`
`Page 1 of 3
`
`Ablynx Drug Fails Again in
`Mid-Stage Trial
`
`Published: Mar 26, 2018
`
`By Alex Keown
`
`’s anti-IL-6R
`For the second time
`Ablynx
`Nanobody, vobarilizumab has failed to pass
`muster. This morning Belgium-based company
`said
`vobarilizumab did not meet primary
` in a Phase II dosing study for lupus
`endpoints
`patients.
`
`The primary endpoint of the mid-stage study was
`the percentage of subjects who achieved a dose-
`response at Week 24. Ablynx said there was no
`dose-response reported in patients after the 24
`week period, according to a modified BILAG-
`based combined lupus assessment (mBICLA). The
`312 patient trial tested four dose regimens of
`vobarilizumab plus one placebo dose in patients
`with moderate to severe, active seropositive
`systemic lupus erythematosus (SLE).
`
`Systemic lupus erythematosus, the most
`common form of lupus, is an autoimmune
`disorder that triggers inflammation in different
`tissues of the body. SLE causes the immune
`system attacks its own tissues and causes
`
`https://www.biospace.com/article/ablynx-drug-fails-again-in-mid-stage-trial
`
`7/21/2019
`
`Lassen - Exhibit 1063, p. 1
`
`
`
`Ablynx Drug Fails Again in Mid-Stage Trial | BioSpace
`
`Page 2 of 3
`
`widespread inflammation and tissue damage in
`the affected areas, according to the U.S. Centers
`for Disease Control and Prevention.
`Approximately five million people suffer from a
`form of SLE. About 90 percent of diagnosed
`patients are women.
`
`In its announcement the company did not
`present full data regarding the failure, but it
`noted that demographics and baseline
`characteristics were similar across all treatment
`arms and were reflective of a typical SLE
`population. Ablynx did note that there were
`adverse events reported in 12.4 percent of all
`patients treated with vobarilizumab, including
`two deaths. That was in comparison to 6.5
`percent treatment-emergent adverse events in
`the placebo group.
`
`Vobarilizumab targets the interleukin 6 pathway
`via its IL-6 receptor (IL-6R). IL-6 is a pro-
`inflammatory cytokine that plays a role in T-cell
`activation, production of acute phase proteins in
`response to inflammation, induction of
`immunoglobulin production, and stimulation of
`osteoclast differentiation and activation.
`
` “We are disappointed that vobarilizumab didn't
`show a dose-response in the analysis of the
`study's primary endpoint, however,
`vobarilizumab was well tolerated in all tested
`dose groups, confirming its favorable safety
`profile. We will continue to analyze the full data
`set and thank the study participants and their
`families as well as the investigators and staff who
`contributed to this study,” Robert K. Zeldin, chief
`medical officer at Ablynx, said in a statement.
`
`https://www.biospace.com/article/ablynx-drug-fails-again-in-mid-stage-trial
`
`7/21/2019
`
`Lassen - Exhibit 1063, p. 2
`
`
`
`Ablynx Drug Fails Again in Mid-Stage Trial | BioSpace
`
`Page 3 of 3
`
`In 2016 vobarilizumab failed to meet endpoints in
`a Phase IIb trial for rheumatoid arthritis. That
`failure prompted
` to
`AbbVie
`terminate a 2013
` that gave it developmental and
`agreement
`commercial options for the drug in RA. However,
`under the initial agreement, AbbVie also has
`rights to vobarilizumab as an SLE treatment. In its
`announcement today Ablynx said AbbVie will
`review the Phase II lupus data to determine
`whether or not to exercise its option to license
`vobarilizumab.
`
`“Should AbbVie exercise the option, it would trigger a
`payment to Ablynx. If the option is not exercised,
`Ablynx's agreement with AbbVie would terminate,” the
`company said.
`
`The news of the vobarilizumab failure in lupus
`comes two months after Ablynx agreed to be
`acquired by
` in a
`Sanofi
`deal worth $4.8 billion.
`Sanofi’s key interest was Ablynx’s lead compound
`caplacizumab (anti-vWF Nanobody), which is
`being developed as a treatment for acquired
`thrombotic thrombocytopenic purpura (aTTP).
`
`https://www.biospace.com/article/ablynx-drug-fails-again-in-mid-stage-trial
`
`7/21/2019
`
`Lassen - Exhibit 1063, p. 3
`
`
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