On November 10, 2022 BlueSphere Bio, a T-cell receptor (TCR) T-cell therapy company developing a powerful TCR discovery platform and novel therapeutic candidates for patients with hematologic malignancies and solid tumors, reported the presentation of data supporting the potential of its first and lead product candidate, BSB-1001, at the 37th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, being held virtually and in Boston, MA from November 8-12, 2022 (Press release, BlueSphere Bio, NOV 10, 2022, View Source [SID1234623691]).
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BSB-1001 is the first TCR-T cell therapy candidate generated using the Company’s TCXpress platform and is in development for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myeloid dysplastic syndrome (MDS) in conjunction with allogenic hematopoietic stem cell transplantation (alloSCT). BSB-1001 is designed to provide durable responses by eliminating graft-versus-host-disease while eradicating residual cancer cells in AML, ALL and MDS patients receiving alloSCT. Specifically, BSB-1001 targets the minor histocompatibility antigen-1 (HA-1), whose expression is largely limited to hematopoietic cells. The company anticipates filing its first IND for this drug candidate by 1Q 2023.
The TCXpress platform has also enabled the discovery of several new TCRs reactive against other clinically relevant miHAs, in addition to HA-1. These additional TCRs will become part of a panel that positions BlueSphere with best-in-class population coverage in these indications. BlueSphere plans to announce details on these other targets in the coming months.
Presentations Highlights:
Title: 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
Presenter: Robert Keefe, Ph.D., Chief Development Officer
Data Highlights:
BSB-1001 is a highly potent cell therapy with the potential to be an effective in treatment for patients with AML undergoing alloSCT.
BSB-1001 demonstrated robust cancer cell killing in vitro, even at low doses relative to target cells.
Genetic manipulations to remove the endogenous TCR had no impact on BSB-1001, supporting the manufacturing process’ ability to generate a high-quality product.
Multiple analyses indicate BSB-1001 is highly renewable and expandable following freeze thaw, highlighting the quality and potency of the final cell therapy product.