i-novion was established to develop pharmaceutical products using its proprietary PTSgel and PTSsol pentablock copolymer drug delivery technology platform. PTSgels are thermosensitive compositions that enable the development of novel sustained release formulations of proteins, peptides, antibodies, vaccines, siRNA, diagnostic biologic agents and small molecules for injection or topical application or. PTSsols are versatile, non-irritating carriers that solubilize both hydrophobic and hydrophilic molecules for topical or parental delivery. The technology is patent pending and covered by U.S. Provisional Application Nos. 62/330,010 and 62/330,020. i-novion also in-licenses certain intellectual property from the University of Missouri, including US Patent Nos. 8,551,531 issued in October 2013 and 9,011,927 issued in April 2015. In addition, the company is contemplating product-specific patent applications, allowing for even longer exclusivity periods for specific PTSgel- and PTSsol-based products.
PTSgels enable the creation of patent protected, longer acting versions of drugs without the need to chemically modify the parent molecule via, e.g., PEGylation, an albumin fusion protein or binding moiety, or a receptor/Fc construct. Since a new chemical entity is not created, the time and cost required to conduct nonclinical development activities can be significantly reduced relative to what is required for a new molecular entity (NME).
PTSgels have no apparent limitation regarding the molecular weight or biophysical nature of molecules. Compositions suitable for the extended delivery of water soluble large molecules, e.g., monoclonal antibodies or fragments thereof, and hydrophobic small molecules such as brinzolamide, cyclosporine and corticosteroids (difluprednate) have been successfully made. Importantly, PTSgels are highly biocompatible and maintain structural integrity and bioactivity of drugs being delivered and thus are uniquely well suited for the delivery of proteins when compared to competitive approaches.
PTSgel formulations are liquid at room temperature and form solid gels when exposed to body temperature. As such, suitable compositions can be made for subcutaneous or local injection, including subconjunctival, intracameral, intravitreal or suprachoroidal injection to form drug-eluting depots on or in the eye. One attractive feature of the PTSgel technology is that it renders relatively short-lived molecules long-acting without affecting their native properties. For instance, small antibody fragments are desirable in ophthalmic indications due to their enhanced penetration to the back of the eye, which would be adversely affected by molecular engineering. To overcome this problem, minipumps placed surgically into the vitreous of the eye are currently being investigated for single chain Fv (scFv) antibody fragments. A PTSgel formulation injected into the vitreous once every few months would appear to be a far superior drug product.
PTSsol formulations remain liquid at physiologic temperatures but create clear and stable solutions of relatively insoluble drugs, e.g., difluprednate, brinzolamide, cyclosporine without resorting to suspensions or emulsions. The PTSsol formulations would be suitable for topical ocular, dermatologic, otic, or other similar applications. Furthermore, the PTSsol formulations provide a sustained release of the drug, permitting less frequent dosing, such as once a day.
PTSgels or PTSsol, in addition to being used for delivering hydrophobic or hydrophilic drugs, can also deliver a combination of the both types of drug admixed in the polymer at the same time.
Business Modeli-novion’s technology has great versatility, and is equally suited for proprietary molecules and for the development of superior formulations of molecules that are currently approved by FDA for use in man but are no longer protected by composition of matter patents. For the former, i-novion is conducting research in collaboration with a partner to deliver a lead development candidate that meets the partner’s target profile. Once successful, such candidate will be licensed in a given indication. For off-patent or re-purposed molecules, such product candidates are generally eligible for review by FDA via the 505(b)2 pathway which offers a lower risk, a less expensive and much faster route to the approval of new, differentiated products with tremendous commercial value as compared to traditional development programs for new chemical entities. I-novion is planning to establish dedicated companies for specific disease areas, such as for ophthalmic indications. By leveraging the availability of active pharmaceutical ingredients (API) from FDA-approved GMP manufacturers vs. the greatly reduced requirement for preclinical safety data under the 505(b)2 pathway, such spin-off’s will typically be able to progress from project inception to the filing of an Investigational New Drug Application (IND) in 12 to 18 months. For topical formulations, a Phase 1 “first-in-man” clinical trial will often not be required, allowing the rapid initiation of a Phase 2a human proof-of-concept study. A successful, Phase 2a study typically represents a major value inflection point. Meanwhile, i-novion is working to continuously improve on and expand its technologies and leverage those into broad applications.
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