- |||||||||| Undisclosed PSMA TriKE / GT Biopharma
Journal, Trispecific: A PSMA-targeted Tri-specific Killer Engager enhances NK cell cytotoxicity against prostate cancer. (Pubmed Central) - Nov 17, 2024
Finally, in vivo testing of PSMA TriKE showed improved tumor control and survival of mice as compared to IL-15 and untreated control groups. In conclusion, PSMA TriKE demonstrates potential as a new therapy for advanced prostate cancer by providing additional signals to NK cells to maximize their anti-tumor potential in prostate cancer, especially in the setting of a hostile TME.
- |||||||||| GTB-3650 / GT Biopharma
Trial initiation date, Trispecific: HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML (clinicaltrials.gov) - Nov 5, 2024
P1, N=45, Not yet recruiting,
In conclusion, PSMA TriKE demonstrates potential as a new therapy for advanced prostate cancer by providing additional signals to NK cells to maximize their anti-tumor potential in prostate cancer, especially in the setting of a hostile TME. Initiation date: Oct 2024 --> Jan 2025
- |||||||||| PSMA TriKE / GT Biopharma
Maximizing NK cell immunotherapy in prostate cancer via TriKEs (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1482;
Peripheral Blood Mononuclear Cells (PBMCs) from normal donors or prostate cancer patients were either used directly or magnetically enriched for NK cells in assays co-culturing cells with PCa cell lines in the presence or absence of PSMA TriKE or B7H3 TriKE...NK cell cytotoxicity is also improved, even in the presence of enzalutamide resistant lines (figure 1C), hypoxia (figure 1D), or Myeloid Derived Suppressor Cells...Conclusions Our findings indicate that TriKE molecules improve PCa control in several systems and in the presence of varied TME-specific stresses. These pre-clinical studies highlight the potential for using TriKE molecules in the setting of metastatic Prostate Cancer and pave the way for future, targeted, NK cell immunotherapeutic interventions in this setting.
- |||||||||| cam1615SS1 / GT Biopharma
Journal, Trispecific: A tri-specific killer engager against mesothelin targets NK cells towards lung cancer. (Pubmed Central) - Mar 14, 2023
Importantly, TriKE triggered NK cell responses from patients at all stages of disease and treatment, suggesting TriKE can enhance current therapies. These pre-clinical studies suggest mesothelin-targeted TriKE has the potential to overcome the immunosuppressive environment of NSCLC to treat disease.
- |||||||||| cam1615SS1 / GT Biopharma, GTB-5550 / GT Biopharma
Tri-specific killer engagers target natural killer cells towards mesothelioma (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1510;
Conclusions GTB-5550 drove NK cell responses towards all mesothelioma subtypes, while cam1615SS1 successfully targeted epithelial peritoneal mesothelioma. In future studies we aim to combine TriKE with immune checkpoint inhibitors to test their potential to drive innate immune responses in the context of currently approved therapies.
- |||||||||| GTB-3550 TRIKE / GT Biopharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Trispecific, Metastases: GTB-3550 Tri-Specific Killer Engager (TriKE (clinicaltrials.gov) - Apr 1, 2022
P1/2, N=12, Terminated,
Clinical manufacturing is underway with an IND planned to open clinical trials in 2023 in a number of solid tumors and multiple myeloma. N=60 --> 12 | Trial completion date: Aug 2025 --> Sep 2021 | Active, not recruiting --> Terminated | Trial primary completion date: Feb 2024 --> Aug 2021; Development of GTB-3550 halted due to development of the second generation camelid nanobody TriKE drug product, GTB-3650.
- |||||||||| Review, Journal: CD33-Targeted Therapies: Beating the Disease or Beaten to Death? (Pubmed Central) - Dec 16, 2021
Gemtuzumab ozogamicin was the first and only CD33-directed antibody-drug conjugate to be US Food and Drug Administration approved for AML...Promising new strategies include cellular therapy mechanisms and linker molecules. This is an exciting target that requires a considerable amount of precision to yield clinical benefit.
- |||||||||| Xtandi (enzalutamide) / Pfizer, Astellas, Bausch Health, GTB-3550 / GT Biopharma, GTB-5550 / GT Biopharma
Novel B7-H3 targeting dual nanobody NK cell engagers display robust activity against a broad spectrum of solid and hematologic malignancies. (Foyer ABC [VIRTUAL]) - Oct 29, 2021 - Abstract #ESMOIO2021ESMO_IO_256;
These were used to evaluate how the BiKE and GTB-3550 induce NK cell degranulation (CD107a) and interferon gamma production...Results PB NK cells were robustly activated, compared to controls, when treated with GTB-5550 or BiKE and cultured with enzalutamide resistant PCa, osteosarcoma (U2OS, SaOS2), rhabdomyosarcoma (RH30), ovarian carcinoma (MA148, OVCAR8), AML (MV4;11, THP-1) and multiple myeloma (MM1S) cell lines...Legal entity responsible for the study The authors. Funding GT Biopharma, Inc.
- |||||||||| GTB-3550 TRIKE / GT Biopharma
Enrollment closed, Trispecific, Metastases: GTB-3550 Tri-Specific Killer Engager (TriKE (clinicaltrials.gov) - Sep 21, 2021
P1/2, N=60, Active, not recruiting,
Trial Registration NCT03214666 Recruiting --> Active, not recruiting
- |||||||||| Novel therapy for relapsed childhood acute lymphoblastic leukemia () - Oct 23, 2019 - Abstract #EHOC2019EHOC_7;
Since bcl-2 pathway prevents apoptosis, the efficacy of bcl-2 inhibitors, Navitoclax and Venetoclax, in ALL is being investigated...Palbociclib, CDK6 inhibitor, is used as monotherapy in KMT2A-r acute leukemia...Immunotherapy Antibody-based immunotherapy Blinatumomab: It is an antibody capable of binding to CD19 and CD3 and transmitting T-cell cytotoxicity to lymphoblasts presenting CD19...Denintuzumab mafodatin: It is a humanized CD19 antibody bound with monomethyl auristatin F (MMAF)...ADCT-402: It is a humanized anti-CD19 antibody conjugated with Pyrrolobenzodiazepine dimer cytotoxin...DT2219: It is a bispecific, recombinant, diphtheria toxin-based immunotoxin that recognizes CD19 and CD22-presenting cells...Inotuzumab ozogamicin: It is a novel monoclonal antibody against CD22 conjugated to the toxin Calicheamicin...Epratuzumab: It is a humanized monoclonal anti-CD22 antibody...Rituximab: It is a chimeric monoclonal CD20 antibody...Ofatumumab: It is a humanized anti-CD20 antibody...Obinutuzumab: It a type II humanized anti-CD20 monoclonal antibody...Etanercept (anti-TNF) and Tociluzumab (anti IL-6) can be used in the treatment of cytokine release syndrome. There are many marching studies on CAR-T cell therapy.
- |||||||||| GTB-3550 TRIKE / GT Biopharma
Enrollment open, Trispecific, Metastases: GTB-3550 Tri-Specific Killer Engager (TriKE (clinicaltrials.gov) - Sep 17, 2019
P1/2, N=60, Recruiting,
There are many marching studies on CAR-T cell therapy. Not yet recruiting --> Recruiting
- |||||||||| OXS-3550 / GT Biopharma
Journal, Myeloid-derived suppressor cells, IO biomarker: 161533 TriKE stimulates NK-cell function to overcome myeloid-derived suppressor cells in MDS. (Pubmed Central) - Apr 19, 2019
Furthermore, 161533 TriKE-treated MDS NK cells had higher proliferation and enhanced NK-cell function than 1633 BiKE-treated cells without the IL-15 linker. Collectively, our data demonstrate novel characteristics of the 161533 TriKE that support its application as an immunotherapeutic agent for MDS patients.
- |||||||||| GTB-3550 TRIKE / GT Biopharma
Trial completion date, Trial initiation date, Trial primary completion date, Trispecific, Metastases: GTB-3550 Tri-Specific Killer Engager (TriKE (clinicaltrials.gov) - Jan 17, 2019
P1/2, N=60, Not yet recruiting,
Collectively, our data demonstrate novel characteristics of the 161533 TriKE that support its application as an immunotherapeutic agent for MDS patients. Trial completion date: Aug 2024 --> Aug 2025 | Initiation date: Jan 2019 --> Jan 2020 | Trial primary completion date: Feb 2023 --> Feb 2024
- |||||||||| OXS-1550 / GT Biopharma
Journal: Development of a Deimmunized Bispecific Immunotoxin dDT2219 against B-Cell Malignancies. (Pubmed Central) - Dec 24, 2018
In order to overcome this limitation for DT2219, a promising bispecific targeted toxin which targets CD19 and CD22, we deimmunized the DT moiety, and thereby developed an exciting improved drug (dDT2219) which still has the potential to sufficiently target B-cell malignancies but also limits clearance because of its reduced immunogenicity...The new dDT2219 combines potent anti-tumor cell activity with a reduced immunogenicity. With regard to the frequent development of neutralizing antibodies after multiple administrations with immunotoxins, dDT2219 shows promise to overcome this limitation and thus might maintain effectiveness even after multiple treatment cycles.
- |||||||||| GTB-3550 TRIKE / GT Biopharma
Trial completion date, Trispecific, Metastases: GTB-3550 Tri-Specific Killer Engager (TriKE (clinicaltrials.gov) - Nov 27, 2018
P1/2, N=60, Not yet recruiting,
With regard to the frequent development of neutralizing antibodies after multiple administrations with immunotoxins, dDT2219 shows promise to overcome this limitation and thus might maintain effectiveness even after multiple treatment cycles. Trial completion date: Jun 2023 --> Jul 2024
- |||||||||| OXS-1550 / GT Biopharma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma (clinicaltrials.gov) - Sep 27, 2018
P1/2, N=18, Completed,
Trial completion date: Jun 2023 --> Jul 2024 Recruiting --> Completed | N=44 --> 18 | Trial completion date: Jun 2020 --> Mar 2018 | Trial primary completion date: Jun 2019 --> Mar 2018
- |||||||||| OXS-1550 / GT Biopharma
Trial completion date, Trial primary completion date: HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma (clinicaltrials.gov) - Sep 6, 2018
P1/2, N=44, Recruiting,
Recruiting --> Completed | N=44 --> 18 | Trial completion date: Jun 2020 --> Mar 2018 | Trial primary completion date: Jun 2019 --> Mar 2018 Trial completion date: Jun 2019 --> Jun 2020 | Trial primary completion date: Jun 2018 --> Jun 2019
- |||||||||| GTB-3550 TRIKE / GT Biopharma
Trial initiation date, Trispecific, Metastases: GTB-3550 Tri-Specific Killer Engager (TriKE (clinicaltrials.gov) - Dec 5, 2017
P1/2, N=60, Not yet recruiting,
Trial completion date: Jun 2019 --> Jun 2020 | Trial primary completion date: Jun 2018 --> Jun 2019 Initiation date: Nov 2017 --> Nov 2018
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