BEVERLY HILLS, Calif., Dec. 28, 2020 /PRNewswire/ -- GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company's proprietary NK cell engager (TriKE™) technology platform is pleased to announce the filing of U.S. and international patent applications, and the initiation of clinical development of TriKE™ therapy for the treatment of HER2+, HER3+ and HER2+/HER3+ heterodimer complex breast and gastrointestinal cancers.

Building upon the success of GTB-3550, where in FDA clinical trials patient #7 showed a 61.7% reduction in cancer cells for high-risk Myelodysplastic Syndromes (HR-MDS), GT Biopharma is expanding the therapeutic utility of its TriKE™ platform to attack solid tumor cancers.  The Company's HER2 TriKE is based on its modular therapeutic platform, which is composed of a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-HER2 antibodies, and a modified form of IL-15.  The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill cancer cells.

Anthony Cataldo, Chairman and Chief Executive Officer of GT Biopharma commented, "We are pleased our HER2 TriKE™ therapeutic product candidate has shown good efficacy in animal models enabling us to initiate GMP manufacturing for FDA clinical trial development. We anticipate submitting our IND application to FDA next year requesting allowance to proceed with an evaluation in patients with complex breast and gastrointestinal cancers. The TriKE™ platform lends itself to liquid and solid tumors as well as infectious diseases."

HER2, HER3 and HER2/HER3 Heterodimer Complex

About 15% of breast cancer cells have a high density of human epidermal growth factor receptor 2 (HER2) expressed on the cell's surface.  The frequency of HER2 overexpression in gastric and gastroesophageal cancer ranges from 4.4% to 53.4%, with a mean of 17.9%¹.  HER2 is responsible for telling the cell to divide.  Cells with too many HER2 receptors divide uncontrollably which causes the cancer to grow.  HER3 is another receptor in the same family as HER2 whose levels can also be increased in cancer cells.  HER2 and HER3 can bind together, and collectively accelerate the growth of cancer cells.  While targeted therapy against HER2 is an effective first-line treatment in HER2+ breast cancer, acquired resistance remains a clinical challenge.

Breast Cancer

Breast cancer is a group of diseases in which cells in the breast divide in an uncontrolled manner, typically resulting in a lump or mass.  Most breast cancers begin in the milk glands (lobules), or in the ducts that connect the lobules to the nipple.  In 2020, it is estimated there will be 276,480 new cases of female breast cancer in the USA².  More than 3.8 million women in the USA have been diagnosed with breast cancer as of January 2019³.  Approximately 13% of women will be diagnosed with invasive breast cancer in their lifetime and 3% will die from breast cancer⁴. 

Gastrointestinal Cancer

Gastrointestinal cancer is the fifth most common cancer worldwide, and accounts for 6.8% of all cancers.  It is third most common cause of cancer-specific mortality worldwide according to the World Health Organization.  In the USA, gastrointestinal cancers represent 1.5% of all new cancers with estimated annual new cases to be 26,240 and estimated deaths to be 10,800.  Gastrointestinal cancer is often diagnosed at an advanced stage, defined as unresectable locoregional or metastatic disease, which has very poor prognosis with 5-year survival not exceeding 5–20%⁵.

About GT Biopharma, Inc.

GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based our proprietary TriKE™ NK cell engager platform.  Our TriKE™ platform is designed to harness and enhance the cancer killing abilities of a patient's immune system natural killer cells (NK cells).  GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE™ technology.

Forward-Looking Statements

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.  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.  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.  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 31, 2019 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.

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.  You should not place undue reliance on our forward-looking statements, which are subject to risks and uncertainties relating to, among other things:  (i) the sufficiency of our cash position and our ongoing ability to raise additional capital to fund our operations, (ii) our 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) our ability to achieve approval of a marketable product, (v) design, implementation and conduct of clinical trials, (vii) the results of our clinical trials, including the possibility of unfavorable clinical trial results, (vii) the market for, and marketability of, any product that is approved, (viii) the existence or development of treatments that are viewed by medical professionals or patients as superior to our products, (ix) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, and social conditions, and (x) various other matters, many of which are beyond our control.  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.

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 27A of the Securities Act, to the extent applicable.  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.  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.

For more information, please visit www.gtbiopharma.com.

Contact
Andrew Barwicki
516-662-9461 / Andrew@barwicki.com

¹ World J Gastroenterol. 2016 May 21; 22(19): 4619–4625.
² National Cancer Institute (https://seer.cancer.gov/statfacts/html/breast-subtypes.html)
³ Miller KD, Siegel RL, Lin CC, et al. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019:1-23.
⁴ National Cancer Institute, SEER Cancer Statistics Review, (https://seer.cancer.gov/csr/1975_2017)
⁵ Klempner, S.J. et al, J Hematol. Oncol. 12, 50 (2019).

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SOURCE GT Biopharma, Inc.