bovine type V collagen oral solution (IW001) / ImmuneWorks - LARVOL DELTA

Nebulized type V collagen prevents bleomycin-induced pulmonary fibrosis in mice (ATS 2012) - Presentation time: 8:15 AM - 4:30 PM; Sunday, May 20, 2012; P=NA, N=13; Compared to normals, greater expression of col(V) in the lungs from pts with IPF was observed; Plasma levels of anti-col(V) antibodies correlated directly with forced vital capacity in IPF pts (n=13, p<0.03); Nebulized IW001 prevented fibrosis as shown by lower hydroxyproline concentrations (p<0.05); Autologous antigen presenting cell-induced proliferation in splenic T cells were reduced in col(V)-treated mice (p<0.003)

Clinical data • Preclinical-animal • Fibrosis

Characterization of aspartate kinase and homoserine dehydrogenase from Corynebacterium glutamicum IWJ001 and systematic investigation of L-isoleucine biosynthesis. (PubMed) - J Ind Microbiol Biotechnol - "The results demonstrated the strongly feed-back resistant TD(F383V) might be the main driving force for L-isoleucine over-synthesis in this case, and the partially feed-back resistant HD(G378S) might prevent the accumulation of toxic intermediates. Information exploited from such mutation-bred production strain would be useful for metabolic engineering."

Journal • Biosimilar

A phase one, open label, multi-dose study to evaluate the safety, tolerability, and biologic effects of three doses of IW001 in patients with idiopathic pulmonary fibrosis (IPF) (ATS 2012) - Presentation time: 8:15 AM - 4:30 PM; Tuesday, May 22, 2012; P1, N=11; IW001-01; The first cohort of 11 pts demonstrated that IW001 at 0.1mg per day is well tolerated with no unexpected AEs; Decrease of IgG specific to Col(V) could be observed after 6 mos of treatment (T-test, 11 pts, p=0.069); Most noticeable decreases were observed with IgG1 and IgG4 anti-Col(V) subclasses

Interim P1 data • Fibrosis

The 138 residue of acetohydroxyacid synthase in Corynebacterium glutamicum is important for the substrate binding specificity. (PubMed, Enzyme Microb Technol) - "In this study, AHASs from an L-valine-producing C. glutamicum VWB-1 and an L-isoleucine-producing C. glutamicum IWJ001 were analyzed...YTW-104/pJYW4-ilvB-ilvNCE could produce 25.93 g/L L-valine. The results indicate that the 138 valine of IlvB in AHAS could play an important role, leading to the increased L-valine biosynthesis in C. glutamicum."

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