Transgene Products
About Transgene
Transgene, based in Strasbourg, is a biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. Additional information about Transgene is available on the Internet at www.transgene.fr.
Transgene Products Utilising Co-X-GeneTM Technology
Unlike the Virax products which are based on fowlpox vector technologies, both Transgene products utilise modified vaccinia Ankara virus (MVA)
as the delivery vector.
TG4001 (Therapeutic Vaccine to treat Human Papilloma Virus) is in advanced development with a completed Phase II trial showing promising safety and efficacy. A Phase IIb trial has commenced so as to optimise the product profile. Transgene has licensed TG4001 to the pharmaceutical company Roche for treatment of HPV related pathologies.
TG4010 (Therapeutic Vaccine to treat Non-Small Cell Lung Cancer) is also in advanced development with successful Phase IIb testing in NSCLC achieved. Transgene reported that the FDA had supported the approach for further development of TG4010 in Phase III trials and that it is finalising discussions with potential partners to complete the last stages of clinical development and bring TG4010 to the market. The Company would benefit from any payments to Transgene upon completion of such an agreement together with future milestone payments and royalties.
I. Therapeutic Vaccine to Treat Papilloma Virus Infection and Prevent Development of Cervical Cancer
Background
HPV is the most common sexually transmitted disease. HPV type 16, one of the High-Risk HPV types (HR-HPV), is responsible for more than half of all cervical cancers. Most infected people spontaneously eliminate their viral infection within six to 12 months. Patients who do not eliminate their virus and develop long-lasting HR-HPV infection are at greatest risk of developing cervical cancer. Cervical cancer is the second leading cause of cancer-related mortality by cancer in women worldwide, causing about 470,000 deaths per year, 80% of which occur in under-developed countries. In countries where screening programs are in place, the risk of cancer is reduced because pre-cancerous, asymptomatic lesions such as High-Grade Cervical Intraepithelial Neoplasia (CIN2/3) are detected and then excised by a surgical procedure called conisation. The progression from silent, persistent HPV infection to CIN2/3 and then to cervical cancer takes several years. Despite the fact that spontaneous regression is possible at each step, cervical cancer remains a serious health concern if all lesions are not detected and treated in a timely manner. This provides a strong rationale for developing a therapeutic vaccine to address pre-cancerous conditions from silent, persistent HPV infections to CIN2/3 lesions. Due to the wider use of HPV testing, an increasing number of women are being diagnosed with a HR-HPV infection, but no anti-viral treatment is currently available. An effective therapeutic vaccine that could prevent the occurrence of cervical dysplasia in this population is thus desirable. Compared to the use of mass prophylactic vaccination against HPV, this therapeutic vaccination would specifically target the patients who were not able to eliminate spontaneously their HPV infection.
The annual incidence of high grade cervical dysplasia (CIN 2/3) in Europe and the USA is estimated at 700,000 of which approximately 70% is caused by HPV16 and HPV like virus. The target market for a vaccine would be about 490,000 patients per year. Pricing a vaccine at the same level as the current treatment (conization), upon launch of product by 2010, the expected peak sale would be in the order of €250 million.
TG4001: Therapeutic HPV Vaccine
The first Transgene product (TG4001) co-expresses human papilloma virus antigens and the cytokine, IL-2 in modified vaccinia Ankara virus vector (MVA) for the treatment of cervical intraepithelial neoplasia.
Development Status
Phase II testing of TG4001 for the treatment of CIN2/3 has been successfully completed. Based upon highly promising results Transgene recently entered into an exclusive licensing deal with Roche for the treatment of HPV related pathologies. Phase III clinical testing of TG4001 is expected to commence in early 2008 in Europe and the USA.
II. Therapeutic vaccine for Small Cell Lung Cancer
Background
With 1.1 million new cases a year across the world and 350 000 deaths in Europe and USA, lung cancer is a major public health issue. In general, the prognosis for the progress of the disease is not very good because diagnosis is often too late. Current treatments (surgery, chemotherapy, radiotherapy) have serious side-effects and are hard to endure for the patients. There are two types of lung cancer, "small cell" and "non small cell" cancer. Non small cell lung cancer (NSCLC) presents 80% of cases observed. In 60% of NSCLC patients the antigen MUC1 is over expressed. An anti-MUC1 directed immunotherapy would target these cells for destruction by the patients' immune system.
Current Cancer therapies cost an average of $10,000 (US) per year per patient. Upon product launch and treating at peak of about 50,000 patients, the Transgene product could present a market opportunity of greater than AUD 1 billion.
TG4010: Non-Small Lung Cancer Vaccine
The second Transgene product (TG4010) co-expresses the MUC-1 antigen and the cytokine, IL‑2 and is designed to treat MUC-1 positive tumors. MUC-1 is a highly glycosylated mucin over-expressed in many cancers such as kidney, pancreatic, stomach, ovarian, colorectal non-small cell lung, prostate and breast. Transgene's first target for approval is the non-small cell lung cancer (NSCLC) indication.
III. Development Status
Clinical testing of TG4010 for NSCLC has shown promising indications of anti-tumour activity. Interim results of a Phase IIb trial in NSCLC have been reported. The trial met its primary endpoint for progression free survival at six months with the response rate being substantially higher for the combination of TG4010 with chemotherapy compared to chemotherapy alone.
IV. Licence Value
The Transgene licence provides Virax with an upfront payment, a share of Transgene development milestone payments and a royalty on North American sales. The Net present value of the Virax-Transgene license was estimated in December 2007 as USD 17 million based upon external independent analysis by Dr Kris Motmans, formerly of Bryan, Garnier and Company. Detail of the Analysts Reports' can be found under the 'Investor information' section of this website.