Oxford, UK & London, UK– 5 December 2016: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE: OXB), a leading gene and cell therapy group, today notes the findings reported by Novartis on their clinical trial (ELIANA) evaluating the efficacy and safety of CTL019, an investigational chimeric antigen receptor T cell (CAR T) therapy, in relapsed/refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). Oxford BioMedica produces the lentiviral vector expressing CTL019 and has a CAR-T partnership with Novartis.
The findings were presented during an oral session on Saturday 3rd December 2016 at the 58th American Society of Hematology (ASH) annual meeting (Abstract #221, December 3, 4:00-5:30 p.m.). Novartis reported that the global Phase II study found that 82% (41 of 50) of infused patients achieved complete remission or complete remission with incomplete blood count recovery at three months post CTL019 infusion. For all patients with complete remission, no minimal residual disease was detected. In addition, the estimated relapse-free rate among responders was 60% (95% CI: 36, 78) six months after infusion with CTL019. Novartis confirmed their intention to file CTL019 with the US Food and Drug Administration (FDA) in early 2017 for pediatric and young adult patients with r/r B-cell ALL.
John Dawson, Chief Executive Officer of Oxford BioMedica, commented: “We are pleased that Novartis has reported exciting progress with its investigational therapy CTL-019, and that Novartis confirm their commitment to advancing CTL019 and working closely with the FDA and EMA in the coming months.”