Shares of Panacea Biotec Ltd soared 9% on 8 January after the company announced that enrollment in the Phase III clinical trial of DengiALL, its tetravalent dengue vaccine candidate, had been completed.

DengiALL is a single-dose vaccine that protects against all four strains of the dengue virus (DEN-1 through DEN-4). It employs weakened (attenuated) forms of the virus to safely simulate a natural infection, educating the immune system to recognise and fight the real virus later. This “all-in-one” strategy is crucial since being infected with one kind of dengue might make a subsequent infection with a different type far more severe; DengiALL is designed to offer balanced and protective immunity against all four strains at the same time.

The filing added, “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 company stated that it has enrolled 10,335 people and will now follow and monitor them for two years following treatment (vaccine or placebo) to determine the vaccine’s efficacy and immunogenicity. Panacea further stated that DengiAll is intended to be India’s first indigenous single-shot dengue vaccine, with a potential market introduction in 2027.

In a filing on 14 August 2024, the business stated that with the clearance of the Drugs Controller General of India (DCGI), it has begun the Phase III clinical trial of DengiALL, a tetravalent dengue candidate vaccine, in India. DengiALL development began at Panacea Biotec in 2006 with the licensing and transfer of novel attenuated tetravalent dengue virus strains from Panacea Biotec to the National Institutes of Health in the United States.

Panacea Biotec conducted Phase I/II clinical trials in the Indian population, with three years of safety follow-up ending in 2020. Panacea Biotec and ICMR then signed a memorandum of understanding in March 2022 to conduct Phase III clinical trials in India.
 
The clinical trial was scheduled to take place at 19 sites across India, with 10,335 participants total.

At 1:33 pm, the shares of Panacea Biotec were trading % higher at Rs 407.10 on NSE.

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