VX-A901 / Veraxa Biotech - LARVOL DELTA

An immunocytokine with target cell-restricted IL-15 activity for induction of anti-tumor immunity against acute myeloid leukemia (SITC 2023) - P1/2 | "We recently completed a phase I trial evaluating safety/tolerability and preliminary efficacy of an Fc-optimized FLT3/CD135 antibody (FLYSYN, NCT02789254) to induce NK cell anti-leukemia reactivity against AML cells...MIC135 did not induce unwanted effects against healthy FLT3 expressing cells. Conclusions MIC135 induces NK cell reactivity against leukemia cells in a target cell-restricted manner and exhibits superior efficacy compared to Fc-optimized antibodies, thus constituting a promising treatment option for AML."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • IL15

Phase I study evaluating the Fc-optimized FLT3 antibody FLYSYN in AML patients with measurable residual disease. (PubMed, J Hematol Oncol) - P1/2 | "FLYSYN monotherapy is safe and well-tolerated in AML patients with MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II trial. Trial registration This clinical is registered on clinicaltrials.gov (NCT02789254)."

Journal • P1 data • Residual disease • Acute Myelogenous Leukemia • Hematological Disorders • FLT3

[VIRTUAL] FLYSYN: Results of the first application study of the Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia with minimal residual disease (DGHO 2020) - P1/2 | "The results of our phase I trial demonstrate that FLYSYN is safe and very well tolerated as monotherapy in AML patients with molecular MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II clinical trial."

IO Biomarker • Residual disease • Acute Myelogenous Leukemia • Fatigue • Hematological Malignancies • Leukemia • Musculoskeletal Diseases • Oncology • FLT3 • IDH2 • NPM1 • RUNX1

[VIRTUAL] FLYSYN: Results of the first application study of the Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia with minimal residual disease (DGHO 2020) - P1/2 | "The results of our phase I trial demonstrate that FLYSYN is safe and very well tolerated as monotherapy in AML patients with molecular MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II clinical trial."

IO Biomarker • Residual disease • Acute Myelogenous Leukemia • Fatigue • Hematological Malignancies • Leukemia • Musculoskeletal Diseases • Oncology • FLT3 • IDH2 • NPM1 • RUNX1

[VIRTUAL] FLYSYN: Results of the first application study of the Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia with minimal residual disease (DGHO 2020) - P1/2 | "The results of our phase I trial demonstrate that FLYSYN is safe and very well tolerated as monotherapy in AML patients with molecular MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II clinical trial."

IO Biomarker • Residual disease • Acute Myelogenous Leukemia • Fatigue • Hematological Malignancies • Leukemia • Musculoskeletal Diseases • Oncology • FLT3 • IDH2 • NPM1 • RUNX1

[VIRTUAL] FLYSYN: Results of the first application study of the Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia with minimal residual disease (DGHO 2020) - P1/2 | "The results of our phase I trial demonstrate that FLYSYN is safe and very well tolerated as monotherapy in AML patients with molecular MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II clinical trial."

IO Biomarker • Residual disease • Acute Myelogenous Leukemia • Fatigue • Hematological Malignancies • Leukemia • Musculoskeletal Diseases • Oncology • FLT3 • IDH2 • NPM1 • RUNX1

Immunocytokines with Target Cell-Restricted IL-15 Activity for Induction of NK Cell Reactivity Against Acute Myeloid Leukemia (AML) (ASH 2018) - P1/2; "...Our FLT3 mAb termed FLYSYN is currently clinically evaluated in AML patients with minimal residual disease (NCT02789254)...MIC135, which was chosen for further development due to its superior characteristics described above, did not induce unwanted effects against healthy FLT3 expressing cells and potently reduced leukemic burden in a NSG xenotransplantation model with primary AML and polyclonal NK cells. Conclusion : In summary, MIC stimulate NK cells in a target cell-restricted manner, clearly outperform Fc-optimized antibodies and thus constitute a promising treatment option for AML."

Acute Myelogenous Leukemia • Biosimilar • Gene Therapies • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation

A CD135 immunocytokine with target cell-restricted IL-15 activity for treatment of AML (AACR 2022) - P1/2 | "With the aim to eradicate MRD and thus improve long-term survival in AML, we recently conducted a phase I trial evaluating safety/tolerability and preliminary efficacy of an Fc-optimized antibody targeting CD135/FLT3 (FLYSYN, NCT02789254) to induce NK cell anti-leukemia reactivity...Furthermore, our MIC135 did not induce unwanted effects against healthy FLT3 expressing cells. Taken together, MIC135 induces NK cell reactivity against leukemia cells in a highly target cell-restricted manner and displays higher efficacy than Fc-optimized antibodies, thus constituting a promising treatment option for AML."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • IL15

FLYSYN-101: FLYSYN in MRD Positive AML (clinicaltrials.gov) - P1/2; N=31; Completed; Sponsor: Synimmune GmbH; Active, not recruiting ➔ Completed

Clinical • Minimal residual disease • Trial completion • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD69 • FLT3 • NPM1

Interim Results of a First in Man Study with the Fc-Optimized FLT3 Antibody Flysyn for Treatment of Acute Myeloid Leukemia with Minimal Residual Disease (ASH 2019) - P1/2; "Our data suggest that FLYSYN is safe and very well tolerated as monotherapy in MRD positive AML patients. Preliminary efficacy data are promising, and recruiting is ongoing in cohort 6 in which 15 mg/m² FLYSYN is given for three times. Up-dated results will be presented at the ASH meeting."

Residual disease • FLT3 • NPM1

[VIRTUAL] First-in-Human Phase I Dose Escalation and Expansion Study Evaluating the Fc Optimized FLT3 Antibody Flysyn in Acute Myeloid Leukemia Patients with Minimal Residual Disease (ASH 2020) - P1/2 | "Together, the results of our phase I trial demonstrate that FLYSYN is safe and very well tolerated as monotherapy in AML patients with molecular MRD. Early efficacy data are promising and warrant further evaluation in an up-coming phase II clinical trial."

Clinical • IO biomarker • P1 data • Residual disease • Acute Myelogenous Leukemia • Fatigue • Hematological Malignancies • Leukemia • Musculoskeletal Diseases • Oncology • FLT3 • IDH2 • NPM1 • RUNX1 • RUNX1T1

GenScript ProBio Enters into Agreement with SYNIMMUNE for Manufacturing of their Innovative Antibody Drug (PRNewswire-Asia) - "GenScript ProBio is delighted to announce the signing of a manufacturing service agreement for Synimmune's innovative FLYSYN antibody project for clinical Phase II production. FLYSYN is a fms-like tyrosine kinase 3 (FLT3) specific antibody for the treatment of acute myeloid leukemia (AML) patients in complete remission...'We are confident that GenScript ProBio will produce SYNIMMUNE's lead antibody drug product FLYSYN to all global quality GMP standards within the agreed upon timeline'."

Licensing / partnership • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

FLYSYN-101: FLYSYN in MRD Positive AML (clinicaltrials.gov) - P1/2; N=31; Active, not recruiting; Sponsor: Synimmune GmbH; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Induction of NK Cell Reactivity against B-Cell Acute Lymphoblastic Leukemia by an Fc-Optimized FLT3 Antibody. (PubMed, Cancers (Basel)) - P1/2; "At present, we evaluate an Fc-optimized (amino acid substitutions S239D/I332E) FLT3 antibody termed 4G8-SDIEM (FLYSYN) in patients with acute myeloid leukemia (NCT02789254)...FLT3 expression did not correlate with that of CD20, which is targeted by Rituximab, a therapeutic monoclonal antibody (mAb) employed in B-ALL treatment regimens...This was mirrored by potent 4G8-SDIE mediated NK cell ADCC in experiments with FLT3-transfectants, the cell line SEM and primary cells as target cells. Taken together, the findings presented in this study provide evidence that 4G8-SDIE may be a promising agent for the treatment of B-ALL, particularly in CD20-negative cases."

Journal • FLT3