BlueSphere accepted as a virtual member of Johnson & Johnson Innovation – JLABS, a premier global network of health incubators
PITTSBURGH, Aug. 14, 2024 (GLOBE NEWSWIRE) — BlueSphere Bio, a drug development company focused on the discovery of novel T-cell receptor (TCR) based therapies, announced it has been accepted as a virtual member of Johnson & Johnson Innovation – JLABS. JLABS is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-enhancing healthcare solutions to patients around the world.
“We are very excited to join JLABS,” said Chief Executive Officer Keir Loiacono, Esq. “At BlueSphere, we have a staged development strategy to bring the next generation of TCR-based therapies to the clinic as quickly and efficiently as possible. Being part of JLABS will help us achieve that goal.”
BlueSphere uses their proprietary TCXpressTM platform to identify novel TCRs for known and unknown antigens relevant to hematologic malignancies, solid tumors, and rare disease. Using TCXpress, BlueSphere has built a differentiated and stepwise clinical development strategy for TCR-based therapeutics, starting in hematologic malignancies. For their first-in-human study, the company has recently received a letter to proceed from the FDA to treat high-risk AML, ALL, and MDS patients in conjunction with CD34+ stem cell transplant. This TCR T-cell therapy candidate (BSB-1001) targets the minor histocompatibility antigen HA-1. Expanding upon this lead program, the company has three additional TCR candidates ready for product development that can be used to expand HLA population coverage and the addressable market size in this high-risk leukemia space. In addition, BlueSphere recently announced their TCX-102 program, an autologous TCR-T cell therapy that will treat AML patients with mutated NPM-1, a foundational mutation commonly found in this indication. An IND is expected in Q2 of 2025 for the TCX-102 program. Together, these five TCR-T candidates give BlueSphere a uniquely broad portfolio of cell therapies to address significant unmet medical needs in hematologic oncology.
Looking beyond these hematologic programs, BlueSphere has recently announced a strategic collaboration with the NCI in recurrent respiratory papillomatosis (RRP), a rare orphan disease. BlueSphere will provide validated HPV-specific TCRs to the experts at NCI, who will then manufacture the TCR-T cell product and administer it under an NCI-sponsored clinical trial.
About BlueSphere
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. BlueSphere Bio was founded upon the proprietary 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.
BlueSphere is leveraging the breadth and depth of TCXpress™ to develop a portfolio of TCR-based assets with an initial clinical focus on acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and myeloid dysplastic syndrome (MDS). BSB-1001 is a TCR T cell therapy targeting the minor histocompatibility antigen-1 (HA-1) and is the first clinical candidate in the Company’s TCX-101 clinical program. Under the TCX-101 clinical program, BSB-1001 will be dosed simultaneously with allogeneic hematopoietic stem cell transplant. BlueSphere anticipates enrolling its first patient in the TCX-101 program in 4Q2024. Using TCXpress™, the company has also discovered and nominated three additional miHA targeting TCRs for clinical development, all for use in the same clinical setting as BSB-1001. These additional miHA candidates will become part of the TCX-101 Program as a panel that positions the Company with best-in-class HLA coverage in these hematologic indications.
In addition to TCX-101, BlueSphere has further broadened its AML therapy pipeline to address an additional subset of patients by discovering and nominating a lead TCR reactive against mutant NPM-1 for the TCX-102 program. The TCX-102 program will be autologous and not given in combination with stem cell transplant. An IND is expected in the second quarter of 2025.
Finally, in addition to a strategic collaboration with the National Cancer Institute to advance a novel TCR T-cell therapy targeting the rare orphan disease, recurrent respiratory papillomatosis (RRP), BlueSphere is identifying a broad panel of TCRs to deploy in its own first solid tumor program, which will be announced later 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
