Pipeline

IMT504

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.

Rabies

IMT504 is a novel immune therapy to treat rabies. Currently, 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%. Current vaccines are effective at protecting against this outcome provided that the vaccination is given before or shortly after exposure to a biting incident.

Since 2001, over a million people worldwide have died from rabies. While the number is fortunately small in the U.S., in much of the world it is still a significant problem with no treatment options for patients who have progressed to late-stage rabies disease.

COVID Vaccine with IMT504 Adjuvant

IMT504 is an oligodeoxynucleotide (ODN), which is a synthetic molecule that stimulates different kinds of cells of the immune system of animals and humans. ODNs 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.

Kidney transplant recipients have impaired responses to mRNA COVID-19 vaccines: Even after 4 vaccine shots, many kidney transplant recipients have poor responses. Kidney failure patients on dialysis do not initially respond as well to current vaccines and also rapidly lose measurable antibodies when compared to the general population.

COVID 19 in Kidney Failure Patients

Kidney transplant recipients have impaired responses to mRNA COVID-19 vaccines: Even after 4 vaccine shots, many kidney transplant recipients have poor responses. Kidney failure patients on dialysis do not initially respond as well to current vaccines, and also rapidly lose measurable antibodies when compared to the general population.

CUBT906 - First in Class Antibody Drug Conjugate for Targeting CD56 Positive Brain Tumors

CUBT906 is our fully human 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. The technology was originally developed at the National Cancer Institute (NCI) at the National Institutes of Health (NIH) in collaboration with Children’s Hospital of Philadelphia (CHOP).

Monoclonal antibodies by their very nature are incredibly target specific. With CUBT906, we are targeting CD56 positive brain tumors. Among the functions CD56 are involved with (also known as a neural cell adhesion molecule or NCAM) is cell migration and growth. We are targeting these cells on the tumors to stop both of those functions. CD56 is overexpressed on brain tumors, particularly early-stage tumors. The antibody will carry an extremely potent anticancer drug conjugate such as PBD (pyrrolobenzodiazapine) 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 exert 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, however, comes with an increased urgency to make sure that the drug is only delivered to the target. That is why a monoclonal antibody is an ideal vehicle to deliver this “payload.”

Historically, it has been difficult to get monoclonal antibodies across the Blood Brain Barrier (BBB) and so to ensure that we are delivering enough drug to the tumor, as well as to limit the delivery of the drug as much as possible to the tumor site, we are administering the drug through surgical intervention directly to the remaining tumor during surgery to remove whatever part of the tumor can be removed safely. This allows the drug to attack whatever partial tumor material remains.

Glioblastoma

Glioblastoma is an aggressive malignant brain tumor without a defined therapy. The current prognosis for patients with glioblastoma is very poor with estimates placing the overall median survival rate at 15 months. The development team is being led by the lead inventor of the technology, Dr. Dimiter Dimitrov, Director, Center for Antibody Therapeutics at University of Pittsburgh, and esteemed neurosurgeon Nick Boulis of Emory University Hospital.

Metformin Reformulation to treat degenerative eye disease

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 age-related macular degeneration (AMD), Stargardt disease, retinitis pigmentosa, choroideremia, and late-onset retinal degeneration. 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. Curative Biotech will reformulate metformin to treat intermediate dry AMD and Geographic Atrophy (late stage dry AMD) for the first indications.

Research has shown that metformin can activate AMPK, reduce 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.

Age-Related Macular Degeneration (AMD)

AMD is a visually threatening condition, most often found in patients over age 60. Early and Intermediate AMD are characterized by enlarged drusen behind the eye’s retina. Close to 10% of the world’s population is over 60, increasing the prevalence of age-related macular degeneration. Dry AMD accounts for 80-90% of AMD cases, while wet AMD is 10-20% of cases. Currently there are no approved drug treatments for Dry AMD or Geographic Atrophy (late stage dry AMD). Wet AMD is caused by blood vessels that leak in the retina. These abnormal blood vessels may leak fluids or blood into the back of the eye.

Curative Biotech will reformulate metformin to treat intermediate dry AMD and Geographic Atrophy for the first indications. Development to be led by the lead inventor on the NEI Patents, Dr. Kapil Bharti. Curative is in negotiations with NEI to conduct the first clinical trial. This product may be eligible for 505(b)(2) treatment as a reformulation of an already approved drug.