BlueSphere Bio Presents Data Demonstrating the Potential of Lead Product Candidate at 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting

• BSB-1001 is the first product candidate from the TCX-101 platform
• Data supports BSB-1001 as a potential treatment to improve outcomes for patients with acute myeloid leukemia (AML) receiving a hematopoietic stem cell transplantation (HSCT)

PITTSBURGH, Nov. 10, 2022 (GLOBE NEWSWIRE) — 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, today announced the presentation of data supporting the potential of its first and lead product candidate, BSB-1001, at the 37^th Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held virtually and in Boston, MA from November 8-12, 2022.

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.

About BlueSphere Bio

BlueSphere Bio is the first translational sciences stand-alone company formed by UPMC Enterprises, the innovation, commercialization, and venture capital arm of the Pittsburgh-based health system. The company was founded upon the unique, advanced TCR discovery platform – TCXpress™, designed to isolate and functionally characterize TCRs with speed and efficiency. This platform will be used to identify panels of specific TCRs reactive against shared antigens in various clinical settings for use in either TCR-based cell therapy or in antibody-like molecules, such as bi-specific T cell engagers. While the company’s initial focus is on oncology, the platform could be deployed in other therapeutic areas such as auto-immunity. BlueSphere anticipates filing its first IND application in the first quarter of 2023 for a novel TCR T-cell therapy for patients with high-risk leukemias, including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myeloid dysplastic syndrome (MDS) in the context of allogeneic stem cell transplantation. Concurrent with its use for shared antigens, BlueSphere is deploying TCXpress™ and NEOXpress™, a proprietary patient-specific neoantigen discovery platform, to target patient-specific neoantigens and anticipates additional virtual patient data from multiple solid tumor types over the next several months.

Company Contact
Kim Jaffe
Senior Vice President, Head of Business Development & Strategy
+1- 609-306-7042
kjaffe@bluespherebio.com

Media Contact
Andrew Mielach
LifeSci Communications
+1-646-876-5868
amielach@lifescicomms.com