GTB-3650 / GT Biopharma - LARVOL DELTA

GT Biopharma Advances GTB-3650 Phase 1 Trial to Cohort 2 Following Successful Initial Human Dosing and Evidence of Early Immune Activation Signals (GT Biopharma Press Release) - "GT Biopharma, Inc...announced successful completion of dosing in Cohort 1 and subsequent initiation of dosing in Cohort 2 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies...Cohort 1 has been successfully completed with patients having undergone the first and second dosing cycles. Following the formal safety review, no safety or tolerability issues were observed, allowing the company to move forward with Cohort 2, with the first patient now having been treated with the first dose cycle...Based on multiple assays of various blood biomarkers, both patients in Cohort 1 have shown early evidence of increased immunologic activity, supporting GTB-3650’s ability to activate endogenous NK cells and induce NK cell expansion. The company plans on releasing more detailed results later in 2025 following enrollment and completion of additional dose cohorts."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome

HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Masonic Cancer Center, University of Minnesota | Trial completion date: Nov 2029 ➔ Oct 2027 | Trial primary completion date: Nov 2028 ➔ Mar 2027

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-3650, Second-Generation TriKE for the Treatment of Hematologic Malignancies (GT Biopharma Press Release) - "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....Initial data from the Phase 1 trial expected in 2025."

P1 data • Trial status • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Masonic Cancer Center, University of Minnesota | Not yet recruiting ➔ Recruiting

Enrollment open • Trispecific • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

GT Biopharma Reports Third Quarter 2024 Financial Results (GlobeNewswire) - "GTB-3650 TriKE Phase 1 trial first patient dosed expected in Q4 2024; initial clinical data expected in Q2 2025; GTB-5550 TriKE IND submission for treatment of B7H3 positive solid tumors expected in 1H 2025; GTB-5550 Phase 1 dose escalation basket trial initiation expected in 2025 evaluating multiple solid tumor types, including prostate, breast, head and neck, ovarian, lung, liver, and GI..."

IND • New P1 trial • P1 data • Acute Myelogenous Leukemia • Breast Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Liver Cancer • Lung Cancer • Ovarian Cancer • Prostate Cancer

HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML (clinicaltrials.gov) - P1 | N=45 | Not yet recruiting | Sponsor: Masonic Cancer Center, University of Minnesota | Initiation date: Oct 2024 ➔ Jan 2025

Trial initiation date • Trispecific • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

GT Biopharma to Host Virtual KOL Event Showcasing its NK Cell Engager Pipeline and Broad Indication Potential on October 10, 2024 (GT Biopharma Press Release) - "GT Biopharma, Inc...announced it will host a virtual KOL event on Thursday, October 10, 2024 at 12:00 PM ET...The event will feature Jeffrey Miller, MD and Mark Juckett, MD from the University of Minnesota Medical School, who will give an overview of the NK cell therapy landscape, discuss current limitations and provide perspective on the future direction of the field as it expands into exciting new therapeutic areas beyond oncology including inflammatory autoimmune indications...Dr. Miller will elaborate on GT Biopharma’s TriKE platform which has created an extensive pipeline of NK cell engagers. He will define where these engagers may best fit into the broader therapeutic landscape. Dr. Juckett will speak to GT Biopharma’s Phase 1 trial expected to start in Q4 evaluating GTB-3650 monotherapy for the treatment of acute myeloid leukemia (AML)."

Clinical • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Immunology • Leukemia • Oncology

HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML (clinicaltrials.gov) - P1 | N=45 | Not yet recruiting | Sponsor: Masonic Cancer Center, University of Minnesota

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

GT Biopharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "GTB-3650 TriKE Phase 1 trial initiation expected in 2H 2024; initial clinical data expected in 1H 2025; GTB-5550 TriKE IND submission for treatment of B7H3 positive solid tumors expected in 1H 2025; GTB-5550 Phase 1 dose escalation basket trial initiation expected in 2025 evaluating six solid tumor types, including prostate, breast, head and neck, ovarian, lung, and GI."

IND • New P1 trial • P1 data • Breast Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Ovarian Cancer • Prostate Cancer • Solid Tumor

GT BIOPHARMA ANNOUNCES FDA CLEARANCE OF INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR GTB-3650, AN NK CELL ENGAGER FOR TREATMENT OF CD33+ LEUKEMIA (GT Biopharma Press Release) - "GTB-5550 TriKE IND submission for treatment of B7H3 positive solid tumors expected in Q1 2025; 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...GT Biopharma...announced FDA clearance of its IND application for GTB-3650, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to start in second half of 2024...'As we ramp up our clinical activities, we plan to start the Phase 1 trial with GTB-3650 in the coming months followed by multiple data readouts in 2025.'....The Phase 1 dose escalation study will evaluate GTB-3650 in up to six cohorts of adult patients with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)."

IND • New P1 trial • P1 data • Acute Myelogenous Leukemia • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Leukemia • Lung Cancer • Myelodysplastic Syndrome • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

GT Biopharma Reports First Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "IND clearance for GTB-3650, a 2nd generation nanobody TriKE for treatment of CD33+ leukemia expected in Q2 2024."

IND • Acute Myelogenous Leukemia

GT Biopharma Reports Fourth Quarter and Full-Year 2023 Financial Results (GlobeNewswire) - "Remain in active dialogue with the FDA regarding IND clearance for GTB-3650, a 2nd generation nanobody TriKE for treatment of CD33+ leukemia. Phase 1 trial with GTB-3650 anticipated to start in 2H 2024. Anticipate submitting an IND for GTB-5550 targeting B7H3 for multiple solid tumors, including prostate and breast, in Q4 2024."

IND • New P1 trial • Acute Myelogenous Leukemia • Breast Cancer • Prostate Cancer

GT Biopharma Announces IND Submission for GTB-3650 for Treatment of CD33+ Leukemia (GlobeNewswire) - "GT Biopharma...announced the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for the development of GTB-3650, a 2nd generation nanobody TriKE for the treatment of patients with CD33+ leukemia, including relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS)."

IND • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

GT Biopharma Reports Third Quarter 2023 Financial Results (GlobeNewswire) - "IND submission for GTB-3650, 2^nd generation nanobody TriKE^® for treatment of CD33+ leukemia, expected in Q4 2023; Phase 1 clinical trial initiation evaluating GTB-3650 for treatment of CD33+ leukemia anticipated in 2024; Cash of approximately $16 million as of September 30, 2023, provides ample runway to fund operations into 2H 2024; anticipated to be sufficient to initiate clinical trial activities on GTB-3650."

Commercial • IND • New P1 trial • Hematological Malignancies • Leukemia • Oncology

GT Biopharma Reports Second Quarter 2023 Financial Results (GlobeNewswire) - "GT Biopharma, Inc...today announced second quarter 2023 results for the period ended June 30, 2023....'We expect to advance GTB-3650, a second generation nanobody TriKE® for the treatment of CD33+ leukemia, with GTB-5550 for the treatment of B7H3+ solid tumors to follow'...The Company had cash, cash equivalents and short-term investments of $18.0 million as of June 30, 2023, compared to $16.5 million as of December 31, 2022. We expect ample runway to fund operations into Q3 2024....R&D expenses for the three months and six months ended June 30, 2023 were $2.1 million and $3.7 million, compared to $1.1 million and $3.2 million for the same comparable periods of 2022."

Commercial • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

GT Biopharma Reports First Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "'...we expect to submit an investigational new drug (IND) filing with the U.S. Food and Drug Administration for GTB-3650 in the 2H 2023'...The Company anticipates that the IND submission of GTB-5550 will follow after GTB-3650....R&D expenses for the first quarter of 2023 were $1.7 million compared to $2.1 million for the same quarter in 2022. Research and development expenses are related to our continued development and production of our most advanced TriKE® product candidates GTB-3650 and GTB-5550 along with the progression of other promising product candidates. R&D expenses decreased over the previous year primarily due to reduction in in-house staff and compensation to consultants as we prepare to advance our next generation GTB-3650 camelid nanobody product into the clinic."

Commercial • IND • Oncology

GT Biopharma Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "...'Looking ahead we are on track to submit an investigational new drug (IND) filing with the U.S. Food and Drug Administration for our lead-asset GTB-3650 in the first half of 2023'."

IND • Hematological Malignancies • Oncology

A Novel Dual-Antigen Targeting Approach Enables Off-the-Shelf CAR NK Cells to Effectively Recognize and Eliminate the Heterogenous Population Associated with AML (ASH 2022) - "In the initial study, the iNK cell backbone (iNK cells without the α3 MICA/B CAR) induced potent activity against the AML cell line HL60, and displayed further enhancement of activity with the addition of anti-CD33 TriKE (GTB-3650), representing combined effects of natural cytotoxicity and antibody-dependent cellular cytotoxicity. Studies with primary AML targets, +/- preincubation of decitabine and all-trans retinoic acid, known to upregulate NKG2D ligands in AML, are in progress and will be discussed. In summary, dual-targeting strategies using off-the-shelf CAR NK cells targeting α3 MICA/B in combination with antigen-specific TriKE targeting CD33 represent an ideal clinical strategy to enhance efficacy and durability of treatment in advanced AML."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Graft versus Host Disease • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Leukemia • Oncology • Transplantation • IL15 • NKG2D

GT Biopharma and Fate Therapeutics Present Preclinical Data Highlighting Novel Dual Antigen Targeting Approach For The Treatment of AML at ASH 2022 (GlobeNewswire) - "GT Biopharma, Inc....announced the presentation of new preclinical data at the American Society of Hematology's 64th Annual Meeting (ASH 2022). The presentation highlights the potential of a novel dual antigen targeting approach for the treatment of acute myeloid leukemia (AML) by combining GT Biopharma’s Tri-specific Killer Engager (TriKE) with the induced pluripotent stem cell (iPSC) product platform of Fate Therapeutics, Inc....α3 MICA/B iNK cells exhibited antigen-specific activation in vitro as measured by interferon-gamma production and CD107a degranulation across a broad range of solid tumor cell lines. α3 MICA/B iNK cells demonstrated robust cytotoxicity in vitro against an array of AML cell lines, including those with proteolytic cleavage of the α1 and α2 domains of MICA/B, which is a known mechanism of tumor escape from NK cell cytotoxicity. The kinetics of cytotoxicity were enhanced in combination with in combination with GTB-3650, a second-generation anti-CD33 TriKE."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

GT Biopharma to Present New Data on Novel Dual-Antigen Targeting Approach Against AML at Upcoming 2022 ASH Annual Meeting (GlobeNewswire) - "GT Biopharma, Inc...announced the presentation of new data at the American Society of Hematology's 64th Annual Meeting...The study utilized a combination of GT Biopharma’s investigational GTB-3650, a CD33 targeting Tri-specific Killer Engager (TriKE), and Fate Therapeutics’ multiplexed-engineered, iPSC-derived, CAR NK cells targeting the α3 domain of MICA and MICB. Preclinical data to be presented demonstrate that iPSC-derived, MICA/B-targeted CAR NK cells induced potent activity against the AML cell line HL60, and that further enhancement of activity was achieved in combination with GTB-3650 through antibody-dependent cellular cytotoxicity."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

GT Biopharma Affirms Manufacturing Timeline For Lead Investigational Asset GTB-3650 (GlobeNewswire) - "GT Biopharma...announced entering into a Settlement and Investment Agreement (the 'Agreement') with its contract manufacturing partner Cytovance Biologics. The signed Agreement, covers all work required to facilitate the registration of an investigational new drug (IND) filing with the U.S. Food and Drug Administration ('FDA') of its lead investigational asset GTB-3650....The Company now expects to file its investigational new drug ('IND') application with the FDA for its GTB-3650 product no later than March 31, 2023, and to file its IND application with the FDA for its GTB-5550 product no later than June 30, 2023."

IND • Licensing / partnership • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

"$GTBP GT Biopharma Affirms Manufacturing Timeline For Lead Investigational Asset GTB-3650 https://t.co/eOwatXxfk3" (@stock_titan)

GT Biopharma Reports Second Quarter Fiscal 2022 Financial Results and Business Update (GlobeNewswire) - "We expect to file an Investigational New Drug (IND) application for GTB-3650 in the first half of 2023, subsequently followed by an IND application for GTB-5550."

IND • Oncology