A PHASE II MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGE FINDING STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ALX-0061 ADMINISTERED SUBCUTANEOUSLY IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Start Date01 Jan 2016

Sponsor / Collaborator-

EUCTR2014-003034-42-BG / Not yet recruitingPhase 2

A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061

Start Date15 Jul 2015

Sponsor / Collaborator

Ablynx NV

EUCTR2014-003033-26-CZ / Not yet recruitingPhase 2

A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Start Date08 Jul 2015

Sponsor / Collaborator

Ablynx NV

100 Clinical Results associated with Vobarilizumab

100 Translational Medicine associated with Vobarilizumab

100 Patents (Medical) associated with Vobarilizumab

Literatures (Medical) associated with Vobarilizumab

01 Jul 2024·Neurology-Neuroimmunology & Neuroinflammation

Interleukin-6 Signaling Blockade Induces Regulatory Plasmablasts in Neuromyelitis Optica Spectrum Disorder

Article

Author: Toda, Tatsushi ; Tsuji, Asato ; Koto, Shusuke ; Kobayashi, Kazuhiro ; Akatani, Ritsu ; Hara, Atsushi ; Chihara, Norio ; Matsumoto, Riki

BACKGROUND AND OBJECTIVES:

Interleukin-6 receptor antibodies (IL-6R Abs), including satralizumab, are increasingly used to prevent relapse for neuromyelitis optica spectrum disorder (NMOSD). However, the detailed mechanism of action of this treatment on the lymphocyte phenotype remains unclear. This study focused on B cells in patients with NMOSD, hypothesizing that IL-6R Ab enables B cells to acquire regulatory functions by producing the anti-inflammatory cytokine IL-10.

METHODS:

Peripheral blood mononuclear cells were stimulated in vitro to induce the expansion of B-cell subsets, double-negative B cells (DNs; CD19⁺ IgD^-, CD27^-) and plasmablasts (PBs; CD19⁺, CD27^hi, CD38^hi). Whole B cells, DNs, or PBs were isolated after culture with IL-6R Ab, and IL-10 expression was quantified using quantitative PCR and a cytometric bead array. RNA sequencing was performed to identify the marker of regulatory PBs induced by IL-6R Ab.

RESULTS:

DNs and PBs were observed to expand in patients with NMSOD during the acute attacks. In the in vitro model, IL-6R Ab increased IL-10 expression in B cells. Notably, IL-10 expression increased in PBs but not in DNs. Using RNA sequencing, CD200 was identified as a marker of regulatory PBs among the differentially expressed upregulated genes. CD200⁺ PBs produced more IL-10 than CD200^- PBs. Furthermore, patients with NMOSD who received satralizumab had a higher proportion of CD200⁺ PBs than patients during the acute attacks.

DISCUSSION:

Treatment with IL-6 signaling blockade elicited a regulatory phenotype in B cells and PBs. CD200⁺ PBs may be a marker of treatment responsiveness in the context of NMOSD pathophysiology.

01 May 2024·Angiogenesis

Notch ligands are biomarkers of anti-TNF response in RA patients

Article

Author: Kitajewski, Jan K ; Lewis, Myles J ; Sweiss, Nadera ; Zack, Stephanie R ; Meyer, Anja ; Pitzalis, Costantino ; Deen, Sania ; Shahrara, Shiva ; Satoeya, Neha ; Volin, Michael V ; Zanotti, Brian

Notch and its ligands play a critical role in rheumatoid arthritis (RA) pathogenesis. Hence, studies were conducted to delineate the functional significance of the Notch pathway in RA synovial tissue (ST) cells and the influence of RA therapies on their expression. Morphological studies reveal that JAG1, DLL4, and Notch1 are highly enriched in RA ST lining and sublining CD68⁺CD14⁺ MΦs. JAG1 and DLL4 transcription is jointly upregulated in RA MΦs reprogrammed by TLR4/5 ligation and TNF, whereas Syntenin-1 exposure expands JAG1, DLL4, and Notch1 expression levels in these cells. Single-cell RNA-seq data exhibit that JAG1 and Notch3 are overexpressed on all fibroblast-like synoviocyte (FLS) subpopulations, in parallel, JAG2, DLL1, and Notch1 expression levels are modest on RA FLS and are predominately potentiated by TLR4 ligation. Intriguingly, JAG1, DLL1/4, and Notch1/3 are presented on RA endothelial cells, and their expression is mutually reconfigured by TLR4/5 ligation in the endothelium. Synovial JAG1/JAG2/DLL1 or Notch1/3 transcriptomes were unchanged in patients who received disease-modifying anti-rheumatic drugs (DMARDs) or IL-6R Ab therapy regardless of disease activity score. Uniquely, RA MΦs and endothelial cells rewired by IL-6 displayed DLL4 transcriptional upregulation, and IL-6R antibody treatment disrupted RA ST DLL4 transcription in good responders compared to non-responders or moderate responders. Nevertheless, the JAG1/JAG2/DLL1/DLL4 transcriptome was diminished in anti-TNF good responders with myeloid pathotype and was unaltered in the fibroid pathotype except for DLL4. Taken together, our findings suggest that RA myeloid Notch ligands can serve as markers for anti-TNF responsiveness and trans-activate Notch receptors expressed on RA FLS and/or endothelial cells.

01 Dec 2023·Rheumatology and therapy

Generation-Dependent Retention Rates and Reasons for Discontinuation of Molecular Targeted Therapies in Patients with Rheumatoid Arthritis: From FIRST Registry

Article

Author: Nagayasu, Atsushi ; Kubo, Satoshi ; Todoroki, Yasuyuki ; Tanaka, Yoshiya ; Hanami, Kentaro ; Kanda, Ryuichiro ; Nakayamada, Shingo ; Ueno, Masanobu ; Miyazaki, Yusuke ; Sonomoto, Koshiro ; Aritomi, Takafumi ; Matsunaga, Satsuki ; Miyagawa, Ippei

INTRODUCTION:

The study aimed to optimize medical care for elderly patients with rheumatoid arthritis (RA) by examining the 3-year continuation rate of different molecular targeted therapies across age groups in Japan, which has a significant elderly population.

METHODS:

The study included patients with RA who started molecular targeted therapies between 2013 and 2019 and divided them into three age groups. The primary outcome was to assess the 3-year continuation rate of each drug and analyze reasons for treatment discontinuation using inverse probability of treatment weighting.

RESULTS:

Among 2292 patients analyzed, tumor necrosis factor (TNF) inhibitors were most commonly used in those younger than 65 years of age (43.5%), while Janus kinase (JAK) inhibitors were also utilized (17.1%). In contrast, JAK inhibitors were less frequently used in patients aged 75 years and older (7.8%), with cytotoxic T lymphocyte antigen 4 immunoglobulin fusion proteins (CTLA4-Ig) being the most common (39.2%). JAK inhibitors and anti-interleukin-6 receptor (IL-6R) antibodies had higher continuation rates than other drugs in patients under 65 years (p < 0.001). For those aged 65-74 years, JAK inhibitors and CTLA4-Ig had higher continuation rates (p < 0.001), while among those aged 75 years and older, CTLA4-Ig and IL-6R antibodies had higher continuation rates (p < 0.001). Inadequate efficacy was the main reason for discontinuation in all age groups, while infection leading to discontinuation increased with age.

CONCLUSIONS:

The study highlights the need to consider different age groups separately in elderly RA care. Among patients aged 75 years and older, abatacept and anti-IL-6R antibodies showed the highest continuation rates, suggesting their potential suitability and efficacy for this specific age cohort.

News (Medical) associated with Vobarilizumab

02 Jul 2024

·www.biospace.com

Scinai Publishes Q1 2024 Financial Results and Provides Business Update

JERUSALEM, July 2, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing inflammation and immunology (I&I) biological products and on providing CDMO services through its Scinai Bioservices business unit, today published its financial results for the quarter ended March 31, 2024, and provided a business update. Business Update & Recent Highlights Financing In support of the Company's strategic pivot, on January 3, 2024, we raised $1.69 million in gross proceeds from the exercise of certain of our outstanding warrants and the issuance of new warrants. H.C. Wainwright & Co. acted as exclusive placement agent in connection with the offering. Nasdaq Compliance and Conversion of EIB Loan into Equity On June 7, 2024 the Company announced that on June 5, 2024, it received formal notification from the Listing Qualification Department (the "Staff") of the Nasdaq Stock Market ("Nasdaq") that the Company had regained compliance with the minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) (the "Rule"). In the notification provided by the Staff on June 5, 2024, the Staff stated that the Company remains non-compliant with the equity requirement in Listing Rule 5550(b)(1), or any of the alternative requirements under Listing Rule 5550(b), and accordingly the Company presented its plan to get back into compliance with the equity requirement with the Nasdaq Hearing Panel on June 18, 2024. The Plan presented to the panel included a debt-to-equity loan restructuring deal the Company is working on with its lender, the European Investment Bank (the "EIB"). On June 13, 2024 the Company announced that it received a letter of Intent from the EIB. This LoI outlined specific indicative terms for converting the EIB's loan into equity. The Company expects to receive a binding term sheet in July and have the financial contract with EIB fully amended by the end of August. Based on the above plan, the Company requested from the Nasdaq Hearing Panel an extension of the deadline for regaining compliance with the equity requirement. The Company expects to receive the decision of the Hearing Panel in the coming weeks. CDMO business unit In the first six months of 2024 we received CDMO work orders valued at approximately $500K, and we are in advanced contract discussions with several other potential clients. We maintain confidence in our sales guidance for 2024 of $1.25 million in expected revenues. As our CDMO unit is new and we are in a rapid growth stage, acquiring new clients and building our reputation and brand awareness of our CDMO services, we expect revenues from the CDMO business to increase materially in the coming years. This is also coupled with growing demand for boutique CDMO services from early-stage biotech companies looking for fast project onset at competitive pricing without compromising on meeting the most stringent scientific and quality standards. In addition, in 2024 we have been pursuing extensive targeted marketing activities, including online advertisements, direct outreach campaigns and participation in major pharmaceutical conferences, such as BIO Europe Spring in Barcelona (March 2024), and the BioMed Israel conference in Tel Aviv, Israel (May 2024), at which we marketed our CDMO services and met potential partners for our R&D pipeline and potential investors. Our CDMO unit is currently focused both on executing drug development projects for our clients and on validating our processes and facilities to be ready for cGMP inspection by the Israeli Ministry of Health. In June, we held a first of its kind, hands on aseptic processing course at our facility in Jerusalem in collaboration with key figures in the industry including Ms. Rachel Shimonovitz, Head of GMP inspectorate of the Israeli Ministry of Health, and ADRES Int'l Biotech, a leading Israeli regulatory and quality consulting services firm. The course attracted many senior role holders from the Israeli biotech industry who came to our facility for this two-day education and training course. Pipeline Development We are aggressively advancing the NanoAb preclinical development. At the end of April 2024, we concluded an in-vivo proof of concept animal study in collaboration with Prof. Amos Gilhar, a world-renowned dermatologist of the prestigious Technion Israel Institute of Technology. The results look promising and corroborate our aspiration for the development of a novel, local biologics therapeutic for the treatment of patients suffering from plaque psoriasis. On June 4, 2024, we met for a scientific advisory meeting with the Paul Erlich Institute (the PEI) of Germany, the scientific advice of which is considered acceptable guidance for IMPD filing with the European Medicines Agency (EMA) and is also considered the European comparable to a pre-IND meeting with the FDA in the U.S. We expect their final minutes of the meeting in the coming couple of weeks. Upon guidance from the PEI, we expect to commence preparations for a pre-clinical toxicology study before commencing a first-in-human clinical trial of our anti-IL NanoAbs for the treatment of plaque psoriasis in 2025. Additional NanoAbs for treatment of additional autoimmune diseases, such as asthma, atopic dermatitis and wet AMD, have been discovered and characterized at Max Planck and University Medical Center Göttingen as part of their research collaboration agreement with Scinai. Scinai holds exclusive options for exclusive licenses at pre-agreed financial terms for each of the resulting NanoAbs. We are pursuing a strategic partnership for both our COVID-19 self-administered inhaled NanoAb, which demonstrated highly promising in vivo results in animals as both a therapeutic and prophylactic treatment, and our anti-IL-17 nanoAb for the treatment of plaque psoriasis and other potential indications. Q1 2024 Financial Summary R&D expenses for the three months ended March 31, 2024, amounted to $1,568 thousands, compared to $1,995 thousands for the three months ended March 31, 2023. The decrease was primarily due to a reduction in salaries and reduced use of subcontractors. Marketing, general and administrative expenses for the three months ended March 31, 2024, amounted to $484 thousands, compared to $1,191 thousands for the three months ended March 31, 2023. The decrease was primarily due to a reduction in each of salaries, share-based compensation and professional services. Financial income for the three months ended March 31, 2024, amounted to $231 thousands compared to $329 thousands for the three months ended March 31, 2023. Net loss for the three months ended March 31, 2024, was $2,159 thousands compared to net loss of $3,515 thousands for the three months ended March 31, 2023. As of March 31, 2024, Scinai had cash and cash equivalents and short-term deposits of $4,826 thousands compared to $4,870 thousands as of March 31, 2023. About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development projects. Company website: . Company Contacts Investor Relations | +972 8 930 2529 | ir@scinai.com Business Development | +972 8 930 2529 | bd@scinai.com Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. Examples of such statements include, but are not limited to, execution of a binding term sheet providing for revised terms of the Finance Contract with EIB, the accounting impact of execution of such revised terms and the ability of the Company to regain and remain compliant with the continued listing standards of Nasdaq, the potential of Scinai's NanoAb program, expected revenues of Scinai's CDMO business and timing of pre-clinical and clinical studies of the Company's anti-IL NanoAbs for the treatment of plaque psoriasis and their results. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to, the risk that the Company will not execute a binding term sheet with the EIB providing for revised terms of the Finance Contract with EIB and the risk that execution of such binding term sheet will not resolve the deficiency notice of Nasdaq with respect to the Company's shareholders' equity; the risk that the Company will otherwise be unable to regain compliance and remain compliant with the continued listing requirements of Nasdaq; lower than anticipated revenues of Scinai's CDMO business in 2024 and thereafter, failure to sign agreements with other potential clients of the CDMO business; a delay in the commencement and results of pre-clinical and clinical studies, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other NanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of NanoAbs will not be met or that Scinai will not be successful in bringing the NanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful; the risk that the European Investment Bank (EIB) may accelerate the financial facility under its finance contract with Scinai; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 15, 2024, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason. Logo - Company Codes: NASDAQ-NMS:SCNI

Financial StatementLicense out/in

22 Feb 2018

·www.globenewswire.com

ABLYNX ANNOUNCES 2017 FULL YEAR RESULTS

REGULATED INFORMATION A year of many momentous moments GHENT, Belgium, 22 February 2018 - Ablynx [Euronext Brussels and Nasdaq: ABLX] today announced its financial results for the year ended 31 st December 2017, which have been prepared in accordance with IFRS as issued by the IASB and adopted by the European Union, business highlights year-to-date and the outlook for the remainder of the year. 2017 Highlights Compelling Phase III data for caplacizumab (wholly-owned, anti-vWF Nanobody®) for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP), a potential €1.2 billion per annum market, which will support both the ongoing regulatory review process in Europe and the planned Biologics License Application (BLA) in the USA Successful US initial public offering (IPO) raising $230 million Completed the dose escalation part of the Phase IIb RESPIRE study in 36 infants with the wholly-owned anti-RSV (respiratory syncytial virus) Nanobody, ALX-0171, and initiated the parallel dose part in 144 infants, with topline results expected in Q4 2018 Research collaboration with Sanofi on up to eight new programmes, focussed on immune-mediated inflammatory diseases, with €23 million in upfront payments and up to €2.4 billion in potential milestones plus tiered royalties Received €15 million milestone payment from Merck KGaA for the completion of a pre-clinical package for ALX-1141, targeting ADAMTS-5 in osteoarthritis, which has since entered Phase I trials Total revenues of €55.5 million and net cash burn [1] of €60.4 million resulting in a cash position, including cash, other financial assets, restricted cash and deposits of €354.3 million On 29 th January 2018, Ablynx announced an offer by Sanofi to acquire all its outstanding ordinary shares (including shares represented by American Depository Shares (ADSs), warrants and convertible bonds) at a price of €45 per share, which represents an aggregate equity value of approximately €3.9 billion. This proposed transaction was unanimously approved by both the Sanofi and Ablynx Board of Directors. The tender offer is expected to be launched in the beginning of the second quarter of 2018. Sanofi will publish an offer document in which it will set out the full details of its tender offer, and the Board of Directors of Ablynx will publish a response memorandum (' memorie van antwoord '), in which it will set out its position on the tender offer. Dr Edwin Moses, CEO of Ablynx said: "We experienced many momentous moments this year including the compelling Phase III results for our lead product caplacizumab and our successful US initial public offering. Caplacizumab has the potential to change the lives of patients affected by aTTP, a devastating disease for which there is currently no approved drug available. We are proud to be pioneers in the treatment of aTTP and are working with the regulatory authorities to obtain marketing approval and make caplacizumab rapidly available to patients." "We are also pleased with the progress made with our anti-RSV Nanobody, ALX-0171, that is delivered via nebulisation, a technique with potential in other pulmonary diseases, and we look forward to the results from our Phase IIb RESPIRE study which should be available before the end of this year." "The offer made by Sanofi on 29 th January 2018 to acquire Ablynx for €3.9 billion represents compelling value for shareholders and builds on a successful existing partnership. We strongly believe that Sanofi's global infrastructure, commitment to innovation and commercial capabilities will accelerate Ablynx's therapeutic programmes and maximise the potential of our pipeline and unique Nanobody technology platform to the benefit of all stakeholders." Operational review R&D update In January , Ablynx's partner, Merck KGaA, reported encouraging results from their Phase Ib study of the bi-specific anti-IL-17A/F Nanobody, in patients with moderate to severe psoriasis. In February , Ablynx submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for caplacizumab, its wholly-owned anti-vWF-Nanobody, caplacizumab, for the treatment of aTTP, including data from the Phase II TITAN study. In November, the MAA was further updated with the positive results of the Phase III HERCULES study that were announced in October . In May , Ablynx received a €15 million milestone payment from Merck KGaA for the completion of a pre-clinical package for a novel Nanobody (ALX-1141) targeting ADAMTS-5 in osteoarthritis, with Merck KGaA subsequently starting a Phase I study. In June , Ablynx achieved a second milestone in the immuno-oncology collaboration with Merck & Co., Inc., (known as MSD outside the USA and Canada) triggering a €2.5 million payment to Ablynx. In July , Ablynx received Fast Track designation from the FDA for caplacizumab for the treatment of aTTP. In August , Ablynx announced the completion of the sequential dose escalation part of the Phase IIb RESPIRE study in 36 infants hospitalised as a result of a RSV infection and the initiation of the parallel dose part in 144 infants with ALX-0171, the Company's inhaled anti-RSV Nanobody. Results from this Phase IIb study are expected in Q4 2018. In October , Ablynx announced positive topline results from the Phase III HERCULES study of caplacizumab, in 145 patients with aTTP. The study met its primary and two key secondary endpoints and reported a favourable safety profile. In December , Ablynx reported additional clinically important benefits of caplacizumab from its Phase III HERCULES study in aTTP at the 59 th Annual Meeting of the American Society of Hematology (ASH) as part of the late-breaking abstracts session. Also in December , Ablynx announced positive data from a single and multiple dose Phase I study of caplacizumab, demonstrating comparable pharmacokinetics in 60 healthy Japanese and Caucasian subjects. Corporate developments In June , Ablynx appointed Dr Markus Ewert as Chief Business Officer to lead Ablynx's business development activities and become a member of the Executive Committee. In July , Ablynx announced a research collaboration and global exclusive licensing agreement with Sanofi to develop up to eight Nanobody product candidates initially focused on immune-mediated inflammatory diseases. Ablynx received an upfront payment of €23 million plus research funding for the initially selected targets and is eligible to receive further option exercise fees from additional targets and up to €2.4 billion in potential future milestone payments and royalties on the net sales of any products originating from the collaboration. In October , following the positive Phase III data of caplacizumab, Ablynx completed its initial US public offering, raising $230 million in gross proceeds from the sale of 13,144,500 ordinary shares in the form of ADSs, including the full exercise of the underwriters' option, at a price of $17.50 per ADS. The US public offering was nearly three times oversubscribed and was upsized from the $175 million initially targeted. Also in October , Ablynx established Ablynx, Inc., its subsidiary in the USA and appointed Mr Daniel Schneider as the General Manager to lead the commercialisation of caplacizumab in North America. Post-period highlights In January 2018 , Ablynx announced the appointment of Robert Friesen, PhD, as Chief Scientific Officer, effective 1 st March 2018. Dr Friesen will lead the Company's scientific, research and technology activities and become a member of the Executive Committee. In January and February 2018, Ablynx announced changes to its Board of Directors with the departures of Dr Peter Fellner and Dr Bo Jesper Hansen respectively. Dr Russell G. Greig, who has been a non-executive Director of Ablynx since 2012, is now the new Chairman of the Board. On 16 th February 2018 , Ablynx announced that as part of the research collaboration signed in July 2017, Sanofi has exercised its options for two additional multi-specific Nanobody product candidates, triggering the payment to Ablynx of €13 million in exercise fees. On 1 st March 2018, Piet Houwen will join Ablynx as Chief Operating Officer. Mr Houwen will be responsible for the support of Ablynx's business and R&D processes and become a member of the Executive Committee. Outlook for the remainder of 2018 During H1 2018, a BLA will be submitted for caplacizumab in the USA. In Europe, the Company has the potential to receive marketing authorisation for caplacizumab in aTTP in Q3 2018 followed by potential first commercial sales in Germany. For ALX-0171, a Phase II study in Japanese infants, hospitalised as a result of a RSV infection, and a global Phase II study in hematopoietic stem cell transplant patients who become infected with RSV, are expected to be initiated in H1 2018. Results from the ongoing Phase IIb study in RSV-infected hospitalised infants are expected in Q4 2018. The Phase II study results for vobarilizumab (anti-IL6R Nanobody) in 312 systemic lupus erythematosus (SLE) patients are expected in H1 2018 followed by AbbVie's decision on whether to opt-in and license the compound. The Company expects up to three Nanobodies to enter Phase I studies from our collaborative programmes during the year. Detailed financial review (€ million) FY 2017 FY 2016 Variance Total revenue and grant income 55.5 85.2 (35%) R&D income 55.5 84.8 (35%) Grants - 0.4 Operating expenses (109.7) (113.8) (4%) R&D (90.9) (100.3) (9%) G&A (18.8) (13.5) 39% Operating loss (54.2) (28.6) (90%) Net financial result (54.3) 27.5 < (100%) Net loss (108.5) (1.1) < (100%) Net cash burn* (60.4) (1) (72.2) (3) 16% Cash position** at 31 December 354.3 (2) 235.4 (4) 51% (1) excluding €179.3 million net proceeds from Nasdaq IPO (2) including €1.6 million in restricted cash (3) excluding €71.4 million net proceeds from the private placement announced on 1 June 2016 (4) including €1.6 million in restricted cash * Net cash burn is the difference between the cash position of the current year and the previous year minus the proceeds (net of issue costs) from the issue of ordinary shares ** Cash position includes cash, other financial assets, restricted cash and deposits Income statement Total revenues and grant income decreased by 35% to €55.5 million (2016: €85.2 million), mainly driven by lower recognition of upfront payments from the ongoing collaborations with AbbVie and Merck & Co., Inc. Total research and development costs decreased to €90.9 million (2016: €100.3 million) in line with the decrease in external development costs, largely related to lower clinical trials expenditure for vobarilizumab. General and administrative costs increased to €18.8 million (2016: €13.5 million), related to expenditure for consultancies and staff, including pre-commercialisation costs for caplacizumab and costs related to the IPO on Nasdaq completed in October 2017. As a result of the above, the operating loss was €54.2 million (2016: €28.6 million). The net financial loss of €54.3 million comprises finance expenses of €46.6 million resulting from an increase in the fair value of the derivative associated with the convertible bond (following an increase in the Ablynx share price at year-end compared to that at the end of 2016), and finance costs of €7.4 million (mainly related to the amortisation of the debt component of the convertible bond). As a result, the net loss for 2017 increased to €108.5 million (2016: net loss of €1.1 million). Balance sheet The Company's non-current assets of €78.5 million are €53.9 million higher than at 31 December 2016, mainly driven by the purchase of Interest Structured Notes with a maturity of two years and higher receivables for research and development incentives. Ablynx's current assets of €311.3 million consist mainly of cash and cash equivalents and other financial assets. Cash and cash equivalents consist of cash and deposits held on call with several banks. The Company also places cash in term accounts with maturities limited to a maximum of one year. Shareholders' equity increased from €103.1 million at the end of 2016 to €179.9 million at the end of 2017, mainly as a result of the €179.3 million net proceeds from the IPO on Nasdaq and the incorporation of the €108.5 million loss for the period. Non-current liabilities relate to the senior unsecured bonds due on 27 May 2020 with a principal value of €100 million. Current liabilities consist mainly of trade payables and deferred income related to the upfront payments received from partners. Cash flow statement Net cash outflow from operating activities was €57.8 million as compared to a net outflow of €66.6million in 2016. The difference primarily relates to lower operating expenses for the current period. Cash flow from investing activities resulted in a net outflow of €160.0 million as compared to a net inflow of €45.9 million in 2016. The net cash outflow primarily relates to the movements from deposits with a term of less than 1 month to deposits with a term greater than 1 month. Cash flow from financing activities represented a net inflow of €179.5 million compared to a net inflow of €70.4 million in 2016. The difference primarily relates to higher net proceeds from the issue of new shares on Nasdaq in 2017 compared to the net proceeds raised via an accelerated book building procedure in 2016. The Company ended the period with a total liquidity position of €354.3 million (2016: €235.4 million) which consists of cash and cash equivalents of €14.9 million, other financial assets of €337.8 million and restricted cash of €1.6 million. Investor Conference Call and Webcast In light of the pending transaction with Sanofi, Ablynx will not be hosting a conference call to discuss its 2017 full year results. Next financial events 27 March 2018 - online publication Annual Report 2017 26 April 2018 - Annual General Meeting 2018 Glossary of terms ADS American Depositary Shares ASH American Society of Hematology aTTP acquired thrombotic thrombocytopenic purpura BLA biologics license application EMA European Medicines Agency IPO Initial Public Offering MAA marketing authorisation application RA rheumatoid arthritis RSV respiratory syncytial virus SLE systemic lupus erythematosus About Ablynx Ablynx is a biopharmaceutical company engaged in the development of Nanobodies , proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has more than 45 proprietary and partnered programmes in development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie; Boehringer Ingelheim; Eddingpharm; Merck & Co., Inc., Kenilworth, New Jersey, USA; Merck KGaA; Novo Nordisk; Sanofi and Taisho Pharmaceuticals. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com . For more information, please contact Ablynx: Dr Edwin Moses CEO t: +32 (0)9 262 00 07 m: +32 (0)473 39 50 68 e: edwin.moses@ablynx.com Lies Vanneste Director Investor Relations t: +32 (0)9 262 01 37 m: +32 (0)498 05 35 79 e: lies.vanneste@ablynx.com Follow us on Twitter @AblynxABLX Ablynx media relations: Consilium Strategic Communications Mary-Jane Elliott, Philippa Gardner, Sukaina Virji t: +44 (0)20 3709 5700 e: ablynx@consilium-comms.com Joele Frank, Wilkinson Brimmer Katcher Dan Katcher or Joseph Sala t: +1 212-355-4449 Disclaimer Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors' current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its parent or subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Additional Information for US Investors The tender offer for the outstanding ordinary shares ("Shares"), American Depositary Shares issued by J.P. Morgan Chase Bank, N.A., acting as depositary ("ADSs"), warrants ("Warrants") and convertible bonds of Ablynx ("Bonds" and, together with the Shares, ADSs and Warrants, the "Securities") has not yet commenced. This communication is for informational purposes only and is neither a recommendation, an offer to purchase nor a solicitation of an offer to sell any Securities of Ablynx. At the time the tender offer is commenced, Sanofi will file, or cause to be filed, a tender offer statement on Schedule TO with the SEC and thereafter, Ablynx will file a solicitation/recommendation statement on Schedule 14D-9. Holders of Securities are urged to carefully review the documents that will be filed by Sanofi and Ablynx with the SEC because these documents will contain important information, including the terms and conditions of the tender offer. The offer to purchase, the related letter of transmittal and certain other tender offer documents, as well as the solicitation/recommendation statement, are available to all holders of Securities of Ablynx at no expense to them. These documents are available for free at the SEC's website at www.sec.gov. Additional copies may be obtained for free by contacting Sanofi at ir@Sanofi.com or on Sanofi's website at https://en.Sanofi.com/investors. You should read the filings made by Sanofi and Ablynx with the SEC carefully before making a decision concerning the U.S. Offer. [1] Net cash burn is the difference between the cash position of the current year and the previous year minus the proceeds (net of issue costs) from the issue of ordinary shares Attachments: http://www.globenewswire.com/NewsRoom/AttachmentNg/2d4f2974-6e82-4d3d-9220-4d622bf87dcf

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D11005	Vobarilizumab	-	DB14891

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 2	US	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	AR	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	CL	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	CZ	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	DE	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	HU	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	MX	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	PE	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	PH	Ablynx NV	01 Jul 2015
Systemic Lupus Erythematosus	Phase 2	PL	Ablynx NV	01 Jul 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02309359 (CTgov)	Phase 2	Rheumatoid Arthritis	345	Placebo+ALX-0061+Methotrexate (ALX-0061 75 mg q4w + MTX)	vhhfxqtlmd(dqvhqjnaxe) = qgxqmjywlk jgbmiewmdm (thxmbolfai, dabssmwytl - mzrrxlkswj) View more	-	21 Aug 2019
				Placebo+ALX-0061+Methotrexate (ALX-0061 150 mg q4w + MTX)	vhhfxqtlmd(dqvhqjnaxe) = zpsiqxrcnt jgbmiewmdm (thxmbolfai, zmafarqtwu - mvpbfeijrn) View more
NCT02287922 (CTgov)	Phase 2	Rheumatoid Arthritis	251	Placebo+ALX-0061 (ALX-0061 150 mg q4w)	jknxphzxqb(lsjjiacewt) = dtepfojomk yzknevmmit (pdiaepyhfq, kthyfrpdgo - nwhimdgciy) View more	-	21 Aug 2019
				Placebo+ALX-0061 (ALX-0061 150 mg q2w)	jknxphzxqb(lsjjiacewt) = ajkevuwaec yzknevmmit (pdiaepyhfq, ozsnvgaiep - arnymkqume) View more
NCT02518620 (CTgov)	Phase 2	Rheumatoid Arthritis	406	MTX+ALX-0061 (ALX-0061 150 mg q2w + MTX (C201 All Subjects))	vtquljfntw(qzzszhbtta) = ddbzdihodn nknjnquikw (fjdlfkjlaq, kcwsqovyhg - ydcocuancf) View more	-	19 Jul 2019
				ALX-0061 (ALX-0061 150 mg q2w (C202 All Subjects))	vtquljfntw(qzzszhbtta) = vltzndiqxk nknjnquikw (fjdlfkjlaq, zoemxitple - nufhrdyfum) View more
NCT02437890 (CTgov)	Phase 2	Systemic Lupus Erythematosus	312	Placebo (Placebo)	udzoeaqqtn(qwderrofao) = ykiwdqlkwf kvzliyflwj (kopkucfnih, txpwwyfksn - svudccavlp) View more	-	06 Feb 2019
				Placebo+ALX-0061 (ALX-0061 75 mg q4w)	udzoeaqqtn(qwderrofao) = yulzvdtgpj kvzliyflwj (kopkucfnih, dbfalkkqpa - bvhkrtabhd) View more
NCT02437890 (PipelineReview) Manual	Phase 2	Systemic Lupus Erythematosus	312	vobarilizumab	uufgqwhnyp(rgxtynkhnl) = did not meet the primary endpoint of dose response based on the modified BILAG-based combined lupus assessment (mBICLA) at Week 24. tjidrjutnt (ytivgegpxj )	Negative	26 Mar 2018
				Placebo
EULAR2017	Phase 2	Rheumatoid Arthritis	345	Vobarilizumab 75mg q4w	fckpbtpmlk(rcjpzlntjl) = hzsrgwdsgj pbhajdnjeh (ksrcbmbaxe ) View more	-	14 Jun 2017
				Vobarilizumab 150mg q4w	fckpbtpmlk(rcjpzlntjl) = hibynqaeke pbhajdnjeh (ksrcbmbaxe ) View more
EULAR2017	Phase 2	Rheumatoid Arthritis	251	Vobarilizumab 150mg q4w	kliysoxofg(kjxnrmdtzj) = ttlnoqjlqw odyockvftv (utzvtccivo ) View more	Positive	14 Jun 2017
				Vobarilizumab 150mg q2w	kliysoxofg(kjxnrmdtzj) = zuxeuedziz odyockvftv (utzvtccivo ) View more
ACR2014	Not Applicable	-	-	ALX-0061	rjpgnltvfa(emjshshefu) = ernmzesxrp cxucpgbzrx (bhyojltwts, 3.6) View more	-	14 Nov 2014
				Tocilizumab (TCZ)	rjpgnltvfa(emjshshefu) = qmlcbqypkr cxucpgbzrx (bhyojltwts, 16) View more
Phase I/II study (EULAR2014)	Phase 1/2	Rheumatoid Arthritis	-	ALX-0061 IV 1 mg/kg Q4W	xkykiejaez(tyagrctjam) = nkkoeysdbh acuqoamduz (hhivhhcvou ) View more	-	11 Jun 2014
				ALX-0061 IV 3 mg/kg Q4W	xkykiejaez(tyagrctjam) = ypmspqwcji acuqoamduz (hhivhhcvou ) View more

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