B-cell acute lymphoblastic leukemia (B-ALL), characterized by the clonal expansion of immature lymphoblastic cells, is traditionally treated with lengthy chemotherapy followed by allogeneic stem cell transplantation (aSCT) for high-risk patients. However, patients with relapsed or refractory B-ALL still present a dismal prognosis.
B-cell precursor acute lymphoblastic leukemia (BCP-ALL) is the most common pediatric cancer. Although pediatric ALL is cured in over 90% of cases, children with high-risk BCP-ALL present increased chance of treatment failure and relapse.
Avencell Therapeutics Inc. has received clinical trial clearances from the FDA and EMA to conduct a phase I/II trial (Quadvance) of AVC-203 for the treatment of relapsed or refractory B-cell malignancies.
GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate in combination therapy for the treatment of adults with relapsed or refractory multiple myeloma.
Although CD19-directed CAR T cells can initially induce remission in 70-90% of patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), post-CAR relapses are frequent. These relapses are driven by insufficient persistence of CAR T cells, allowing for antigen-positive B-ALL re-emergence and loss of the targeted epitope either in isolation or as part of lineage-switching.
Autolus Therapeutics Inc. has picked up plenty of financial momentum, about $600 million worth, in its runup to a November 2024 PDUFA date for its CD19 CAR T therapy. Helping propel that momentum is Biontech SE, another CAR T therapy developer. For $50 million cash, Biontech bought the rights to use Autolus’ manufacturing and commercial infrastructure in the U.K. so it can advance its CAR T-cell BNT-211 program in the clinic.
