Oxford BioMedica notes the sBLA submission to FDA for Kymriah™ in adult patients with r/r DLBCL

31 October 2017

Oxford, UK – 31 October 2017: Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis confirming submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for KymriahTM (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). KymriahTM is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer.

The submission is based on results from the Novartis-sponsored, global, multi-centre Phase II JULIET study (NCT02445248), the first global, multi-centre registration study for KymriahTM in adult patients with r/r DLBCL. In April 2017, Novartis received Breakthrough Therapy designation for r/r DLBCL which, if approved, would be the second indication for KymriahTM.

Novartis plans to submit an additional application for marketing authorization for KymriahTM with the European Medicines Agency (EMA) in both DLBCL and paediatric ALL later this year. Novartis plans additional regulatory filings for KymriahTM outside the US and EU in 2018.

In August 2017, KymriahTM became the first available chimeric antigen receptor T cell (CAR-T) therapy when it received FDA approval five weeks prior to its PDUFA date and was launched for patients up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia (ALL) that is refractory or has relapsed at least twice.

Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes KymriahTM. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate KymriahTM and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products.

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