Intarcia receives $140m Gates Foundation grant for needle-free HIV tech
Intarcia is a Boston biotech which has manufactured an osmotic pump for controlled subdermal drug delivery – the ITCA 650 – using the firms proprietary Medici Drug Delivery System.
The device is designed to replace the need for daily needle injections, with placement of the pump only requiring a 15-minute procedure every 6 months.
The Gates Foundation has given Intarcia $50M as a program-related investment, with up to $90M in non-dilutive milestone-based grants tied to the Global Access program.
The programme will develop the ITCA 650 for use with Pre-exposure prophylaxis (PrEP) therapies for HIV – a regime which helps reduce transmission of the disease in high-risk individuals.
Kurt Graves, CEO of Intarcia, said in a statement: “With Medici, and each of our new once- or twice-yearly therapies, we’re aiming to solve some of the biggest unmet needs in the treatment and prevention of major chronic diseases”.
Needle-free continuous delivery
The ITCA 650 platform comprises of an osmotic mini-pump, stabilisation technology for high formulation temperatures and tech for subdermal installation of the implant.
The stabilisation tech allows the device to stabilise proteins, antibody fragments and other highly potent small molecules at or above human body temperatures for up to three years or more.
For delivery under the skin, extracellular fluid enters the pump device via a semi-permeable membrane.
The water then enters into a high saline chamber which expands to drive the piston at a controlled rate, allowing a steady, consistent release of formulation at the other end.
Intarcia initially developed the device for use in delivering glucagon-like peptide-1 (GLP-1) therapy for type 2 diabetes, with a Phase III FREEDOM trial results being successfully completed in 2Q 2016.
The biotech is currently waiting on a November submission of an NDA for US FDA approval.
Adherence of PrEP
According to the US CDC, PrEP can be effective as an oral prophylactic in reducing transmission of HIV by up to 92% in high risk individuals.
However, since the drug has to be taken daily for three months to be effective, many individuals do not complete the course of drugs.
The ITCA 650 pump is therefore hoped to improve PrEP adherence in resource limited settings, to tackle the HIV epidemic in sub-Saharan communities.
Sue Desmond Hellman, CEO of the Gates Foundation, said “the prospect of an implantable prophylactic device could make a world of difference for people most in need.”
