MelVir is based on AVIR Green Hills Biotechnology´s finding that melanomas are associated with the expression of endogenous retroviruses. This finding provides the foundation for early diagnosis and therapy of melanoma.

The key advantage of AVIR Green Hills Biotechnology´s MelVir-diagnostic tool is the finding, that retrovirus-specific antibodies are prevalent in more than 90 percent of melanoma patients. Importantly, antibodies can be detected at an early stage of disease, which is vital for the cure of melanoma.

MelVir TECHNOLOGIES

AVIR Green Hills Biotechnology scientists described a new melanoma-associated antigen, i.e. MERV (melanoma-associated endogenous retrovirus). Specifially, it was shown that MERV-derived antigens are expressed in primary melanomas and metastases but not in benign lesions, suggesting that expression remains stable throughout the entire process of cancer progression. Moreover, the finding that melanoma patients have circulating antibodies that are reactive with antigenic determinants of the MERV envelope protein indicate that these retroviral proteins are immunogenic. MelVir diagnostics and MelVir therapeutics are based on this key finding.

MelVir DIAGNOSTICS

MERV sequences are antigenic. We have shown that an antibody response to MERV proteins occurs in melanoma patients and characterized an immunodominant MERV epitope (MERV/env-G1). Pre-clinical tests utilizing env-G1 for detecting melanoma-specific antibodies in melanoma patients showed excellent sensitivity and specificity already at an early stage of disease. An ELlSA prototype to screen for anti-MERV antibodies in sera from melanoma patients was therefore established.

Moreover, using env-G1 as an antigen, we generated monoclonal antibodies that specifically binds to the MERV envelope protein in ELISA, immunohistochemistry, and immunocytology on MERV-env transfected cells. We screened a total of 186 melanocytic lesions and found reactivity with mAb 5B10 in 93% of all primary melanoma cases and in 91% of all melanoma metastases. In contrast, only 3% of all melanocytic nevi were reactive. These results indicate a highly significant difference of antibody reactivity with malignant and benign lesions. Therefore this antibody has great potential to be used as a diagnostic tool to aid the distinction between benign and malignant melanocytic lesions. As a consequence, MelVir diagnostics can significantly boost the accuracy of early stage melanoma diagnosis

OUTLINE

  • Melanoma is the most deadly form of skin cancer. If diagnosed early, melanoma is a surgically curable disease. Excision of thin melanomas offers excellent chance for cure.
  • If melanoma is diagnosed late, chances for survival are poor.
  • Early diagnosis is a clear medical need.
  • We have discovered and validated a novel mela-noma marker already prevalent at early stages of the disease.
  • Patents secure our Intellectual Property Rights on this novel marker family -
  • We offer this marker technology for licensing / co-development in the area of diagnostics.

CLINICAL NEEDS

  • Initial diagnosis and staging
  • Particular focus on stage I / II diagnosis
  • Detection of Minimal Residual Disease

MARKET SITUATION

  • Melanoma is the 7th most frequent cancer. Millions of diagnostic procedures are performed every year.
  • Presently, no molecular marker supports early stage diagnosis.

MelVir THERAPEUTICS

Due to the high prevalence of MERV proteins in melanoma tissue, therapeutic approaches based on MERV antigens are promising avenues as well. MERV proteins are specifically prevalent in melanoma tissue but not in tissues derived from benign nevi. Therefore MERV proteins represent excellent targets for immunotherapy. AVIR Green Hills Biotechnology is targeting the MERV protein on the melanoma cells with monoclonal antibodies directed against the envelope protein of MERV and with vaccines containing MERV antigens.

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Core Competences