![\"GT](\"https:\/\/ci6.googleusercontent.com\/proxy\/pak7lSr2lMmwgGMnAh9fvZGuTo_wi85MClwiXebIpzE-gE1Ru8TbkzbWX-MatxxLGojFGNNmpuUB25at53grpvrNT6MmXGo6Jxy2f6zFNythYI4=s0-d-e1-ft#https:\/\/mma.prnewswire.com\/media\/1483265\/GTBP_SmallLogo_Logo.jpg\" "\\"GT"){kind=logo}
<\/div>\nGTB-5550 TriKE\u2122 was evaluated in several preclinical models overexpressing B7H3, and was found to be effective at promoting NK cell killing of multiple cancer cell types.\u00a0 B7H3 is over-expressed on several cancer types including non-small cell lung cancer, squamous cell carcinoma, and breast, renal, pancreatic, ovarian, liver and colorectal cancers.\u00a0 GTB-5550 TriKE\u2122 is presently undergoing GMP manufacturing scale-up in preparation for filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for evaluation in humans.<\/p>\n
B7H3 is a member of the B7 family of immune checkpoint inhibitors which includes PD-1\/PD-L1 and CTLA-4\/CD80.\u00a0 Merck’s Keytruda\u00ae (pembrolizumab) and Bristol-Myer Squibb’s YERVOY\u00ae (ipilimumab) targeting the PD-1\/PD-L1 and CTLA-4\/CD-80 checkpoints, respectively, have demonstrated significant survival benefit and are blockbuster immune-oncology therapeutics.<\/p>\n
B7H3 expression on cancer cells is highly associated with undesirable treatment outcomes and survival time.\u00a0 Targeting B7H3 on cancer cells with TriKE\u2122 and redirecting NK cells to attack and kill cancer cells expressing B7H3, could result in a therapeutic treatment that limits the metastatic potential and invasiveness of certain solid tumor cancers.<\/p>\n
Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer, commented: “We are pleased to report our GTB-5550 TriKE\u2122 has passed this important development milestone, and demonstrated effectiveness in promoting redirected and target-specific killing by NK cells.”<\/p>\n
About GT Biopharma, Inc.<\/b><\/p>\n
GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based our proprietary TriKE\u2122 NK cell engager platform.\u00a0 The TriKE\u2122 platform is designed to activate and redirect the target cell killing abilities of the patient’s natural killer cells (NK cells) without the need for supplemental\u00a0ex vivo<\/i>\u00a0engineered donor or autologous NK cells, or induced pluripotent stem cells (iPSC).\u00a0 The Company has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE\u2122 technology.\u00a0 GT Biopharma’s lead TriKE\u2122 product candidate, GTB-3550\u00a0TriKE\u2122, is being evaluated in a multicenter Phase I\/II trial (ClinicalTrials.gov\u00a0NCT03214666<\/a>) for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.<\/p>\n Forward-Looking Statements<\/b><\/p>\n This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict, including statements regarding the potential acquisition, the likelihood of closing the potential transaction, our clinical focus, and our current and proposed trials.\u00a0 Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes”, “hopes”, “intends”, “estimates”, “expects”, “projects”, “plans”, “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking.\u00a0 Our forward-looking statements are not a guarantee of performance, and actual results could differ materially from those contained in or expressed by such statements.\u00a0 In evaluating all such statements, we urge you to specifically consider the various risk factors identified in our Form 10-K for the fiscal year ended December\u00a031, 2020 in the section titled “Risk Factors” in Part I, Item 1A and in our subsequent Form 10Q Quarterly filings with the Securities and Exchange Commission, any of which could cause actual results to differ materially from those indicated by our forward-looking statements.<\/p>\n Our forward-looking statements reflect our current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information on current business plans.\u00a0 You should not place undue reliance on our forward-looking statements, which are subject to risks and uncertainties relating to, among other things:\u00a0 (i)\u00a0the sufficiency of our cash position and our ongoing ability to raise additional capital to fund our operations, (ii)\u00a0our ability to complete our contemplated clinical trials, or to meet the FDA’s requirements with respect to safety and efficacy, (iii) our ability to identify patients to enroll in our clinical trials in a timely fashion, (iv)\u00a0our ability to achieve approval of a marketable product, (v)\u00a0design, implementation and conduct of clinical trials, (vii)\u00a0the results of our clinical trials, including the possibility of unfavorable clinical trial results, (vii)\u00a0the market for, and marketability of, any product that is approved, (viii)\u00a0the existence or development of treatments that are viewed by medical professionals or patients as superior to our products, (ix)\u00a0regulatory initiatives, compliance with governmental regulations and the regulatory approval process, and social conditions, and (x)\u00a0various other matters, many of which are beyond our control.\u00a0 Should one or more of these risks or uncertainties develop, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated by our forward-looking statements.<\/p>\n We intend that all forward-looking statements made in this press release will be subject to the safe harbor protection of the federal securities laws pursuant to Section\u00a027A of the Securities Act, to the extent applicable.\u00a0 Except as required by law, we do not undertake any responsibility to update these forward-looking statements to take into account events or circumstances that occur after the date of this press release.\u00a0 Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.<\/p>\n TriKE\u2122 is a trademark of GT Biopharma, Inc. For more information, please visit\u00a0www.gtbiopharma.com<\/a>.<\/p>\n Contact: Investor & Media Relations:
\nKeytruda\u00ae is a registered trademark of Merck and Co., Inc.
\nYERVOY\u00ae is a registered trademark of Bristol-Myer Squibb, Inc.<\/p>\n
\n<\/b><\/p>\n
\n<\/i>David Castaneda
\nDavid@gtbiopharma.com<\/a>
\n<\/u>414-351-9758<\/p>\n
![https:\/\/mma.prnewswire.com\/media\/1483265\/GTBP_SmallLogo_Logo.jpg<\/a><\/p>\n<\/div>\n <\/p>\n","protected":false},"excerpt":{"rendered":"POTENTIAL TREATMENT OF SEVERAL SOLID TUMOR CANCERS INCLUDING: NON-SMALL CELL LUNG CANCER, SQUAMOUS CELL CARNINOMA, BREAST CANCER, RENAL CANCER, PANCREATIC CANCER, OVARIAN CANCER, LIVER CANCER, COLORECTAL CANCER BEVERLY HILLS, Calif., Aug. 3, 2021 \/PRNewswire\/ \u2014\u00a0GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage biopharmaceutical company focused on developing target-directed, tri-specific Natural Killer (NK) cell engager therapies [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17,343],"tags":[],"yoast_head":"\nGT Biopharma Announces Positive Preclinical Results For GTB-5550 B7H3 TriKE\u2122 - Lebanon News Gazette<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/lebanonnewsgazette.com\/gt-biopharma-announces-positive-preclinical-results-for-gtb-5550-b7h3-trike\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GT Biopharma Announces Positive Preclinical Results For GTB-5550 B7H3 TriKE\u2122 - Lebanon News Gazette\" \/>\n<meta property=\"og:description\" content=\"POTENTIAL TREATMENT OF SEVERAL SOLID TUMOR CANCERS INCLUDING: NON-SMALL CELL LUNG CANCER, SQUAMOUS CELL CARNINOMA, BREAST CANCER, RENAL CANCER, PANCREATIC CANCER, OVARIAN CANCER, LIVER CANCER, COLORECTAL CANCER BEVERLY HILLS, Calif., Aug. 3, 2021 \/PRNewswire\/ \u2014\u00a0GT Biopharma, Inc. 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