Telomir Pharmaceuticals Reports New Data Showing Telomir-1 Significantly Reduces PSA Levels in Human Prostate Cancer Cells

Rhea-AI Summary

Telomir Pharmaceuticals (NASDAQ:TELO) reported preclinical data on November 25, 2025 showing its lead candidate Telomir-1 reduced PSA release in androgen-responsive LNCaP human prostate cancer cells in a concentration-related manner.

Prior PC3 xenograft results cited include an approximately 50% tumor volume reduction with Telomir-1 alone and full tumor-volume reduction with paclitaxel plus Telomir-1 with no mortality in that cohort. The company said Telomir-1 shows activity across epigenetic regulators, reduces oxidative stress, and did not elongate telomeres in preclinical tests.

Telomir is continuing preclinical work and advancing IND-enabling activities as it prepares for planned clinical testing.

Positive

• ~50% tumor volume reduction in PC3 xenograft model
• Full tumor-volume reduction with paclitaxel + Telomir-1 and no mortality in that arm
• Concentration-related PSA reduction in androgen-stimulated LNCaP cells
• Advancing IND-enabling activities toward planned clinical testing

Negative

• Preclinical-stage: no human clinical data reported yet
• PSA reduction observed in vitro only (LNCaP cells), not in patients

Insights

Translational Oncology Analyst

Preclinical signals show Telomir-1 lowers PSA and reduced tumor volume in mice; findings are promising but remain preclinical.

Telomir-1 produced a concentration-related reduction in PSA release in androgen-stimulated LNCaP cells and demonstrated approximately 50% tumor-volume reduction in a PC3 xenograft model, with full tumor-volume reduction in combination with paclitaxel and no mortality reported. These results link a clinically recognized biomarker (PSA) to cellular metabolic and viability effects and show activity in both androgen-responsive and -independent preclinical models.

Key dependencies and risks include the early stage of the data (in vitro and xenograft), limited detail on study design and reproducibility, and the well-known gap between preclinical efficacy and human clinical outcomes. The company states it is advancing IND-enabling work; successful translation requires robust toxicology, pharmacokinetics, and controlled efficacy replication.

Items to watch next are completion of IND-enabling studies, the formal IND submission and clearance, and any disclosed first-in-human study design or timelines. Progress on those regulatory and safety milestones will meaningfully change the program's risk profile.

PSA is a validated FDA-recognized clinical endpoint in assessing prostate cancer treatment response; Telomir-1 lowered PSA levels in a dose-related manner.

MIAMI, FLORIDA / ACCESS Newswire / November 25, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a preclinical-stage biotechnology company developing therapies that target epigenetic and metabolic drivers of cancer and age-related disease, today reported new preclinical findings demonstrating that its lead therapeutic candidate, Telomir-1, reduced PSA (prostate-specific antigen) levels in androgen-responsive human prostate cancer cells (LNCaP).

PSA is one of the most widely used and FDA-accepted clinical biomarkers in evaluating prostate cancer treatment activity. PSA is a protein secreted by prostate cancer cells, and elevated PSA levels generally correlate with increased tumor burden and tumor activity. Demonstrating a reduction in PSA in vitro provides additional biological context relevant to Telomir-1's ongoing preclinical characterization.

Key Findings

In an in vitro study conducted by SmartAssays, LNCaP prostate cancer cells were stimulated with dihydrotestosterone (DHT), a potent androgen that increases PSA production. Under these conditions, Telomir-1 produced a concentration-related reduction in PSA release, paralleling its inhibitory effects on cellular energy metabolism and cell viability.

These in vitro PSA findings are consistent with previously reported Telomir-1 activity in a mouse model implanted with aggressive, non-androgen responsive human prostate cancer cells (PC3 xenografts). In that model, Telomir-1 demonstrated a measurable anti-tumor effect, including approximately 50% reduction in tumor volume when administered as a single agent. In the combination arm of paclitaxel plus Telomir-1, tumor volume was fully reduced, and no mortality occurred. By comparison, paclitaxel alone also resulted in full tumor-volume reduction but was associated with mortality in the study cohort.

The PC3 model represents an androgen-independent tumor type, meaning the cancer cells no longer rely on hormones like testosterone to grow and are generally more aggressive and treatment-resistant. The PSA reductions observed in this new study were generated in androgen-responsive LNCaP cells, which depend on androgen signaling and reflect clinically relevant prostate cancer biology. Together, these datasets indicate that Telomir-1 has shown preclinical activity in both hormone-responsive and hormone-resistant prostate cancer models, based on epigenetic, metabolic, and viability-related measures.

CEO Perspective

"Our mission has always been to advance science that addresses the deeper biological mechanisms driving cancer and aging," said Erez Aminov, Chief Executive Officer of Telomir. "Patients today still face treatments that are often difficult to tolerate and do not address the underlying drivers of tumor behavior. As we continue developing Telomir-1, our focus remains on exploring these fundamental pathways and generating data that deepen our understanding of the biology at play. Every study adds clarity to the scientific foundation we are building and reinforces why this work matters-for patients, for the field, and for the future of therapies designed to engage the root biology of disease."

Scientific Perspective

"Despite advances in hormonal therapies, chemotherapy, and targeted agents, prostate cancer continues to present substantial unmet medical needs," said Dr. Itzchak Angel, Chief Scientific Advisor at Telomir. "Many existing treatments can cause meaningful side effects, including fatigue, metabolic disturbances, cardiovascular strain, and disruptions in sexual function, all of which can significantly affect quality of life and long-term treatment tolerability. There remains a need for additional biological approaches that explore different aspects of tumor biology, and the preclinical findings with Telomir-1 contribute to that ongoing scientific assessment."

Building on Prior Findings

Across multiple models, Telomir-1 has demonstrated:

• Reduction of PSA levels in androgen-stimulated human prostate cancer cells.

• Reactivation of key tumor-associated pathways in prior studies in prostate cancer, including STAT1, CDKN2A, MASPIN, RASSF1A, and TMS1.

• Activity across epigenetic regulators implicated in tumor progression.

• Anti-cancer activity in a wide range of cancer types, including triple-negative breast cancer, prostate and pancreatic cancers, as well as in leukemia.

• Reduction of oxidative stress and improvements in mitochondrial-related measures in preclinical systems.

• No elongation of telomeres in cancer cells, supporting a favorable preclinical safety profile.

• Approximately 50% reduction in tumor volume and absence of chemotherapy-associated mortality in combination with Paclitaxel in PC3 xenograft work.

Next Steps

Telomir is continuing its preclinical program for Telomir-1 across multiple areas, including oncology, aging biology, autism-related pathways, and other age-associated diseases. In parallel, the Company is advancing its regulatory, IND-enabling activities to support the planned IND submission. These efforts represent essential components of the development pathway, and the Company continues to make meaningful progress as it prepares for future clinical testing.

About Telomir Pharmaceuticals

Telomir Pharmaceuticals (NASDAQ:TELO) is a preclinical biotechnology company developing small-molecule therapeutics that target the root epigenetic mechanisms underlying cancer, aging, and degenerative disease. The Company's lead candidate, Telomir-1, has demonstrated activity in preclinical studies involving modulation of DNA and histone methylation, restoration of redox balance, and normalization of cellular function.

For more information, please visit www.telomirpharma.com.

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

View the original press release on ACCESS Newswire

FAQ

What did Telomir (TELO) announce on November 25, 2025 about Telomir-1?

Telomir announced preclinical data showing concentration-related PSA reduction in androgen-responsive LNCaP cells and referenced prior ~50% tumor reduction in a PC3 xenograft model.

How did Telomir-1 perform in the PC3 xenograft study mentioned by Telomir (TELO)?

Telomir-1 produced an approximately 50% reduction in tumor volume as a single agent; the paclitaxel plus Telomir-1 arm showed full tumor-volume reduction with no mortality.

Does the Telomir (TELO) announcement include clinical trial results in humans?

No; the results reported are preclinical (in vitro and animal xenograft models) and no human clinical data were reported.

What is the investor significance of Telomir (TELO) advancing IND-enabling activities?

Advancing IND-enabling activities indicates the company is preparing documentation and studies needed to seek regulatory clearance to start human trials.

What specific prostate-cancer biomarker did Telomir (TELO) report reducing with Telomir-1?

Telomir reported reduction of PSA (prostate-specific antigen) release in androgen-stimulated LNCaP prostate cancer cells.