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India Emerging as Global Leader in Immuno-Oncology Drugs

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Rising Cancer Burden Drives Local Drug Development

India faces a huge burden from cancer with over 1.3 million new cases reported each year. Cancer is now the third leading cause of death in India claiming over 400,000 lives annually. This enormous disease burden has pushed India to develop its own Immunotherapy and Immuno-Oncology capabilities to serve the large domestic market as well as exports.

With traditional chemotherapy and radiotherapy options having limited efficacy against many cancers, the promise shown by Immuno-Oncology drugs in attacking tumors by enhancing the body's natural immune response has created huge interest. Several Indian pharmaceutical companies are now focusing their R&D efforts on developing novel Immuno-Oncology therapies.

Local Development of Checkpoint Inhibitors

Checkpoint inhibitors that target India's Immuno-Oncology checkpoints like PD-1, PDL-1 and CTLA-4 have emerged as a breakthrough in cancer treatment in recent years. Global giants like Merck, Bristol-Myers Squibb and Roche have checkpoint inhibitors approved worldwide. However, the extremely high costs of these drugs limit their access in India and other developing nations.

This has motivated domestic drugmakers to develop more affordable biosimilars and novel checkpoint inhibitors. Companies like Dr. Reddy's, Natco, Emcure, and others already have biosimilar versions of checkpoint drugs in late stages of clinical trials or awaiting regulatory approvals. Dr. Reddy's recently launched a biosimilar of blockbuster drug Keytruda. Natco and Emcure are also developing low-cost biosimilar versions.

Additionally, novel Indian checkpoint inhibitors targeting new immune pathways are in clinical trials. Panacea Biotech's LRRC15 antibody and Immunoplus' IMC-001 are examples of such homegrown drugs which can address unmet needs. If approved, these novel Indian drugs can reduce dependency on imports and boost cost-effective access.

Combination Therapies Gaining Traction

Monoclonal antibodies that target single immune checkpoints have limitations. Combining them with other agents is emerging as a strategy to enhance efficacy. Indian companies are actively pursuing combination therapies involving checkpoint inhibitors with other drugs.

For example, Panacea Biotec is evaluating the combination of its LRRC15 antibody with chemotherapy drug paclitaxel for pancreatic cancer. Biotech giant Biocon is testing the combination of recombinant interleukin-2 (Proleukin) with checkpoint inhibitor Nivolumab (Opdivo) for renal cell carcinoma.

Researchers believe such combination regimens can elicit strong anti-tumor immune responses, improving clinical outcomes compared to single agent therapies. If proven successful, these Indian combination therapies will be highly cost-effective options for the local market and globally.

Cell Therapy Gaining Momentum

Another important area gathering attention is Immuno-Oncology cell therapies which involve manipulating a patient’s own cells to fight cancer. India’s Maxcure Cell Therapies is conducting phase I/II trials of its CAR-T cell therapy for blood cancers. The therapy involves extracting patient’s T cells, modifying them using chimeric antigen receptor (CAR) gene therapy and infusing back to target cancer cells.

In another approach, ImmunoBug Therapies is testing its bacterial therapeutic to stimulate anti-cancer immunity. Such engineered cellular therapies offer the promise of long term remissions with a single dose by reprogramming the immune system unlike conventional drugs. If proven safe and effective, these cell therapies can emerge as transformative treatment options.

Government Support Boosting Indigenous Capabilities

The Government of India has recognized Immuno-Oncology as a strategic priority and is actively supporting its development through funding, infrastructure and policy initiatives. Major research grants under national programs like DBT's BIRAC are accelerating the translation of indigenous IO innovations.

The opening of premier research centers such as ACTREC near Mumbai have boosted advanced immunotherapy research capabilities. Fast track approvals and schemes like ‘Pharmax' are incentivizing investments in novel drug R&D. If sustained, such efforts are set to establish India as a formidable player in developing the next generation of affordable and globally accessible Immuno-Oncology solutions.

With its vast patient pool facing a cancer epidemic and growing pharmaceutical expertise, India is well positioned to emerge as a leader in Immuno-Oncology innovations. Domestic development of checkpoint inhibitors, combination therapies and cellular treatments will boost affordable access for patients at home. If successful, these ‘Made in India’ immune therapies can also be exported globally. Backed by government support, Indian immunotherapies hold immense potential to revolutionize cancer treatment worldwide.

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