Panacea Biotec witnessed a sharp rise in its share price after the company announced a key milestone in the development of its dengue vaccine candidate, DengiALL. The firm confirmed that enrollment for the Phase III clinical trial of the vaccine has been successfully completed, triggering positive investor sentiment.

About DengiALL — The Dengue Vaccine Candidate

DengiALL is being developed as a single-dose, tetravalent vaccine intended to provide protection against all four dengue virus serotypes — DEN-1, DEN-2, DEN-3, and DEN-4. The vaccine is based on live attenuated strains of the virus, which are weakened forms designed to stimulate immunity without causing the disease.

This balanced approach is crucial because contracting one dengue strain can heighten the risk of severe complications if infected later by another strain. By targeting all four serotypes simultaneously, DengiALL aims to reduce this risk and offer comprehensive protection.

Clinical Trial Progress and the Road Ahead

The company reported that 10,335 volunteers have been enrolled in the ongoing Phase III trial. These participants will be followed for a period of two years after vaccination to assess safety outcomes, immune responses, and overall efficacy.

If results are positive, Panacea Biotec anticipates that DengiALL could emerge as India’s first indigenously developed single-shot dengue vaccine, with a potential commercial launch projected around 2027.

Journey of DengiALL’s Development

The dengue vaccine program has been in progress for nearly two decades:

• Development commenced in 2006, supported through collaboration with the U.S. National Institutes of Health (NIH)
• Phase I/II trials in India concluded with three-year safety follow-up by 2020
• In March 2022, an MoU was signed with ICMR to facilitate Phase III trials
• Phase III studies received approval from the Drugs Controller General of India (DCGI) and are being conducted across 19 trial sites nationwide

Summary

Panacea Biotec’s share price jumped after the company completed enrollment of 10,335 participants for the Phase III trial of its dengue vaccine DengiALL. The vaccine is a single-dose tetravalent candidate intended to protect against all four dengue virus strains. Participants will be monitored for two years to evaluate safety and effectiveness. Developed since 2006 in collaboration with NIH, and advanced with ICMR support, DengiALL could become India’s first indigenous single-shot dengue vaccine by 2027, subject to successful trial results and regulatory approvals.

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