Panacea Biotec up 9% on completing Phase III enrollment for DengiAll trial

Panacea Biotec shares jumped 9.3 per cent on BSE, logging an intra-day high at ₹418.35 per share. The buying on the counter came after the company said enrollment is complete for the Phase III clinical trial of its tetravalent dengue vaccine candidate DengiALL.

 

DengiALL is a single-shot vaccine designed to protect against all four types of the dengue virus (DEN-1 to DEN-4). It uses weakened (attenuated) versions of the virus to safely mimic a natural infection, training the immune system to recognise and fight the real virus later. This "all-in-one" approach is critical because being infected by one type of dengue can sometimes make a second infection by a different type much more severe; DengiALL is engineered to provide balanced and protective immunity against all four strains simultaneously.

 

At 9:39 AM, Panacea Biotec’s share price was trading 8.93 per cent higher at ₹417.95 on the BSE. In comparison, the BSE Sensex was down 0.12 per cent at 84,858.27. The stock commands a market capitalisation of ₹2,559.97 crore, with a 52-week high at ₹581 and a 52-week low at ₹282.15. 

 

In a year, Panacea Biotec shares have slipped around 15 per cent as compared to Sensex’s rise of 8.7 per cent. 

 

“We are now delighted to inform you that enrollment of study participants in the context of DengiAll Phase-III clinical trial has been completed,” the filing read. 

 

The company said it has enrolled 10,335 participants, and will now follow and monitor them for two years after dosing (vaccine or placebo) to assess the vaccine’s efficacy and immunogenicity. Panacea added that DengiAll is expected to be India’s first indigenous single-shot dengue vaccine, with a potential market launch by 2027.

 

In a filing on August 14, 2024, the company shared that with the approval of the Drugs Controller General of India (DCGI), it had started the Phase III clinical trial of tetravalent dengue candidate vaccine, DengiALL, in India. The development of DengiALL was initiated at Panacea Biotec in 2006 with the licensing and transfer of novel attenuated tetravalent strains of dengue virus between Panacea Biotec and National Institutes of Health, USA. 

 

Panacea Biotec had undertaken Phase I/II clinical trials in the Indian population with three years of safety follow-up completed in 2020. Subsequently, Panacea Biotec and ICMR entered into an MOU in March 2022 for Phase III clinical trials in India.

 

The clinical trial was to be conducted at 19 sites with 10,335 participants across India.