Active Discovery Programs

IN-105 (Oral Insulin)

Subcutaneous Insulin is very effective in the treatment of diabetes but its prescription is generally delayed due to inconvenience of needle usage and potential hypoglycemia (caused by excess insulinisation). In contrast, Oral Insulin (ie. Insulin in tablet form) is simple and painless to administer. Additionally, it is delivered through the portal vein, mimicking the natural physiology of the body. If successful in the clinic, Oral Insulin could become a very important therapy for intervention in earlier stages of diabetes.

Biocon is developing IN-105 – a conjugated Insulin molecule that is orally delivered and targeted towards the treatment of diabetes. During the last year, we have made significant progress along its development lifecycle. Biocon’s R&D group has successfully developed a tablet for oral delivery of IN-105, its formulation carefully selected to give consistent absorption and glucodynamic (glucose-lowering) effect. In the clinic, this molecule has completed Phase I trials and is expected to enter Phase II in India later this year to illustrate proof of concept. The encouraging results of the Phase Ia and Ib studies represent a vital hurdle crossed in the development of IN-105 as a product. IN-105 will enter Phase I trials in Europe towards the end of the year.


Anti-CD6 (T1h)

Rheumatoid Arthritis (RA) is a chronic, inflammatory, systemic disease in which the immune system attacks the joints and causes its destruction. RA also impacts multiple systems in the body, including the heart, skin, blood vessels and lungs. The introduction of biologics that target the signaling molecules and different cell types in the immune system has significantly advanced the treatment of RA. While joint damage is hard to reverse, the inflammatory conditions that are present during RA have been greatly reduced, causing an improvement in patient quality of life. T1h is a novel humanised Monoclonal Antibody that blocks the activity of CD6, a specific antigen found on the surface of an important cell type in the immune system, T cells. T1h suppresses T cell proliferation in vitro and is expected to modify the course of arthritic disease in the clinic by modulating T cell behaviour. Biocon’s T1h has completed a Phase I study in patients with RA. The product was found to be safe and well tolerated. A Phase II dose-range finding study, designed to evaluate the safety and efficacy of T1h in patients with severe RA, is expected to start in 2007.


BVX-10

Another promising target for therapeutic intervention in RA is the Tumour Necrosis Factor Alpha TNFa, a cytokine that has multiple biologic actions, including mediation of inflammatory responses and modulation of the immune system. There is evidence that TNFa plays a central role in autoimmune and inflammatory diseases, contributing to the progression of both infl ammation and joint destruction. Biocon’s BVX-10 is a novel human Monoclonal Antibody directed against TNFa. It was developed in collaboration with our partner Vaccinex, a biotechnology company in Rochester NY, using their unique and proprietary ActivMab platform technology. Phase I trials are expected to start in Q1 2009.


BVX-20

Non-Hodgkin's Lymphoma (NHL) is the most common cancer of the lymphoid organs. Its incidence in western countries varies from 6 to 16/100,000 and in the EU specifically, an approximate 50,000 new cases are diagnosed each year. Biocon’s BVX-20 is a novel human Monoclonal Antibody that binds to CD20, a protein located on both normal and malignant B-cells. After binding, BVX -20 kills B-cells by recruiting the body’s own immune system. BVX-20 is intended for use in the treatment of patients with relapsed or chemotherapy resistant follicular B-cell NHL and CD20 positive diffuse large B-cell NHL in combination with chemotherapy. This Monoclonal Antibody was also developed in collaboration with Vaccinex using their ActivMab technology. Phase I trials in India are expected to start in Q3 2008.


BN-054 (Oral BNP)

High blood pressure is one of the major risk factors for development of cardiovascular diseases like stroke, heart attack, heart and kidney failure. Recent studies have established that Small Molecular Weight Peptides called Natriuretic Peptides cause increased sodium excretion, vasodilation and inhibition of rennin-aldosterone actions in the body, thus potentially reducing blood pressure while also being cardioprotective. One such peptide, B-type Natriuretic Peptide (BNP) has been approved by US FDA for congestive heart failure.

BN-054 (Oral BNP) is a B-type Natriuretic Peptide conjugated using a patented technology and process. This molecule is likely to be tested clinically in essential Hypertension, Congestive Heart Failure (CHF), Congestive Obstructive Pulmonary Disease (COPD) and Chronic Kidney Disease (CKD). BN-054 is in early stage preclinical studies. Product development is ongoing at Biocon and initial toxicology/ pharmacology is expected to start in 2008.