Bioxytran Preprint Explores Potential of Galectin-3 Modulation to Enhance Immune Checkpoint Inhibitor Response

January 10, 2025

New preprint examines the role of galectin-3 in immunotherapy resistance and the potential for galectin antagonists to improve cancer treatment response

BOSTON, January 10, 2025 — Bioxytran, Inc. (OTCQB: BIXT), a clinical-stage biotechnology company developing oral and intravenous therapeutics for viral diseases, fibrosis, stroke, dementia, Alzheimer's disease, and other significant unmet medical needs, today announced the publication of a preprint examining the potential role of galectin-3 modulation in improving the effectiveness of immune checkpoint inhibitors (ICIs) in oncology.

The preprint, titled “Immune Checkpoint Inhibitors (ICI): Prospects for Galectin-3 Modulation to Increase Objective Response Rate (ORR) and Remission-free Survival in Oncology Patients,” was authored by Dr. Adesuyi Ajayi, Dr. David Platt, and Andrew Blumenthal.

The article reviews potential mechanisms underlying resistance to ICI therapy and examines the role of galectin-3 in the tumor microenvironment, including its potential contribution to reduced treatment response.

Exploring Galectin-3 and Immunotherapy Resistance

Immune checkpoint inhibitors have become an important class of cancer therapies by helping restore the ability of the immune system to recognize and attack cancer cells.

However, not all patients respond to ICI treatment, and resistance can limit the effectiveness of these therapies.

Bioxytran's preprint examines the theory that galectin-3 may contribute to resistance to immune checkpoint inhibition and explores whether modulation of galectin-3 could potentially improve treatment response.

The article specifically evaluates the potential relationship between galectin-3 expression and outcomes associated with ICI therapy, including objective response rate (ORR) and remission-free survival.

Galectin-3 as a Potential Biomarker of ICI Response

The preprint highlights galectin-3 as a potential predictive biomarker of ICI treatment failure in non-small cell lung cancer (NSCLC).

According to the analysis presented in the article, approximately 90% of patients with high galectin-3 levels failed to experience tumor shrinkage after three treatments.

In contrast, the article reports that low to moderate galectin-3 expression in the tumor correlated strongly with a positive response to ICI therapy.

These observations form part of Bioxytran's broader investigation into the role of galectins in cancer biology and their potential relationship to treatment response.

Further clinical research would be required to establish galectin-3's predictive value and determine whether modulating the protein can improve outcomes for patients receiving ICIs.

Investigating the Galectin-3 Mechanism

The preprint examines a proposed mechanism through which galectin-3 may contribute to ICI resistance within the tumor microenvironment.

According to the article, galectin-3 may occupy the antibody binding site associated with the PD-1 receptor, potentially interfering with the ability of an immune checkpoint inhibitor to bind to PD-1.

The proposed interaction was investigated using Surface Plasmon Resonance, a technique used to study molecular interactions, as well as cryogenic electron microscopy.

The article proposes that when galectin-3 interferes with ICI binding, the PD-1 receptor may remain available for interaction with PD-L1, contributing to T-cell suppression.

In vitro testing described in the article indicates that galectin-3 antagonists may be capable of reversing this effect.

Additional research is needed to determine whether these findings translate into improved responses in patients receiving immunotherapy.

Potential to Complement Immune Checkpoint Inhibitors

Bioxytran's research is focused on the possibility that galectin-3 antagonists could be used alongside existing cancer therapies rather than replacing them.

The preprint explores whether inhibiting galectin-3 could potentially remove one mechanism of immune suppression and allow immune checkpoint inhibitors to function more effectively.

This combination approach could potentially address one of the major challenges in immunotherapy: patients who initially respond poorly or develop resistance to treatment.

The Company's research remains investigational, and additional preclinical and clinical studies would be necessary to determine whether combining galectin-3 antagonists with ICIs can improve patient outcomes.

Galectins and the Tumor Microenvironment

Bioxytran's cancer research extends beyond the potential interaction between galectin-3 and PD-1.

The Company has also published a cancer metastasis presentation titled “Galectin Antagonists in Cancer,” which examines the role of galectins in cancer progression and the tumor microenvironment.

The presentation explores mechanisms through which cancer cells can evade immune surveillance and discusses current treatment approaches and potential strategies for addressing limitations in existing therapies.

Bioxytran's research focuses particularly on the “Galectin Effect”, describing the role of galectins in processes associated with tumor growth, metastasis, and immune suppression.

Investigating Galectin Antagonists in Cancer

Galectins are a family of carbohydrate-binding proteins involved in a range of biological processes.

Bioxytran's research investigates whether antagonizing galectins can interfere with mechanisms that support cancer progression and immune suppression.

The Company's cancer presentation examines the potential role of galectins within the tumor microenvironment and explores how galectin antagonists could potentially be used alongside other cancer treatment modalities.

This research forms part of Bioxytran's broader strategy of developing complex carbohydrate-based therapeutics designed to interact with disease-related biological pathways.

Building on a Broad Body of Galectin Research

Bioxytran's cancer research draws on a substantial body of published scientific literature examining galectins and their involvement in cancer.

According to the Company, more than 4,000 peer-reviewed articles have examined the role of galectins in cancer.

Bioxytran's researchers have synthesized findings from this literature into their preprint and cancer presentation, with a particular focus on galectin-3's potential role in immune suppression, tumor progression, and treatment resistance.

The Company believes this research provides a foundation for continued investigation of galectin antagonists as potential components of combination cancer therapies.

A Potential Combination Approach to Cancer Treatment

The central hypothesis presented by Bioxytran is that galectin-3 antagonism could potentially complement existing immunotherapies.

Rather than developing a therapy intended to act independently of current cancer treatments, the Company's research explores whether targeting galectin-3 could address biological mechanisms that limit the effectiveness of ICIs.

If supported by additional research, this approach could provide a potential strategy for improving treatment response in selected oncology patients.

At this stage, however, the findings represent a research hypothesis and require further validation through appropriately designed studies.

Advancing Bioxytran's Cancer Research

The publication of the preprint represents another step in Bioxytran's investigation of galectin biology and complex carbohydrate-based drug design.

The Company is continuing to evaluate how galectin antagonists may interact with biological pathways involved in cancer, viral infection, fibrosis, and other diseases.

The research also supports Bioxytran's broader platform strategy of identifying disease-related carbohydrate-protein interactions that could potentially be targeted through rationally designed carbohydrate structures.

Next Steps in Galectin-3 Research

Bioxytran will continue evaluating the potential role of galectin antagonists in cancer and their possible use in combination with existing treatment approaches.

Future research will be needed to further characterize the relationship between galectin-3 expression and immunotherapy response and to determine whether galectin-3 antagonism can improve clinical outcomes.

The Company will also continue investigating its broader galectin antagonist platform across multiple disease areas.

About Bioxytran, Inc.

Bioxytran, Inc. is a clinical-stage biotechnology company developing a library of novel complex carbohydrate structures using artificial intelligence software that interprets Nuclear Magnetic Resonance imaging of druggable targets, including the galectin fold, to support rational drug design.

The Company's platform technologies include glycovirology, cancer metastasis, and oxygen delivery, with applications directed toward significant unmet medical needs in virology, degenerative disease, hypoxia, and other areas.

Bioxytran's leading drug candidate, ProLectin-M, is an investigational antiviral designed to antagonize galectins implicated in inflammatory, fibrotic, and malignant diseases. The Company is also advancing development programs focused on pulmonary fibrosis and stroke treatment.

For more information, visit www.bioxytraninc.com.

Research Materials

“Immune Checkpoint Inhibitors (ICI): Prospects for Galectin-3 Modulation to Increase Objective Response Rate (ORR) and Remission-free Survival in Oncology Patients”

http://dx.doi.org/10.13140/RG.2.2.31077.31202

“Galectin Antagonists in Cancer”

https://tinyurl.com/bdcth9j2

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of applicable securities laws, including statements concerning the potential of galectin-3 modulation, galectin antagonists, immune checkpoint inhibitors, combination cancer therapies, future research, potential treatment responses, and the potential applications of Bioxytran's technology. These statements are based on current expectations and are subject to risks, assumptions, and uncertainties that could cause actual results to differ materially from those expressed or implied.

Factors that may affect future results include preclinical and clinical study outcomes, validation of scientific hypotheses, regulatory decisions, development timelines, funding availability, manufacturing considerations, strategic partnerships, and other risks described in Bioxytran's filings with the U.S. Securities and Exchange Commission. The findings described in the preprint are investigational and do not establish the safety or efficacy of galectin antagonists for cancer treatment or any other indication. Bioxytran undertakes no obligation to update forward-looking statements except as required under applicable law.

Bioxytran, Inc.

Website: www.bioxytraninc.com

Investor Contact:

Michael Sheikh

509-991-0245

mike.sheikh@bioxytraninc.com

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