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 liver which is a central organ in glucose metabolism. During last year we have made significant progress along its development lifecycle. Biocon has successfully developed and scaled up the carefully selected formulation to give consistent absorption from GUT. The molecule has been well studied in Phase I and Phase II clinical studies in type II diabetes patients. Data from Phase II has been presented IN EASD, Rome September 2008. Currently, a Phase III study in type II diabetes is on going to evaluate the long term effect of IN-105 has been completed. The data analysis is in progress. A US IND was filed in December 2009 for conducting a Pharmacokinetic and pharmacodynamic study in Type I diabetics subjects. FDA has not raised any objections within the stipulated 30 days from the filing. The study has been initiated post DCGI approval.


Anti-CD6 (T1h)

Inflammatory autoimmune diseases like Psoriasis, Rheumatoid Arthritis (RA) and Multiple Sclerosis (MS) requires therapeutic intervention to modulate the immune system and alleviate disease symptoms. Autoimmune diseases are chronic in nature and patients require life long treatment. T cells found in the immune system which cause these diseases is a natural target for immunomodulation.

T1h suppresses T cell proliferation in vitro. Two clinical trials completed by Biocon, in Psoriasis and Rheumatoid Arthritis patients has clearly established the role of CD6 in these diseases and targeting CD6 with T1h is causing significant improvement in symptoms in these diseases. T1h was safe and well tolerated. A Phase III efficacy clinical trial in Psoriasis was initiated in May 2010.

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 humanized 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. Proof of concept has been shown in animal studies and GLPtox studies in relevant animal models is complete.

Phase I studies in Non-Hodgkin’s Lymphoma is expected to start in 2011.

Iatrica

Biocon and IATRICa are working towards development of targeted immunuconjugates and monoclonal antibody fusion proteins for oncology indications. This project is in discovery stage. The goal is to develop a therapeutic vaccine where the T cell mediated immunity is enhanced and maintained against a tumor which otherwise evades immune responses. Methods of developing and characterizing monoclonal antibody fusion proteins production is being studied currently.

Phybrid

Biocon has entered into a strategic partnership with Amylin, a US based pharmaceutical company for Joint global development and commercialization for a novel peptide hybrid in metabolic disorders (diabetes, obesity and cardiovascular indications).