Vaccinex Reports Positive Effect of Pepinemab Treatment on New Biomarker of Brain Inflammation in Neurodegenerative Diseases
October 26 2023 - 9:30AM
Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology
company, today reports novel findings for its lead product,
pepinemab, in a highlighted podium presentation at the Clinical
Trials on Alzheimer’s Disease (CTAD) Conference in Boston, MA.
Vaccinex has previously reported results of a phase 2 trial in
Huntington’s disease (HD) that suggest pepinemab treatment prevents
decline in glucose uptake associated with astrocyte activation and
significantly slows cognitive decline as measured by the
Huntington’s Disease Cognitive Assessment Battery (HD-CAB). The
company now reports data indicating that pepinemab treatment
significantly reduced blood levels of GFAP, a biomarker of reactive
astrocytes, providing further evidence of the drug’s potential to
reverse harmful astrocyte activation and brain inflammation.
Astrocytes are key regulatory cells in the brain that, under
conditions of brain injury or disease, switch from their normal
supportive physiological functions to inflammatory activity that is
believed to aggravate damage to brain tissue. This transition is
marked by release of glial fibrillary acidic protein (GFAP), a
characteristic astrocyte protein, into blood. Importantly, results
from a highly sensitive S-PLEX GFAP immunoassay demonstrated a
significant reduction in plasma GFAP levels in HD patients treated
with pepinemab compared to those receiving placebo. Elevated GFAP
levels in blood have also been found to correlate with Aβ amyloid
deposits in brain and to be associated with higher risk of dementia
and faster rates of cognitive decline in AD. A committee convened
by the Alzheimer’s Association has recently recommended GFAP as a
leading blood-based biomarker of astrocytic activation and brain
inflammation in AD.
Given the many physiological parallels between neurodegenerative
processes in HD and AD, we believe that similar biological effects
of pepinemab treatment are likely in the two indications. This is
being tested in an ongoing randomized, placebo-controlled trial,
SIGNAL-AD, supported by awards from the Alzheimer’s Drug Discovery
Foundation and the Alzheimer’s Association, for which it is
anticipated that the last patient will complete 12 months of
treatment by June 2024. Early evidence of limited benefit to AD
patients treated with antibodies to Aβ amyloid has stimulated a
search for differentiated treatments that could further improve
responses. It has been known for some time that beta amyloid
deposits can also be present in the brain of elderly subjects who
do not progress to Alzheimer’s. As noted by Howard Fillit, MD,
Chief Science Officer for the Alzheimer’s Drug Discovery
Foundation, “If there’s no strong immune reaction to the buildup,
there’s no inflammation and no progression of disease.” We believe
that preventing astrocyte activation and reducing brain
inflammation with pepinemab treatment could be an attractive
alternative or complement to anti-Aβ antibodies with potential for
greater efficacy.
About PepinemabPepinemab is a humanized IgG4
monoclonal antibody designed to block SEMA4D, which can trigger
collapse of the actin cytoskeleton and loss of homeostatic
functions of astrocytes and glial cells in the brain and dendritic
cells in immune tissue. Pepinemab has been administered to more
than 400 patients and appears to be well-tolerated and to have a
favorable safety profile.
About Vaccinex Inc.Vaccinex, Inc. is pioneering
a differentiated approach to treating slowly progressive
neurodegenerative diseases and cancer through the inhibition of
semaphorin 4D (SEMA4D). The Company’s lead drug candidate,
pepinemab, is designed to block SEMA4D, a potent biological
effector that is believed to trigger damaging inflammation in
chronic diseases of the brain and inhibit immune infiltration and
activation in tumors. In neurodegenerative diseases, pepinemab is
being studied as a monotherapy in the Phase 1/2a SIGNAL-AD study in
Alzheimer’s Disease, with ongoing exploration of potential Phase 3
development in Huntington’s disease. In oncology, pepinemab is
being evaluated in combination with KEYTRUDA® in the Phase 1b/2
KEYNOTE-B84 study in recurrent or metastatic head and neck cancer
(HNSCC) and in combination with BAVENCIO® in a Phase 1b/2 study in
patients with metastatic pancreatic adenocarcinoma (PDAC). The
oncology clinical program also includes several
investigator-sponsored studies in solid tumors including breast
cancer and melanoma.
Forward Looking StatementsTo the extent that
statements contained in this presentation are not descriptions of
historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,”
or “our”), they are forward-looking statements reflecting
management’s current beliefs and expectations. Such statements
include, but are not limited to, statements about the use and
potential benefits of pepinemab in neurodegenerative diseases like
AD and HD, and cancer, and other statements identified by words
such as “anticipate,” “believes,” “appears,” and similar
expressions or their negatives (as well as other words and
expressions referencing future events, conditions, or
circumstances). Forward-looking statements involve substantial
risks and uncertainties that could cause the outcome of our
research and pre-clinical development programs, clinical
development programs, future results, performance, or achievements
to differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, uncertainties inherent in the execution, cost and
completion of preclinical studies and clinical trials, that interim
and preliminary data may not be predictive of final results and
does not ensure success in later clinical trials, uncertainties
related to regulatory approval, risks related to our dependence on
our lead product candidate pepinemab, the impact of the COVID-19
pandemic, the possible delisting of our common stock from Nasdaq if
we are unable to regain compliance with the Nasdaq listing
standards, and other matters that could affect our development
plans or the commercial potential of our product candidates. Except
as required by law, we assume no obligation to update these
forward-looking statements. For a further discussion of these and
other factors that could cause future results to differ materially
from any forward-looking statement, see the section titled “Risk
Factors” in our periodic reports filed with the Securities and
Exchange Commission (“SEC”) and the other risks and uncertainties
described in the Company’s annual year-end Form 10-K and subsequent
filings with the SEC.
Investor ContactElizabeth Evans, PhDChief
Operating Officer, Vaccinex, Inc.(585)
766-2033eevans@vaccinex.com
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