Seoul National University Bundang Hospital Establishes the first "International PSP Research and Treatment Center" in Korea

• MOU Signed Among SNUBH-CurePSP-GemVax for the Establishment of International PSP Research and Treatment Center
• Tackling Global Challenges in an Aging Era… "Aspiring to become a global research and treatment hub for the rare neurodegenerative disease"

SEOUL, South Korea, Dec. 9, 2024 /PRNewswire/ -- Seoul National University Bundang Hospital ("SNUBH"), CurePSP, Inc. ("CurePSP") and GemVax & KAEL Co., Ltd. ("GemVax"; KOSDAQ: 082270) have announced the establishment of Korea's first International Progressive Supranuclear Palsy ("PSP") Research and Treatment Center.

On December 6, the three organizations signed a tripartite Memorandum of Understanding ("MOU") to create a comprehensive center, dedicated to advancing research and treatment for PSP and other neurological conditions as well as various conditions related addictions. This initiative aims to address the pressing global challenges posed by such conditions in an aging society through advancements in research, education, medical care, treatment and commercialization thereof.

The signing ceremony took place at 11 a.m. in the main conference room of Seoul National University Bundang Hospital, attended by key figures including Dr. Junghan Song, President & CEO of SNUBH; Professor Sanghoon Jheon; Dr. Kristophe Diaz, Executive Director & CSO of CurePSP; and Mr. Sukjoon Lee, CEO of GemVax.

The International PSP Research and Treatment Center (the "Center") will integrate the infrastructure and expertise of the three parties to execute a comprehensive array of functions, including education, research, and treatment, as well as the potential commercialization of therapies for PSP and other neurological conditions. Additionally, the Center will address coexisting or related conditions, including behavioral and neurological disorders linked to addiction, with a specific focus on substance abuse.

SNUBH will support the stable operation of the center and lead advancements in medical care, education, and research. CurePSP, a U.S.-based nonprofit charitable organization, drawing upon its 30 years of global experience, will act as an advisor, connector, and subject matter expert in all aspects of the Center's development and will provide guidance on best practices for PSP care, education, and research initiatives while leveraging its extensive global network to establish the international connections necessary for the Center's success. GemVax will provide funding and oversee the process necessary for the establishment of the Center while spearheading the research, development, and commercialization of PSP therapeutics.

The Center is expected to achieve world-class competitiveness by integrating the infrastructure and expertise of the participating institutions. It aims to make a significant contribution to public welfare, particularly for socially marginalized groups, while enhancing Korea's global leadership in the field of neurodegenerative and neurological care.

Dr. Junghan Song, President & CEO of SNUBH, stated, "The establishment of the International PSP Research and Treatment Center is expected to serve as a significant turning point in providing practical support to patients with rare and intractable diseases. SNUBH will make every effort to play a leading role in research and treatment development to overcome neurodegenerative diseases, building on the collaboration with CurePSP and GemVax."

Professor Sanghoon Jheon of SNUBH remarked, "SNUBH is dedicated to advancing global standards in education, research, and medical care, ensuring that humanity can enjoy healthier and happier lives. The International PSP Research and Treatment Center will focus its efforts on becoming an international hub for fostering exceptional professionals and advancing research to conquer rare and intractable diseases."

Dr. Kristophe Diaz, Executive Director of CurePSP, stated, "During this visit, I met with Korean PSP patients, their families, and the healthcare professionals providing their care to assess the current state of patient support and treatment. I also engaged in discussions with members of the National Assembly and government officials about international systems and support measures for overcoming rare and intractable diseases and developing effective treatments." He added, "We are deeply grateful to the Korean companies and government for their dedication to conquering PSP, and CurePSP will actively collaborate to strengthen the capabilities of the newly established International PSP Research and Treatment Center in Korea through our global network and expertise."

CurePSP is the leading nonprofit organization dedicated to the awareness, care and cure for three neurodegenerative diseases: progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and multiple system atrophy (MSA). As a catalyst for new treatments and a cure, CurePSP establishes important partnerships and funds critical research internationally. Through its advocacy and support efforts, CurePSP enhances education, care delivery and quality of life for people living with PSP, CBD and MSA and their families. Science, community and hope are at the heart of CurePSP's mission and all its services. CurePSP is a registered 501(c)(3) charity within the United States (EIN: 52-1704978)

Sukjoon Lee, CEO of GemVax expressed optimism, stating, "The International PSP Research and Treatment Center will elevate Korea's capabilities in medical care, professional training and new drug development for rare diseases to a global standard." He added, "We hope the center will serve as a hub for quickly delivering safe and effective treatments to patients with rare neurodegenerative diseases both domestically and internationally, while providing world-class care." Lee further emphasized, "The company will also focus on upcoming PSP clinical trials and ALS research to ensure that new treatments can reach the market as swiftly as possible."

PSP is an intractable Parkinson's syndrome, a neurodegenerative disease with symptoms similar to Parkinson's, but with a rapid progression and no fundamental cure. Key symptoms include gait disturbance, postural instability, cognitive decline, eye movement disorders, and sleep disturbances, and the cause of the disease is still unknown.

In October, GemVax presented topline results from its GV1001 Phase 2 clinical trial for PSP at the Neuro2024 conference held in Canada. The company plans to conduct global Phase 3 clinical trial for PSP in due course.

About Phase 2a PSP Clinical Trial (NCT05819658)

The Phase 2a PSP clinical trial was a 24-week, multicenter, randomized, double-blind, placebo-controlled, prospective phase 2a exploratory clinical trial to evaluate the safety and efficacy of GV1001 0.56 mg or 1.12 mg compared to placebo for the treatment of patients with PSP. The primary outcome of the study was change from baseline in the total score of PSP-Rating Scale after 24 weeks of GV1001 administration. Secondary endpoints included change from baseline in the total score of PSP-Rating Scale at 3 months, MoCA-K, K-FAB and ES-ADL at both 3 and 6 months. Overall safety of GV1001 administration was also assessed.

About GV1001

GV1001 is a synthetic peptide consisting of 16 amino acids based on the key sequence of telomerase. GV1001 has been studied for the potential treatment of neurodegenerative diseases including Alzheimer's disease and PSP. In neurodegenerative diseases, GV1001 has been demonstrated to modulate phenotypes of glial cells, and to regulate neuroinflammation. In addition to the Phase 2a PSP clinical trial, a Phase 2 Alzheimer's disease clinical trial of GV1001 is currently ongoing in the U.S. and Europe (NCT05189210).

About PSP

Progressive supranuclear palsy is a rare progressive and adult-onset neurodegenerative disease that currently has no disease-modifying drug. Approximately seven in 100,000 people worldwide is affected by PSP and is more common in men. People over the age of 60 are mainly affected. The symptoms of PSP include loss of balance, changes in personality, weakness of eye movements, especially in the downward direction, difficulty in swallowing, slurred speech and cognitive impairment. 

About GemVax & KAEL

GemVax & KAEL Co., Ltd. is a pioneering clinical-stage biopharmaceutical company based in Korea, dedicated to developing proprietary therapeutics for neurodegenerative diseases including progressive supranuclear palsy and Alzheimer's disease. As for PSP, GemVax is currently conducting a Phase 2a study in Korea to evaluate the efficacy and safety of GV1001 in patients with PSP. Preparations are also underway for a global PSP clinical trial. In addition, GemVax is currently conducting a Phase 2 Alzheimer's disease clinical trial in the U.S. and Europe. For more information, visit www.gemvax.com and follow us on Linkedin. 

Forward-Looking Statements

This document contains information that includes or is based upon "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements may or may not include identifying words such as "plan," "will," "expect," "anticipate," "intend," "believe," "potential," "continue," and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties. All forward-looking statements are based on management's current estimates, projections, and assumptions, and GemVax undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.

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