BlueSphere Bio, a drug development company focused on novel T-cell receptor (TCR) based therapies for oncology and non-oncology indications, announced a collaboration with NMDP BioTherapies℠ (formerly Be The Match BioTherapies), an organization offering solutions for companies developing and commercializing cell and gene therapies, to advance BlueSphere’s first clinical trial evaluating a novel cell therapy for patients with high-risk leukemias. Under the partnership, NMDP will provide HLA-matched healthy donor hematopoietic stem cells that meet Food and Drug Administration (FDA) and BlueSphere’s eligibility requirements for the company’s upcoming, FDA-cleared 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). BSB-1001 is a TCR T-Cell therapy product candidate that will be delivered simultaneously with an allogeneic stem cell transplant in patients with active disease or a high risk of relapse.
“We are excited to partner with BlueSphere Bio to help bring the BSB-1001 therapy to physicians and patients,” said Dr. Steve Devine, Chief Medical Officer at NMDP and Associate Scientific Director, CIBMTR®. “BlueSphere Bio’s BSB-1001 therapy could provide a novel and effective way to treat patients with AML, ALL, and MDS in combination with allogeneic stem cell transplant and prevent relapse, furthering our mutual goal to save more lives.”
In standard of care alloHSCT, T cells from the donor can attack and kill not only the patient’s malignant cells but also healthy cells. This graft versus host disease (GvHD) phenomena can be life threatening, even when the tumor has been eliminated or is under control as a result of the alloHSCT. BSB-1001 is an engineered TCR T cell therapy that targets the blood-restricted antigen, HA-1. BlueSphere will provide high-risk leukemia patients with a T cell depleted stem cell transplant alongside the engineered BSB-1001 T cells. Because the patient will not receive any non-HA-1 targeting T cells during the therapy, this allows the HA-1 specific T cells to kill any remaining leukemia cells without targeting healthy tissues in the patient (GvHD). This should reduce the risk of GvHD while potentially enhancing the graft versus leukemia effect. Notably, because of the unique product and trial design, the TCX-101 trial will enroll patients with active morphologic disease or features placing them at high risk of relapse. Additionally, patients will receive simultaneous administration of BSB-1001 with alloHSCT to optimally target residual leukemia, without the use of immunosuppressive drugs.
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NMDP BioTherapies will provide allogeneic stem cells from healthy donors who are HLA matched to patients enrolled in TCX-101. This includes bioinformatics consulting to identify available donors from the NMDP donor registry who meet specific HLA and other criteria. NMDP BioTherapies will also oversee the consent and workup of donors and will manage the supply chain from apheresis collection through delivery to BlueSphere Bio’s manufacturing and clinical sites under a rigorous quality system.
“NMDP BioTherapies offers everything we need to provide our team, and ultimately patients, with critical donor material required for making the different components of our therapy. Its large, diverse registry of volunteer donors, robust supply chain, quality infrastructure, and critical bioinformatics consulting are the ideal solution for meeting our specific donor requirements,” said Keir Loiacono, Esq., Chief Executive Officer, BlueSphere Bio. “We are confident our partnership with NMDP BioTherapies will help deliver this potentially life-saving therapy to leukemia patients who have run out of meaningful treatment options.”
SOURCE: GlobeNewswire