New preclinical findings highlight Telomir-1’s ability to reverse CDKN2A gene silencing by DNA methylation, reactivating this gene – often called the body’s natural “cell cycle brake.” These results build on prior STAT1 data, supporting Telomir-1’s profile as a potential first-in-class broad-spectrum DNA methylation reset therapy.
MIAMI, FLORIDA / ACCESS Newswire / September 9, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), a preclinical-stage biotechnology company developing therapies that target the root causes of biological aging, cancer, and age-related diseases, today announced new preclinical cancer data showing that Telomir-1 reverses DNA methylation of CDKN2A, a master tumor suppressor gene silenced in many aggressive cancers.
Reactivating Cancer’s Brakes
CDKN2A is one of the body’s most important natural defenses against cancer. Often called the “cell cycle brake,” this gene tells cells when to stop dividing and helps damaged cells self-destruct. In many cancers, CDKN2A is switched off by abnormal DNA methylation, leaving tumors free to grow unchecked. By resetting this methylation, Telomir-1 appears to turn the brake back on – restoring a critical safeguard that cancer cells had disabled.
Why DNA Methylation Matters
DNA methylation is a key epigenetic process that controls whether genes are switched on or off. In healthy cells, methylation helps regulate normal development and repair. In cancer, however, abnormal DNA methylation can silence critical tumor suppressor genes like CDKN2A and STAT1, allowing tumors to grow unchecked and evade the immune system. Similarly, widespread changes in DNA methylation patterns are recognized as one of the hallmarks of aging, contributing to the loss of cellular function and the onset of age-related diseases.
By demonstrating the ability to reduce DNA methylation of these important targets, Telomir-1 is showing potential to directly address these fundamental biological processes. This positions Telomir-1 not only as a novel oncology candidate, but also as a potential first-in-class longevity drug candidate targeting the root causes of aging and disease.
In aggressive human prostate cancer cell models (PC3 xenografts), Telomir-1 inhibited CDKN2A DNA methylation more effectively than both Rapamycin and chemotherapy. These results complement Telomir’s previously reported data showing that Telomir-1 also resets STAT1, a master regulator of immune surveillance. Together, these findings suggest that Telomir-1 may broadly reverse cancer-induced silencing of key tumor suppressors – tackling two of cancer’s most fundamental escape mechanisms: unchecked growth and immune evasion.
CEO Perspective
“This new evidence reinforces Telomir-1’s potential as a first-in-class longevity drug candidate that addresses the root causes of aging and age-related diseases through its ability to reset abnormal DNA methylation patterns,” said Erez Aminov, Chief Executive Officer of Telomir. “By demonstrating that Telomir-1 can reverse cancer-induced gene silencing in tumor suppressors such as CDKN2A and STAT1, we are beginning to show how epigenetic reprogramming may restore fundamental cellular functions that are disrupted in both cancer and aging.”
Scientific Perspective
“These findings are highly significant,” said Dr. Itzchak Angel, Chief Scientific Advisor at Telomir. “By simultaneously reactivating STAT1 and CDKN2A, Telomir-1 demonstrates the ability to reset epigenetic silencing across multiple tumor suppressor pathways. This dual restoration of both immune surveillance and cell cycle control represents a powerful mechanistic advance in cancer epigenetics and provides a compelling rationale for further translational development.”
Advancing Toward the Clinic
Telomir is actively assessing Telomir-1 across multiple aggressive cancers beyond prostate, with additional studies underway. The company’s pre-IND program is running in full gear, with CMC activities scaling up toward GMP production and IND-enabling studies ongoing as Telomir moves toward its first IND submission.
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 are on file with the SEC and available at www.sec.gov. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact Information
Helga Moya
info@telomirpharma.com
(786) 396-6723
SOURCE: Telomir Pharmaceuticals, Inc.
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