User:Oceanflynn/sandbox/Innate Immunotherapeutics

Innate Immunotherapeutics is a biopharmaceutical company, formerly known as Virionyx, with headquarters in Sydney, Australia and a branch in Auckland, New Zealand. Their focus in 2009 was the "development of a new generation of immune response modifier for potential use in the treatment of a range of infectious diseases, certain cancers, and as a novel cellular and humoral adjuvant." By 2017 the drug developed by Innate, called MIS416, was in clinical trials as a drug to manage secondary progressive multiple sclerosis (SPMS). Their proprietory drug, MIS416, was designed by Virionyx Corporation. In April 2009 Virionyx changed its name to Innate Immunotherapeutics to reflect a repositioning of the company as it focused on the "development of thier proprietary drug candidate MIS416." The company moved their headquarter from Auckland, New Zealand to Sydney, Australia.

MIS416
MIS416 is a vaccine adjuvant and "immunogen co-delivery system" In 2011, in an NIH publication MIS416 was described as a"non-toxic microparticle adjuvant derived from Propionibacterium acnes comprising immunostimulatory muramyl dipeptide and bacterial DNA promotes cross-priming and Th1 immunity". In 2015, Innate Immunotherapeutics describe it as an "immunomodulator" for "patients with chronic progressive multiple sclerosis".

History
In 2009, Gill Webster, Ph.D., was Innate Therapeutics' chief scientific officer. By 2009, MIS416 had "shown promising activity in preclinical proof-of-principle studies in cancer, infectious and autoimmune diseases In a 2009 article published by BioPharm International, researchers discussed the potential of the then-novel, MIS416 adjuvant as a therapeutic vaccine "for patients with cancer or acquired chronic infections, such as HIV, hepatitis, tuberculosis, and malaria". MIS416 is "a myeloid-directed microparticle immune response modifier (derived from Propionibacterium acnes), which was originally developed as a vaccine adjuvant." " MIS416 has been suggested to modulate T-cell-mediated autoimmune responses in EAE by simultaneously activating innate Toll-like receptor 9 and nucleotide-binding oligomerization domain-containing protein 2."

In 2014, "The restricted uptake of MIS416 by phagocytic cells has been suggested to lead to targeted modulation of the innate immune system [97]."

"MIS416 was initially used in patients with SPMS outside of a formal clinical trial setting under compassionate use legislation in New Zealand."

"Recently, in a phase Ib/IIa clinical trial, MIS416 was shown to suppress the development of proinflammatory T helper (Th)1, Th2, and Th17 cells in EAE, and to increase the serum levels of IFN-γ and IFN-γ-associated proteins in 19 patients with SPMS [97]. A phase IIb trial is underway to further investigate the effect of MIS416 in progressive forms of MS (NCT02228213) [98].

Clinical trials
Innate Immunotherapeutics undertook a 12-month clinical study (NCT02228213) with 13 patients with early funding from the research arm, Fast Forward LLC, of the National MS Society in the U.S. In 2016, the Phase 2B, placebo-controlled clinical trial of MIS416 which includes nine patients from the original trial, was underway. Research on MIS416 is undertaken in collaboration with Raleigh, North Carolina's INC Research under the tenure of CEO Alistair Macdonald.