( MENAFN - GlobeNewsWire - Nasdaq) TCX-101 Clinical Program : TCR T-Cell therapy product candidate (BSB-1001) to be delivered simultaneously with allogeneic stem cell transplant in patients with active disease or high risk of relapse First patient to be enrolled in 4Q2024 Nomination of Three additional novel TCR candidates expand HLA population coverage and addressable market size TCX 102 Development Program : Autologous TCR-based cell therapy program will target AML patients with mutated NPM-1 IND anticipated 2Q2025 PITTSBURGH, June 03, 2024 (GLOBE NEWSWIRE) -- Today, BlueSphere Bio, a drug development company focused on the discovery of novel T-Cell receptor (TCR) based therapies, announced that the Food and Drug Administration (FDA) has cleared BlueSphere's Investigational New Drug application (IND) for a Phase 1/2a trial (TCX-101) of its first-in-human (BSB-1001) product candidate for patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myeloid dysplastic syndrome (MDS), in conjunction with allogeneic hematopoietic stem cell transplantation (alloHSCT). The Company anticipates enrolling the first patient in this multi-center, open-label study in 4Q2024. Notably, because of the unique product and trial design, the TCX-101 trial will enroll patients with active morphologic disease or cytogenetic features placing them at high risk of relapse.
Additionally, patients will receive simultaneous administration of BSB-1001 with all.
