TCX-201

PITTSBURGH, Feb. 06, 2023 (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 Keir Loiacono, Chief Executive Officer of BlueSphere Bio, will present a corporate overview at the 2023 BIO CEO & Investor Conference held in New York City, NY from February 6-9, 2023. The in-person presentation will highlight the Company’s first and lead product candidate, BSB-1001, currently being developed for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myeloid dysplastic syndrome (MDS) in conjunction with allogeneic hematopoietic stem cell transplantation (alloSCT). The Company anticipates filing its first investigational new drug application later this year. Presentation details:Date: Tuesday, February 7, 2023Time: 10:30 a.m. ETLocation: Marriott Marquis Times Square For more information about the BIO CEO & Investor Conference, please refer to the conference website at www.bio.org/events/bio-ceo-investor-conference. 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 can be used in various clinical settings to discover TCRs 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 oncology, the platform could be deployed in other therapeutic areas, such as auto-immunity. BSB-1001, targeting the minor histocompatibility antigen-1 (HA-1) and part of BlueSphere’s TCX-101 Program, is the first TCR-T cell therapy candidate generated using TCXpress and is in development for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myeloid dysplastic syndrome (MDS) in conjunction with allogeneic hematopoietic stem cell transplantation (alloSCT). BlueSphere anticipates filing its first IND application for BSB-1001 in 2023. In addition, the TCXpress platform has enabled the discovery of several new TCRs reactive against other clinically relevant miHAs, which will become part of the TCX-101 Program as a panel that positions the Company with best-in-class population coverage in these indications. In addition to TCX-101, BlueSphere is currently identifying a broad panel of TCRs to deploy in its first solid tumor program, which will be announced later this year. Concurrent with its use for shared antigens, BlueSphere is deploying TCXpress™ and NEOXpress™, a proprietary patient-specific neoantigen discovery platform, to develop its TCX-201 Program, which aims to identify TCRs reactive against patient-specific neoantigens. The Company anticipates virtual patient data from multiple solid tumor types this year. Company ContactKim JaffeSenior Vice President, Head of Business Development & Strategy+1- 609-306-7042kjaffe@bluespherebio.com Media ContactAndrew MielachLifeSci Communications+1-646-876-5868amielach@lifescicomms.com

Dr. Bahceci brings more than two decades of combined clinical and drug development experience PITTSBURGH, Pa., Jan. 30, 2023 (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 appointment of Erkut Bahceci, M.D., as Chief Medical Officer. “Dr. Bahceci has a wide breadth of experience in clinical trial design across all stages of development that will prove to be invaluable as we approach our entrance into the clinic with BSB-1001, the first candidate from our TCX-101 Program, later this year,” said Keir Loiacono, Chief Executive Officer of BlueSphere Bio. “Beyond industry experience, Dr. Bahceci has a deep understanding of the needs of patients and the treatment landscape from his years as a clinician, focused on allogeneic stem cell transplants.” 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 allogeneic hematopoietic stem cell transplantation (alloSCT). BSB-1001 targets the minor histocompatibility antigen-1 (HA-1), whose expression is largely limited to hematopoietic cells. Dr. Bahceci added, “This is an incredibly exciting time to join BlueSphere Bio. Despite the effectiveness of allogeneic stem cell transplants for a broad range of hematological malignancies, a significant number of patients relapse. BSB-1001 is designed to provide durable remission by eradicating residual cancer cells after transplant and could potentially transform the treatment landscape. As a part of the broader TCX-101 Program, which aims to provide best-in-class population coverage in these indications, BSB-1001 represents only a fraction of TCXpress’s potential to provide new therapeutics for a broad range of cancers and I look forward to working closely with the team to help realize the promise of TCR T-cell therapies for treating patients.” Dr. Bahceci holds more than 20 years of combined clinical and drug development experience. Most recently, he served as the Senior Vice President and Head of Oncology Development at Takeda Pharmaceuticals. Prior to Takeda, he worked at Astellas in roles of increasing responsibility up to the Head of Clinical Science, Hematologic Malignancies. While at Astellas, he led the development of gilteritinib from first-in-human studies to worldwide approval in relapsed or refractory AML. Before joining Astellas, he worked at Bristol-Myers-Squib, leading the U.S. team for dasatinib. He began his career in the pharmaceutical industry at Bayer, where he served as Associate Director of Medical Sciences-Oncology. Dr. Bahceci received his M.D. degree from Marmara University in Istanbul, Turkey and conducted his residency training in Internal Medicine at Mercy Hospital in Chicago and National Heart Lung and Blood Institute, National Institutes of Health in Bethesda, Maryland, followed by fellowship in Hematology and Oncology at National Heart Lung and Blood Institute. He was appointed to the faculty of the Yale University School of Medicine in 2000, where he performed allogeneic and autologous stem cell transplants and conducted research on immunotherapy, including chimeric activating receptor (CAR) T cell therapy, until 2007. 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 can be used in various clinical settings to discover TCRs 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 oncology, the platform could be deployed in other therapeutic areas, such as auto-immunity. BSB-1001, targeting the minor histocompatibility antigen-1 (HA-1) and part of BlueSphere’s TCX-101 Program, is the first TCR-T cell therapy candidate generated using TCXpress and is in development for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myeloid dysplastic syndrome (MDS) in conjunction with allogeneic hematopoietic stem cell transplantation (alloSCT). BlueSphere anticipates filing its first IND application for BSB-1001 in 2023. In addition, the TCXpress platform has enabled the discovery of several new TCRs reactive against other clinically relevant miHAs, which will become part of the TCX-101 Program as a panel that positions the Company with best-in-class population coverage in these indications. In addition to TCX-101, BlueSphere is currently identifying a broad panel of TCRs to deploy in its first solid tumor program, which will be announced later this year. Concurrent with its use for shared antigens, BlueSphere is deploying TCXpress™ and NEOXpress™, a proprietary patient-specific neoantigen discovery platform, to develop its TCX-201 Program, which aims to identify TCRs reactive against patient-specific neoantigens. The Company anticipates virtual patient data from multiple solid tumor types this year. 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