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Telomir says data show Telomir-1 reversed epigenetic silencing
Telomir says data show Telomir-1 reversed epigenetic silencing

Business Insider

time18-07-2025

  • Health
  • Business Insider

Telomir says data show Telomir-1 reversed epigenetic silencing

In a regulatory filing, Telomir Pharmaceuticals (TELO) reported new preclinical results evaluating the effects of its lead candidate, Telomir-1, in a murine xenograft model using PC3 human prostate cancer cells. The data demonstrated that Telomir-1 reversed epigenetic silencing by DNA methylation of the STAT1 gene, a tumor suppressor and immune response regulator, in a dose-dependent manner. STAT1 is frequently silenced in advanced cancers via promoter hypermethylation, disrupting immune detection and apoptotic pathways. In this study, Telomir-1 administered orally daily for 21 days resulted in full reversal of STAT1 hypermethylation in tumor tissue. No such reversal was observed in the Paclitaxel group, and only partial demethylation was observed with Rapamycin In addition to STAT1, Telomir-1 also reduced hypermethylation of TMS1, a pro-apoptotic tumor suppressor commonly silenced in prostate cancer. While PTX and Rapamycin showed comparable or greater effects on TMS1 methylation, Telomir-1 is unique in its ability to modulate both STAT1 and TMS1-two genes that together regulate immune response and apoptosis. Importantly, TMS1 also plays a central role in inflammasome activation, which not only contributes to tumor cell death but also supports the immune system's ability to detect and clear abnormal cells. When TMS1 is hypermethylated, this immune signaling pathway is disrupted-reducing caspase-1 activation and inflammatory cytokine release. This can impair immune surveillance and allow cancer cells to persist undetected. By reducing TMS1 hypermethylation, Telomir-1 may help restore immune recognition and enhance the tumor's sensitivity to both chemotherapy and immunotherapy. Telomere length analysis in PC3 tumor tissue showed no measurable elongation following Telomir-1 administration. This finding is relevant given concerns that telomere-targeting compounds may promote tumor progression through telomere extension in malignant cells. In contrast, Telomir-1 demonstrated selective activity without altering telomere length in this model. Telomir is conducting ongoing research to evaluate Telomir-1 across multiple therapeutic areas, including oncology, Wilson's disease, age-related macular degeneration, autism spectrum disorder, and dysphonia. The company is continuing preclinical development across these programs and plans to announce its initial IND indication at a future date. 'We remain encouraged by the preclinical data and continue to explore Telomir-1's potential across several disease areas. Our team is committed to advancing this program thoughtfully and strategically as we move toward clinical development,' said Erez Aminov, CEO of Telomir. Elevate Your Investing Strategy:

Telomir Pharmaceuticals Announces Telomir-1 Demonstrates Dose-Dependent Restoration of Neurological, Liver and Kidney Functions in Preclinical Wilson's Disease Model
Telomir Pharmaceuticals Announces Telomir-1 Demonstrates Dose-Dependent Restoration of Neurological, Liver and Kidney Functions in Preclinical Wilson's Disease Model

Associated Press

time11-06-2025

  • Business
  • Associated Press

Telomir Pharmaceuticals Announces Telomir-1 Demonstrates Dose-Dependent Restoration of Neurological, Liver and Kidney Functions in Preclinical Wilson's Disease Model

Treatment reversed tremors, ataxia, anxiety-like behavior, liver and kidney pathology damage, reduced copper accumulation, normalized ALT, AST, and bilirubin levels, and improved survival. Building on previous data in Werner syndrome, showing Telomir-1 reset the epigenetic clock, extended telomere length, restored gene expression, reversed muscle loss, and rescued survival-alongside data in Age Related Macular Degeneration (AMD) demonstrating retinal regeneration and restored vision-the drug continues to show broad regenerative potential across rare genetic degenerative diseases MIAMI, FL / ACCESS Newswire / June 11, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), or the 'Company,' a preclinical-stage biotechnology company focused on reversing biological aging and degenerative diseases, today announced compelling new preclinical data demonstrating that its lead drug candidate, Telomir-1, significantly reversed neurological, hepatic and kidney symptoms in a clinically relevant animal model of Wilson's disease. Wilson's disease is a rare and potentially fatal genetic disorder caused by mutations in the ATP7B gene, which impair the body's ability to eliminate excess copper. As copper builds up-primarily in the liver and brain-it leads to inflammation, tissue damage, and multi-organ dysfunction. Patients may experience liver failure, psychiatric disturbances, tremors, and progressive neurological decline. Current treatments involve lifelong copper chelation or liver transplantation, highlighting the urgent need for safer, disease-modifying therapies. These new results build on earlier in vitro studies that confirmed Telomir-1's high binding affinity for copper and its ability to exchange and regulate key ions. The current in vivo findings now confirm that Telomir-1's copper-regulating properties translate into meaningful behavioral, physiological and histological improvements in a genetic animal model of Wilson's disease. In the ATP7B C271X -/- zebrafish model, which mimics human Wilson's disease Telomir-1 demonstrated dose-dependent and statistically significant reversal of major disease features: Key Findings from the Study: 'We've now seen Telomir-1 generate breakthrough results across some of the most challenging age-related and genetic diseases-including AMD, Wilson's disease, cancer, progeroid and Werner syndromes, and early findings suggesting reversal of key factors in type 2 diabetes,' said Erez Aminov, Chairman and CEO of Telomir. 'In our AMD model, Telomir-1 restored vision and regenerated retinal structure using FDA-recognized surrogate endpoints. In Werner syndrome, it reset the epigenetic clock and reversed hallmarks of accelerated aging. And in Wilson's disease, we saw a reversal of neurological, liver and kidney damage. These results point to the broad therapeutic potential of Telomir-1 across diseases driven by cellular degeneration. We believe this positions Telomir-1 as a powerful new platform for longevity, neuroprotection, and regenerative medicine.' 'These recent findings establish Telomir-1 as a potent disease-modifying compound in a clinically relevant model of Wilson's disease,' added Dr. Angel, Chief Scientific Advisor. 'Its ability to reverse behavioral and neurological dysfunction, normalize histological and functional biomarkers, and extend survival underscores its therapeutic promise across both rare and age-related disorders.' Telomir Pharmaceuticals is currently advancing Telomir-1 through IND-enabling studies and expects to file its first IND for a rare disease indication by year-end, with human clinical trials planned for the first half of 2026. Cautionary Note Regarding Forward-Looking Statements This press release, statements of Telomir's management or advisors related thereto, and the statements contained in the news story linked in this release contain 'forward-looking statements,' which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications, and the safety of Telomir-1. Any forward-looking statements in this press release are based on Telomir's current expectations, estimates and projections only as of the date of this release. These and other risks concerning Telomir's programs and operations are described in additional detail in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which is on file with the SEC. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moya [email protected] (786) 396-6723 SOURCE: Telomir Pharmaceuticals, Inc press release

Telomir Pharmaceuticals to Participate in BIO 2025 in Boston as Company Prepares for IND Submission and Advances Breakthrough Longevity Platform
Telomir Pharmaceuticals to Participate in BIO 2025 in Boston as Company Prepares for IND Submission and Advances Breakthrough Longevity Platform

Miami Herald

time02-06-2025

  • Business
  • Miami Herald

Telomir Pharmaceuticals to Participate in BIO 2025 in Boston as Company Prepares for IND Submission and Advances Breakthrough Longevity Platform

Company to meet with prospective partners as it accelerates toward IND submission for Telomir-1, with plans to begin human dosing in the first half of 2026 MIAMI, FL / ACCESS Newswire / June 2, 2025 / Telomir Pharmaceuticals, Inc. (Nasdaq:TELO) ("Telomir" or the "Company"), an emerging leader in age-reversal science, today announced its participation in the BIO International Convention 2025, taking place in Boston, MA from June 16-19, 2025. The Company has scheduled a full week of BIO One-on-One Partnering™ meetings to explore strategic collaborations, licensing opportunities, and potential M&A transactions. Telomir is actively preparing to submit an Investigational New Drug (IND) application by the end of this year for its lead candidate, Telomir-1-a novel small molecule designed to elongate telomeres, regenerate cells, and reverse core mechanisms of biological aging. The Company is gearing up for its pre-IND meeting with the FDA, with the goal of initiating first-in-human dosing in the first half of 2026. As part of its expanding pipeline, Telomir is advancing a rare-disease exploratory and developmental strategy focused on high-need orphan indications where cellular aging plays a central role. These include: Werner's syndrome, a rare adolescent- or adult-onset disorder often referred to as "adult Progeria," which is expressed by many features of premature aging, including early graying, cataracts, metabolic dysfunction, and cancer disease, a rare genetic disorder caused by copper accumulation in tissues. Telomir-1 has already demonstrated in preclinical testing copper-modulating capabilities, reversal of copper-induced toxicities and reactive oxygen species production, offering a potential disease-modifying approach that directly addresses the root cause of toxicity and inflammation associated with Wilson' an ultra-rare pediatric condition that causes rapid aging in children, where Telomir-1 has shown in animal models restoration of lifespan and normalization of disease including rare neuromuscular subtypes that impair vocal cord function and may be linked to inflammation and accelerated tissue degeneration. The Company plans to meet with the FDA to establish novel clinical endpoints across its rare disease programs, aiming to unlock accelerated development pathways and regulatory flexibility. In parallel, Telomir-1 is also being investigated in autism spectrum disorder, where its potential impact on telomere biology, oxidative stress, neurodegeneration and inflammation may offer a novel therapeutic approach for neurodevelopmental conditions. Beyond rare and neurological disorders, Telomir has achieved significant preclinical success across a range of high-impact therapeutic areas, underscoring the versatility of its platform: Vision Restoration: Structural and functional recovery of the retina in FDA-recognized endpoints in animal models of age-related macular degeneration (AMD).Longevity and Aging: Consistent age-reversal, increased lifespan, and improved health in standard aging, Werner's syndrome and in Progeria Disease: In preclinical models of Type 2 diabetes,Telomir-1 led to the reversal of elevated blood glucose, restoration of insulin sensitivity, improved pancreatic islet function, and a marked reduction in oxidative stress and systemic In a preclinical model of aggressive human prostate cancer, Telomir-1 alone at both low and high doses reduced tumor growth by approximately 50%, while also exhibiting a protective effect on healthy cells. These findings directly counter concerns that telomere-elongating drugs may promote cancer; instead, Telomir-1 actively suppressed tumor Disease: Development of Telomir-Ag2, a novel drug candidate with potent activity against multidrug-resistant bacteria, including MRSA. "The breadth of our preclinical data showcases the potential of Telomir-1 not just as a treatment-but as a platform for addressing aging-related and rare diseases at the source," said Erez Aminov, Chief Executive Officer of Telomir. "As we prepare for IND submission and for a pre-IND meeting with the FDA, we look forward to connecting with potential partners at BIO to explore licensing and M&A opportunities that can help accelerate our path to the clinic." Dr. Angel, Chief Scientific Advisor at Telomir, added:"In all my years in drug development, I've never seen a molecule with this kind of cross-indication potential. The science behind Telomir-1 is remarkable-it's addressing cellular aging at its root, and the preclinical data speak for themselves. What excites me most is how this one molecule may have the power to transform how we treat aging-related, metabolic, and rare genetic diseases across the board." Cautionary Note Regarding Forward-Looking Statements This press release, statements of Telomir's management or advisors related thereto, and the statements contained in the news story linked in this release contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications, and the safety of Telomir-1. Any forward-looking statements in this press release are based on Telomir's current expectations, estimates and projections only as of the date of this release. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications and safety of Telomir-1. These and other risks concerning Telomir's programs and operations are described in additional detail in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which is on file with the SEC. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moya info@ 396-6723 SOURCE: Telomir Pharmaceuticals, Inc

Telomir Pharmaceuticals to Participate in BIO 2025 in Boston as Company Prepares for IND Submission and Advances Breakthrough Longevity Platform
Telomir Pharmaceuticals to Participate in BIO 2025 in Boston as Company Prepares for IND Submission and Advances Breakthrough Longevity Platform

Associated Press

time02-06-2025

  • Business
  • Associated Press

Telomir Pharmaceuticals to Participate in BIO 2025 in Boston as Company Prepares for IND Submission and Advances Breakthrough Longevity Platform

Company to meet with prospective partners as it accelerates toward IND submission for Telomir-1, with plans to begin human dosing in the first half of 2026 MIAMI, FL / ACCESS Newswire / June 2, 2025 / Telomir Pharmaceuticals, Inc. (Nasdaq:TELO) ('Telomir' or the 'Company'), an emerging leader in age-reversal science, today announced its participation in the BIO International Convention 2025, taking place in Boston, MA from June 16-19, 2025. The Company has scheduled a full week of BIO One-on-One Partnering™ meetings to explore strategic collaborations, licensing opportunities, and potential M&A transactions. Telomir is actively preparing to submit an Investigational New Drug (IND) application by the end of this year for its lead candidate, Telomir-1-a novel small molecule designed to elongate telomeres, regenerate cells, and reverse core mechanisms of biological aging. The Company is gearing up for its pre-IND meeting with the FDA, with the goal of initiating first-in-human dosing in the first half of 2026. As part of its expanding pipeline, Telomir is advancing a rare-disease exploratory and developmental strategy focused on high-need orphan indications where cellular aging plays a central role. These include: The Company plans to meet with the FDA to establish novel clinical endpoints across its rare disease programs, aiming to unlock accelerated development pathways and regulatory flexibility. In parallel, Telomir-1 is also being investigated in autism spectrum disorder, where its potential impact on telomere biology, oxidative stress, neurodegeneration and inflammation may offer a novel therapeutic approach for neurodevelopmental conditions. Beyond rare and neurological disorders, Telomir has achieved significant preclinical success across a range of high-impact therapeutic areas, underscoring the versatility of its platform: 'The breadth of our preclinical data showcases the potential of Telomir-1 not just as a treatment-but as a platform for addressing aging-related and rare diseases at the source,' said Erez Aminov, Chief Executive Officer of Telomir. 'As we prepare for IND submission and for a pre-IND meeting with the FDA, we look forward to connecting with potential partners at BIO to explore licensing and M&A opportunities that can help accelerate our path to the clinic.' Dr. Angel, Chief Scientific Advisor at Telomir, added: 'In all my years in drug development, I've never seen a molecule with this kind of cross-indication potential. The science behind Telomir-1 is remarkable-it's addressing cellular aging at its root, and the preclinical data speak for themselves. What excites me most is how this one molecule may have the power to transform how we treat aging-related, metabolic, and rare genetic diseases across the board.' Cautionary Note Regarding Forward-Looking Statements This press release, statements of Telomir's management or advisors related thereto, and the statements contained in the news story linked in this release contain 'forward-looking statements,' which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications, and the safety of Telomir-1. Any forward-looking statements in this press release are based on Telomir's current expectations, estimates and projections only as of the date of this release. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications and safety of Telomir-1. These and other risks concerning Telomir's programs and operations are described in additional detail in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which is on file with the SEC. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moya [email protected] (786) 396-6723 SOURCE: Telomir Pharmaceuticals, Inc press release

Telomir Pharmaceuticals Confirms Telomir-1 Restores Vision and Retinal Structure in Age-Related Macular Degeneration (AMD) Animal Model Using FDA-Recognized Surrogate Endpoints
Telomir Pharmaceuticals Confirms Telomir-1 Restores Vision and Retinal Structure in Age-Related Macular Degeneration (AMD) Animal Model Using FDA-Recognized Surrogate Endpoints

Associated Press

time29-05-2025

  • Business
  • Associated Press

Telomir Pharmaceuticals Confirms Telomir-1 Restores Vision and Retinal Structure in Age-Related Macular Degeneration (AMD) Animal Model Using FDA-Recognized Surrogate Endpoints

A unique oral drug candidate that is shown to restore vision and regenerate the retina in an animal model, addressing a major unmet need in ocular therapeutics MIAMI, FLORIDA / ACCESS Newswire / May 29, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ('Telomir' or the 'Company'), an emerging leader in age-reversal science, today announced compelling preclinical results from a study evaluating its novel oral therapeutic, Telomir-1, in a genetically modified zebrafish model of age-related macular degeneration (AMD). Following a 14-day oral dosing regimen, Telomir-1 reversed central vision response and vision acuity, restored retinal degeneration and architecture, and significantly reduced oxidative stress-achieving improvements across several FDA-recognized surrogate endpoints relevant to AMD. The study utilized the Sen57wrn-/-ND6-/+ zebrafish model, which combines genetic mutations associated with premature aging (WRN), mitochondrial dysfunction (ND6), and chronic senescence (Sen57). These animals exhibit progressive retinal degeneration, visual impairment, and oxidative stress-closely modeling dry AMD and geographic atrophy in humans. Model Transformation: From Degeneration to Recovery Before treatment, the aged (18-month-old) zebrafish demonstrated clear signs of neurodegeneration and visual impairment. Mutant animals showed sluggish, uncoordinated swimming behavior and delayed responses to visual stimuli such as light and movement-evidence of significant vision loss. Microscopic analysis of their retinas revealed approximately 15% total retinal degeneration, affecting several critical layers: In addition to retinal damage, the diseased animals exhibited reactive oxygen species (ROS) levels nearly four times higher than healthy controls-indicating intense oxidative stress-and suffered a 15% mortality rate during the two-week study window. After receiving Telomir-1, treated animals demonstrated marked recovery: Histological cross-sections confirmed Telomir-1's ability to regenerate not only the inner retinal layers, but also additional retinal structures-supporting improved-laminar retinal restoration and function. Collectively, these results demonstrate Telomir-1's ability to restore visual function, reverse retinal degeneration, reduce oxidative stress, and improve survival-all from a short oral treatment regimen. 'This breakthrough reinforces our vision at Telomir: to redefine how we treat age-related diseases by going beyond symptom management and targeting the root mechanisms of degeneration,' said Erez Aminov, Chief Executive Officer of Telomir. 'To our knowledge, no oral drug has ever demonstrated this level of retinal restoration and vision recovery in any AMD model-this is a meaningful leap forward for patients and the field.' 'The preclinical success achieved in this AMD model is truly remarkable,' added Dr. Angel, Chief Scientific Advisor of Telomir. 'Telomir-1 when studied orally, restored both structure and function in the retina, demonstrating not just neuroprotection, but true regenerative capacity-a property rarely seen in ophthalmic drug development.' Cautionary Note Regarding Forward-Looking Statements This press release, statements of Telomir's management or advisors related thereto, and the statements contained in the news story linked in this release contain 'forward-looking statements,' which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications, and the safety of Telomir-1. Any forward-looking statements in this press release are based on Telomir's current expectations, estimates and projections only as of the date of this release. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications and safety of Telomir-1. These and other risks concerning Telomir's programs and operations are described in additional detail in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which is on file with the SEC. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moya [email protected] (786) 396-6723 SOURCE: Telomir Pharmaceuticals, Inc press release

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