HYDERABAD — Hyderabad-based biotechnology startup PopVax has launched an RNA foundry designed to manufacture personalised mRNA cancer vaccines, marking a significant development in India's biotechnology sector. The facility, founded by Soham Sankaran, uses artificial intelligence to analyse patient tumour sequencing data and identify unique neoantigens — abnormal proteins specific to each tumour.
The process begins with tumour genetic sequencing. PopVax's AI-powered computational pipeline identifies potential targets and designs a custom mRNA sequence. The foundry then manufactures the mRNA, packages it into lipid nanoparticles for cellular delivery, and conducts quality-control testing including assessments of RNA identity, integrity, particle size, mRNA content, encapsulation efficiency, sterility and endotoxin levels.
The entire process takes approximately 8-10 weeks and carries an estimated cost of $300,000 (Rs 2.84 crore) per vaccine. PopVax aims to manufacture more than 100 personalised cancer vaccines over the next 12 months. The facility can operate round the clock.
PopVax, which began during the Covid-19 pandemic with two people in a small rented laboratory, has grown into a 10,000-square-foot research facility. The company's technology platform was originally developed for its Covid-19 vaccine candidate PVX-001, which entered a Phase I clinical trial in Australia in August 2026.
Understanding that faster regulatory pathways are crucial for drug development, PopVax is conducting its first human trials in Australia, where approvals can be obtained in about 30 days compared to several months in India. The Indian government has introduced regulatory changes to simplify the approval process, which could speed up clinical trials domestically.
Personalised cancer vaccines are therapeutic, given to patients already diagnosed with cancer to help fight the disease or prevent recurrence. Unlike preventive vaccines, these therapeutics use neoantigens — proteins produced by cancer cell mutations — as targets to train the immune system to recognise and attack cancer cells.
The approach holds particular promise for aggressive and complex tumours that are highly resistant to conventional therapies like chemotherapy and radiation. Research has shown promise in cancers including melanoma, while studies are also exploring their potential in triple-negative breast cancer and other hard-to-treat malignancies.
Several pharmaceutical companies are investigating similar approaches. The collaboration between Moderna and Merck is testing an individualised mRNA cancer vaccine, intismeran autogene, in combination with the immunotherapy drug pembrolizumab in melanoma patients. A Phase III trial reported improvements in recurrence-free survival. Researchers are also investigating personalised vaccines in pancreatic cancer and other difficult-to-treat cancers.
While the technology shows significant promise, regulatory approval remains pending. First USFDA approval for personalised cancer vaccines is expected around 2027. Access to investigational products requires medical supervision and relevant regulatory permissions. PopVax says patients and their doctors can explore access through compassionate use and expanded-access programmes where regulators permit.
The RNA foundry represents an attempt to build the manufacturing infrastructure for a new generation of personalised medicines in India. By integrating research, development and manufacturing capabilities under one roof, PopVax aims to advance personalised RNA-based medicine development and contribute to India's emerging biotechnology and RNA therapeutics ecosystem.
