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Return to: BRIUMVI (ublituximab)
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#Post#: 1712--------------------------------------------------
(CMSC) Ublituximab, going into Phase 3 trials, may be as good as
Ocrevus or better
By: agate Date: June 2, 2017, 7:45 pm
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Presented at the annual CMSC conference (New Orleans, May 2017),
this paper is discussed in MedPage Today, May 28, 2017. The
shorter infusion time (than Ocrevus) looks promising:
[quote]CMSC: Anti-CD20 Tx Offers Rapid B-Cell Depletion in MS
Patients
Agent can be delivered with shorter infusions
by Ed Susman, Contributing Writer, MedPage Today
NEW ORLEANS -- Treatment with ublituximab, an investigational
glycoengineered anti-CD20 antibody, was well tolerated and
demonstrated rapid and robust B-cell depletion in patients with
relapsing or primary progressive multiple sclerosis (MS),
researchers reported here.
"Ublituximab efficiently depletes 99% of B cells, meeting the
endpoint of the greater than 95% depletion within 2 weeks of the
second dose, comparable to ocrelizumab (Orcevus)," said Amy
Lovett-Racke, PhD, of the Ohio State University in Columbus, at
the Consortium of Multiple Sclerosis Centers (CMSC).
However, Lovett-Racke reported that T-cell populations dipped a
bit after patients took ublituximab, but then remained stable
through 24 weeks of therapy.
Ublituximab is a novel chimeric monoclonal antibody targeting a
unique epitope on the CD20 antigen. It is glycoengineered to
enhance affinity for all variants of receptors, thereby
demonstrating greater antibody-dependent cellular cytotoxicity
activity than rituximab (Rituxan) and ofatumumab (Arzerra),
Lovett-Racke said.
Ublituximab is currently in multiple phase III trials for
treatment of hematologic malignancies, Lovett-Racke and
co-authors pointed out. For this MS study, the dose was reduced,
she explained.
The 52-week, phase II, placebo-controlled, multi�center study
was designed to assess the infusion time and optimal dose as
well as safety/tolerability of the agent in relapsing MS
patients The patients were about age 40, and 67% were women. The
mean duration of MS was 8.8 years.
During the placebo run-in phase of the trial, about 5% to 10% of
B cells are in the peripheral blood, and "that is pretty normal
levels of B cells," Lovett-Racke said. She illustrated how one
patient with a normal level of B cells at the start of the
treatment phase of the study showed a "complete loss of B cells
within just 24 hours of treatment. And this loss is maintained
through the initial 4 week period" of analysis.
The researchers studied 60-minute, 90-minute, and 3-hour
infusions schedules. The initial infusion schedule for patients
was 4 hours, and then shortened for the second dose at day 15,
and again at week 24 to 1-1.5 hours. During the first 2 weeks,
each person in the study-drug arm received 450 mg of
ublituximab.
The primary endpoint was the responders rate, defined as the
percentage of patients who achieved a 95% or greater reduction
in peripheral CD19-positive B-cells within 2 weeks of the second
infusion of ublituximab on day 15.
Patients who began the study on placebo showed fluctuating B
cells counts until they were switched over to ublituximab
therapy, and then their B cell levels dropped dramatically.
"After 2 days of treatment with ublituximab, the B cell counts
have effectively dropped to 0 and remains at that level through
week 4 for all the cohorts no matter what their initial therapy
was or how long the infusions took to deliver the drugs,"
Lovet-Racke said.
There were no severe adverse events reported, even in patients
who received rapid infusions with the study drug.
Lovett-Racke also noted that T-cell counts remain stable across
the different subgroups. "There is some fluctuation, but all the
values remain in the normal range," she said.
The authors concluded that "unlike other anti-CD20s, ublituximab
can be delivered in shorter infusions, providing a convenience
benefit for patients."
CMSC session moderator Aliza Ben-Zacharia, DNP, of Mt. Sinai
School of Medicine in New York City, praised the authors for
presenting B-cell and T-cell data.
"One of my concerns is that when you engineer certain molecules,
there can always be some safety concerns," she noted. "When you
manipulate a molecule, what are we creating? I liked that Dr.
Lovett-Racke presented both B-cell and T-cell data. Most of the
time, people just present the B-cell information."
But she cautioned that this was a phase II study, "so we have a
long way to go yet with this molecule before it will be used in
practice."
The study was sponsored by TG Therapeutics. Some co-authors were
company employees.
______________________
Lovett-Racke and Ben-Zacharia disclosed no relevant
relationships with industry.[/quote]
#Post#: 2926--------------------------------------------------
Phase 2 multicenter study of ublituximab in patients w/relapsing
forms of MS
By: agate Date: June 3, 2020, 6:57 pm
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From Multiple Sclerosis Journal (April 30, 2020)--"A phase 2
multicenter study of ublituximab, a novel glycoengineered
anti-CD20 monoclonal antibody, in patients with relapsing forms
of MS":
https://journals.sagepub.com/doi/full/10.1177/1352458520918375
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