BioSapien Doses First Patient in First-in-Human MediChip™ Clinical Trial at Burjeel Cancer Institute

Milestone marks the transition of BioSapien’s localized chemotherapy platform into human clinical evaluation in Abu Dhabi.

Hub71 startup, BioSapien, a clinical-stage biotechnology company developing localized drug-delivery platforms for cancer treatment, today announced that the first patient has been dosed in its Phase I clinical trial evaluating MediChip™-5-FU at Burjeel Cancer Institute, Burjeel Medical City, in Abu Dhabi.

As part of Hub71, Abu Dhabi's global technology ecosystem, BioSapien is among the innovative startups advancing transformative technologies in high-impact sectors. The milestone highlights the potential of Abu Dhabi's innovation ecosystem to support the progression of breakthrough healthcare solutions from development to clinical evaluation.

The milestone marks the first administration of MediChip in a human patient and the beginning of clinical evaluation of a new approach to delivering chemotherapy directly at the tumor site.

The Phase I study, OPTIMISE-REFORM, is evaluating MediChip-5-FU in patients with localized rectal cancer, with an initial focus on safety and tolerability.

MediChip is a biodegradable, 3D-printed implant designed to deliver 5-fluorouracil (5-FU), a widely used chemotherapy agent, directly at the tumor site through controlled local drug release. The approach is intended to concentrate drug delivery where it is needed while limiting exposure to surrounding healthy tissues and the rest of the body.

For patients with rectal cancer, the longer-term ambition is to investigate whether localized chemotherapy could contribute to organ-preserving treatment strategies and reduce the need for major surgery. These potential benefits remain to be established through clinical evaluation.

“Today, MediChip moves from years of development into human clinical evaluation. That is what we have been building toward,” said Dr. Khatija Ali, Founder and CEO of BioSapien. “Getting an investigational therapy to its first patient takes far more than a promising idea. It takes rigorous science, clinical-grade manufacturing, regulatory execution and a team that can deliver across every one of those disciplines. Today, that work enters its next chapter.”

The first patient dosing follows the opening of the world’s first clinical site for MediChip at Burjeel Cancer Institute, announced earlier this month. The study brings together BioSapien’s drug-delivery technology and the clinical expertise and research infrastructure of its partners in Abu Dhabi.

The trial follows extensive product development, manufacturing preparation, analytical testing and regulatory and ethics review. The study will generate initial human safety data to inform MediChip’s continued clinical development.

BioSapien's milestone reflects Hub71's commitment to fostering an environment where pioneering startups can access the networks, partnerships and opportunities needed to scale their innovations. By connecting ambitious founders with Abu Dhabi's wider innovation ecosystem, Hub71 contributes to the development of advanced technologies with the potential to address global healthcare challenges.

Dr. Mohammad Adileh, Principal Investigator for the study and Director of the Surgical Oncology Division at Burjeel Cancer Institute, leads the clinical evaluation at the site.

The study is supported by an independent review committee comprising oncology and clinical research experts, providing independent oversight as the platform enters first-in-human evaluation.

“First patient dosing is an important step, but it is the beginning of the clinical evidence-generation process,” Dr. Ali added. “Our focus now is on the patient, the quality of the data and executing this trial to the highest standards.”