Nasdaq Grants Vaccinex Extension Until March 4, 2024 to Regain Compliance with Listing Rule
December 04 2023 - 8:00AM
Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology
company pioneering a differentiated approach to treating
Alzheimer’s disease and cancer, previously reported that on October
10, 2023 it was advised by Nasdaq that the Company was no longer in
compliance with Nasdaq’s minimum bid price requirement and that
Nasdaq could move to suspend trading of the common stock and to
delist the Company’s securities unless the company appealed
Nasdaq’s determination. The Company appealed that decision and has
been granted an exception until March 4, 2024 to address this
issue. Subject to fulfilling its commitments to Nasdaq, it is
expected that Vaccinex shares will continue to be listed on the
Nasdaq Capital Market throughout this time and subsequently if
compliance is restored.
Vaccinex continues to advance its key programs
with particular focus on a potential near-term catalyst, the
randomized phase 2 trial of its pepinemab antibody to counter
neuroinflammation in Alzheimer’s disease (AD). The last patient in
this trial is expected to complete the planned 12-months of
treatment by early June 2024. Key endpoints include brain metabolic
activity, a recognized biomarker of clinical progression in AD, as
well as treatment effects on cognition employing several validated,
clinically meaningful Alzheimer’s cognitive scales.
Investors will recall that Vaccinex has
previously completed a randomized phase 2 study in Huntington’s
disease (HD) in which it was demonstrated that pepinemab treatment
significantly reduced characteristic decline in brain metabolic
activity as measured by FDG-PET imaging and also reduced or
prevented cognitive decline. There are numerous physiological
parallels between neurodegenerative processes in Alzheimer’s and
Huntington’s disease. A key common feature is the contribution of
reactive astrocytes (astrogliosis) to brain inflammation and
damage. Vaccinex scientists have demonstrated that the stress of
disease in both AD and HD leads to upregulation of SEMA4D in
neurons that can trigger astrogliosis resulting in a loss of normal
supportive physiological functions such as brain metabolic activity
and a gain of inflammatory activity marked by release of glial
fibrillary acidic protein (GFAP) into the blood. Importantly,
treatment with pepinemab in HD patients was shown to reverse
disease associated changes in these two biomarkers, which we
believe is evidence that pepinemab prevents astrocyte activation.
Elevated plasma GFAP levels have also been reported to correlate
with Aβ amyloid deposits in brain of patients with AD and to be
associated with higher risk of dementia and faster rates of
cognitive decline. We believe that these findings portend a
potentially favorable clinical outcome for pepinemab treatment in
AD.
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 other glial cells in the
brain and of innate immune cells that regulate immune responses.
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, blocks SEMA4D, a potent
biological effector that it believes triggers damaging inflammation
in chronic diseases of the brain and prevents immune infiltration
into 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, supported by funding from Gateway Discovery Foundation, 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.
Vaccinex has global commercial and
development rights to pepinemab and is the sponsor of the
KEYNOTE-B84 study which is being performed in collaboration
with Merck Sharp & Dohme Corp, a subsidiary of Merck and
Co, Inc. Kenilworth, NJ, USA. Additional information
about the study is available at: clinicaltrials.gov.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ,
USA.
BAVENCIO®/avelumab is provided by Merck KGaA,
Darmstadt, Germany, previously as part of an alliance between
the healthcare business of Merck KGaA and Pfizer.
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 our ability to regain compliance with the minimum
bid price standard, the continued listing of our common stock on
the Nasdaq Capital Market, our plans, expectations and objectives
with respect to the results and timing of the KEYNOTE-B84 clinical
trial, planned interim analysis, the use and potential benefits of
pepinemab in R/M HNSCC, lung cancer, metastatic pancreatic
adenocarcinoma (PDAC) and other indications, the potential for
benefits as compared to single agent KEYTRUDA® or BAVENCIO®,
expectations with respect to the collaboration of Merck,
expectations and objectives with respect to the results and timing
of the SIGNAL-AD clinical trial, the potential to initiate a Phase
3 trial in HD and any impact from ongoing FDA discussions, the
expected timeline for disclosure of trial results at scientific
conferences or through publications, and other statements
identified by words such as “believes,” “being,” “may,” “will,”
“appears,” “expect,” “continue,” “estimate,” “ongoing,”
“potential,” “prevents,” “suggest”, 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, our ability to regain
compliance with the minimum bid price standard, the possible
delisting of our common stock from Nasdaq if we are unable to
comply with Nasdaq listing standards, whether Nasdaq will confirm
that we have regained compliance with the minimum bid price
standard or otherwise grant further relief from delisting,
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, 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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