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    DRUG:

    BSB-1001

    i
    Other names: BSB-1001, α-HA-1 targeted TCR-T cell therapy, TCX-101-HA1
    Company:
    BlueSphere Bio
    Drug class:
    TCR modulator, Minor histocompatibility antigen 1 modulator
    Related drugs:
    27d
    Phase 1/2a Ascending Dose Study to Evaluate the Safety BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS (clinicaltrials.gov)
    P1/2, N=38, Not yet recruiting, BlueSphere Bio, Inc
    New P1/2 trial
    |
    melphalan • BSB-1001
    2years
    A Phase 1/1b Multicenter Ascending Dose Study to Evaluate the Safety of HA-1 Minor Histocompatibility Antigen-Reactive TCR-Modified T Cells (BSB-1001) in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant (alloSCT) for MRD+ AML or ALL or High/Very High Risk MDS (TCT-ASTCT-CIBMTR 2023)
    Enrollment is anticipated to begin in 2Q2023. BSB is developing a panel of TCRs targeting additional hematopoietically-restricted miHAs.
    Clinical • P1 data • IO biomarker
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD34 (CD34 molecule)
    |
    HLA-A*02
    |
    BSB-1001
    2years
    A Phase 1/1b Multicenter Ascending Dose Study to Evaluate the Safety of HA-1 Minor Histocompatibility Antigen-Reactive TCR-Modified T Cells (BSB-1001) in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant (alloSCT) for MRD+ AML or ALL or Poor/Very Poor Risk MDS (ASH 2022)
    The anti-HA-1 T cell product (BSB-1001) is composed of donor CD8+ T cells transduced with a lentivirus vector encoding the anti-HA-1 TCR and the RQR8 tag, which expresses an epitope from CD20, thereby enabling the in vivo killing of BSB-1001 cells with rituximab. Enrollment is anticipated to begin in 1Q2023. BSB is also developing panels of TCRs targeting additional relatively hematopoietically-restricted miHAs with prioritization based on the frequencies of the restricting HLAs and the immunogenic/nonimmunogenic miHA alleles.
    Clinical • P1 data • IO biomarker
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD34 (CD34 molecule)
    |
    HLA-A*02
    |
    Rituxan (rituximab) • BSB-1001
    2years
    Manufacture of allogeneic, HLA-matched, TCR-edited T-cell therapy reactive against minor histocompatibility antigen 1 to treat Acute Myeloid Leukemia in combination with CD34 HSCT with the potential for high potency and durability (SITC 2022)
    Conclusions Taken together, the results indicate that BSB-1001 is an active, highly potent drug product candidate, with a potential to be effective in treating HA-1+ HLA-A*02:01 AML patients in the setting of alloSCT. The phenotype and high cytolytic bioactivity indicate that the clinical response has a potential to be very potent and durable.
    Combination therapy
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD34 (CD34 molecule) • CD69 (CD69 Molecule)
    |
    HLA-A*02
    |
    BSB-1001