Curative Biotech has three-pronged pipeline
Accelerated Development
Curative Biotechnology, Inc., a development-stage biomedical company targeting novel treatments for rare diseases, focuses on therapies with potentially accelerated development paths as a result of either the disease, the nature of the therapeutic itself or the stage of clinical development. At the heart of the company, which is based in Boca Raton, Florida, is a clinical product development engine that rests on its S.O.A.R. filter (Science, Opportunity, Acceleration, Rare Disease).
Curative Biotechnology envisions a world where all patients have a therapeutic option. The company has three primary therapeutic development programs.
The first program was acquired from Mid-Atlantic BioTherapeutics, Inc. and includes worldwide rights for the development of IMT504, a novel, patented immunotherapy to treat symptomatic rabies. IMT504 is being developed to treat patients whose disease has progressed beyond the stage where it can be addressed by the existing approved rabies vaccines. IMT504 has been granted orphan drug designation in the US, which can provide significant benefits including tax credits, market exclusivity and waiver of certain FDA fees.
Rabies is one of only a small number of diseases which qualify for the FDA Tropical Disease Priority Review Voucher (PRV) Program that is granted to sponsors of approved tropical disease product applications that meet certain criteria. This program has the potential to assist Curative Biotech and MABT in advancing IMT504 to the marketplace.
At present there is no effective therapy for rabies encephalitis. Vaccines are available only for pre-exposure and immediate post-exposure prophylaxis. Once signs of infection develop, however, there is no effective treatment and, uniquely among infectious diseases, it has a case fatality rate of almost 100 percent. Current vaccines are effective at protecting against this outcome provided that the vaccination is given before or shortly after exposure to a biting incident.
IMT504 is an oligodeoxynucleotide (ODN). ODNs are synthetic molecules that stimulate different kinds of cells of the immune system of animals and humans and have been studied as vaccine adjuvants, as well as cancer and infectious disease immunotherapies. ODNs cause B cells and plasmacytoid dendritic cells to activate, proliferate, secrete immunoglobulin, and express co-stimulatory molecules.
IMT504 has been shown to be effective in creating survival in a gold standard animal model meant to simulate treatment LATER than the window where current vaccines are known to be effective. In early human volunteer safety testing, IMT504 was highly immunogenic and well-tolerated in all volunteers.
The second program was acquired from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), for use of a novel monoclonal antibody (mAB) drug conjugate to treat brain cancer (glioblastoma). CURB906 is a fully humanized CD56 monoclonal antibody carrying a cytotoxic drug conjugate directly to the tumor site to kill the tumor by inhibiting tumor growth and migration of the tumor. Monoclonal antibodies, by their nature, are target specific. CURB906 targets CD56 positive brain tumors. CD56 (also known as a neural cell adhesion molecules or NCAMs) are involved with cell migration and growth, and the drug candidate aims to stop them.
CD56 is overexpressed on brain tumors, particularly early-stage tumors. The antibody will carry an extremely potent anticancer drug conjugate such as PBD (pyrollobenzodiazapine) or similar structural analogs. PBDs can be 100 to even 1,000 times more potent than chemotherapy drugs and have been shown to have broad-spectrum anti-tumor activity in vivo. These novel drugs express their activity by binding in the minor groove of DNA and linking the two DNA strands together in a way that cells find difficult to recognize and repair. This increased potency comes with an increased urgency to ascertain that the drug is only delivered to the target. That is why a monoclonal antibody is an ideal vehicle to deliver this “payload,” according to the company.
Additionally, it has been difficult to get monoclonal antibodies across the Blood Brain Barrier (BBB). To ensure that we enough drug is being delivered to the tumor, as well as to limit the delivery of the drug as much as possible to the tumor site, the drug is being administered through surgical intervention directly to the remaining tumor.
In January 2021, Curative Biotechnology executed an Exclusive Patent License Agreement to practice inventions contained within a number of patent applications with the National Eye Institute (NEI), of the National Institutes of Health (NIH), including the repurposed use of Metformin to treat Retinal Degeneration (RD) without using eye injections. This potential therapy holds great promise for multiple indications. With decades of safety data from the approved drug, Metformin, the company may be eligible for the 505 B 2 pathway at the FDA, specifically created to accelerate development for new formulations and/or routes of administration of already approved drugs. Curative Biotechnology is working on this reformulation and expects to file an IND with the FDA to begin human trials by the end of the year. This license agreement also contains worldwide rights.
Intellectual property has been exclusively licensed from the National Eye Institute at NIH specifically claiming the ability to use metformin, one of the world’s leading generic drugs, to treat various types of retinal degeneration (RD). Metformin has been used to treat diabetes in the United States since 1995.
The degeneration of the retinal pigment epithelium (RPE) is associated with various types of RD such as Stargardt disease, retinitis pigmentosa, choroideremia, late-onset retinal degeneration, and age-related macular degeneration (AMD). All of these indications appear to share some or all of the three main causes of RD: - Reduced AMP-activated protein kinase (AMPK) activity - Extreme Vascular Endothelial Growth Factor (VEGF) secretion - Increased Calcium (CA2+) levels in RPE cells.
Research has shown that metformin can activate AMP-activated protein kinase, reduce vascular endothelial growth factor (VEGF) secretion, and correct baseline calcium levels in patient derived RPE cells. The new treatment indications will require reformulating the drug into an eye drop, injectable or other topical delivery method to be able to deliver sufficient drug to the RPE layer to have a therapeutic effect.
The company changed its name from Connectyx Technologies Holdings Group, Inc. late in 2020. (FINRA). The new corporate name better reflects the commitment to finding therapeutics for patients with rare diseases who have unmet medical needs and the expertise in driving the innovations needed to shape the future of rare drug development, according to Curative Biotechnology.
The company recently secured bridge financing that included management participation. The non-dilutive bridge loan involved warrants at a premium to the market closing price of CTYX stock on November 18, 2020.