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ProMIS Neurosciences Achieves Milestone in Development of Therapeutic Alpha-Synuclein Vaccine

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ProMIS Neurosciences Inc. (Nasdaq: PMN) has announced the selection of a lead vaccine candidate, PMN400, targeting synucleinopathies including Multiple System Atrophy, Parkinson’s disease, and Dementia with Lewy bodies. The company is focused on developing therapeutics for neurodegenerative diseases by targeting toxic misfolded proteins. This announcement marks a significant advancement in the company's efforts to address these debilitating conditions.
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The announcement of PMN400 as a lead vaccine candidate by ProMIS Neurosciences Inc. represents a significant milestone in the fight against synucleinopathies such as Multiple System Atrophy (MSA), Parkinson’s disease and Dementia with Lewy bodies. These diseases are characterized by the accumulation of misfolded alpha-synuclein proteins, which are believed to play a central role in the pathogenesis of these conditions. The development of a vaccine that can target these toxic proteins offers a potential disease-modifying therapy, which could substantially alter the treatment landscape for patients suffering from these debilitating diseases.

From the perspective of stakeholders, the selection of a lead candidate implies that the company is moving forward from preclinical studies to clinical trials, which is a critical step in the drug development process. This transition often leads to increased investor attention and can affect the company's stock value. Success in clinical trials could greatly increase the company's market capitalization, while failure could have the opposite effect. The long-term implications for patients could be profound, potentially improving quality of life and reducing healthcare costs associated with managing these conditions.

ProMIS Neurosciences' progress in advancing PMN400 has immediate implications for the company's financial health and future prospects. The biotech sector is known for its high volatility, largely due to the binary nature of clinical trial outcomes. The announcement of a lead vaccine candidate typically leads to increased market speculation and can drive short-term stock price movements. Investors will closely monitor the company's burn rate and capital-raising activities, as entering clinical trials is a capital-intensive phase. Furthermore, partnerships or licensing deals could be on the horizon, which could provide non-dilutive funding and validation of the company's technology.

It is important to note that the success rate for drugs entering Phase 1 clinical trials is relatively low and the path to regulatory approval is long and uncertain. Therefore, while the selection of a lead vaccine candidate is a positive development, it is just one of many hurdles the company will need to overcome. Investors should consider the risks associated with drug development, including the possibility of unsuccessful trials or regulatory setbacks.

The therapeutic market for neurodegenerative diseases such as MSA, Parkinson’s disease and Dementia with Lewy bodies is currently underserved, with limited disease-modifying treatments available. The advancement of PMN400 thus represents not only a significant scientific achievement but also a considerable market opportunity for ProMIS Neurosciences. The global Parkinson's disease market alone was valued at several billion dollars and is expected to grow with the aging population. A successful vaccine could capture a substantial share of this market.

Market penetration will depend on several factors including the vaccine's efficacy, safety profile, cost and the ability of ProMIS to establish strong commercialization strategies. Additionally, payer acceptance and reimbursement policies will be crucial for widespread adoption. As the vaccine progresses through clinical trials, real-world data on its impact on disease progression will be key in determining its market potential. The company's ability to communicate this data effectively to clinicians, payers and patients will be critical in gaining market share.

Lead vaccine candidate selected for advancement against synucleinopathies including Multiple System Atrophy, Parkinson’s disease and Dementia with Lewy bodies

CAMBRIDGE, Massachusetts and TORONTO, Ontario, Jan. 22, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of therapeutics targeting toxic misfolded proteins in neurodegenerative diseases, today announced the selection of a lead vaccine candidate, PMN400, against multiple synucleinopathies including Multiple System Atrophy (MSA), Parkinson’s disease and Lewy Body Dementia.

“We are excited about the potential of our ground-breaking technology in neurodegenerative diseases,” said Neil Warma, Chief Executive Officer of ProMIS Neurosciences. “While our primary focus is on the further clinical development of our lead antibody candidate, PMN310, which is currently advancing in a Phase 1a clinical trial for the treatment of Alzheimer’s disease, we are also enthusiastic about the potential of our platform for the development of novel targeted antibody therapeutics and vaccines to combat several of these debilitating diseases. Importantly, this program is supported by a grant that has allowed us to select this promising drug candidate and could enable us to broaden the application of our platform across multiple neurodegenerative diseases using targeted antibody therapeutics and vaccines to bring novel treatments to patients in need.”

The pioneering work that enabled this stage of development to be achieved was made possible through a $1.16 million (CAD) research grant by the Weston Family Foundation to the University of British Columbia to support the research of the team led by Neil Cashman, M.D., ProMIS Chief Scientific Officer and Professor Emeritus at the University of British Columbia. The team also includes Scott Napper, Ph.D., from the Vaccine and Infectious Disease Organization (VIDO) and Professor of Biochemistry, Microbiology, and Immunology at the University of Saskatchewan, Marco Prado, Ph.D., the Canada Research Chair in Neurochemistry of Dementia and Professor of Anatomy & Cell Biology / Physiology and Pharmacology, at the University of Western Ontario, and Joel Watts, Ph.D., Canada Research Chair in Protein Misfolding Disorders and Associate Professor within the Department of Biochemistry and the Tanz Centre for Research in Neurodegenerative Diseases at the University of Toronto.

Using a proprietary computational platform, ProMIS identified potential conformational epitopes (misfolded portions) unique to toxic alpha-synuclein involved in synucleinopathies. Formulations of several of these epitopes were tested in mouse vaccination studies leading to the selection of a lead vaccine candidate for testing in mouse models replicating cognitive and motor deficits of human disease.  

Results from the vaccination studies are being submitted for presentation at the 2024 meeting of the American Academy of Neurology (AAN) taking place from April 13-18, 2024 in Denver, Colorado.

About ProMIS Neurosciences Inc.

ProMIS Neurosciences Inc. is a clinical 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 applies a 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.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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. 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, and subsequent quarterly reports. 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 Relations
Anne Marie Fields, Managing Director
annemarie.fields@sternir.com
Tel. 212-362-1200


FAQ

What is the name of the lead vaccine candidate selected by ProMIS Neurosciences Inc.?

The lead vaccine candidate selected is PMN400.

What are the synucleinopathies targeted by the lead vaccine candidate?

The lead vaccine candidate targets synucleinopathies including Multiple System Atrophy (MSA), Parkinson’s disease, and Lewy Body Dementia.

What is the focus of ProMIS Neurosciences Inc. as a biotechnology company?

ProMIS Neurosciences Inc. is focused on the generation and development of therapeutics targeting toxic misfolded proteins in neurodegenerative diseases.

What is the ticker symbol for ProMIS Neurosciences Inc.?

The ticker symbol for ProMIS Neurosciences Inc. is PMN.

Where is the company headquartered?

The company is headquartered in Cambridge, Massachusetts and Toronto, Ontario.

When was the announcement made?

The announcement was made on January 22, 2024.

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