Transgene Announces Positive Phase II Results for its HPV Therapeutic Vaccine in Precancerous Cervical Lesions


Transgene S.A. announced positive results of the Phase II trial for its therapeutic vaccine candidate TG4001 (MVA-HPV-IL2) in the treatment of high-grade Cervical Intraepithelial Neoplasia (CIN2/3) which is related to Human Papilloma Virus type 16 (HPV16).

HPV infection is the most common sexually transmitted disease affecting about 400 million women worldwide. Most infections are spontaneously eliminated in less than one year. In the remaining cases, persistent high-risk HPV infection can lead, after several years or decades, to precancerous lesions - called cervical intraepithelial neoplasia (CIN) - and then to cervical cancer. The only currently available treatment of CIN 2/3 is surgical resection of the lesions. Within the so-called "high-risk HPV" category, i.e. the genotypes responsible for cervical cancer, the HPV16, 18, 31 and 33 genotypes have the highest risk of transforming infected cells into cancerous cells. HPV type 16 alone is responsible for more than half of all cervical cancers.

The Phase II trial, performed in nine centres in France, enrolled 21 women with HPV16 CIN2/3. The women ranged from 25 to 44 years of age with an average age of 34 years. The spontaneous regression rate in this population is estimated at approximately 20%. All patients received three injections of the therapeutic vaccine at the dose of 5.107 pfu administered sub-cutaneously. Colposcopy was performed every two months, together with cytology and virology testings, over a six month period following the first vaccine injection. Results at month six are available for 18 patients. In the Phase II trial, TG4001 administration enabled surgery to be avoided in 9 out of 18 women. According to the recommendations of the American Association of Cancer Research task force on the treatment and prevention of intra-epithelial neoplasia, obtaining a 50% regression rate in CIN 2/3 with a new treatment is clinically meaningful (Clin. Cancer Res., (8):314-346, 2002).

Based on these results, Transgene will actively pursue the clinical development of TG4001 with the aim of making therapeutic vaccination a non-invasive and safe alternative to the surgical resection of precancerous cervical lesions. Transgene's TG4001 product candidate is based on the MVA virus carrying and expressing HPV16 E6 and E7 genes. The MVA vector is a highly attenuated strain of vaccinia virus that combines an extensive history of safety with the ability to stimulate a strong immune response to antigens.

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