Eveliqure Biotechnologies and Serum Institute of India (SII) have announced a strategic collaboration and licence agreement for the development, manufacturing and commercialisation of novel anti-diarrhoeal vaccines.

Under the collaboration, SII will obtain non-exclusive global rights to ShigETEC, Eveliqure’s proprietary vaccine programme targeting Shigella and enterotoxigenic E. coli (ETEC), for paediatric population. The collaboration aims to develop broad-spectrum anti-diarrhoeal vaccines and accelerate clinical development and global access to these critical vaccines for children.

Eveliqure will receive a one-time upfront fee along with development, regulatory and commercial milestone payments, in addition to royalties on net sales. The companies will collaborate continuously throughout the programme, with SII leading the development and global commercialisation efforts. Eveliqure will retain rights to the traveller and military markets and remains free to pursue additional collaborations in these fields.

Currently, no licensed vaccines exist to prevent infections from the two most prevalent bacterial pathogens, Shigella and ETEC, which account for approximately 200 million diarrhoea cases annually in children under five and contribute to high mortality rates and development deficits (stunting).

ShigETEC, an oral live attenuated vaccine candidate, is derived from an engineered Shigella strain lacking the ability to invade gut epithelial cells, eliminating a key virulence feature of shigellosis. By deleting highly variable sugar antigens on the bacterial surface, the vaccine is designed to induce broad-spectrum Shigella immune protection. In addition, ShigETEC expresses ETEC toxoid antigens to induce protective antibodies capable of inactivating potent diarrhoeagenic toxins.

Following successful completion of a phase-I(a) tolerability and immunogenicity study (NCT05409196) in European adults, Eveliqure advanced ShigETEC into paediatric development with a phase-I(b) study in Bangladesh, covering different age groups, including infants of 6-11 months. This trial has recently finished, and data analysis is underway. An ongoing phase-II(b) Controlled Human Infection Model (CHIM) study in the US enrolling healthy, Shigella-naïve adults is expected to report results in 2026.

"We are excited to collaborate with SII in an area of significant unmet need. This collaboration aligns with our mission to deliver high-impact vaccines worldwide, particularly to the most vulnerable populations, young children living in endemic countries", said Dr Gábor Somogyi, CEO, Eveliqure.

The phase-II (b) study is being conducted at the Johns Hopkins University and funded by the National Institute of Allergy and Infectious Diseases (NIAID). The project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 81556, awarded to the SHIGETECVAX consortium.

"We are pleased to collaborate with Eveliqure to advance the development of vaccines targeting major causes of diarrhoeal disease. By combining Eveliqure’s innovation with SII’s global development and manufacturing expertise, we aim to accelerate access to effective vaccines for children in regions that need them most", said Dr Umesh Shaligram, Executive Director, SII.