On September 26, 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 preclinical data supporting the ability of its TCXpress and iTCXpress platforms to rapidly and efficiently identify novel TCR candidates at the 7th annual CAR-TCR Summit from September 19 – 22, 2022 (Press release, BlueSphere Bio, SEP 26, 2022, View Source [SID1234621411]).
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Mark Shlomchik, M.D., Ph.D., co-founder and chief scientific officer of BlueSphere Bio, commented, "The potential of TCRs as a targeting modality is immense, but has been limited by our ability to effectively identify potential candidates from the vast diversity of naturally occurring TCRs. The data from this presentation provides further validation of our multi-platform approach to rapidly screen and identify promising TCRs capable of recognizing any desired target. This is enabling us to identify a series of TCRs useful in allogeneic stem cell transplant and is scalable and rapid enough to enable targeting of patient-specific tumor neoantigens, when used in conjunction with our NEOXpress platform. We are also ready to partner with others to identify panels of specific TCRs for applications in tumor immunology, autoimmunity and infectious disease, using either TCR-based cell therapy or in antibody-like molecules, such as bi-specific T cell engagers."
TCXpress and iTCXpress have enabled the discovery of BlueSphere’s first clinical candidate, a TCR T-cell therapy reactive against the minor histocompatibility antigen (miHA) HA-1. The company anticipates filing its first IND by 1Q2023, which will include its novel anti-HA-1 TCR T-cell therapy, in conjunction with allogeneic stem cell transplantation, in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and acute lymphoblastic leukemia (ALL). 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, as it advances its programs into the clinic. BlueSphere plans to announce details on these other targets in the coming months.
Presentation Highlights
Title: TCXpress and iTCXpress: A Direct, High-throughput Platform Utilizing Parallel Processes for Efficient and Cost-Effective Discovery and Characterization of Novel TCRs.
Presenters: Jennifer Roy, Associate Scientist, BlueSphere Bio and Stephanie Stras, Associate Scientist, BlueSphere Bio
Data Highlights:
The functionality and versatility of TCXpress and iTCXpress provides an elegant, innovative approach to identifying TCR candidates for engineering TCR-T adoptive cell therapy.
By applying both direct and parallel cloning methods, BlueSphere can rapidly produce specific, expressible TCRs from both liquid and solid tumors with efficiencies above 80%.
The TCXpress approach reduces the cost of TCR identification to approximately $5/TCR to create a scenario where screening larger libraries for functional candidates is financially and logistically feasible.
BlueSphere can identify numerous unique clonotypes without expansion and instead can utilize expansion as a potential enhancement in process when necessary.
About TCXpress
TCXpress is a proprietary high-throughput and efficient T-cell receptor (TCR) capture, expression and functional screening platform capable of processing thousands of single T cells directly into functionally expressed TCRs within a matter of days, thereby creating extensive libraries without the need for sequencing or TCR gene synthesis. TCXpress is used in conjunction with iTCXpress, a proprietary bioinformatics platform that helps to quickly analyze and identify a broad range of unique antigen-specific TCRs for downstream processing and functional testing.