Biocon Biopharmaceuticals, the subsidiary of Biocon Limited, has set up a joint venture initiative with the Centre for Molecular Immunology, a Cuban-based monoclonal antibody and cell culture technology major to extend its product portfolio with two additional monoclonal antibodies (MABs) and three cancer vaccines.

The two novel MABs are h-T1, a humanised anti-CD6 targeting immuno-suppressive monoclonal antibody for T-cells Lymphoa, Rheumatoid arthritis and Psoriasis and the q-T3, a chimeric anti-CD3 targeting immuno-suppressive monoclonal antibody for organ transplant. The three cancer vaccines are EGF, TGFa and HER 1.

An agreement was signed between the two partners, Kiran Mazumdar-Shaw, representing Biocon and Patricia Sierra representing Centre for Molecular Immunology at an informal ceremony at Havana in the presence of the Indian ambassador Balakrishnan and secretary of the Council of State of Cuba, Dr Jose M Miyar. Representatives of both countries praised the importance of the partnership as an outstanding example of South-south co-operation in the biotechnology.

The current product range of Biocon Biopharmaceuticals includes h-R3, a humanised anti EGFR (epidermal growth factor receptor) targeting monoclonal antibody for a variety of cancers including head and neck, brain tumours, non-small cell lung cancers. The other products are a recombinant GCSF (Granulocyte Stimulating Factor) and EPO (Erythroprotein).

A Phase IIB 4-arm clinical trial for h-R3 is about to commence to evaluate the efficacy in Squamous Cell Carcinoma of solid head and neck tumours. Following the outcome of this trial, other cancers will also be treated with h-R3 and evaluated through a series of clinical trials.

"With immuno-therapy being the most recent form of treatment for oncology and autoimmune diseases where antibodies and vaccines are used to managing the symptom, Biocon will introduce a product portfolio that will target both receptors (EGFR &HER1) and proliferation factors (EGF and TGFa aimed at complete remission and possible cure," said Shaw.

The phase II clinical trial conducted in Cuba and Canada have demonstrated complete remission in >60 per cent of patients treated with h-R3. The Phase II trials using EGF vaccine along with chemotherapy and radiotherapy in non-small cell lung cancer has demonstrated a doubling of survival time as well as a 400-fold increase in anti EGF antibody titres as compared to the baseline, thus indicating a highly significant therapeutic movement.