Date: 2014-10-10
Type of information: Production agreement
Compound: clinical grade material utilising Oxford BioMedica’s LentiVector® gene delivery technology
Company: Oxford BioMedica (UK) Novartis (Switzerland)
Therapeutic area: Cancer - Oncology
Type agreement: production
manufacturing
Action mechanism:
Disease:
Details: * On May 1, 2013, Oxford BioMedica has announced that it has signed an agreement with Novartis to manufacture clinical grade material utilising Oxford BioMedica’s LentiVector® gene delivery technology. Oxford BioMedica will be responsible for manufacturing several batches of a lentiviral vector encoding CTL019 technology. This vector will be used to transduce patients’ immune cells (T-cells) in an ex vivo process before they are re-infused into patients. CTL019 targets a protein called CD19 that is associated with a number of B-cell malignancies including chronic lymphocytic leukemia, B-cell acute lymphocytic leukaemia and diffuse large B-cell lymphoma.
Financial terms: Under the terms of the agreement, Oxford BioMedica will also provide certain process development services and expects to receive between £2.5 million and £4 million from Novartis over the next 12 months.
Latest news: * On January 29, 2016, Oxford BioMedica announced that the Group has initiated work on a second Chimeric Antigen Receptor T cell (CART) programme for an undisclosed indication. Under an agreement signed with Novartis in October 2014, Oxford BioMedica will undertake process development and manufacturing for the lentiviral vector associated with the new programme. Oxford BioMedica is currently manufacturing lentiviral vector expressing CTL019 for Novartis and carrying out process development work to establish the next-generation manufacturing process. The Group also granted Novartis a non-exclusive licence in oncology under the Group’s LentiVector® platform and an exclusive licence for the worldwide development and commercialisation of all CART cell products arising from the process development collaboration. In return, Oxford BioMedica will receive undisclosed royalties on potential future sales of CART products covered by the agreement. * On October 10, 2014, Oxford BioMedica announced that it has signed further contracts with Novartis which build on the collaboration with Novartis announced in May 2013. Under the terms of the new agreement, Novartis will pay $14 million upfront including a $4.3 million equity subscription for a non-exclusive worldwide development and commercialisation licence in oncology under the Group’s LentiVector® platform. Oxford BioMedica will manufacture lentiviral vectors expressing CTL019/CART-019. The manufacturing contract has an initial three year term. Additionally, Oxford BioMedica has granted Novartis an exclusive licence for the worldwide development and commercialisation of all Chimeric Antigen Receptor (CAR) T cell products arising from the process development collaboration. According to the terms of the deal, Oxford BioMedica is eligible to receive up to $90 million from Novartis over the next three years. This amount includes the upfront licence payment, the equity investment, manufacturing and process development services and various performance incentives. The equity investment comprises 70,807,500 ordinary shares at 3.8p, the average middle market price for the 10 business days prior to 7 October 2014. Oxford BioMedica will also receive undisclosed royalties on potential future sales of CTL019 and other CAR T cell products covered by the agreement.
