Formosa Pharmaceuticals Pipeline

APP13007

APP13007, derived from our proprietary APNT formulation platform, is an aqueous-based ophthalmic nanosuspension positioned for the treatment of post-operative pain and inflammatory eye conditions. The active ingredient in APP13007 is a potent corticosteroid agent whose efficacy and safety for dermatological use has been well established more than 30 years in the US, Europe, and Japan. APP13007 will represent the first ophthalmic application of the known API. APP13007 is nearing completion of Phase 2 studies in the United States.

APP13007 is available for regional or global partnering/licensing.

 

APP13002

APP13002, also derived from our proprietary APNT formulation platform, is another aqueous-based ophthalmic nanosuspension utilizing a potent antibiotic known for its broad spectrum of antibacterial activity. This formulation, which represents a novel application of the known API, targets infectious eye diseases such as blepharitis. APP13002 has the potential for combination therapies with other eye therapies, such as APP13007.

 

MPT0E028

Developed by Professor Jing-Ping Liou’s research group at Taipei Medical University (TMU), anti-cancer agent MPT0E028 is being co-developed by TMU and Formosa Pharmaceuticals. MPT0E028 is a novel pan-HDAC (histone deacetylase) inhibitor, upregulating H3 and tubulin acetylation, leading to cell cycle arrest and cell death. Results from in vitro studies have shown that MPT0E028 significantly inhibits tumor growth in various solid tumor cells, such as hepatomas and colorectal cancer. In animal xenograft studies, orally-administered MPT0E028 demonstrated compelling tumor growth inhibition without affecting body weight.

MPT0E028 has completed pre-clinical assessments, including pharmacology, pharmacokinetics, toxicology, safety pharmacology, and formulation design. The IND has been approved by both US-FDA and Taiwan FDA. Phase 1 clinical trials at National Taiwan University Hospital and Taipei Medical University Hospital have been completed, evaluating the safety and maximum tolerated dose (MTD), as well as the pharmacokinetic and pharmacodynamic profile in late stage solid tumor patients. Additionally, based on its mechanism of action, MPT0E028 is being explored for potential application in cancer-related conditions and other therapeutic areas.

Formosa Pharmaceuticals owns 36% of MPT0E028.

 

TSY0110

In collaboration with EirGenix, Inc., Formosa Pharmaceuticals is developing a biosimilar of ado-trastuzumab emtansine (trade name, Kadcyla®). This antibody-drug conjugate utilizes trastuzumab manufactured by EirGenix, Inc. and Formosa Laboratories’ in-house capabilities in CMC and bioconjugation. Through our in-house analytics, we have shown that our TSY0110 drug substance has exceptional similarity to Kadcyla® in the major physicochemical categories of molecular weight, aggregation, and drug-antibody ratio (DAR). Additionally, TSY0110 has proven to be similar to Kadcyla® with regard to thermal and plasma stability.

TSY0110 is being positioned for filing for clinical trials in 2021 and is available for licensing and/or partnering.

 
TSY0110 - Formosa Pharmaceuticals, Inc.

TSY0210

TSY0210 is a well-known antibiotic with a focused, but potent antibacterial spectrum that addresses a third of the priority pathogens identified by the World Health Organization (WHO). Formosa Pharmaceuticals has access to a novel manufacturing process that provides robust yields with enhanced purity compared to the marketed product, which has sales in limited regions. Together with AimMax Therapeutics, Formosa Pharmaceuticals is positioning TSY0210 for novel disease applications. Additionally, due to its low water solubility, TSY0210 is a prime candidate for the APNT nanotechnology platform and will be studied accordingly to improve dissolution and physicochemical properties.

 
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