Symposium

San Antonio, Texas, December 10, 1999 — At the 22nd Annual Breast Cancer Symposium, TRANSGENE (NASDAQ:TRGNY; Nouveau Marché: TRANSGENE) today presented the results from a Phase II clinical trial using the Company's cancer vaccine, VV-MUC1-IL2, in women with metastatic breast cancer. These data, combined with pre-clinical data and results from another clinical trial in men with prostate cancer, demonstrate a favorable safety profile and anti-tumor activity in selected patients with advanced cancer treated with VV-MUC1-IL2. VV-MUC1-IL2 is a cancer vaccine in which the genes for the tumor antigen MUC1 and the immune stimulant IL2 have been inserted into a vaccinia virus. Treatment with the vaccine is intended to induce a reaction by the body's immune system against the MUC1 tumor antigen. MUC1 has been detected in tumor tissues of a majority of patients with breast cancer, prostate cancer, as well as several other types of tumors.

The Phase II study presented by Dr. David Miles of the Imperial Cancer Research Fund at Guy's Hospital, London, was conducted in 31 patients at sites in the United Kingdom, France, Belgium, and Israel. Treatment with the vaccine resulted in objective tumor regression and a partial remission in two patients, both of whom had advanced metastatic disease that did not respond to either chemotherapy or hormonal therapy.

"These results are notable in that we saw systemic anti-tumor activity," said Dr, Miles. "The ability to induce a partial remission in patients with visceral metastases who have progressive disease after intensive chemotherapy is important evidence of the potential role of therapeutic vaccines in the treatment of cancer."

"The use of vaccines for advanced cancer could represent an important new avenue in cancer treatment," said Michael Ross, Vice President of Medical and Regulatory Affairs of TRANSGENE. "The MUC1 tumor antigen provides an avenue to attack breast cancer, prostate cancer as well as other types of cancers. TRANSGENE's proprietary vaccinia virus platform has enabled us to move this product forward very rapidly."

The MUC1 product is part of TRANSGENE's broader effort to develop technologies that will enhance the human immune system's ability to reject cancer cells. Utilizing the same vaccinia virus vector, TRANSGENE has a second cancer vaccine in clinical trials based on the MVA strain carrying the genes for antigens from the human papilloma virus (HPV) type 16, which is responsible for more than 50% of cases of cervical cancer. TRANSGENE's second major focus in oncology is the general enhancement of the body's immune response to cancer, with currently three products in clinical trials: Adenovirus-IL2, Vero-IL2, and Adenovirus-IFN-γ.

"We are extremely encouraged by TRANSGENE's clinical progress in each of our anti-cancer initiatives," said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "This continued success and our commitment to an extensive and diverse vector platform confirms our dedication to the field of gene therapy."


TRANSGENE, based in Strasbourg, France, with US offices near Boston, Massachusetts, is a leading integrated gene therapy company dedicated to the discovery and development of gene delivery technologies and gene therapy products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. The Company's proprietary technology platform consist of multiple vector families with a special emphasis on vaccinia virus, adenovirus and synthetic vectors. TRANSGENE has entered in two significant partnerships with Schering-Plough and Human Genome Sciences.

Source: Transgène

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Transgene initiates a Phase I trial with its MVA-HPV-IL2 product in cervical cancer

-Received Notice of Allowance of Additional US Patent for Cancer Vaccines-

Strasbourg, France, September 14, 1999 — TRANSGENE (NASDAQ:TRGNY; Nouveau Marché: TRANSGENE) announced today the initiation of its first clinical trial with MVA-HPV-IL2, the Company's sixth product in the clinic. The Phase I clinical trial is being conducted at the Baylor College of Medicine in Houston, Texas, in patients with grade 3 cervical intraepithelial neoplasia (CIN3), a pre-cancerous stage disease, under a TRANSGENE sponsored Investigational New Drug (IND). This is the company's third IND approved by the Food and Drug Administration. Two additional Phase I clinical trials with the same product are being implemented in the United States and in Switzerland.

The MVA-HPV-IL2 product is part of TRANSGENE's effort to develop cancer vaccines to enhance the human immune system's ability to reject cancer cells. The MVA-HPV-IL2 vaccine consist of TRANSGENE's proprietary vaccinia virus vector based on the MVA strain carrying the genes for antigens from the human papilloma virus (HPV) type 16, which is responsible for more than 50% of the cases of cervical cancer. Approximately 100,000 cases of cervical cancer are newly diagnosed in Europe and the United States per year. The clinical trials with this product are designed to explore its potential utility in the treatment and prevention of cervical cancer caused by HPV16.

In addition, TRANSGENE announced that it received Notice of Allowance from the United States Patents and Trademarks Office of a key patent covering its cancer vaccines technology. The patents, entitled "Expression of a tumor-specific antigen by a recombinant virus vector and use thereof", covers methods of treating virally-induced tumors and viral vectors encoding at least the essential region of a non-structural protein from papillomavirus, especially selected E1, E2, E4, E5, E6 and E7 of HPV-16. The US patent adds to TRANSGENE's portfolio of patents previously granted in Europe, the United States and Japan protecting intellectual property on the cancer vaccines technology which TRANSGENE is developing through the clinical trial above-mentioned.

"With this sixth product entering clinical development, TRANSGENE confirms its dedication to lead the development of gene therapy products, in particular in the field of oncology" said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "We are pleased to see this commitment supported by a strong patent position, allowing TRANSGENE to foresee the development of this additional product on a worldwide basis."

TRANSGENE's other approaches in oncology include another cancer vaccine using the vaccinia virus in which the virus expresses MUC1, a tumor antigen expressed in a wide range of adenocarcinomas, which is in Phase  clinical trials in the United States and Europe, in patients with breast and prostate cancers. The major direction of TRANSGENE's anti-cancer program is the general enhancement of the body's immune response to cancer, with currently three products in clinical trials: Adenovirus-IL2, Vero-IL2, and Adenovirus-IFN-γ.


TRANSGENE, based in Strasbourg, France, with US offices near Boston, Massachusetts, is a leading integrated gene therapy company dedicated to the discovery and development of gene delivery technologies and gene therapy products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. The Company's proprietary technology platform consist of five vector families, including three of viral origin (adenovirus, retrovirus, vaccinia virus) and two of non viral origin (cellular and synthetic vectors). TRANSGENE currently has four Phase II studies ongoing in four different types of cancers. TRANSGENE has entered in two significant partnerships with Schering-Plough and Human Genome Sciences.

Source: Transgène

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Transgene initiates a phase I trial with its adenovirus-IFNγamma product in malignant melanoma

-Brings total number of products in the clinic to five-

Strasbourg, France, June 22, 1999 — TRANSGENE (NASDAQ:TRGNY) announced today the initiation of a new clinical trial using adenovirus-IFN-γ for the first time. This Phase I clinical trial is being conducted at the University of Rochester in Rochester, New York, in patients with advanced malignant melanoma, under a TRANSGENE sponsored Investigational New Drug (IND). This is the company's second IND approved by the Food and Drug Administration. Additional Phase I clinical trials are being implemented in Europe.

The adenovirus-IFN-γ project is part of TRANSGENE's effort to enhance the human immune system's ability to reject cancer cells and thus provide an improved, less toxic alternative to chemotherapy and radiation in the treatment of advanced cancer. The product is based on TRANSGENE's adenovirus technology and is designed to produce interferon-γ, a natural cytokine that helps to stimulate the body's immune system. Studies in laboratory animals have indicated the potential value of this compound in stimulating the immune system and enhancing the response against cancer, both alone and in combination with other forms of immunotherapy.

TRANSGENE has two other product in clinical trials which incorporate interleukin-2, another member of the cytokine family, which is known for it important role in stimulating the immune system. The other major approach in TRANSGENE's oncology program is based on the development of anti-cancer vaccines, where tumor specific antigens are produced by vaccinia viruses in an effort to boost the body's immune response against these antigens.

"With the launch of this new trial, TRANSGENE is advancing its strategy to fight cancer," said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "The very encouraging preliminary results from our breast cancer Phase II trial released a few weeks ago at the ASCO conference, ours various other ongoing trials and an extensive and diverse vector platform make TRANSGENE a leader in this field."


TRANSGENE, based in Strasbourg, France, with US offices near Boston, Massachusetts, is a leading integrated gene therapy company dedicated to the discovery and development of gene delivery technologies and gene therapy products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. The Company's proprietary technology platform consist of five vector families, including three of viral origin (adenovirus, retrovirus, vaccinia virus) and two of non viral origin (cellular and synthetic vectors). TRANSGENE currently has four Phase II studies ongoing in four different types of cancers. TRANSGENE has entered in two significant partnerships with Schering-Plough and Human Genome Sciences.

Source: Transgène

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Transgene initiates a second Phase II trial with its Vero-IL2 product in mesothelioma

Strasbourg, France, March 10, 1999 — TRANSGENE (NASDAQ:TRGNY) announced today the initiation of a second Phase II clinical trial of its Vero-IL2 product in Freiburg, Germany, in the laboratory of Professor Mertelsmann, with the enrollment of the first two patients. The study will include 20 patients with malignant mesothelioma, a form of lung cancer arising in the pleura (lining) of the lung.

TRANSGENE's Vero-IL2 product is an immortal cell line genetically modified to produce interleukine-2, a natural cytokine that helps to stimulate the body's immune system. Earlier studies in cats and dogs shower Vero-IL2 to be beneficial in the treatment of spontaneously occurring tumors. More recently, two Phase I clinical trials completed in France and Switzerland have suggested some anti-tumor activity and demonstrated preliminary evidence of safety and tolerance to this therapy. In addition, the first Phase II trial with this product began in Spring 1998 in patients with malignant melanoma, the most aggressive form of skin cancer.

"The initiation of a second clinical trial for our Vero-IL2 product is a solid indication of the continued progress TRANSGENE is making in the clinic," said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "We are anxious to move this product along for the treatment of malignant mesothelioma, as there is a large unmet medical need for patients suffering with this disease. With the beginning of this trial, TRANSGENE will have four ongoing Phase II gene therapy clinical trials for the treatment of several cancers."

TRANSGENE's objective is to use its Vero-IL2 or a second vector, Adenovirus-IL2, to encourage the human immune response to reject cancer cells, thus providing the potential for a less toxic alternative to current chemotherapy and radiation treatments of advanced cancers. Another direction in TRANSGENE's anti-cancer program is continuing efforts for the development of anti-cancer vaccines, where tumor specific antigens are produced by vaccinia viruses in an effort to boost the body's immune response.


TRANSGENE, based in Strasbourg, France, is an integrated biotechnology company dedicated to the discovery and development of gene therapy technologies and products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. Its proprietary technology platform includes adenoviral, vaccinia viral, retroviral, cellular and a range of synthetic vectors for gene delivery. Three of these vector families are currently in clinical development for several disease applications. TRANSGENE currently has four Phase II studies ongoing targeting a number of different cancers. TRANSGENE has two major partnering agreements with Schering-Plough and Human Genome Sciences.

Source: Transgène

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