About

The targeted delivery of therapeutics is considered the Holy Grail for treatment of diseases such as cancer and viral infections with the need to selectively treat infected/abnormal cells while sparing normal cells and avoiding toxicity. There is a significant body of literature that supports the observation of abnormal iron metabolism in multiple types of stressed cells. This appears to be associated with an increase in cell surface transferrin (TRF) receptors to support the increased intracellular demand for iron which in turn supports rapid cell division and replication. This observation of increased iron demand has been made in multiple tumor types as well as a range of virus and parasite-infected cells.

Curadox BioPharma, Inc. has developed CB-TD1, a novel drug candidate that capitalizes on these observations and the desire to target only those abnormal cells with an increased iron demand. The drug, intended for intravenous administration, is a conjugate compound that utilizes readily available and well-characterized drug substances in an easily reproduced, low cost and stable manufacturing process.

Executive Team

David Barshis

CEO

Seasoned Life Sciences executive with 30+ years of global experience in high-growth healthcare segments; leadership roles with P&G, Burroughs Wellcome, Warner Lambert and multiple startups/early stage companies; expertise in new product development.

AnnaMarie Daniels

Chief Clin/Reg Officer

Trained as a microbiologist and biochemist, AnnaMarie brings 30+ years of experience specializing in the design and implementation of clinical and regulatory strategies for new product development in pharma and medical device companies; senior executive roles with Boston Scientific, J&J, and multiple startups/early stage companies.

James Pekarsky

CFO

Accomplished executive with 30+ years of domestic and international experience in general management, finance, and operations for both health care and high tech companies; founder and CEO of BioPharmX Corp.

Advisory Board

W. Page Faulk, MD. FRC, Path., Chief Scientific Officer

Internationally-renowned immunopathologist contributing to over 350 publications during his 50-year research and academic career; originator of the TRF-DOX conjugate technology; MD from Tulane University followed by fellowships at Mayo and University of California Medical Center.

Klara Barabas, PhD, VP of Product Development

Biophysicist with expertise and publications in the basic science and medical applications of transferrin-drug conjugates; completed post-doc training at UCSF as a National Science Fellow, and the Imperial College of Science (London) as a Wellcome Trust Fellow.

Science

The CB-TD1 novel drug candidate is a conjugate compound that utilizes readily available and well-characterized drug substances in an easily reproduced, low cost and stable manufacturing process. The conjugate, comprised of transferrin (TRF), either human-derived or recombinant, and the well-known chemotherapeutic agent doxorubicin (DOX), is irreversibly crosslinked via a stable glutaraldehyde reaction. The mechanism of action (MOA) of CB-TD1 is selective binding of the conjugate to abnormal cells via the upregulated surface receptors for TRF in response to the increased iron demand of these cells. Once the TRF has bound to the TRF receptor, the conjugate is endocytosed where apoptosis of the cell almost immediately occurs as a result of a redox reaction within the cell. The cross linking technology utilized with CB-TD1 can be extended to conjugate other oncology drugs, antiviral drugs, as well as anti-parasitic drugs to transferrin to take advantage of the selective delivery via unregulated transferrin receptors to infected cells while sparing normal cells.

Pipeline

Oncology

Curadox Biopharma, Inc. (CBI) will develop its first product, CB-TD1, as a minimally toxic treatment for ovarian cancer. CB-TD-1 has already shown compelling results in in vitro testing performed by the National Cancer Institute as well as in vivo studies and preliminary clinical studies (20 patients in 3 studies). These studies, including a Compassionate Use approval by the US FDA, demonstrated a high degree of efficacy with little to no toxicity. The company plans to initiate clinical studies in advanced and/or treatment resistant ovarian cancer followed by additional clinical studies in other oncology indications.

Compared to doxorubicin:CB-TD1 demonstrates a 10-fold increase in cytotoxicity in a wide range of human tumor cellsCB-TD1 is less toxic to normal cells, thus resulting in little to no systemic toxicityCB-TD1 is readily transported across cellular and nuclear membranes where multiple oxidative and DNA-damaging actions occur leading to apoptosis vs. DNA intercalationCB-TD1 overcomes doxorubicin resistance because of the different mechanism of actionCB-TD1 does not dissociate to allow free intra- or extra-cellular doxorubicin, thus bypassing the leading mechanism of doxorubicin resistance in cancer.

PHASE 1

Antiviral

In vitro virology studies have shown marked activity of CB-TD1 in both HIV and CMV infected cells and similar to the work in cancer cells, shows minimal effect on uninfected cells and with less toxicity that the current standard of care drugs for those viral infections. The current literature indicates that COVID infected cells also have significant up-regulation of transferrin receptors indicating that this may present a large opportunity with a relatively rapid development path. Further in vitro and in vivo work will be performed to assess the opportunity in coronavirus infections.

PRECLINICAL

Infections

Although no in vitro or in vivo studies have yet been performed with CB-TD1 in protozoan parasitic infections, there is a significant body of literature that documents up-regulation of transferrin receptors in parasite infected cells in order to support the increased iron need. In vitro and in vivo models will be developed to assess this potential. There is also an opportunity to use the same transferrin cross linking technology with other anti-parasitic agents.

DEVELOPMENT

Investors

Safe Harbor Statement

Certain statements contained herein are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Forward-looking statements in this document include, but are not limited to, statements relating to long-term stability, the Company’s plan of operations and finances, and proposed clinical trials. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and that actual results may differ materially from estimates in the forward-looking statements. The Company undertakes no obligation to revise these forward-looking statements to reflect events or circumstances after the date hereof.

Contact

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