GT Biopharma Advances GTB-3650, a Second Generation Tri-Specific Killer -TriKE®, in Studies Enabling IND | New


BEVERLY HILLS, Calif., September 13, 2021 / PRNewswire / – GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical-stage immuno-oncology company focused on the development of innovative therapies based on the natural killer cell activator (NK ) Company’s exclusive, the TriKE® protein Biological Technology Platform today announces the advancement of GTB-3650 in studies enabling IND, with which it plans to supplant the ongoing Phase 1 program with the GTB-3550.

The therapeutic and commercial advantages of GTB-3650 over GTB-3550 include:

  • Based on second generation camelid single domain antibody technology which has several advantages over traditional IgG monoclonal antibodies
  • Improved potency and improved binding affinity
  • Similar preclinical safety profile
  • Commercial manufacturing capabilities through agreement with Cytovance
  • Exclusive patented molecule, which, unlike GTB-3550, is 100% owned by GT Biopharma

“We look forward to advancing the GTB-3650 into the clinic” noted Greg Berk, MD, President of R&D and Medical Director of GT Biopharma. “This transition marks the next logical evolution of our TriKE® platform. As the company focuses its resources on the most promising pipeline candidates, GTB-3650 will now be able to leverage the strong evidence gathered from our pilot of first generation TriKE® Complementing this developmental breakthrough was the transition of all manufacturing processes to Cytovance Biologics, a cGMP specialty contract manufacturing organization, ”commented Dr. Berk.

About Camelid Antibodies

Camelid antibodies are single domain antibodies (sdAbs) from the camelid mammal family which includes llamas, camels and alpacas. These animals produce 2 main types of antibodies. One type of antibody produced by camels is the conventional antibody made up of 2 heavy chains and 2 light chains. They also produce another type of antibody made up of only 2 heavy chains and no light chains. This is known as heavy chain IgG (hcIgG). Although these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also called single domain antibodies, contain only the VHH region of the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of processing. genetic engineering, format flexibility or modularity, low immunogenicity, and higher tissue penetration rate.

About GTB-3650

The GTB-3650 is the company’s leading second-generation TriKE Killer Engager Tri-Specific® program currently in preclinical development for the treatment of relapsed / refractory acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS).

About GT Biopharma, Inc.

GT Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutics based on our proprietary TriKE® NK cell engagement platform. Our TriKE® is designed to harness and enhance the cancer killing capabilities of natural killer cells in a patient’s immune system. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota continue the development and commercialization of therapies using TriKE® Technology. For more information, please visit

1. “Potent cytolytic activity and specific delivery of IL15 in a second generation trispecific killer”, by Felices, R. Lenvik, Kodal et al., July 13, 2020, Cancer immunology research.

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 direction and our current and proposed trials. Words and phrases reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes”, “hopes”, “intends”, “believes”, “expects” , “plans”, “plans”, “plans” and their variations, or the use of the future, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Our forward-looking statements are not guarantees of performance, and actual results could differ materially from those contained or expressed by such statements. When evaluating all of these statements, we invite you to specifically consider the various risk factors identified in our annual report on Form 10-K for the fiscal year ended. December 31, 2020, our subsequent current reports on Form 8-K, our quarterly report on Form 10-Q for the quarter ended June 30, 2021, and our other documents filed with the Securities and Exchange Commission, each of which could cause actual results to differ materially from those shown in our forward-looking statements.

Our forward-looking statements reflect our current views regarding future events and are based on current financial, economic, scientific and competitive data and information available 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 continued ability to raise additional capital to finance our operations , (ii) our ability to complete planned clinical trials, or meet FDA requirements for safety and efficacy, (iii) our ability to identify patients to enroll in our clinical trials in a timely manner , (iv) our ability to achieve marketable product approval, (v) the design, implementation and conduct of clinical trials, (vii) the results of our clinical trials, including the possibility of adverse clinical trial results, (vii) the market and commercialization of any product that is approved, (viii) the existence or development of treatments that are considered by healthcare professionals or patients co even superior to our products, (ix) regulatory initiatives, compliance with government regulations and regulatory approval process and social conditions, and (x) various other matters, many of which are beyond our control. If one or more of these risks or uncertainties develop, or if the underlying assumptions prove to be incorrect, actual results may differ 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 be subject to the safe harbor protection of federal securities laws in accordance with Section 27A of the Securities Act, to the extent applicable. Except as required by law, we assume no responsibility to update these forward-looking statements to reflect events or circumstances that occur after the date of this press release. In addition, we assume no responsibility for keeping you informed of the occurrence of unforeseen events that could cause actual results to differ from those expressed or implied by such forward-looking statements.

Tricycle® is a registered trademark owned by GT Biopharma, Inc.


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SOURCE GT Biopharma, Inc.


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