This section highlights FDA-related milestones and regulatory updates for drugs developed by GT Biopharma (GTBP).
Over the past two years, GT Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
GTB-3650 and GTB-5550. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
GTB-3650 - FDA Regulatory Timeline and Events
GTB-3650 is a drug developed by GT Biopharma for the following indication: For Treatment of CD33+ Leukemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- GTB-3650
- Announced Date:
- May 19, 2025
- Indication:
- For Treatment of CD33+ Leukemia
Announcement
GT Biopharma Tells Benzinga Co. Advances GTB-3650 Phase I Trial To Cohort 2 Following Successful Initial Human Dosing And Evidence Of Early Immune Activation Signals
AI Summary
GT Biopharma recently announced progress in its Phase I clinical trial for GTB-3650, a second-generation TriKE therapy targeting CD33-expressing blood cancers. The company successfully completed dosing for Cohort 1, reporting no safety or tolerability issues, which allowed the trial to advance to Cohort 2. Early biomarker analysis from Cohort 1 revealed increased immunologic activity, showing that natural killer (NK) cells were activated and expanded, a promising sign for the therapy’s potential effectiveness.
Moving forward, the trial will continue to assess safety, dosing parameters, and immune responses across multiple cohorts and involve up to 14 patients over a four-month period. GT Biopharma plans to present more detailed results in 2025, underscoring the company’s commitment to advancing its immuno-oncology treatments and providing hope for patients with challenging hematologic malignancies.
Read Announcement- Drug:
- GTB-3650
- Announced Date:
- January 27, 2025
- Indication:
- For Treatment of CD33+ Leukemia
Announcement
GT Biopharma, Inc announced that the first patient was dosed in a Phase 1 trial evaluating GTB-3650, its second-generation TriKE, for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.
AI Summary
GT Biopharma recently announced a significant milestone in its new treatment development by dosing the first patient in a Phase 1 trial. The study is testing GTB-3650, their second-generation TriKE, for patients with relapsed or refractory blood cancers that express the CD33 protein. GTB-3650 is designed to help the body’s own natural killer cells fight cancer more effectively. In the trial, up to 14 patients will be treated using a regimen where the drug is given for two weeks followed by a two-week break, over a period of up to four months. Researchers will closely monitor the treatment's safety, how it works in the body, and the response of the patients' immune cells. The company looks forward to sharing initial results from the trial in 2025, marking a hopeful step for new cancer treatment options.
Read Announcement- Drug:
- GTB-3650
- Announced Date:
- January 27, 2025
- Indication:
- For Treatment of CD33+ Leukemia
Announcement
GT Biopharma, Inc announced that Initial data from the Phase 1 trial expected in 2025
AI Summary
GT Biopharma, Inc. has begun dosing patients in a Phase 1 trial for its new therapy, GTB-3650, which is developed to treat certain blood cancers. The trial targets relapsed or refractory cancers that express the CD33 marker, such as acute myeloid leukemia. GTB-3650 is a second-generation therapy that uses a special technology to boost the activity of the body’s natural killer cells against cancer cells. In this trial, around 14 patients will receive the treatment in cycles, with dosing periods set for two weeks on and two weeks off. The company is excited to advance this study and plans to share the first set of results in 2025, marking an important step forward in their efforts to develop new cancer treatments.
Read Announcement- Drug:
- GTB-3650
- Announced Date:
- June 27, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- For Treatment of CD33+ Leukemia
Announcement
GT Biopharma, Inc announced that GTB-3650 Phase 1 trial initiation expected in H2 2024
AI Summary
GT Biopharma, Inc. has reached an important milestone with the FDA's clearance of its IND application for GTB-3650, a novel immuno-oncology therapy. This clearance paves the way for a Phase 1 clinical trial scheduled to start in the second half of 2024. The trial will focus on adult patients with relapsed or refractory CD33-expressing hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndrome. GTB-3650 is designed to harness and activate natural killer (NK) cells, offering a potential new approach to overcome some limitations of current AML treatments. The study will assess safety, pharmacokinetics, and in vivo NK cell expansion, with an early read on clinical activity expected in the first half of 2025. This progress marks a significant step in advancing GT Biopharma’s innovative therapeutic portfolio in the fight against blood cancers.
Read Announcement- Drug:
- GTB-3650
- Announced Date:
- June 27, 2024
- Indication:
- For Treatment of CD33+ Leukemia
Announcement
GT Biopharma, Inc announced FDA clearance of its IND application for GTB-3650
AI Summary
In a significant development, GT Biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the GTB-3650 therapy. This clearance allows the company to begin a Phase 1 clinical trial in the second half of 2024. The trial will test GTB-3650 in adults with relapsed or refractory CD33-expressing blood cancers, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Researchers will evaluate safety, appropriate dosing, the drug’s behavior in the body, and its effect on natural killer (NK) cells, which are key in fighting cancer. This milestone is a major step forward in addressing unmet treatment needs in serious blood cancers. Michael Breen, Executive Chairman and Interim CEO, expressed optimism about GTB-3650’s potential to improve outcomes and advance innovative immuno-oncology therapies. The news excites many.
Read Announcement- Drug:
- GTB-3650
- Announced Date:
- June 27, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 2025
- Indication:
- For Treatment of CD33+ Leukemia
Announcement
GT Biopharma, Inc announced that initial clinical data expected in H1 2025
AI Summary
GT Biopharma, Inc has announced that initial clinical data from its GTB-3650 study is expected in the first half of 2025. The Phase 1 trial will test the new therapy in patients with relapsed or refractory CD33 expressing hematologic cancers, including acute myeloid leukemia and high‐risk myelodysplastic syndrome. Researchers will assess safety, pharmacokinetics, and pharmacodynamics, as well as whether the treatment stimulates the patient’s natural killer cells to fight cancer. This early data readout is seen as an important milestone that will provide insight into the therapy’s potential effectiveness and help guide further clinical development. The company is optimistic that the findings will pave the way for additional studies and enhance its portfolio of treatments in immuno-oncology, reinforcing its commitment to innovative approaches in cancer care.
Read Announcement
GTB-5550 - FDA Regulatory Timeline and Events
GTB-5550 is a drug developed by GT Biopharma for the following indication: Multiple Myeloma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- GTB-5550
- Announced Date:
- June 27, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- Multiple Myeloma
Announcement
GT Biopharma, Inc announced that GTB-5550 TriKE® IND submission for treatment of B7H3 positive solid tumors expected in Q1 2025
AI Summary
GT Biopharma, Inc. announced plans to submit an IND application for its GTB-5550 TriKE® in the first quarter of 2025. This IND submission targets treatment of B7H3 positive solid tumors, marking a key advance in the company’s immuno-oncology pipeline. GTB-5550 is designed to harness the patient’s natural killer cells to attack cancer cells found in multiple solid tumor types, including prostate, breast, head and neck, ovarian, lung, and gastrointestinal cancers. The company aims to follow this IND submission with a Phase 1 basket trial in 2025 to assess the safety and potential effectiveness of the therapy across these diverse tumors. This effort shows GT Biopharma’s ongoing commitment to developing innovative cancer treatments using their proprietary TriKE® platform, which could offer new hope for patients battling various solid tumors.
Read Announcement- Drug:
- GTB-5550
- Announced Date:
- June 27, 2024
- Indication:
- Multiple Myeloma
Announcement
GT Biopharma, Inc announced that GTB-5550 Phase 1 dose escalation basket trial initiation expected in 2025 evaluating GTB-5550 in six solid tumor cancers, including prostate, breast, head and neck, ovarian, lung, and GI
AI Summary
GT Biopharma, Inc. announced that its Phase 1 dose escalation basket trial for GTB-5550 is expected to begin in 2025. This trial will evaluate GTB-5550 in six different solid tumor cancers: prostate, breast, head and neck, ovarian, lung, and gastrointestinal. The basket trial approach allows the company to study multiple cancer types at once, which could speed up the process of gathering safety and clinical activity data. GTB-5550 is part of the company’s ongoing efforts to develop innovative immuno-oncology therapies using its TriKE® platform that enhances the body’s natural killer cell response. The trial’s initiation in 2025 is eagerly anticipated as it may provide important insights into treating these challenging cancers and help guide future research and development initiatives in the field.Read Announcement
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