BioGene’s extraordinary team of chemists and pharmaceutical scientists have developed pioneering modular platform technologies that when combined unleash a powerful modality that seamlessly bridges the preclinical to clinical translation gap, one that is set to revolutionise precision medicine as we know it.
Sol-Gel nose to brain platform delivery
Oral delivery of medicines is challenging for various reasons. Therapeutic compounds are exposed to digestive enzymes in the gut and undergo extensive first pass metabolism by the liver. Patients consequently often suffer from gastrointestinal distress and the bioavailability is often low despite high doses. Furthermore, pharmaceutical targets in the brain are protected by the blood brain barrier and to this day, the pharmaceutical industry struggles to overcome this hurdle.
With Sol-gel, we no longer consider the blood brain barrier an obstacle!
Sol-gels are solutions engineered to rapidly gel upon contact with mucosal tissue. Our delivery approach exclusively targets the olfactory cleft, so the blood brain barrier is altogether circumvented enabling direct nose-to-brain delivery. The mucoadhesive and depot properties of Sol-gel provides for sustained and controlled delivery of active pharmaceutical ingredients (APIs) of various chemistries (e.g. siRNA, mAb, Fab fragment, small molecules). In addition, BioGene’s Sol-gels are formulated to be mucosa-friendly, containing neither alcohols nor oils, rendering them suitable for patients of all ages and cultures. Moreover, the increased bioavailability achieved with Sol-gel means that API doses can be substantively reduced, which is anticipated to render treatments more economical, improving patient accessibility, while reducing the adverse effect risk and severity profile.
Figure 3. Direct nose-to-brain delivery of medicines is possible by circumventing the blood-brain barrier entirely through the olfactory cleft thanks to a clever nasal spray device and the mucoadhesive properties of our sol-gel formulation that ensure prolonged sustained release of its payload. Sol-gel thereby enables brain administration of any drug independently of its chemical nature in an easy-to-us, patient-friendly, and cost-effective formaty.
Figure 4. In contrast to conventional nasal sprays (left) that target the nasal cavity leading to rapid ciliary clearance, and leakage, our sol-gel solution and device (right) exclusively targets the olfactory cleft for direct, rapid, sustained and controlled nose-to-brain delivery.
Non-Viral Vector Platform - BioGene’s Bioresponsive LNPs (bLNP)
Figure 5. BioGene’s distinctive bioresponsive lipid nanoparticles protect the genetic cargo from destruction by nucleases in the extra-cellular environment, all the while guaranteeing the release of the entirety of the genetic cargo in the cytosol thanks to a redox potential sensitive endosomal release feature.
The delivery of genetic cargo (e.g. siRNA, mRNA, pDNA etc.) into cells is complicated by their rapid cleavage and destruction by nucleases in the extra-cellular environment. Furthermore, non-viral vector systems that efficiently protect the genetic cargo suffer from poor release of the payload once inside the cell.
To overcome historic delivery challenges plaguing the field, BioGene has developed, validated and patented (US Patent #11,566,044; Granted 31st March 2023) a unique non-viral, bioresponsive vector platform (bLNPs), one that possesses an innovative gene-cargo ‘release’ feature. BioGene’s bLNPs are compatible with a broad range of genetic cargo, facilitating their efficient delivery and timely release intracellularly; this is achieved by exploiting established redox mechanisms present in nature, and inherent across all their cellular systems. Moreover, as these self-assembling bLNPs are inspired by nature, once they’ve performed their task, they degrade into nutrients that have the additional benefit of imparting anti-inflammatory properties.
From a commercialisation and scalability perspective, manufacture of BioGene’s bLNP libraries can be achieved using robust, scalable and well-established chemistries, in high yield and purity, paving the way for economically viable treatment options to address mainstream genetic diseases, such as diabetes & obesity