National Research Council of Canada

Completion of cash acquisition of licenced cord blood bank expanding CytoMed’s strategy to cord blood-derived biologics through its subsidiary, LongevityBank Pte LtdSINGAPORE, Oct. 07, 2024 (GLOBE NEWSWIRE) -- CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or the “Company”), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the treatment of various cancers including blood and solid cancers has obtained full approval for its first-in-human Phase I clinical trial (“ANGELICA Trial”) using its patented allogeneic chimeric antigen receptor T cell (“CAR-T cell”) against several blood and solid tumors in collaboration with the National University Hospital (“NUH”) of Singapore. The ANGELICA Trial is co-supported by the Singapore Ministry of Health through the National Medical Research Council (“NMRC”) Office, and MOH Holdings Pte Ltd under the NMRC Clinical Trial Grant Industry Collaborative Trials (CTG-ICT) scheme (MOH-001646). Grant details are confidential. CAR-T cell therapy is currently an individualised treatment that typically involves taking a patient’s blood cells and modifying these in the laboratory by grafting an artificial protein, known as a chimeric antigen receptor, on the surface of T cells, a type of white blood cells. The modified T cells are then re-infused into the patient to target and destroy cancer cells. Unlike chemotherapy which targets all actively dividing cells including healthy ones, CAR-T cells specifically recognise targets present on cancer cells (antigens) to kill them, thus sparing healthy cells. The ANGELICA Trial taps on blood drawn from young healthy donors, potentially improving the quality of CAR-T cells manufactured, lowering production costs and increasing patients’ timely access to therapy since they can be produced off-the-shelf en masse. Current established CAR-T cell therapies use alpha-beta T cells, a type of immune cells which are largely non-transferable between individual human beings due to the high risk of graft-versus-host disease where the graft attacks the host. CytoMed’s ANGELICA Trial uses a rare subtype of immune cells known as gamma delta T cells which can be modified from healthy donors and re-infused into un-related patients without the need for matching. Dr Anand Jeyasekharan, lead investigator of the study and Senior Consultant, Department of Haematology-Oncology, National University Cancer Institute, Singapore (NCIS), said: “ANGELICA is a first-in-class innovative approach to allogenic CAR-T cell therapy for solid cancers. This investigator-initiated trial protocol has been carefully developed with a team of experts in early phase trials, CAR-T cells and allogenic transplantation. With the support from the NMRC CTG-ICT, we eagerly look forward to initiating the enrolment of patients with relapsed cancer for whom this may represent a new option for treatment.” “We are thrilled to collaborate with NUH, and we hope to provide a meaningful contribution to the development of donor blood immuno-therapy for the treatment of advanced solid and haematological (liquid) tumours in Singapore and worldwide,” says Dr Tan Wee Kiat PhD, the Co-CEO and COO of CytoMed Therapeutics. Chairman Peter Choo commented, “This trial will give significant impetus to CytoMed to forge ahead and develop our repertoire of affordable, allogeneic off-the-shelf immune cell therapies for life-threatening diseases especially cancers.” The ANGELICA Trial comprises two parts. Part 1 (donor protocol) is ongoing with the recruitment of healthy blood donors at NUH. With the continued collaboration between CytoMed Therapeutics and NUH, Part 2 of the trial (recipient protocol) may now proceed with the recruitment of patients who have advanced cancers that are resistant to standard therapy regimens. On a separate note, CytoMed has taken over the assets and licence of a licenced cord blood bank in Malaysia using internal cash resources. Please refer to CytoMed’s announcement on July 17, 2024 and October 3, 2024. This acquisition will sharpen CytoMed’s strategy in cell therapies as it now has access to rare and precious cord blood donated for research and development. There is abundant clinical evidence on cord blood-derived biologics for a wide range of aging diseases and regenerative medicine. This new biotechnology arm will be undertaken through CytoMed’s subsidiary, LongevityBank Pte Ltd. The latter is the holding company of IPSC Depository Sdn Bhd which holds the cord blood banking licence issued by the Ministry of Health, Malaysia. CytoMed will host an earnings conference call to discuss its six months ended June 30, 2024 financial results on October 8, 2024, at 9 a.m. ET (9 p.m. SGT). The investment community may participate in the conference call by tuning into the following Zoom: https://us06web.zoom.us/meeting/register/tZMrcOmppj0sGdA37lASywTyixRflo9w1TZT We encourage stakeholders to join the call, particularly if you have any questions regarding this announcement. In addition, the management team will be available for meetings in New York City from October 28, 2024, to November 1, 2024. Shareholders and potential investors interested in scheduling a meeting can reach out to enquiry@cytomed.sg. About CytoMed Therapeutics Limited (CytoMed) Incorporated in 2018, CytoMed was spun off from the Agency for Science, Technology and Research (A*STAR), Singapore’s leading research and development agency in the public sector. It is a biopharmaceutical company focused on harnessing its licensed proprietary technologies, namely gamma delta T cell and iPSC-derived gamma delta Natural Killer T cell, to create novel cell-based allogeneic immunotherapies for the treatment of various human cancers. The development of novel technologies has been inspired by the clinical success of existing CAR-T therapies in treating haematological malignancies, as well as the current clinical limitations and commercial challenges in extrapolating the CAR-T principle into the treatment of solid tumours. For more information, please visit www.cytomed.sg and follow us on Twitter (“X”) @CytomedSG, on LinkedIn, and Facebook About the National Medical Research Council (NMRC) The NMRC was established in 1994 to oversee research funding from the Ministry of Health and support the development and advancement of biomedical research in Singapore, particularly in the public healthcare clusters and medical schools. NMRC engages in research strategy and planning, provides funding to support competitive research grants and core research enablers, and is responsible for the development of clinician scientists through awards and fellowships. The council’s work is supported by the NMRC Office which is part of MOH Holdings Pte Ltd. Through its management of the various funding initiatives, NMRC promotes healthcare research in Singapore, for better health and economic outcomes. Forward-Looking Statements This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as "may, "will, "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company's expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the following: the Company's plans to develop and commercialize its product candidates; the initiation, timing, progress and results of the Company's current and future pre-clinical studies and clinical trials and the Company's R&D programs; the Company's expectations regarding the impact of future COVID-19 outbreak on its business, the Company's industry and the economy; the Company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company's ability to successfully acquire or obtain licenses for additional product candidates on reasonable terms; the Company's ability to establish and maintain collaborations and/or obtain additional funding and assumptions underlying or related to any of the foregoing and other risks contained in reports filed by the Company with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof. Contact : CytoMed Therapeutics Limitedenquiry@cytomed.sgAttention : Evelyn TanChief Corporate Officer, CytoMed Therapeutics Limited; Chief Executive Officer, IPSC Depository Sdn Bhd

A new study has highlighted the widespread use of physical restraints among caregivers of older adults with advanced dementia living at home, revealing a need for better guidance and alternative care approaches. A new study from Duke-NUS Medical School has highlighted the widespread use of physical restraints among caregivers of older adults with advanced dementia living at home, revealing a need for better guidance and alternative care approaches. Nearly half (47%) of the caregivers surveyed reported physical restraints were used on family members with dementia, pointing to a gap in support and resources. In Singapore, the ageing population is growing rapidly, with those aged 65 and older expected to comprise nearly a quarter of the population by 2030[1]. Among this demographic, at least 10% are expected to develop dementia[2]. While the use of restraints has been extensively studied and largely prohibited in nursing homes in other countries, this study is the first to examine their prevalence and the factors leading to their use in home settings, where the majority of older adults with dementia in Singapore receive care. Assistant Professor Chetna Malhotra from the Lien Centre for Palliative Care at Duke-NUS, who supervised the study, said: "The care of older adults with severe dementia presents unique challenges, especially when physical restraints are involved. These practices, while sometimes used out of a perceived necessity for safety, can impact older adults' physical and psychological health. It has also been associated with depression, post-traumatic stress, incontinence and increased rate of cognitive decline." The study, published in the Journal of the American Geriatrics Society, surveyed 215 family caregivers of patients with advanced dementia. The participants were recruited from public hospitals, home care foundations and hospices between May 2018 and March 2021. The researchers found that common types of restraints used included belts or sheet ties (56%), locked geriatric chairs with fixed tray tables (35%), hand mittens (31%) and ankle or wrist ties (25%). The most common reasons for using these items were: safety (protection from falls and preventing of wandering), preventing removal of catheters or feeding tubes and managing agitated behaviour. However, the research team pointed out that feeding tubes have not been shown to improve quality of life or prolong survival for older adults with severe dementia. Instead, clinical guidelines recommend careful hand feeding. Likewise, agitation is a complex response behaviour that can be particularly taxing for caregivers when accompanied by irritability, restlessness or in rare cases, violence. It also signals unmet needs or a deterioration in health. Caregivers may need help to identify the source of the behaviour and come up with a way to manage it (e.g., reducing noise levels or playing soothing music) that provides compassionate and responsive care while avoiding restraints. Survey respondents were divided on how physical restraints affected older adults' quality of life with 39 per cent suggesting it was not affected, 44 per cent indicating reduced, and 17 per cent indicating improved. The study also found that caregivers who had strong emotional support from friends were less likely to report restraint use. On the other hand, caregivers with higher psychological distress, or who had other caregiving responsibilities, were more likely to report restraint use. Dr Ellie Bostwick Andres, first author of the paper and a senior research fellow from the Lien Centre for Palliative Care at Duke-NUS, said: "There is a concern for caregivers under pressure without adequate support. Many caregivers, struggling to balance employment and caregiving, view restraints as a necessary measure for safety. Unfortunately, they might not be fully aware of the detrimental effects these can have on their loved ones." Professor Patrick Tan, Senior Vice-Dean for Research at Duke-NUS, said: "As Singapore confronts the challenges of an ageing population, understanding the use of restraints in home care is critical. This study not only raises awareness but also calls for a shift towards more supportive approaches to dementia care at home, ensuring better outcomes for older adults and their families." Duke-NUS is a leader in medical research and education, with a commitment to improving patient care through innovative scientific discovery. This study is part of its ongoing efforts to enhance palliative care research and education, especially for patients with neurological conditions in our ageing population. This work was supported by the Singapore Ministry of Health through the National Medical Research Council Office, MOH Holdings Pte Ltd, under its Health Services Research Grant (NMRC/HSRG/0081/2017), and Lien Centre for Palliative Care Research Award. [1] Population in Brief. 2021 [2]

Fast Track Designation underscores the high unmet medical need for treatment and prevention of acute respiratory distress syndrome (ARDS) TORONTO--(BUSINESS WIRE)-- Vasomune Therapeutics, Inc., has announced today that the US Food and Drug Administration (FDA) granted Fast Track designation for AV-001 for the prevention or treatment of moderate-to-severe ARDS in patients hospitalized with viral and/or bacterial respiratory infections. AV-001 is a first-in-class fully synthetic PEGylated peptide targeting the Tie2 receptor which plays a critical role in vascular stability, barrier integrity and endothelial quiescence, particularly within the pulmonary space. Fast track designation represents a significant regulatory milestone and has been granted based on the potential for AV-001 to address an unmet medical need in ARDS, a global disease characterized by extremely high mortality rates, reaching up to 46% in patients with severe cases. Data from the Phase 1 study established safety, a pharmacokinetic pro to once-daily dosing and Tie2 activation demonstrating strong on-target activity. With the co-development support of AnGes Inc., AV-001 is currently in a Phase 2a clinical trial for prevention and treatment of ARDS in pneumonia and is actively recruiting. “Vasomune is focused on the persisting unmet needs of people grappling with ARDS and other diseases driven by vascular endothelial instability,” said Dr. Brian Jahns, President and Chief Operating Officer. “Vasomune is indebted to the United States Department of Defense Congressionally Directed Medical Research Programs award #PR191212 for support to advance AV-001 to the clinic and award #PR203503 for support to research AV-001 in Phase 2a. Vasomune is also grateful to the National Research Council of Canada Industrial Research Assistance Program for providing research and development funding which supported the Phase 1 study.” Ei Yamada, President & CEO of AnGes, said that “The FDA’s support of expedited development marks another important milestone in our endeavor to change the treatment paradigm with AV-001. We look forward to future success with the Phase 2a study, AV001-004.” About AV-001 Originally discovered and designed at Sunnybrook Research Institute at Sunnybrook Hospital in Toronto, AV-001 is being developed by Vasomune Therapeutics, Inc. under a co-development agreement with AnGes, Inc. [TYO: 4563]. AV-001 is a novel investigational medicine that targets the Tie2 receptor, a transmembrane protein most highly expressed on the surface of endothelial cells in the vasculature. AV-001 activates the nonredundant Tie2-Angiopoietin signaling axis, and through stimulation of multiple downstream pathways normalizes the vasculature by enhancing endothelial cell stability, restoring normal barrier defense, and blocking vascular leak. Vascular dysfunction contributes to the underlying disease pathophysiology in patients with bacterial and viral acute respiratory distress syndrome, sepsis, hemorrhagic shock, acute kidney injury, stroke, and vascular dementia. Importantly, in multiple pre-clinical studies AV-001 tightened endothelial cell-cell junctions and promoted endothelial cell survival, which reduced pulmonary edema, and improved lung function compared to untreated controls translating into significantly improved survival. About Vasomune Therapeutics, Inc. Vasomune Therapeutics, Inc. is a private clinical-stage biopharmaceutical company developing the next generation of medicines to harness the body’s ability to defend against illness. Founded in 2014, Vasomune has focused on vascular normalization strategies, and has progressed the lead candidate AV-001 from bench to bedside. Vascular dysfunction is associated with the pathology of several disease states, including bacterial and viral acute respiratory distress syndrome, sepsis, hemorrhagic shock, acute kidney injury, stroke, and vascular dementia. Vasomune’s corporate headquarters and laboratories are located in Toronto, Canada with US offices in Raleigh, NC. For more information about the company please visit . About AnGes, Inc. AnGes, Inc., a biopharmaceutical company founded in December 1999, focuses on the development of gene-based medicines. In March 2019, AnGes obtained conditional and time-limited approval for its lead product, Collategene® (Hepatocyte Growth Factor; HGF—plasmid gene therapy), for the treatment of lower limb ischemic ulcers. In September 2019, AnGes commenced commercialization in Japan of Collategene®, the world’s first marketed drug using plasmid DNA. AnGes is currently working on the development of a Tie2 tyrosine kinase receptor agonist (AV-001) for COVID-19, viral and bacterial-associated pneumonia and an NF-κB decoy oligonucleotide for chronic discogenic lumbar back pain. Furthermore, AnGes acquired EmendoBio in December 2020 to expand its capabilities in genome-editing technologies. For more information, visit .