Hyderabad-based vaccine maker Bharat Biotech and clinical-stage U.S. biotechnology firm Alopexx Inc. will collaborate to co-develop and commercialise anti-microbial vaccine AV0328 in India and other low income and lower middle-income countries.

A proprietary broad-spectrum anti-microbial vaccine candidate of Alopexx, AV0328 is a synthetic vaccine designed to target poly N-acetyl glucosamine (PNAG) found on the surface of a wide range of bacterial, fungal, and parasitic pathogens.

Under the collaboration, Alopexx would be entitled to a one-time upfront and milestone payments as well as royalties on future sales in the licensed territories, Bharat Biotech said on Wednesday (September 11, 2024).

Pre-clinical studies targeting PNAG showed effectiveness in preventing and treating infections caused by over 15 different pathogens. A phase I, first-in-human trial has been completed, demonstrating AV0328 is well-tolerated with no serious adverse events observed. The vaccine induced antibodies are capable of killing a wide range of PNAG-expressing pathogens, reaffirming its potential as a broad-spectrum antimicrobial solution, it said in a release.

To queries from The Hindu on the roadmap, regulatory requirements, time line and the likely investments, Bharat Biotech said AV0328 is an early stage product development. It will go through the regulatory approval process in India and several other countries.

“Our goal is to develop solutions to reduce anti-microbial resistance through vaccination,” Bharat Biotech Executive Chairman Krishna Ella said in the release.

Alopexx CEO Daniel Vlock said the “collaboration brings us one step closer to addressing the critical need for affordable, broad-spectrum antimicrobial solutions, especially in low-and middle-income countries.”

Appreciating the collaborative support provided by Bharat Biotech, he said the “support is not only crucial for advancement of AV0328, but will also significantly bolster our overall clinical programmes.”