ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer’s Disease
May 08 2023 - 9:00AM
- In preclinical studies, PMN310 demonstrated the ability to
selectively target and protect against pathogenic Aβ oligomers
- The IND clearance of PMN310 in the Alzheimer’s disease
indication paves the way for initiation of clinical evaluation
ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN),
a biotechnology company focused on the generation and development
of antibody therapeutics targeting toxic misfolded proteins in
neurodegenerative diseases such as Alzheimer’s disease (AD),
amyotrophic lateral sclerosis (ALS) and multiple system atrophy
(MSA), today announced that it has received clearance from the U.S.
Food and Drug Administration (FDA) for its Investigational New Drug
(IND) application for PMN310 for the treatment of AD. PMN310 is a
novel monoclonal antibody which is designed to be highly selective
for toxic oligomers of amyloid-beta (Aβ) that are believed to be a
major driver of AD.
“Receiving IND clearance for PMN310 marks an important corporate
milestone as we continue towards our goal of delivering
next-generation therapy to patients with Alzheimer’s disease who
have limited options to slow cognitive decline,” said Gail Farfel,
Ph.D., Chief Executive Officer of ProMIS Neurosciences. “Our
preclinical data demonstrated PMN310’s greater selective binding to
toxic oligomers compared to other Aβ-directed antibodies, which we
believe supports the potential clinical profile of PMN310. We look
forward to advancing PMN310 into clinical development and sharing
what we learn from this innovative work.”
In preclinical studies, PMN310 showed strong ex vivo target
engagement of toxic oligomers in brain samples from patients with
AD, with little or no diversion by Aβ monomers or plaque. In a
recent presentation of in vitro data at the AD/PD 2023 conference,
PMN310 was the least impacted by monomer competition, compared to
other Aβ-directed antibodies, resulting in an overall greater
ability to target toxic oligomers. In addition, PMN310 was not
observed to bind to plaque, potentially reducing the risk of
Aβ-related imaging abnormalities (ARIA) observed with
plaque-binding antibodies. The Company believes these data support
a potentially differentiated clinical profile when compared to
other antibody therapeutic candidates in AD.
With the IND clearance for PMN310, the Company plans to initiate
a Phase 1a clinical trial designed to evaluate the
pharmacokinetics, safety and tolerability of a range of PMN310
doses in healthy adult volunteers.
About ProMIS Neurosciences
Inc.
ProMIS Neurosciences Inc. is a development stage biotechnology
company focused on generating and developing antibody therapeutics
selectively targeting toxic misfolded proteins in neurodegenerative
diseases such as Alzheimer’s disease (AD), amyotrophic lateral
sclerosis (ALS) and multiple system atrophy (MSA). The Company’s
proprietary target discovery engine is based on the use of two
complementary techniques. The Company applies its thermodynamic,
computational discovery platform - ProMIS™ and Collective
Coordinates - to predict novel targets known as Disease Specific
Epitopes on the molecular surface of misfolded proteins. Using this
unique approach, the Company is developing novel antibody
therapeutics for AD, ALS and MSA. ProMIS has offices in Toronto,
Ontario and Cambridge, Massachusetts. ProMIS is listed on Nasdaq
and the Toronto Stock Exchange under the symbol PMN.
Forward-Looking Statements
Neither the TSX nor Nasdaq has reviewed and neither accepts
responsibility for the adequacy or accuracy of this
release. Certain information in this news release constitutes
forward-looking statements and forward-looking information
(collectively, “forward-looking information”) within the meaning
of applicable securities laws. In some cases, but not necessarily
in all cases, forward-looking information can be identified by the
use of forward-looking terminology such as “plans”, “excited to”,
“targets”, “expects” or “does not expect”, “is expected”, “an
opportunity exists”, “is positioned”, “estimates”, “intends”,
“assumes”, “anticipates” or “does not anticipate” or “believes”, or
variations of such words and phrases or state that certain
actions, events or results “may”, “could”, “would”, “might”, “will”
or “will be taken”, “occur” or “be achieved”. In addition, any
statements that refer to expectations, projections or other
characterizations of future events or circumstances contain
forward-looking information. Specifically, this news release
contains forward-looking information relating to targeting of toxic
misfolded proteins that the Company believes may directly address
fundamental AD pathology (including the belief and understanding
that toxic oligomers of amyloid-beta are a major driver of AD) and
have greater therapeutic potential due to reduction of off-target
activity, the initiation of the Company’s first-in-human study, and
its ability to enroll the requisite number of patients, dose each
patient in the intended manner and progress the study, statements
related to the presentation of data and the significance of such
data, ProMIS’ pipeline, management’s belief that its patented
platform technology has created an antibody candidate specific to
toxic misfolded oligomers known to be present in Alzheimer’s
disease, and management’s belief that this specificity may indicate
greater therapeutic potential due to lower off-target activity.
Statements containing forward-looking information are not
historical facts but instead represent management's current
expectations, estimates and projections regarding the future of
our business, future plans, strategies, projections, anticipated
events and trends, the economy and other future conditions.
Forward-looking information is necessarily based on a number of
opinions, assumptions and estimates that, while considered
reasonable by the Company as of the date of this news release, are
subject to known and unknown risks, uncertainties and assumptions
and other factors that may cause the actual results, level of
activity, performance or achievements to be materially different
from those expressed or implied by such forward-looking
information, including, but not limited to, the Company’s ability
to fund its operations and continue as a going concern, its
accumulated deficit and the expectation for continued losses and
future financial results. Important factors that could cause actual
results to differ materially from those indicated in the
forward-looking information include, among others, the factors
discussed throughout the “Risk Factors” section of the Company's
most recently filed annual information form available on
www.SEDAR.com, in Item 1A of its Annual Report on Form 10-K for the
year ended December 31, 2022 and the section entitled “Risk
Factors” in its Post-Effective Amendment No. 1 to Form S-1, filed
March 17, 2023, each as filed with the Securities and
Exchange Commission. Except as required by applicable
securities laws, the Company undertakes no obligation to publicly
update any forward-looking information, whether written or oral,
that may be made from time to time, whether as a result of new
information, future developments or otherwise.
For further information:
Visit us at www.promisneurosciences.com
Please submit media inquiries to
info@promisneurosciences.com.
For Investor Relations, please contact: Stern
Investor RelationsSuzanne Messere, Managing
Directorsuzanne.messere@sternir.comTel. 212 698-8801
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