Antiferon (interferon alpha kinoid) / Chong Kun Dang, Neostell, 3P Biopharma, Neovacs, Centurion Pharma, BioSense Global, Edesa Biotech - LARVOL DELTA

IMMUNE AND TRANSCRIPTOMIC DYNAMICS IN LUPUS NEPHRITIS ASSOCIATED WITH INTERFERON α KINOID TREATMENT (EULAR 2025) - "Specifically, it focuses on patients treated with interferon α kinoid (IFN-K), a therapeutic vaccine designed to neutralize interferon α subtypes, which has shown potential to reduce disease manifestations in SLE [4]... The present study highlights the effects of interferon α kinoid treatment on lupus nephritis by demonstrating significant reductions in plasma cell proportions and disease activity over time, as reflected by decreased SLEDAI scores. While only ISG15 showed a significant decrease in gene expression at 6 months, changes in immune cell populations further support the immunomodulatory effects of the treatment. However, limitations such as the small sample size, lack of clinical data, and the secondary nature of the analysis warrant further research to validate these findings and explore their implications in different disease states and treatment contexts."

Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Rheumatology • Systemic Lupus Erythematosus • IFI27 • IFNA1 • MX1 • RSAD2

The Cellular and Spatial Type I Interferon Response Following Skin Exposure to Ultraviolet Light (ACR Convergence 2023) - "And 3) What are the different Type I IFNs (IFN-a, IFN-b, IFN-k) being made after UV exposure?... We have identified the spatial locations of different IFN-I species in the skin following UV light injury. Copy number was highest in the epidermis for IFN-ac. Spatial transcriptomics also illuminates differences in inflammatory versus metabolic programs that are activated in immune (CD45) versus epidermal (cytokeratin positive) and dermal locations."

Graft versus Host Disease • Immunology • Inflammation • Inflammatory Arthritis • Lupus • IFIT1 • IFNA1 • ISG15 • PTPRC

Keratinocyte VISTA Suppresses Skin IFN-I Production by Regulating DNA Damage Repair and Cytosolic DNA Sensing (ACR Convergence 2023) - "Vsir-/- skin had increased IFN-k mRNA, IFN-b protein, as well as total STING protein levels (Fig... These studies identify VISTA as a suppressor of IFN-I production in keratinocytes and demonstrate STING-dependent IFN-I production in the absence of VISTA. As oxidized DNA is resistant to degradation in the cytosol where it can serve as a potent trigger of cGAS-STING, VISTA promotion of DNA repair may indirectly suppress STING signals. Antibody-mediated activation of VISTA in keratinocytes demonstrates its potential as a target to suppress IFN-I production in the context of photosensitivity and lupus."

Dermatology • Immunology • Inflammatory Arthritis • Lupus • KRT14 • OGG1 • VSIR

Immune checkpoint VISTA regulates DNA sensing and repair pathways that contribute to type I interferon (IFN-I) production in the skin (P828) (IMMUNOLOGY 2023) - "Together, this study identifies VISTA as a novel regulator of IFN-I production, by modulating DNA damage repair and sensing. The keratinocyte-intrinsic role of VISTA is therapeutically relevant as lupus keratinocytes express high IFN-k and are direct targets of UV-induced DNA damage."

Immune Modulation • Immunology • Inflammatory Arthritis • Lupus • IGF2BP1 • VSIR

Human papilloma virus infection as an antigenic stimulus in psoriasis (PsoriasisG2C 2021) - "IFN-k, a type III IFN, is important in the innate antiviral response and was also increased in psori-asis skin. Our findings support the hypothesis that HPV may act as an antigenic stimulus in psoriasis."

Dermatology • Epstein-Barr Virus Infections • Immunology • Infectious Disease • Inflammation • Oncology • Psoriasis • IL17A • PCR

Therapeutic Potential of Anti-Interferon α Vaccination on SjS-Related Features in the MRL/lpr Autoimmune Mouse Model. (PubMed, Front Immunol) - "Hence, we assessed the immunogenicity, efficacy, and tolerance of IFN-Kinoid (IFN-K), an anti-IFNα vaccination strategy, in a well-known mouse model of systemic autoimmunity with SjS-like features: MRL/MpJ-Faslpr/lpr (MRL/lpr) mice...No adverse effects were observed. We herein report on the strong efficacy of an innovative anti-IFNα vaccination strategy in a mouse model of SjS, paving the way for further clinical development (a phase IIb trial has just been completed in systemic lupus erythematosus with promising results)."

Journal • Preclinical • Immunology • Inflammatory Arthritis • Lupus • Pain • Sjogren's Syndrome • Systemic Lupus Erythematosus • IFNA1

Blood Genomics Identifies Three Subtypes of Systemic Lupus Erythematosus: "IFN-High," "NE-High," and "Mixed". (PubMed, Mediators Inflamm) - "Our research results indicated that identifying the molecular mechanism associated with different SLE subtypes would benefit the molecular diagnosis and stratified therapy. Moreover, repositioning of IFN-K based on subtypes also revealed an improved therapeutic effect, providing a new direction for disease treatment and drug development."

Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Pediatrics • Systemic Lupus Erythematosus • IFNA1

Safety of IFNa kinoid in systemic lupus erythematosus -

P1/2, N=28

NEOVACs' IPO on the alternate exchange of NYSE euronext (Neovacs) -

Target amount to be raised in the IPO is reduced to ?11M, vs. ? 20M initially planned; Funds will be used for conducting P2 trial of IFN-kinoid for lupus

IPO funds

Neovacs announces closing of 7.5 M Euro capital increase with U.S. investors (Neovacs Press Release) - "The proceeds of the capital increase will provide additional funding to the Company to finance the development plan of IFNα-Kinoid, including: A phase IIb clinical trial of IFNα-Kinoid in lupus conducted in Europe, Latin America and Asia, to begin in the second half of 2015; and A phase IIa clinical trial of IFNα-Kinoid in lupus conducted in the United States."

Financing • Immunology • Lupus

Safety of IFNa kinoid in systemic lupus erythematosus (clinicaltrials.gov) - P1/2, N=28; Active, not recruiting; Completion date: Dec 2011 -> Aug 2013

Trial completion date • Immunology • Lupus

Study of IFN-K in Dermatomyositis (clinicaltrials.gov) - P2a; N=30; Recruiting; Sponsor: Neovacs

New P2a trial • Biosimilar • Immunology • Myositis

Neovacs obtains FDA approval to extend its phase IIb clinical trial in lupus to United States (Neovacs Press Release) - P2b, N=178; NCT02665364; Sponsor: Neovacs; "Neovacs...today announced that the Company has received the approval 'Investigational New Drug' (IND), from the Food and Drug Administration (FDA), to extend its ongoing Phase IIb clinical trial of IFNα Kinoid for the treatment of Lupus to the United States...Full Phase IIb results are expected in mid-2017. They will be presented to the relevant health Authorities in Europe (EMA) and in the US (FDA) in order to validate the start into Phase III trial of IFNα Kinoid in Lupus."

Anticipated new P3 trial • Anticipated P2 data • IND • Immunology • Lupus

Neovacs provides corporate update and reports full-year 2017 financial results (GlobeNewswire) - P2b, N=185; NCT02665364; Sponsor: Neovacs; "Completed patient enrollment in phase the IIb clinical study of IFNalpha Kinoid in lupus...top-line results are currently expected end of June 2018...Neovacs intends to begin executing on its action plan for 2018...Validated with healthcare authorities  globally the registration strategy  to conduct the lupus Phase III clinical program."

New P3 trial • P2b data • Immunology • Lupus

Neovacs scientific advisory board endorses company's updated iFNa-kinoid development plan (Nasdaq) - "Phase IIb study is expected to begin by mid-2015. A second Phase I/IIa trial for SLE using IFNα-Kinoid in the U.S. is planned to commence by early 2016."

Anticipated new P2a trial • Anticipated new P2b trial • Immunology • Lupus

Neovacs: Investor Presentation (Neovacs) - “Good safety profile of IFNα-Kinoid at each dose level (few local or systemic reactions, only one flare reported as SAE)”; “All patients developed binding anti-IFNα antibodies. Higher production of binding and neutralizing antibodies in patients with more severe lupus”; “Those antibodies neutralize all 13 subtypes of IFNα, in contrast with monoclonal anti-IFNα antibodies (2 subtypes only are completely neutralized)”; “Improvement of disease biomarkers (IFN signature & C3) is correlated with the intensity and duration of the neutralizing response”; “Follow up until decline of anti-IFNα antibodies of 5 patients with a tapering in CS and no flare 3 years after dosing”

P1/2 data • Immunology • Lupus

Antiferon: Protection of composition-of-matter patents in EP, US until 2020 (Neovacs) - Corporate Presentation: Protection of composition-of-matter patents in EP, US, China, Canada, South Africa, Australia, Japan, Brazil, India, New Zealand until 2023; Protection of composition-of-matter patents in EP, US, Canada, Japan until 2024

Patent • Immunology • Lupus

Neovacs : Successfully raises €6.0 million in private placement with U.S. biotechnology institutional investors (GlobeNewswire) - P2b, N=NA; NCT02665364; Sponsor: Neovacs; "...IFNalpha Kinoid through the completion of preclinical and clinical trials in lupus...Completion of international Phase IIb clinical trial in Lupus."

Preclinical • Trial completion • Immunology • Lupus

Stellar Biotechnology: Corporate Presentation (Stellar Biotechnologies) - Anticipated preliminary data from P2 trial (NCT02665364) for lupus in 2017; Anticipated conditional approval in Korea for lupus in 2018

Anticipated non-US regulatory • Anticipated P2 data • Lupus

Neovacs: BIO Europe (Neovacs) - Anticipated data from P2b trial in lupus in EU, Asia and Latin America in Q1 2017; Anticipated data from P2a trial in lupus in US in Q3 2017; Anticipated initiation of P2a trial in dermatomyositis in adults in EU in Q4 2015; Anticipated data from P2a trial in dermatomyositis in adults in EU in Q1 2017; Anticipated initiation of P2b trial in dermatomyositis in adults in US, EU and Asia in Q2 2017; Anticipated data from P2b trial in dermatomyositis in adults in US, EU and Asia in Q1 2019; Anticipated initiation of P2a/b trial in pediatric dermatomyositis in US and EU in Q3 2016; Anticipated data from P2a/b trial in pediatric dermatomyositis in US and EU in Q3 2018

Anticipated new P2 trial • Anticipated new P2b trial • Anticipated P2a data • Anticipated P2b data • Immunology • Lupus

Neovacs: Investor Presentation (Neovacs) - Anticipated expiry of composition of matter patent in US in 2017; Anticipated expiry of composition of matter patent in EU and US in 2020; Anticipated expiry of composition of matter patent in EU, US, Canada, China, South Africa, Australia, Japan, Brazil, India, New Zealand in 2023; Anticipated expiry of composition of matter patent in EU, US, Canada, and Japan in 2024; Anticipated expiry of method of use patent in EU, US, Canada, China, Australia, Japan, Brazil, Israel, Mexico, India, Korea, Russia in 2032

Anticipated patent expiry • Immunology • Lupus

Neovacs announces the completion of patient enrollment in phase IIb clinical study of IFNalpha Kinoid in lupus (GlobeNewswire) - P2b, N=178; IFN-K-002; Sponsor: Neovacs; "Neovacs...today announced the completion of patient enrollment for its phase IIb clinical study, IFN-K-002, evaluating IFNalpha Kinoid for the treatment of lupus...'We are looking forward to the results from the study in Q2-2018.'"

Enrollment closed • P2b data • Immunology • Lupus

Neovacs obtains FDA “Fast Track” designation for IFNα Kinoid in lupus (SLE) (Neovacs Press Release) - "Neovacs...today announced that the U.S. Food and Drug Administration (FDA) has granted 'Fast Track' status to IFNα Kinoid in Lupus, the most advanced therapeutic vaccine issued from Neovacs R&D."

Fast track designation • Immunology • Lupus

Study of IFN-K in Systemic Lupus Erythematosus (clinicaltrials.gov) - P2b; N=166; Recruiting; Sponsor: Neovacs

New P2b trial • Biosimilar • Lupus

IFN-K-001 phase I/II study in lupus: final results presented today at the American College of Rheumatology (ACR) Annual Scientific Meeting in Chicago in both an ACR press conference and oral session (Neovacs) - P1/2, N=28; IFN-K-001; Neovacs announced results of its IFN-K-001 clinical study in lupus, presented at ACR Annual Scientific Meeting; Detailed analysis of study shows that 100% of pts who received IFNα-Kinoid produced antibodies to IFNα; It also shows that administration of IFNα-Kinoid, especially at higher doses, 120mcg & 240mcg, has statistically significant (p=0.0001) impact on dysregulation of genes related to interferon α (interferon signature) as well as those associated with lupus disease (lupus signature); Antibodies to IFNα raised by IFNα-Kinoid have significant impact on multiple disease markers; Activity of antibodies to IFNα induced by Kinoid administration is confirmed by fact that reduction in dysregulation of lupus-associated genes is clearly observable

P1/2 data • Immunology