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BioSapien, the biotech company behind the MediChip cancer drug-delivery platform, has received the regulatory approvals needed to begin Phase I clinical trials in Abu Dhabi, clearing the way for first-in-human testing within the next few weeks.
The company secured sign-off from the Department of Health, Abu Dhabi (DoH) for its investigational new drug submission, from the Emirates Drug Establishment for the trials themselves, and from an institutional review board, part of the DoH, for its shortlisted clinical sites. BioSapien expects patient enrolment and the start of trials in the coming weeks.
MediChip is a 3D-printed, slow-release implant that attaches to tissue and delivers chemotherapy directly to the tumour site, keeping more of the drug in the tumour microenvironment while reducing the systemic side effects of conventional chemotherapy. Because the delivery is localised, smaller quantities of drug are needed, and the company says the approach can shrink tumours, ease symptoms and potentially avert life-altering surgeries.
The trials will begin in colorectal cancer, with scope to extend to pancreatic and lung cancers and non-cancer indications, colorectal being a priority area for the DoH as one of the most common cancers in the UAE.
Founded in 2018 by Khatija Ali, BioSapien is US-headquartered but has run much of its clinical and fundraising journey through the UAE. It joined Abu Dhabi's Hub71 in 2023, drawn by a faster regulatory pathway than the US, and has raised more than $8 million across a pre-Series A round that began with a $5.5 million close led by Global Ventures in late 2024, later extended with backing from Golden Gate Ventures, Dara Holdings and Globivest.
Earlier funding included a $1.8 million seed led by SOSV and Hikma Ventures, and a $256,000 US National Science Foundation grant.
The trial caps a long development road for Ali, who has described close to a thousand rejections on the way from San Diego to New York to Abu Dhabi.
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