The science of pharmaceutical discovery has enjoyed a long, rich history of innovation, profitability, and patent protection. However, the process of introducing a new drug is long, expensive, and given global governmental pressure to reduce cost, at risk of maintaining profitability in the future. Currently, the number of new compounds being introduced into the pipeline has been decreasing over time, and for those that reach regulatory approval, many are still at risk not being able to obtain governmental certification. For example, drugs that were initially determined to be effective in animal models and pre-clinical studies are later proven to have detrimental effects on critical human tissues. However, the biggest concern continues to be the inability to target unhealthy cells like cancer. As many have noted, companies have great drug pipelines with high opportunities for use. However, the ability to effectively use these portfolios of compounds remains limited.
Consequently, major pharmaceutical companies have turned their attention from introducing new compounds into the drug pipeline and instead have returned to their existing portfolios with the hopes of harvesting maximum value. Estimates for monetized in-use drug formulations have been estimated to be in excess of $100 billion. In this case, it is anticipated that new drug delivery platforms offer the greatest opportunity to have drugs repositioned to have new indications for usage by the medical industry. The implications for this type of approach are numerous. These include extended product life-cycles, creation of new chemical entities (NCEs), and in some instances, an approach to have patent protection extended.
Peptineo has identified the following market-critical requirements:
- Deliver peptide-based pharmaceuticals more quickly by decreasing production time
- Allow for new or previously developed drugs to be repurposed for targeted drug delivery
- Provide capabilities to stabilize peptide-based formulations
- Consistent, structured process for drug discovery
- Need to bring in collaborative support to aid in drug development process
Ac-DEX nanoparticles overcome many known delivery barriers, and have demonstrated significant advantages over conventional formulations as follows: (1) Formulations facilitate passive targeting of host macrophages and Ac-DEX’s acid sensitivity results in a triggered release intracellularly once phagocytosed. Thus, intracellular delivery of drug limits systemic side effects as well as overcomes drug solubility issues. (2) Controlled release of active compounds is achievable with Ac-DEX because it has tunable release kinetics that can range from days to months. (3) The acid sensitivity of Ac-DEX also facilitates dose sparing, in that less drug is required for equal drug activity. (4) Ac-DEX nanoparticles display stable storage outside the cold chain to facilitate stockpiling. (5) The pH neutral by products of Ac-DEX (dextran, acetone, and ethanol) are unique in comparison to other ubiquitously used polymers like polyesters (e.g. PLGA, PCL) which have damaging acidic by-products.
Currently, Peptineo has several products in its development pipeline:
- Qn-1401: Re-formulated aerosolized antibiotic to address infections associated with cystic fibrosis (CF)
- Qn-2251: Re-formulated aerosolized antibiotic addressing ventilator associated pneumonia (VAP)
- Qn-2705: Re-formulated antibiotic for topical applications including MRSA
- Zp-5933: Nucleic acid vaccine for post-exposure prophylaxis targeting norovirus