WelcomeInnate Immunotherapeutics Limited is a medical biotechnology company with offices in Sydney (Australia) and Auckland (New Zealand). The Company has designed and manufactured a unique immunomodulator microparticle technology. This technology can be used to induce the human immune system to fight certain cancers and infections, or modulate certain immune mechanisms implicated in autoimmune diseases such as Multiple Sclerosis. The same technology can be used in the design of better vaccines to potentially treat or prevent diseases such as influenza, cancer, malaria, or tuberculosis.
The microparticle at the core of this technology provides a unique delivery system for a suite of both known and novel immune system triggers or modulators. By attaching selected modulators to the microparticle, these triggers can be delivered reliably to specific cells of the immune system.
Target diseases or applications for drugs developed using this approach include:
- Auto-immune diseases such as Multiple Sclerosis;
- Certain cancers that are known to be immune-sensitive, such as prostate, colon, & renal cancer; and
- Preventive vaccines for malaria and tuberculosis, and therapeutics vaccines for cancers.
The first drug candidate developed using this technology, MIS416, combines two well described immunostimulatory ligands or triggers - NOD2 & TLR9. MIS416, has demonstrated safety and efficacy in a number of different disease or injury models. Due to the significant degree of unmet medical need, Secondary Progressive Multiple Sclerosis has been selected as the initial clinical target for MIS416.
A Phase 1B human study in patients with primary progressive or secondary progressive MS (SPMS) was completed in October 2011 and a follow on 'dose confirmation' Phase 2A study in patients with secondary progressive MS was completed in July 2012. The results from these studies have met or exceeded expectations and the Company is now planning a larger-longer Phase 2B trial in patients with SPMS commencing in Australia in the second quarter of 2014.