Precision Biotherapeutics: CGT

Name of the Directorate: Biomanufacturing

Name of the Thematic Area: Precision Biotherapeutics: Cell and Gene Therapy


Program Overview

Cell & Gene Therapies (CGTs) represent the next frontier in therapeutic innovation. The CGT sector is a rapidly evolving field with transformative potential for treatment of a range of complex and previously untreatable diseases. Owing to their unique ability to directly target the underlying genetic and molecular drivers of disease, CGTs not only unlock new treatment paradigms but also stand as a cornerstone of precision medicine. Years of basic research have led to real progress, as therapies with marked benefits for some cancers and rare genetic disorders, are now beginning to get approved. The potential of this emerging therapeutic modality is highlighted by the increasing number of CGTs which have been approved and are also in the development pipeline. In light of India’s strong academic base and growing ecosystem in this domain, CGT has been identified as one of the priority areas under the ‘Precision Biotherapeutics’ thematic area of the BioE3 Policy for ‘fostering high performance Biomanufacturing’.

Mandate

Through the ‘Precision Biotherapeutics: Cell and Gene Therapy’ programme, the Department aims to foster an innovation ecosystem for enabling the development of novel CGTs with an emphasis on improving clinical outcomes, enhancing safety, and advancing translational applications in the field.

Thrust Areas

Focus areas of the programme include: Design and development of safer and more efficient viral and non-viral gene delivery vectors with application in ex vivo and in vivo gene therapies; Demonstration of ‘Proof-of-Concept’ and early stage validation of innovative cell and gene therapies; Early and late-stage development of CGTs.

Salient Achievements

The DBT-BIRAC joint call for proposals on ‘Precision Biotherapeutics-Cell and Gene Therapy’, was issued recently with the objective of building requisite capabilities and creation of necessary infrastructure for advancing the field through novel approaches/technologies, thereby, enabling the development of a pipeline of indigenous and affordable CGT candidates. Proposals have been invited from academia and industry, individually or in collaborative mode, under the categories: (i) Discovery & Application-oriented Integrated Network Research (Expected Outcomes –TRL: 3-5) and (ii) Bridging the gaps for scale-up (Expected Outcomes –TRL: 5-8). The following are expected to be achieved as an outcome of these efforts: development of gene therapies for inherited hematological diseases; CAR-T cell therapies for cancers; development of viral and non-viral gene delivery mechanisms such as extracellular vesicles and biocompatible polymers; exploring the potential of iPSC derived cell therapies for retinal and neurodegenerative conditions.