GT Biopharma Inc. (GTBP) (Euronext Paris: GTBP.PA) announced today the initiation of a combination trial of OXS-1550 and multi-billion dollar oncology drug, owned by a major Pharmaceutical Company (the Company). This effort is headed by Dr. Daniel Vallera, Director, Section of Molecular Cancer Therapeutics at the Masonic Cancer Center, University of Minnesota. Under this Material Transfer Agreement (MTA) announced on July 19, 2018 between GT Biopharma, Inc and the Company, Dr. Vallera has been supplied with a formulation of their this widely prescribed drug approved for use in several hematologic malignancies for preclinical studies.
Dr. Daniel Vallera said: “Based on our exciting preliminary in vitro experiments, the initial preclinical work suggests a much greater effect when OXS-1550 is given with this drug. We are very excited about our progress with GT’s OXS-1550 (DT2219) combined with ibrutinib, a potent small molecule Bruton Tyrosine Kinase (BTK) inhibitor which is already an established chemotherapeutic agent. We believe combination therapies like these that kill cancer cells based on entirely different mechanisms are the future of cancer treatment.”
Dr. Vallera is the lead researcher for GT Biopharma’s bispecific antibody drug conjugate (ADC) program, and the innovator of DT2219, also known as OXS-1550. OXS-1550 is a bispecific antibody drug conjugate which means it targets two antigens on cancer cells and contains a cytotoxic payload thereby increasing the probability it will kill the cancer cells. OXS-1550 targets cancer cells expressing the CD19 receptor and/or CD22 receptors which includes B-cell leukemias and lymphomas and has a modified form of diphtheria toxin (DT390) as its cytotoxic drug payload. After OXS-1550 binds to cancer cells, it is taken in by the cancer cells and subsequently deploy its cytotoxic diphtheria toxin payload which inhibits protein synthesis and kills the cancer cells.
GT Biopharma’s Chairman and Chief Executive Officer (CEO) Dr. Raymond Urbanski said: “We continue to be very excited about this potential combination. Dr. Vallera’s extraordinary work in the bispecific ADC arena continues to add value to both the science and potentially to patients.”
About GT Biopharma, Inc.: GT Biopharma, Inc. is a clinical stage biopharmaceutical company predominantly focused on the development and commercialization of immuno-oncology products based off our proprietary Tri-specific Killer Engager (TriKE), Tetra-specific Killer Engager (TetraKE) and bi-specific Antibody Drug Conjugate (ADC) technology platforms. Our TriKE and TetraKE platforms generate proprietary moieties designed to harness and enhance the cancer killing abilities of a patient’s own natural killer, or NK, cells. Once bound to a NK cell, our moieties are designed to enhance the NK cell and precisely direct it to one or more specifically-targeted proteins (tumor antigens) expressed on a specific type of cancer, ultimately resulting in the cancer cell’s death. TriKEs and TetraKEs are made up of recombinant fusion proteins, can be designed to target certain tumor antigens on hematologic malignancies, sarcomas or solid tumors and do not require patient-specific customization. They are designed to be dosed in a common outpatient setting similar to modern antibody therapeutics and are expected to have reasonably low cost of goods. Our ADC platform can generate product candidates that are bi-specific, ligand-directed single-chain fusion proteins that, we believe, represent the next generation of ADCs.
GT’s nervous system platform is focused on acquiring or discovering and patenting late-stage, de-risked, and close-to-market improved treatments for nervous system diseases (Neurology and Pain) and shepherding them through the approval process to the NDA. GT Biopharma’s neurology products currently include PainBrake, as well as treatments for the symptoms of myasthenia gravis, and motion sickness.
Except for historical information contained herein, the statements in this release are forward-looking and made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently unreliable and actual results may differ materially. Examples of forward-looking statements in this news release include statements regarding the payment of dividends, marketing and distribution plans, development activities and anticipated operating results. Factors which could cause actual results to differ materially from these forward-looking statements include such factors as the Company’s ability to accomplish its business initiatives, significant fluctuations in marketing expenses and ability to achieve and expand significant levels of revenues, or recognize net income, from the sale of its products and services, as well as the introduction of competing products, or management’s ability to attract and maintain qualified personnel necessary for the development and commercialization of its planned products, and other information that may be detailed from time to time in the Company’s filings with the United States Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.