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

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

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

Neovacs obtains South Korea health authority approval for IND application with IFNα kinoid in lupus (Neovacs Press Release) - P2b, N=166; NCT02665364; Sponsor- Neovacs; “NEOVACS…today announced that South Korea health authority approved Neovacs’s Investigational New Drug application for IFNα Kinoid in phase IIb development in Lupus…The results of this trial are expected for summer 2017.”

Anticipated P2b data • IND • Immunology • Lupus

Neovacs provides corporate update and reports full year 2016 financial results (GlobeNewswire) - P2b, N=178; NCT02665364; Sponsor: NEOVACS; "NEOVACS...today provided a corporate update and announced its full-year 2016 financial results, as approved by its Board of Directors on March 29, 2017...The Phase IIb clinical study already has enrolled more than 80% of its target number of 178 patients. The Independent Data Safety Monitoring Board (iDSMB) issued a favorable opinion for the continuation of the Phase IIb clinical study in January 2017."

DSMB • Enrollment status • Immunology • Lupus

Neovacs: HY 2015 Results (Neovacs) - Anticipated filing of IND for P2a trial in SLE in US in early 2016; Anticipated initiation of P1/2a trial (N=30) in adult dermatomyositis in 2016; Anticipated data from P2b IFN-K-002 trial in SLE in Q1 2017

Anticipated IND • Anticipated new P1/2 trial • Anticipated P2b data • Immunology • Lupus

Neovacs announces the results of its phase IIb study for IFNalpha Kinoid in the treatment of lupus (GlobeNewswire) - P2b, N=185; NCT02665364; Sponsor: Neovacs; “Neovacs…announces the results of its Phase IIb clinical trial of IFNalpha Kinoid in patients with moderate to severe lupus (SLE)...The clinical response in patients treated with IFNalpha Kinoid vs those treated with placebo measured by the BICLA score at week 36, did not achieve a statistical trend as defined in the primary objectives of the study…Neovacs plans to submit the full results of this study and present them at a future international scientific congress.”

P2b data • Immunology • Lupus

Antiferon: Protection of use/method patents in China, US, Russia, EP, Australia, Mexico, Hong Kong, Canada, Japan, Brazil, Israel, India, South Korea until 2032 (Neovacs) - Corporate Presentation

Patent • Immunology • Lupus

Neovacs: FY 2015 Results (Neovacs) - Anticipated completion of patient recruitment in P2b trial (NCT02665364) in lupus in 2016; Anticipated initiation of patient recruitment in P1/2a trial in dermatomyositis in Q2 2016

Anticipated enrollment status • Immunology • Lupus

Neovacs initiates clinical program in dermatomyositis (GlobeNewswire) - "NEOVACS...today announced the launch of its clinical development program in Dermatomyositis (DM), an orphan skin and muscular condition with significant unmet medical need....The decision follows a recommendation earlier this year by the Company's Scientific Advisory Board to pursue IFNα-Kinoid as a potential treatment for DM...Neovacs plans to conduct a multicentric phase I/IIa trial of IFNα-Kinoid in adult DM in 15 patients which is anticipated to launch in early 2016 in France and other European countries."

Anticipated new P1/2 trial • Immunology

Neovacs aims to complete recruitment for research (Investing.com) - P2, N=178; NCT02665364; Sponsor: Neovacs; "Neovacs plans to partner IFN-K, implying possible launches in 2021...Neovacs is aiming to complete recruitment into the 178-patient Phase IIb by late summer 2016, with an expected June 2017 release of preliminary data...Neovacs intends to find a partner to run and fund Phase III studies from 2018. This could enable a US and EU regulatory filing by 2020 and possible marketing from 2021.

Anticipated enrollment status • Anticipated EU regulatory • Anticipated launch Europe • Anticipated launch US • Anticipated licensing / partnership • Anticipated new P3 trial • Anticipated P2b data • Anticipated regulatory • Lupus

Active immunization against IFNα with IFN-kinoid in SLE patients is safe, immunogenic and induces down-regulation of IFN- mediated genes (ACR/ARHP 2011) - P1/2, N=28; Patients with a positive signature have significantly higher dsDNA Ab titers and significantly lower C3 and C4 levels ; Study showed positive immune and pharmacodynamic results with active immunotherapy against Interferon-α in the treatment of SLE

P1/2 data • Immunology

Neovacs announces positive IDSMB review for phase IIb clinical trial of IFNα Kinoid in lupus (Neovacs Press Release) - P2b, N=178; IFN-K-002; Sponsor: Neovacs; "Neovacs...today announces that it received a positive data review by the Independent Data and Safety Monitoring Board (IDSMB) for the ongoing Phase IIb Clinical Trial of IFNα Kinoid in lupus...'All patients are now followed during 9 months, and our goal is to report data in Q2 2018."

DSMB • P2 data • Immunology • Lupus

IFNα kinoid: Anticipated launch and approval in US, Europe and China for SLE in 2020 (Neovacs) - Analyst Report

Anticipated BLA • Anticipated EU regulatory • Anticipated launch Europe • Anticipated launch non-US • Anticipated launch US • Anticipated non-US regulatory • Lupus

Neovacs issued new broad patent in China for IFNα Kinoid (GlobeNewswire) - "Neovacs...today announces that it has been granted a new patent from the Chinese Patent Office (SIPO), titled: 'Method of treatment of a disease related to the overexpression of IFNα...This new patent has been also filed in all major markets in the world, to cover the use of Neovacs’ IFNα Kinoid vaccine for all diseases characterized by an overexpression of the cytokine, Interferon alpha (IFNα), including Lupus, Dermatomyositis and Type 1 diabetes. This patent provides a strong protection until at least 2032."

Anticipated patent expiry • Patent • Immunology • Lupus

Serum IFN alpha, but not IFN beta or IFN omega, correlates with IFN signature in SLE patients (EULAR 2014) - Presentation time: 12.06.2014, 12:00; Abstract #THU0040; P1/2, N=28; NCT01058343; Sponsor:Neovacs; "IFNα, IFNβ and IFNω are detected in the sera of patients with SLE. IFNα and IFNβ/ω are not regulated similarly. Serum IFNβ is significantly associated with mucocutaneous involvement, while serum IFNα is higher in more active disease. The IFN signature score observed in SLE whole blood cells is driven by IFNα."

Biomarker • 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