vobarilizumab (ALX-0061) / Sanofi - LARVOL DELTA

Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis. (PubMed, Ann Rheum Dis) - "This SLR informed the task force regarding the evidence base of various therapeutic regimen for the development of the update of EULAR's RA management recommendation."

Clinical • Journal • Immunology • Rheumatoid Arthritis • Rheumatology

Study to assess safety and efficacy of anti-interleukin 6-receptor (IL6R) nanobody in rheumatoid arthritis (RA) patients (clinicaltrials.gov) - P1/2, N=72; Recruiting -> Active, not recruiting

Enrollment closed • Immunology • Rheumatoid Arthritis

Ablynx 2011 annual results (Ablynx) - P2 POC data anticipated in H2 2012

Anticipated P2 data • Immunology • Rheumatoid Arthritis

RESULTS OF A PHASE 2B STUDY OF VOBARILIZUMAB, AN ANTI-INTERLEUKIN-6 RECEPTOR NANOBODY, AS MONOTHERAPY IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS (EULAR 2017) - " Patients with active RA who were intolerant to methotrexate (MTX) or for whom continued MTX treatment was inappropriate were randomized in a 1:1:1:1 ratio to 1 of the 3 blinded dose groups of vobarilizumab or to open-label tocilizumab (TCZ), all of which were given subcutaneously. In patients with active RA, treatment with vobarilizumab monotherapy had a positive impact on disease activity with no unexpected safety findings."

Adverse events • Clinical • Monotherapy • P2 data • Biosimilar • Immunology • Inflammation • Rheumatoid Arthritis

Ablynx announces 2016 full year results (Ablynx Press Release) - "During H1 2017, Ablynx expects to hold scientific advice and 'end-of-Phase II' meetings with regulators in Europe and the USA to discuss its Phase IIb results with vobarilizumab in RA and plans for a Phase III programme...Ablynx will continue to explore the possibility of a new partnership which would be needed to support further clinical development of this molecule in RA."

Anticipated licensing / partnership • Anticipated new P3 trial • Anticipated regulatory • Immunology • Rheumatoid Arthritis

Assessment of Dose Dependent Effects of Vobarilizumab, an Anti-IL6 Receptor (IL-6R) Nanobody®, on Systemic Biomarkers in Patients with Moderate-to-Severe Rheumatoid Arthritis (RA): Results of Two Phase 2b Studies (ACR-ARHP 2017) - "...Main efficacy and safety results of both RA phase 2b studies with vobarilizumab when used in combination with methotrexate (ALX0061-C201) and as monotherapy (ALX0061-C202) were previously reported (ref 1 and 2)...An open-label tocilizumab (TCZ) arm was included to obtain parallel descriptive information... The observed dose dependent PD biomarker responses and effects on cartilage degradation and joint inflammation biomarkers further support the strong potential for disease modifying activity of vobarilizumab in RA."

Biomarker • Clinical • Combination therapy • P2 data • Immunology • Inflammation • Lupus • Rheumatoid Arthritis

Ablynx initiates Phase II SLE study with its anti-IL-6R nanobody, partnered with Abbvie (Ablynx Press Release) - P2, N=300; NCT02437890; Sponsor: Ablynx; "Ablynx...today announced that it has administered the first dose in the Phase II STEADY study to evaluate the efficacy and safety of its anti-IL-6R Nanobody®, ALX-0061, administered subcutaneously in adult patients with moderate to severe, active seropositive SLE...'The efficacy and safety of this novel anti-IL-6R Nanobody is currently being evaluated in multiple Phase II studies with results from the RA studies anticipated in the second half of 2016 and SLE in 2018.' "

Anticipated P2 data • Trial initiation date • Immunology • Lupus • Rheumatoid Arthritis

Ablynx: Corporate Presentation (Ablynx) - Anticipated initiation of P1 SC safety study for rheumatoid arthritis in 2014; Anticipated initiation of P2b trial for rheumatoid arthritis in 2015; Anticipated top line results from P2b trial for rheumatoid arthritis in 2016

Anticipated new P1 trial • Anticipated new P2b trial • Anticipated P2b data • Immunology • Rheumatoid Arthritis

Biotech group Ablynx sells 100 mln euros of convertibles (Reuters) - “…Ablynx sold 100 million euros ($111 million) of convertible bonds on Wednesday to fund its research and further tests of experimental drugs…. Ablynx also aimed to drive forward jointly owned projects, such as rheumatoid arthritis drug ALX-0061 which it is developing with partner AbbVie”

Clinical • Immunology • Lupus • Rheumatoid Arthritis

Ablynx: Corporate Presentation (Ablynx) - Anticipated initiation of P2b trial for rheumatoid arthritis in 2015; Anticipated data from P2 trial for rheumatoid arthritis in 2016

Anticipated P2 data • Anticipated trial initiation date • Rheumatoid Arthritis

ALX-0061 phase I bioavailability study in healthy volunteers (clinicaltrials.gov) - P1, N=70; Sponsor: Ablynx; Not yet recruiting -> Recruiting.

Enrollment open • Immunology • Lupus • Rheumatoid Arthritis

Impact of clinical remission on physical function in patients with rheumatoid arthritis treated with ALX-0061: Post-hoc analysis of phase I/II data (ACR-ARHP 2014) - Presentation time: Monday, November 17, 2014; 8:30AM–4:00PM; Abstract #1479; P1/2, N=37; Sponsor: Ablynx; NCT01284569; “At week 24, 62.5% (15/24) of pts treated with ALX-0061 achieved DAS28_2.6 remission, while remission using the more stringent Boolean criteria was observed in 29.2% (7/24) of the pts....between 12 and 24 wks, approximately one third, i.e. 37.5% and 29.2%, of pts treated with ALX-0061 remained in DAS28 remission during the last 3 (at wks 16, 20, and 24) and 4 (at wks 12, 16, 20, and 24) consecutive time points, respectively.”

P1/2 data • Immunology • Rheumatoid Arthritis

Ablynx: Corporate Presentation (Ablynx) - Anticipated initiation of P2 trial (NCT02437890) in SLE in mid-2015; Anticipated top-line data from P2 trial (NCT02437890) in SLE in 2018

Anticipated P2 data • Anticipated trial initiation date • Immunology

Results of a Phase IIb Study of Vobarilizumab, an Anti-Interleukin 6 Receptor Nanobody®, in Patients with Moderate-to-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate (CRA-AHPA 2017) - "In patients with active RA despite methotrexate, treatment with vobarilizumab (150mg q4w, 150mg q2w and 225mg q2w) had a positive impact on disease activity with a compelling safety profile. A striking placebo effect was observed and is under investigation. Overall, the results support the advancement of vobarilizumab into phase III of development."

Adverse events • Clinical • P2 data • Biosimilar • Immunology • Rheumatoid Arthritis

Ablynx: FY 2015 Results (Ablynx) - Anticipated top-line data from P2b combination trial (NCT02309359) in rheumatoid arthritis in H2 2016; Anticipated top-line data from P2b monotherapy trial (NCT02287922) in rheumatoid arthritis in H2 2016; Anticipated top-line data from P2 open label extension study (NCT02518620) in rheumatoid arthritis in H2 2018; Anticipated initiation of P3 trial in rheumatoid arthritis in H2 2017

Anticipated new P3 trial • Anticipated P2 data • Anticipated P2b data • Immunology • Rheumatoid Arthritis

Ablynx reports positive phase I data for ALX-0061 in rheumatoid arthritis (Ablynx) - P1/2, N=28; Pts received either placebo or a single dose of ALX-0061 IV; The study treatment was safe & well tolerated, & the biological effective doses were achieved at the doses established in the pre-clinical studies; The dose-dependent changes of the assessed biomarkers of early inflammation (CRP, fibrinogen & platelets) were consistent with the inhibition of the IL-6 pathway; P2 trial has been initiated; Anticipated enrollment for P2 is 36 pts; Anticipated interim P2 data in Q1 '12 with final data expected in Q2 '12

Anticipated P2 data • Anticipated P2 enrollment • P1 data • P2 initiation • Immunology • Rheumatoid Arthritis

Ablynx: Corporate Presentation (Ablynx) - "Efficacious: ACR20, ACR50 and ACR70 scores of up to 100%, 75% and 63%, respectively"; "Up to 75% of patients in DAS28 remission"; "Up to 38% of patients in boolean remission"; "First onset of remission as of week 2"; "Early signs of effect on bone oedema"; "No disease progression as determined by MRI"; "Wide therapeutic window with option to dose every two months"; "Well-tolerated and favourable safety profile across all doses"

P2 data • Immunology • Rheumatoid Arthritis

Ablynx: Goldman Sachs Biotech Symposium (Ablynx) - Anticipated initiation of P2b trial for RA in Q1 2015; Anticipated initiation of P2b trial for SLE in Q1 2015; Anticipated P1 data for subcutaneous formulation for RA in Q4 2014  

Anticipated new P2b trial • Anticipated P1 data • Immunology • Rheumatoid Arthritis

Ablynx: Annual Report 2015 (Ablynx) - Anticipated top-line data from P2b combination trial (NCT02309359) in rheumatoid arthritis in Q3 2016; Anticipated top-line data from P2b monotherapy trial (NCT02287922) in rheumatoid arthritis in Q3 2016

P2b data • Immunology • Rheumatoid Arthritis

Ablynx: Corporate Presentation (Ablynx) - "ALX-0061 – compelling proof-of-concept Phase IIa results"; "Treatment showed strong efficacy and was well tolerated at all doses"; "No increase of adverse events upon extension of treatment"; "No anti-drug antibodies were detected" 

P2 data • Rheumatoid Arthritis

ALX0061 interim P2 results (Ablynx) - P2, N=72; NCT01284569; Consistent reduction of disease activity across all dose levels; DAS28 remission up to 60%

P2 data • Rheumatoid Arthritis

Ablynx: Corporate Presentation (Ablynx) - "Phase IIb combination therapy (+ MTX)"; "Up to 49% of patients in clinical remission at week 24"

P2b data • Immunology

Ablynx: FY 2014 Results (Ablynx) - "ALX-0061 - key milestones in clinical development"; "Phase I sc study"; "ALX-0061 showed >80% bioavailability after sc injection"

P1 data • Rheumatoid Arthritis

Twenty-four weeks of treatment with a novel anti-IL-6 receptor nanobody (ALX-0061) resulted in 84% ACR20 improvement and 58% das28 remission in a phase I/II study in RA (EULAR 2013) - Presentation time: 13.06.2013; 10:50; Abstract #OP0043; P1/2, N=65; Sponsor: Ablynx; NCT01284569; "After 24 weeks of treatment, a total of 18 patients (58%) on ALX-0061 achieved DAS28 remission, of which 8 achieved Boolean remission. All DAS28 components contributed evenly and onset of remission occurred as early as week 2 for certain patients. Clinically meaningful improvements for bone oedema were observed and the global RAMRIS scores showed no worsening after 24 weeks."

P1/2 data • Immunology • Rheumatoid Arthritis

Ablynx: Corporate Presentation (Ablynx) - "ALX-0061 - compelling Phase IIa results in RA patients"; "Treatment was highly efficacious and was well tolerated at all doses"; "No increase of adverse events upon extension of treatment"; "No anti-drugs antibodies were reported"

P2a data • Rheumatoid Arthritis