Serum Institute of India and the Interdisciplinary School of Health Sciences, University of Pune’s work leading to an innovative product and technology using Ashwagandha or Withania somnifera as vaccine adjuvant has received the US patent.

The patent US 8,501,186 B2 granted from August 6, 2013 is in the name of Dr Suresh Jadhav, Dr Bhushan Patwardhan and Dr Manish Gautam. Additional research team included Dr Sunil Gairola, Dr Yojana Shinde from Serum, Dr Dada Patil and Dr Sanjay Mishra from University of Pune.

The grant of patent will now see us pursue into new product development which would take it for clinical trials. This new vaccine adjuvant from Ashwagandha can also be used with any antigen, Dr Suresh Jadhav, executive director, Serum Institute of India told Pharmabiz.

“The patent is significant for many reasons: First, it is a maiden success story of industry-academia collaboration and public private partnership with government support. Second, Ashwagandha being an ayurvedic medicine is quite similar to Chinese Ginseng, which is now expected to give a fillip to new research and business initiatives in Indian medicinal plants. Third, innovative applications of traditional knowledge can be used in the development of vaccines,” said Dr Bhushan Patwardhan, professor & director, Interdisciplinary School of Health Sciences, University of Pune.

The three-year research project titled as ‘Development of Botanical Immunomodulators as Adjuvants For Improving Vaccine Efficacy’ was supported by Department of Science and Technology  and Serum Institute of India with a funding of Rs.90 lakh.

Although, the  project concluded in 2007, the actual development work continued at Serum. Following Indian Patents, the US Patent application was submitted in 2009. Obtaining patents for  botanicals based on traditional texts are stringent because of digitalization of texts. It is only possible if the invention is able to identify and characterize the chemical moieties responsible for the said activity. The present invention was able to identify the active molecules, withanolides and most importantly the novel ratios, which resulted in characteristic T cell stimulary activities. Further, various case studies on fraction of antigens like  meningococcal, diphtheria and tetanus were given to establish the adjuvant activity. Such kind of detailed characterization helped us to establish the patentability of the invention, stated the researchers.

The present invention envisages an adjuvant capable of invoking T cell dependent immune responses against weaker antigens such as polysaccharide. Further, the adjuvant demonstrated significant amount of co-adjuvanicity wherein combination with other licensed adjuvants resulted in a significant dose sparing effect even when used with T-cell dependent antigens such as diphtheria, tetanus and pertusssis group of vaccines. Based on this activity profile, the applications of this adjuvant can be envisaged with vaccines against meningitis, polio, diphtheria, tetanus, hepatitis, and even with vaccines against HIV, tuberculosis, and malaria where T-cell directing adjuvants holds the promise, according to the researchers.

Newer vaccines include synthetic, recombinant or highly purified subunit antigens that are weakly immunogenic. Therefore vaccine formulations often require adjuvants for better immunological efficiency. Plant based products are being considered as one option for immune adjuvants.

Many extracts and formulations prepared from Rasayana plants have shown immunomodulatory activity in various models. Researchers at the Interdisciplinary School of Health Sciences, University of Pune have been actively engaged in establishing immunomodulatory activity of medicinal plants including Ashwagandha, Shatavari and Guduchi. Our studies indicate that these have potential to be developed as Immunoadjuvants.  Accordingly it was desirable to develop well characterized and highly pure adjuvant as compared to crude extracts which can be formulated with vaccines, said Dr Patwardhan.