Kymriah receives FDA RMAT designation in FL

RNS Number : 5180K

Oxford Biomedica PLC

22 April 2020

 

Oxford Biomedica notes the announcement that Kymriah® has received FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma

Oxford, UK - 22^nd April, 2020: Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Group"), a leading gene and cell therapy group, notes the announcement from Novartis that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah^® (tisagenlecleucel), for an investigational new indication to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL).

Kymriah®, which is designed to be a one-time treatment, is the first-ever FDA-approved CAR-T cell therapy. If approved, relapsed or refractory (r/r) follicular lymphoma would become the third B-cell malignancy indication for Kymriah®, joining approvals in children and young adults with r/r pediatric and young adult acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL). Novartis expects US regulatory filing for Kymriah® in r/r follicular lymphoma in 2021. 

The Regenerative Medicine Advanced Therapy (RMAT) designation reflects the unmet need for patients with r/r follicular lymphoma. The RMAT program was created to expedite the development and review of regenerative medicine therapies intended to treat, modify, reverse or cure a serious condition.

Oxford Biomedica is the sole manufacturer of the lentiviral vector used in Kymriah. In December 2019, Novartis extended, by five years, its commercial and clinical supply agreement with Oxford Biomedica to supply the lentiviral vectors used to generate Kymriah® and other undisclosed CAR-T products. The agreement guarantees a minimum of $75 million in manufacturing revenues in addition to undisclosed process development fees and a mid-single digit £ million facility reservation fee, with other financial terms, such as royalties, as previously agreed, and builds upon the initial commercial supply agreement signed in 2017.

Kymriah^® roll in relapsed and refractory B-cell acute lymphoblastic leukaemia and relapsed and refractory diffuse large B-cell lymphoma is continuing with reimbursement approved in 19 countries in at least one indication

To view the full announcement from Novartis, please follow this link:

https://www.novartis.com/news/media-releases/novartis-kymriah-receives-fda-regenerative-medicine-advanced-therapy-designation-follicular-lymphoma

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Enquiries:
Oxford Biomedica plc John Dawson, Chief Executive Officer Stuart Paynter, Chief Financial Officer Catherine Isted, Head of Corporate Development & IR	T: [phone] T: [phone] T: [phone] / E: [e-mail]
Consilium Strategic Communications Mary-Jane Elliott/Matthew Neal	T: [phone]

About Oxford Biomedica

Oxford Biomedica (LSE:OXB) is a leading, fully integrated, gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford Biomedica and its subsidiaries (the "Group") have built a sector leading lentiviral vector delivery platform (LentiVector^®), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology, CNS disorders, liver diseases and respiratory disease. The Group has also entered into a number of partnerships, including with Novartis, Bristol Myers Squibb, Sanofi, Axovant Gene Therapies, Orchard Therapeutics, Santen, Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium and Imperial Innovations, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford Biomedica is based across several locations in Oxfordshire, UK and employs more than 550 people. Further information is available at www.oxb.com

 

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