Oxford Biomedica Regulatory News (OXB)

Oxford Biomedica expands agreement with Cabaletta Bio; adding new viral vector programme for CD19-CAR T therapies

Oxford, UK - 22 August 2023: Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica" or "the Company"), a quality and innovation-led viral vector CDMO, today announces that it has expanded its License and Supply Agreement ("LSA") with Cabaletta Bio, Inc. (Nasdaq: CABA) ("Cabaletta Bio"), a Philadelphia-based clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases. This follows on from the LSA announced in January 2022 and adds CD19 as a new target.

Oxford Biomedica initially licensed its LentiVector® platform to Cabaletta Bio for their lead product candidate, DSG3-CAART. The agreement has now been extended to grant a non-exclusive license to Cabaletta under Oxford Biomedica's LentiVector® platform IP for their CAR-T programme, CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Cabaletta Bio has received two IND clearances to date for CABA-201 and plans to initiate a Phase 1/2 clinical trial for patients with systemic lupus erythematosus and lupus nephritis and a separate Phase 1/2 clinical trial for patients with myositis.

Under the terms of the expanded agreement, Oxford Biomedica will receive an undisclosed upfront payment, as well as additional payments relating to the development and manufacture of lentiviral vectors for use in clinical trials. The Company will also receive certain development and regulatory milestone payments and an undisclosed royalty on net sales of products that utilise the Company's LentiVector® platform.

Dr. Frank Mathias, Chief Executive Officer of Oxford Biomedica, commented: "The expansion of our partnership with Cabaletta Bio stands as a testament to Oxford Biomedica's unwavering commitment to quality and innovation. As a world-leading CDMO with expertise across all key viral vector types, we are committed to enabling our biopharma customers to discover and deliver transformative therapies. We're excited to continue our work with Cabaletta and help them deliver accessible cures for patients with severe autoimmune disease."

Gwendolyn Binder, Ph.D., President, Science and Technology, Cabaletta Bio, commented: "We are delighted to be expanding our agreement with Oxford Biomedica, who have demonstrated their ability to provide quality products and services since the beginning of our partnership. Their commitment to quality and innovation has assisted us in increasing efficiencies and we look forward to broadening this relationship as we prepare for commercial readiness with our lead product candidate, CABA-201."

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Enquiries:

Oxford Biomedica plc:

Taylor Boyd, VP, Head of IR - T: +1 (984) 268 8488 / E: ir@oxb.com

Sophia Bolhassan, VP, Corporate Affairs and IR - T: +44 (0) 7394 562 425 / E: ir@oxb.com

Consilium Strategic Communications:

T: +44 (0)20 3709 5700 / E: oxfordbiomedica@consilium-comms.com

Mary-Jane Elliott / Matthew Neal / Davide Salvi

About Oxford Biomedica

Oxford Biomedica (LSE: OXB) is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world.

One of the original pioneers in cell and gene therapy, the Company has more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies. The Company collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.

Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.com, www.oxbsolutions.com, and follow us on LinkedIn and YouTube.