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- | MGTA-117 / Magenta Therap, busulfan / Generic mfg.
Journal, Gene therapy: Fertility-preserving myeloablative conditioning using single-dose CD117 antibody-drug conjugate in a rhesus gene therapy model. (Pubmed Central) - Nov 3, 2023
Thus, the myeloablative capacity of single-dose CD117-ADC is sufficient for efficient engraftment of gene-modified HSCs while preserving fertility and reducing adverse effects related to toxicity in non-human primates. This targeted conditioning approach thus provides the proof-of-principle to improve risk-benefit ratio in a variety of HSC-based gene therapy products in humans.
- MGTA-117 / Magenta Therap
CD117 Antibody-Drug Conjugate Conditioning Allows Efficient Engraftment of Gene-Modified CD34+ Cells with Fertility Preservation in a Rhesus Gene Therapy Model (SDCC - Ballroom 20CD) - Nov 3, 2023 - Abstract #ASH2023ASH_3109;
The transplanted animals with ADC maintained their fertility. Overall, these data indicate that an ADC-based targeted approach offers safer conditioning and could improve the risk-benefit profile in HSC gene therapy.
- MGTA-117 / Magenta Therap
CAREFULLY ENGINEERED CD117 VARIANTS RESULT IN FULL PROTECTION OF SHIELDED HEMATOPOIETIC STEM AND PROGENITOR CELLS FROM A HIGHLY POTENT CD117-DIRECTED ANTIBODY DRUG CONJUGATE IN VIVO (Room 253) - Feb 11, 2023 - Abstract #EBMT2023EBMT_1017;
In addition, our data show that for highly potent agents such as CIM058-tes, even weak interaction with the immunotherapy can result in cell depletion. Therefore, for ADCs and other highly effective immunotherapies, variants that completely abolish binding to the depleting agent are preferrable over variants with residual binding.
- | MGTA-117 / Magenta Therap
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB) (clinicaltrials.gov) - Feb 9, 2023
P1/2, N=22, Terminated, Sponsor: Magenta Therapeutics, Inc.
Therefore, for ADCs and other highly effective immunotherapies, variants that completely abolish binding to the depleting agent are preferrable over variants with residual binding. N=55 --> 22 | Trial completion date: Oct 2023 --> Feb 2023 | Recruiting --> Terminated | Trial primary completion date: Oct 2023 --> Feb 2023; Sponsor Decision
- MGTA-117 / Magenta Therap
Mgta-117, an Anti-CD117-Amanitin Antibody-Drug Conjugate, in Participants with Relapsed/Refractory Adult Acute Myeloid Leukemia (AML) and Myelodysplasia with Excess Blasts (MDS-EB): Safety, Pharmacokinetics, and Pharmacodynamics Initial Findings from a Phase 1/2 Study () - Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_747;
P1/2
It has shown proof-of-mechanism (robust receptor binding, selective target cell depletion) and rapid clearance with in vivo stability. Further dose escalation continues, and progress is being made toward development of MGTA-117 to enable HSCT in AML/MDS and gene therapy indications.
- MGTA-117 / Magenta Therap
The Pharmacokinetic and Pharmacodynamic Characterization of Mgta-117, an Anti-CD117-Amanitin Antibody-Drug Conjugate for Targeted Conditioning Prior to Transplant, in Nonhuman Primates (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_6420;
The rapid clearance of MGTA-117 from blood was consistent with saturation of CD117 binding and internalization. At doses of 0.3 mg/kg and higher, the observed PD responses within stem cells confirm targeted depletion of CD117 expressing populations, with durable depletion beyond the actual clearance of ADC.
- MGTA-117 / Magenta Therap
Mgta-117, an Anti-CD117 Antibody-Drug Conjugated with Amanitin, in Participants with Relapsed/Refractory Adult Acute Myeloid Leukemia (AML) and Myelodysplasia with Excess Blasts (MDS-EB): Safety, Pharmacokinetics and Pharmacodynamics Initial Findings from a Phase 1/2 Study (ENMCC - 393-396) - Nov 4, 2022 - Abstract #ASH2022ASH_5265;
P1/2
Preliminary data show in vivo stability of the ADC with rapid clearance from blood, robust binding of MGTA-117 on CD117+ cells, and early evidence of single-agent biological activity. The observed PK/PD profile in humans is highly consistent with predictions based on data from studies in preclinical species.
- ||| MGTA-117 / Magenta Therap
Review: MGTA-117 - Amanitin ADChttps://www.adcreview.com/drugmap/mgta-117-amanitin-adc/ (Twitter) - Sep 19, 2022
- | MGTA-117 / Magenta Therap
Journal: Non-Genotoxic Restoration of the Hematolymphoid System in Fanconi Anemia. (Pubmed Central) - Aug 24, 2022
In addition, they show that if sufficient immunosuppression is given to obtain initial donor HSC engraftment, resulting turnover of a majority of the hematolymphoid system can occur likely due to the survival advantage of WT HSCs over FA HSCs. Such non-toxic all antibody-based conditioning strategy could be transformative for FA patients and those with other hematolymphoid diseases.
- MGTA-117 / Magenta Therap
TIP: A phase I/II study of MGTA-117, an anti-CD117 antibody-drug conjugate, in patients with adult acute myeloid leukemia (AML) and myelodysplasia with excess blasts (MDS-EB). (Available On Demand; 145b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5192;
P1/2
CD117 receptor occupancy by MGTA-117 will be measured and MSBE dose will be based on safety and receptor occupancy. The study is designed with the possibility that subjects would proceed to HSCT >28 days after MGTA-117 administration, if eligible per the local transplant practices.
- ||| MGTA-117 / Magenta Therap
Enrollment change: Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB) (clinicaltrials.gov) - Apr 28, 2022
P1/2, N=55, Recruiting, Sponsor: Magenta Therapeutics, Inc.
The study is designed with the possibility that subjects would proceed to HSCT >28 days after MGTA-117 administration, if eligible per the local transplant practices. N=42 --> 55
- MGTA-117 / Magenta Therap
A Single Injection of CD117 Antibody-drug Conjugate Allows for Efficient Engraftment of Gene-modified CD34+ Cells in a Rhesus Gene Therapy Model (Salon H) - Apr 20, 2022 - Abstract #ASGCT2022ASGCT_1276;
In summary, we demonstrated that a single dose of CD117-ADC allows for efficient engraftment of gene-modified CD34+ HSCs and robust HbF induction in a rhesus gene therapy model, achieving a similar level as myeloablative Bu conditioning. This targeted approach for safer conditioning could improve the risk-benefit profile in HSC gene therapy.
- || MGTA-145 / Magenta Therap, MGTA-117 / Magenta Therap
Clinical: $MGTA to focus on MGTA-117 development and is pausing certain MGTA-145 investments, including MGTA-145 dosing and administration optimization clinical trial in healthy subjects. Workforce reduction of 14% (Twitter) - Apr 14, 2022
- || MGTA-117 / Magenta Therap
New P1/2 trial: Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB) (clinicaltrials.gov) - Feb 4, 2022
P1/2, N=42, Recruiting, Sponsor: Magenta Therapeutics, Inc.
- MGTA-117 / Magenta Therap
CD117 ANTIBODY DRUG CONJUGATE-BASED CONDITIONING ENABLES EFFICIENT ENGRAFTMENT OF GENE-MODIFIED CD34+ CELLS IN A RHESUS GENE THERAPY MODEL () - Jan 30, 2022 - Abstract #EBMT2022EBMT_1082;
As a single agent, CD117-ADC enabled engraftment of gene-modified CD34+ HSCs and robust HbF induction comparable to myeloablative busulfan in a clinically-relevant rhesus gene therapy model. A CD117-ADC targeted conditioning approach could improve the clinical risk benefit profile versus current non-targeted conditioning in HSC gene therapy.
- MGTA-117 / Magenta Therap
SINGLE DOSE CD117-TARGETED ANTIBODY DRUG CONJUGATE (ADC) IN COMBINATION WITH LYMPHODEPLETING ANTIBODIES ENABLES ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION IN MICE WITHOUT CHEMOTHERAPY OR RADIATION (ePoster Area [VIRTUAL]) - Jan 30, 2022 - Abstract #EBMT2022EBMT_1081;
Conditioning with 3 mg/kg anti-mCD117-ADC, in combination with lymphodepleting antibodies, enables complete donor chimerism in an allo-HSCT murine model. This targeted conditioning approach could offer a more favorable risk-benefit profile over current conditioning regimens and extend the curative potential of allo-HSCT to patients who otherwise would not be eligible for HSCT.
- MGTA-117 / Magenta Therap
CD117 Antibody Drug Conjugate-Based Conditioning Enables Efficient Engraftment of Gene-Modified CD34+ Cells in a Rhesus Gene Therapy Model (Salt Palace Convention Center Hall A) - Jan 9, 2022 - Abstract #TCTASTCTCIBMTR2022TCT_ASTCT_CIBMTR_1040;
As a single agent, CD117-ADC enabled engraftment of gene-modified CD34+ HSCs and robust HbF induction comparable to myeloablative busulfan in a clinically-relevant rhesus gene therapy model. A CD117-ADC targeted conditioning approach could improve the clinical risk benefit profile versus current non-targeted conditioning in HSC gene therapy.
- MGTA-117 / Magenta Therap, AVROBIO
CD117 Antibody Drug Conjugate-Based Conditioning Allows for Efficient Engraftment of Gene-Modified CD34+ Cells in a Rhesus Gene Therapy Model (GWCC - B207-B208, Level 2) - Nov 5, 2021 - Abstract #ASH2021ASH_2000;
Robust HbF induction was also confirmed at the protein levels in this rhesus gene therapy model with ADC conditioning. This targeted approach for safer conditioning could improve the risk benefit profile in HSC gene therapy.
- MGTA-117 / Magenta Therap, AVROBIO
[VIRTUAL] A NOVEL SHORT HALF-LIFE ANTI-HUMAN CD117-AMANITIN ADC EXHIBITS DUAL HSCT CONDITIONING AND ANTI-LEUKEMIA ACTIVITY AND EXTENDS SURVIVAL IN MULTIPLE PRECLINICAL MODELS OF AML (ePoster Area) - Mar 19, 2021 - Abstract #EBMT2021EBMT_3506;
These data demonstrate that MGTA-117 has potential to be a potent targeted conditioning and anti-leukemia agent. Together with prior reports demonstrating MGTA-117 as an effective conditioning agent in an animal model, this targeted ADC approach has the potential to improve HSCT outcomes in AML by reducing leukemic burden peri-transplant and may decrease the toxicities associated with current conditioning regimens.
- MGTA-117 / Magenta Therap, AVROBIO
[VIRTUAL] A NOVEL SHORT HALF-LIFE ANTI-HUMAN CD117-AMANITIN ADC EXHIBITS DUAL HSCT CONDITIONING AND ANTI-LEUKEMIA ACTIVITY AND EXTENDS SURVIVAL IN MULTIPLE PRECLINICAL MODELS OF AML (ePoster Area) - Mar 19, 2021 - Abstract #EBMT2021EBMT_3505;
These data demonstrate that MGTA-117 has potential to be a potent targeted conditioning and anti-leukemia agent. Together with prior reports demonstrating MGTA-117 as an effective conditioning agent in an animal model, this targeted ADC approach has the potential to improve HSCT outcomes in AML by reducing leukemic burden peri-transplant and may decrease the toxicities associated with current conditioning regimens.
- MGTA-117 / Magenta Therap, AVROBIO
[VIRTUAL] A NOVEL SHORT HALF-LIFE ANTI-HUMAN CD117-AMANITIN ADC EXHIBITS DUAL HSCT CONDITIONING AND ANTI-LEUKEMIA ACTIVITY AND EXTENDS SURVIVAL IN MULTIPLE PRECLINICAL MODELS OF AML (ePoster Area) - Mar 19, 2021 - Abstract #EBMT2021EBMT_3504;
These data demonstrate that MGTA-117 has potential to be a potent targeted conditioning and anti-leukemia agent. Together with prior reports demonstrating MGTA-117 as an effective conditioning agent in an animal model, this targeted ADC approach has the potential to improve HSCT outcomes in AML by reducing leukemic burden peri-transplant and may decrease the toxicities associated with current conditioning regimens.
- MGTA-117 / Magenta Therap, AVROBIO
[VIRTUAL] A NOVEL SHORT HALF-LIFE ANTI-HUMAN CD117-AMANITIN ADC EXHIBITS DUAL HSCT CONDITIONING AND ANTI-LEUKEMIA ACTIVITY AND EXTENDS SURVIVAL IN MULTIPLE PRECLINICAL MODELS OF AML (ePoster Area) - Feb 4, 2021 - Abstract #EBMT2021EBMT_3217;
These data demonstrate that MGTA-117 has potential to be a potent targeted conditioning and anti-leukemia agent. Together with prior reports demonstrating MGTA-117 as an effective conditioning agent in an animal model, this targeted ADC approach has the potential to improve HSCT outcomes in AML by reducing leukemic burden peri-transplant and may decrease the toxicities associated with current conditioning regimens.
- [VIRTUAL] A Single Dose of a Novel Anti-Human CD117-Amanitin Antibody Drug Conjugate (ADC) Engineered for a Short Half-Life Provides Dual Conditioning and Anti-Leukemia Activity and Extends Survival Compared to Standard of Care in Multiple Preclinical Models of Acute Myeloid Leukemia (AML) () - Dec 20, 2020 - Abstract #TCTASTCTCIBMTR2021TCT_ASTCT_CIBMTR_441;
- MGTA-117 / Magenta Therap
[VIRTUAL] A Single Dose of a Novel Anti-Human CD117-Amanitin Antibody Drug Conjugate (ADC) Engineered for a Short Half-Life Provides Dual Conditioning and Anti-Leukemic Activity and Extends Survival Compared to Standard of Care in Multiple Preclinical Models of Acute Myeloid Leukemia (AML) (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_805;
These data demonstrate that MGTA-117 has potential to be a potent targeted conditioning and anti-leukemia agent. Together with prior reports demonstrating MGTA-117 as an effective conditioning agent in an animal model, this targeted ADC approach has the potential to improve HSCT outcomes in AML by reducing leukemic burden peri-transplant and may decrease the toxicities associated with current conditioning regimens.
- || MGTA-145 / Magenta Therap, MGTA-117 / Magenta Therap, CD45-ADC / Magenta Therap
.@MagentaTx $MGTA will report updates across its product portfolio, including MGTA-145, MGTA-117 & CD45 ADC, at #ASH20. (Twitter) - Nov 4, 2020
- MGTA-117 / Magenta Therap
[VIRTUAL] MGTA-117: An Anti-CD117 Antibody Drug Conjugate (ADC) Designed for Patient Conditioning for Stem Cell Transplant and Gene Therapy Provides a Broad Therapeutic Window Across Species () - Aug 31, 2020 - Abstract #PEGS2020PEGS_595;
Prior to transplant, patients are conditioned by removing their own bone marrow stem cells using poorly tolerated toxic, non-selective chemotherapy and radiation. This presentation will highlight preclinical proof of concept data demonstrating that antibody-drug conjugates may be safer, targeted agents for patient preparation with the aim of extending the use of curative bone marrow transplant and improving outcomes for patients.
- MGTA-117 / Magenta Therap, busulfan / Generic mfg., Mozobil (plerixafor) / Sanofi
[VIRTUAL] A SINGLE DOSE OF SHORT HALF-LIFE CD117 ANTIBODY DRUG CONJUGATE ENABLES HEMATOPOIETIC STEM CELL BASED GENE THERAPY IN NONHUMAN PRIMATES (ePoster Area) - Jul 3, 2020 - Abstract #EBMT2020EBMT_4992;
In a rhesus model of auto-gene modified HSCT, a single dose of the ADC enabled engraftment of gene modified HSCs. These proof of concept studies validate the use of CD117-ADC for targeted HSPC depletion prior to transplant and support its use as a new conditioning agent for auto-gene modified HSCT.
- MGTA-117 / Magenta Therap, busulfan / Generic mfg., Mozobil (plerixafor) / Sanofi
[VIRTUAL] A SINGLE DOSE OF SHORT HALF-LIFE CD117 ANTIBODY DRUG CONJUGATE ENABLES HEMATOPOIETIC STEM CELL BASED GENE THERAPY IN NONHUMAN PRIMATES (ePoster Area) - Jul 3, 2020 - Abstract #EBMT2020EBMT_4991;
In a rhesus model of auto-gene modified HSCT, a single dose of the ADC enabled engraftment of gene modified HSCs. These proof of concept studies validate the use of CD117-ADC for targeted HSPC depletion prior to transplant and support its use as a new conditioning agent for auto-gene modified HSCT.
- MGTA-117 / Magenta Therap, busulfan / Generic mfg., Mozobil (plerixafor) / Sanofi
[VIRTUAL] A SINGLE DOSE OF SHORT HALF-LIFE CD117 ANTIBODY DRUG CONJUGATE ENABLES HEMATOPOIETIC STEM CELL BASED GENE THERAPY IN NONHUMAN PRIMATES (ePoster Area) - Jul 3, 2020 - Abstract #EBMT2020EBMT_4990;
In a rhesus model of auto-gene modified HSCT, a single dose of the ADC enabled engraftment of gene modified HSCs. These proof of concept studies validate the use of CD117-ADC for targeted HSPC depletion prior to transplant and support its use as a new conditioning agent for auto-gene modified HSCT.
- ||| MGTA-117 / Magenta Therap
Clinical: Magenta Conditioning Lead Clinical Candidate MGTA-117 Demonstrates Broad Tolerability and High Therapeutic Index in Non-human Primates https://t.co/m4yjUVupyK (Twitter) - Feb 24, 2020
- |||| MGTA-117 / Magenta Therap
Preclinical: CD117 ADC showing exceptional preclinical promise to induce myeolablation and facilitate engraftment of autologous gene-modified HSCs with minimal toxicities. #TCTM20 (Twitter) - Feb 21, 2020
- || MGTA-117 / Magenta Therap
#TCTM20 Uchida: single dose of anti-CD117 ADC allowed engraftment of autologous gene-marked HSC without chemo. (Twitter) - Feb 21, 2020
- MGTA-117 / Magenta Therap, busulfan / Generic mfg., Mozobil (plerixafor) / Sanofi
[VIRTUAL] A SINGLE DOSE OF SHORT HALF-LIFE CD117 ANTIBODY DRUG CONJUGATE ENABLES HEMATOPOIETIC STEM CELL BASED GENE THERAPY IN NONHUMAN PRIMATES (ePoster Area) - Feb 8, 2020 - Abstract #EBMT2020EBMT_1999;
In a rhesus model of auto-gene modified HSCT, a single dose of the ADC enabled engraftment of gene modified HSCs. These proof of concept studies validate the use of CD117-ADC for targeted HSPC depletion prior to transplant and support its use as a new conditioning agent for auto-gene modified HSCT.
- MGTA-117 / Magenta Therap, busulfan / Generic mfg., Mozobil (plerixafor) / Sanofi
A Single Dose of CD117 Antibody Drug Conjugate Enables Hematopoietic Stem Cell Based Gene Therapy in Nonhuman Primates (World Center Marriott - Cypress 3) - Dec 8, 2019 - Abstract #TCTASTCTCIBMTR2020TCT_704;
Two rhesus NHP were mobilized with GCSF and plerixafor...The gene marking in the granulocytes is comparable to busulfan conditioned animals previously reported (Tisdale, Molecular Therapy 2019)...These proof of concept studies validate the use of CD117-ADC for targeted HSPC depletion prior to transplant and support its use as a new conditioning agent for auto-gene modified HSCT. This targeted approach for safer conditioning could improve the risk benefit profile for patients undergoing HSCT and enable more patients to benefit from these potentially curative therapies.
- CD117-ADC / Magenta Therap, busulfan / Generic mfg., Mozobil (plerixafor) / Sanofi
A Single Dose of CD117 Antibody Drug Conjugate Enables Autologous Gene-Modified Hematopoietic Stem Cell Transplant (Gene Therapy) in Nonhuman Primates (Valencia BC (W415BC), Level 4 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4823;
A single administration of the tool CD117-ADC was fully myeloablative (>99% HSPC depletion) and comparable to HSPC depletion observed following busulfan conditioning (6 mg/kg, once daily for 4 consecutive days)...A single rhesus macaque was mobilized with granulocyte-colony stimulating factor (G-CSF, 20 mcg/kg/day x 5) and plerixafor (1 mg/kg on day 5 of G-CSF) prior to apheresis...These proof of concept studies validate the use of CD117-ADC for targeted HSPC depletion prior to transplant and support its use as a new conditioning agent for autologous gene modified HSCT. This targeted approach for safer conditioning could improve the risk benefit profile for patients undergoing stem cell transplant and enable more patients to benefit from these potentially curative therapies.