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Active Discovery Programs

- Novel Molecules

Biocon is leveraging its 'credibly capable' expertise in drug discovery and development processes, cutting-edge infrastructure as well as best-in-class manufacturing capabilities to build a unique Novel Molecules pipeline. These molecules are aimed at addressing local as well as global unmet medical needs in the areas of diabetes, autoimmune/ inflammation and oncology. Our objective is to translate breakthrough innovative ideas into affordable, yet transformative, high quality medicines for patients globally.

Our pipeline is spread across the entire drug discovery and development value chain that takes advantage of our end-to-end capabilities from discovery through regulatory as well as therapeutic area expertise, built over the years.

These Novel Molecules span a wide range of platforms and products and include conventional peptides and monoclonal antibodies (MAbs), novel fusion MAbs, and small interfering RNA (siRNA) that have either been discovered in-house or in-licensed through strategic partnerships. We have a strong process to progress these discovery programs through stage gates by rigorous evaluation of their ‘functional activities’ and ‘mechanism of action’ to differentiate from competition. Our skills in manufacturing processes, analytical development as well as cutting-edge translational and clinical sciences enable us to maximize the overall probability of success in the clinic. Biocon aims to develop these molecules till early clinical proof of concept, at which stage these assets would become attractive for global development through partnerships.

Key enablers driving the successful progression of the Novel Molecules pipeline comprise:

  • Strong and motivated scientific teams with experience and successful track record in novel drug discovery and development
  • Rigorous review and evaluation of programs through stage gates
  • Deep understanding of therapeutic areas
    Drive to build and demonstrate differentiated mechanisms of action from competition
  • Collaborations with global key opinion leaders in the relevant fields
  • A team of expert consultants, scientific and clinical advisory boards
Novel Assets Under Clinical Development
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Key Success Factors in Novel Molecules
Translating great laboratory discoveries into clinical success is a major challenge for the global biopharma industry. High failure rates are leading to escalating costs of drug development and the drying up of R&D pipelines.

Lack of availability and testing in relevant animal models of disease, understanding of pharmacokinetic (PK) and pharmacodynamic (PD) relationship, access to and testing in patient samples, selection of right patients and precision medicine approach are some of the key factors contributing to this failure.

To translate our new molecule discoveries to the clinic more effectively, we have strengthened our already existing translational sciences capabilities by building a dedicated and experienced scientific team within R&D and entered into key collaborations. A part of this team is housed at the Mazumdar Shaw Center for Translational Research (MSCTR) to collaborate with clinicians at the Mazumdar Shaw Cancer Center (MSCC). We expect a significant part of the translational sciences work to be done in collaboration with global academic institutions like Harvard University, Massachusetts, US; Trinity College Dublin, Ireland; National Centre for Biological Sciences (NCBS); Indian Institute of Science (IISc), Bangalore, India and others.

Diabetes is a global epidemic and the number of people with diabetes in India is growing at an alarming rate. There is a need for effective therapies from pre/early diabetes to late-stage disease. Biocon is developing a first-in-class orally delivered Insulin Tregopil (formerly referred to as IN-105) for the treatment of diabetes.

During the year, a major technological achievement was the development of a unique and specific assay for measuring Insulin Tregopil. This assay accurately differentiates between endogenous insulin and Insulin Tregopil in human plasma and thereby enables the assessment of pharmacokinetic effects of Insulin Tregopil. A patent application has been filed on this novel assay methodology.

The results of the global Phase I study conducted in the US have established the important role of Insulin Tregopil in post-prandial glycemic control. It has demonstrated fast action of Insulin Tregopil with distinctive properties compared to other prandial insulins like Aspart. There is a clear linear relationship between the dose of administered Insulin Tregopil and the decrease in postprandial glucose excursion rates. There is no drugdrug interaction between Tregopil and Metformin, suggesting no interference in efficacy between the two drugs. High carbohydrate or protein or fat diet does not seem to influence the effect of Insulin Tregopil. The clinical studies on Insulin Tregopil, which were conducted in the US under a US IND, were initiated in partnership with Bristol- Myers Squibb (BMS) prior to their divestment of the diabetes franchise to AstraZeneca.

The positive outcome of these clinical studies has encouraged Biocon to move this molecule to the next phase of clinical development in Type 1 and Type 2 diabetes patients. We are in the process of designing the clinical study in consultation with our Scientific Board, comprising key opinion leaders and experts in the field of diabetes and endocrinology. We will be looking at validating the key findings of the Phase I study in a larger patient cohort, which will provide for a more attractive partnership or licensing opportunity at a later date.

Biocon is developing a number of molecules addressing unmet needs in the autoimmune and inflammation disease areas. The portfolio spans a diverse set of targets and therapeutic modalities.

Our novel first-in-class anti-CD6 humanized monoclonal antibody, Itolizumab, is being marketed as ALZUMAb™ for the treatment of chronic plaque psoriasis in India since 2013. The successful journey of this molecule from the laboratory to the market further epitomizes Biocon’s 'credible capability'. Biocon is the first and the only company in the world to clinically validate CD6 as a target for autoimmune diseases. This novel monoclonal antibody is undergoing a bridging Phase I – PK & Safety study in healthy volunteers in Australia. The first sentinel dosing has been completed and the drug was well tolerated with no adverse effects. The study is expected to enable a global IND filing with a subcutaneous route of administration. The distinct mechanism of action of Itolizumab compared to other available therapies has the potential to unlock key differences in safety and efficacy in multiple autoimmune diseases such as Psoriatic Arthritis, Multiple Sclerosis etc.

Biocon is the first biopharma organization in India venturing into the exciting space of siRNA-based (small interfering RNA) therapeutics. We have made significant progress in our collaboration with Quark Pharma in advancing two siRNA based programs, QPI-1007 and QPI-1024. A pivotal global Phase II/III study investigating QPI-1007 in Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) patients has started enrolling patients in the US and is on track to enroll patients in India soon. The QPI-1024 discovery program to identify a lead siRNA molecule to treat graft dysfunction in lung transplant patients is making steady progress.

Novel immune checkpoint inhibitors have created much excitement in the field of cancer in general and cancer immunotherapy in particular. Monotherapy as well as combinations of approved and investigational checkpoint inhibitors are currently being tested in the clinics with much anticipation of better patient outcomes. Biocon
is building an exciting pipeline of fusion MAb molecules with the concept of preferentially delivering immune modulators to tumor sites, thereby enhancing efficacy while limiting systemic toxicity.

Our lead molecule in this program, FmAb2, which combines a monoclonal antibody against EGFR with TGFb Receptor fragment that binds and neutralizes TGFb, has demonstrated the differentiated mechanism and efficacy of this experimental drug in a preclinical mouse tumor model. FmAb2 has achieved preclinical ‘proof of concept’ and is currently in advanced preclinical development.

To enhance scientific capability and credibility in the immuno-oncology area, Biocon successfully organized an Immuno-Oncology symposium with eminent scientists such as Prof. Vijay Kuchroo (Harvard), Prof. Gordon Freeman (Harvard) and Prof. Varsha Gandhi (MD Anderson Cancer Center) as key speakers. This was followed by a round table discussion where Indian Key Opinion Leaders (KOLs) in the field presented their perspectives. This event, which was attended by Biocon scientists as well as clinicians and scientists from MSCC and MSCTR, will form a basis for prospective collaborations.

Bringing innovative and transformative medicines to global markets at affordable prices is one of Biocon’s long cherished objectives. High quality talent, proven capabilities in discovery, process and product development, as well as translational and clinical sciences in large molecule therapeutics leading to high-value licensable research assets, set us apart from competition. Through innovative and incisive deal-making, we expect the Novel Molecules pipeline to contribute to Biocon’s revenues through licensing fees in the short-term and product introductions in the long run.

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