MegaPro Biomedical Co., Ltd. (hereinafter referred to as “MegaPro” or the “company”) is a Taiwan located, clinical stage company, which is a spin-off from Industrial Technology Research Institute (ITRI). MegaPro is currently focused on nanomedicine development. The company has two technology platforms, nanoparticles and nanomicelles. The company has two lead products (i) an iron oxide nanoparticle for Iron Deficiency Anemia (IDA), and (ii) as a Magnetic Resonance Imaging (MRI) contrast agent.

The core team has significant experience in the field of nanomedicine development. From its founding in 2014, the Company has focused on development of a proprietary PEGylated iron oxide nanoparticle (hereinafter referred to as the “IOP Injection”). IOP injection is an iron oxide nanoparticle conjugated chemically with mPEG-silane, and is highly soluble in water. The IOP injection has been developed for two applications; (i) as a new MRI contrast agent and; (ii) as the first non-sugar based intravenous (IV) iron for treating iron deficiency anemia with fewer side effects and higher potency than current therapies.

Iron deficiency is a common cause of anemia in patients with Chronic Kidney Disease (CKD). Iron supplement treatment is widely adopted for the correction of IDA. Currently available parenteral iron preparations are generally considered equally efficacious but vary in their safety profiles, typically due to their excipients and coating materials. Intravenous iron has been shown to be an effective method of treatment for iron deficiency anemia in the non-dialysis dependents CKD patient population.

IOP Injection was developed to provide intravenous iron with a low potential for free and labile iron content after administration, allowing larger doses of iron to be administrated safely in a single visit. Additionally, IOP injection was developed to provide a low incidence of hypersensitivity to the coating material (mPEG-SILANE). IOP injection is also intended for high uptake efficiency by the reticuloendothelial system (RES) to provide an efficacious, as well as safe, treatment strategy for the treatment of iron deficiency anemia in non-dialysis dependent CKD patients.

Thoroughly GLP compliant toxicity studies for the IOP Injection have been conducted. Study results indicated the IOP injection is well tolerated and has good safety margins. The Phase I clinical trials for the IOP Injection were completed with healthy volunteers December 2016. This Phase I trial was designed to evaluate the MTD, DLT and PK profile and efficacy profile of IOP Injection for magnetic resonance imaging (MRI) contrast agent in healthy subjects. It is expected that the phase II trial for iron deficiency anemia will be conducted in the USA in Q3 2018.