ActoBiotics™
Third Generation Pharma Products
ActoBiotics™ consist of food-grade bacteria (Lactococcus lactis), genetically engineered to synthesize and secrete therapeutic proteins and peptidesin situ. ActoBiotics™ are delivered to patients via oral administration instead of injection, and specifically target receptors and cells localized in gastrointestinal (GI) tissues. Because of this selective and targeted delivery to GI receptors, ActoBiotics™ are expected to yield excellent efficacy combined with a more favorable side effect profile.
Importantly, ActoBiotics™ are manufactured by a straightforward production process. They are formulated as simple oral capsules, resulting in greater patient compliance and reduced treatment cost. Finally, because ActoBiotics™ are delivering proteins and peptides with proven pharmacological activity, their development risk is substantially lower than for newly discovered drug compounds.
Clearly, ActoBiotics™ display significant competitive advantages over first and even second generation pharma products (conventional chemical drugs and biologicals respectively).
Taken together, these features position ActoBiotics™ as promising third generation therapeutics:
Oral administration
ActoBiotics™ are generally formulated in capsules or an oral rinsing form for oral administration. Compared to biopharmaceuticals, of which most have to be administered by injection, this represents a significant advantage in terms of patient convenience and treatment cost.
High efficacy through gastrointestinal targeting
Because of their topical and localized delivery in the gut, ActoBiotics™ can selectively and efficiently address the relevant receptors and pathways present in GI tissues. These are more difficult to reach with current protein-based therapeutics, which are mostly delivered by intravenous or subcutaneous injection. In fact, many of the current biopharmaceuticals can not easily reach the same concentration at the desired site of action.
Excellent safety and favorable side effect profile
Importantly, ActoBiotics™ can be designed to limit systemic exposure. This implies that their potential effect on non-target organs is minimal, resulting in a superior side effect profile compared to injected biopharmaceuticals or conventional chemical drugs with broad systemic exposure.
Furthermore, the total amount of active drug molecules released by ActoBiotics™ is generally much lower than for injected biopharmaceuticals. This reduces overall drug exposure, decreases the risk for adverse events and provides for a superior safety profile.
Favorable pharmacokinetics
When delivered into the GI tract, ActoBiotics™ reside there for 8-48 hours. During this time, they continuously release an appropriate amount of active drug molecules. As such, they mimic the way in which natural biomolecules are released by our own cells in the body. Such natural and slow release profile is in contrast with the pharmacokinetic profile of many conventional drug products, which often show a highconcentration peak upon delivery, followed by a quick decline shortly thereafter.
Versatility of the platform
Using the TopAct™ platform, almost any protein or peptide (with the exception of glycosilated proteins) can be engineered and formulated into an ActoBiotic™ . With the platform opportunities seemingly unlimited, ActoGeniX has already created a broad and diverse portfolio of candidate ActoBiotics™ for a wide range of diseases.
Efficient drug discovery
The creation of a new ActoBiotic™ using the TopAct™ technology is a straightforward procedure, and takes between four to six weeks. This implies that ActoGeniX is capable of generating new drug leads, ready for testing in preclinical models, within a very competitive timeframe.
Reduced failure risk in drug development
One of the main reasons for the skyrocketing costs of new drug development is the high failure rate of novel therapeutic leads during thepreclinical and clinical drug development process. For its ActoBiotics™ , ActoGeniX can select peptides and proteins with documented efficacy and safety profiles, yielding a higher success rate and a more straightforward development path than for newly discovered drug entities.
Ease of manufacturing
ActoBiotics™ are produced by conventional bacterial fermentation, followed by freeze-drying. The lyophilized powder is then formulated into capsules for oral administration. This is a straightforward and cost-effective manufacturing process.