Business Wire

Oxford BioMedica Notes the Longer-Term Analyses from Pivotal Kymriah® Trials, Which Showed Durable Responses Are Maintained in Patients with Advanced Blood Cancers

Jaa

Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis on the longer-term analyses of both the ELIANA and JULIET pivotal trials in children and young adult patients with relapsed or refractory (r/r) acute lymphoblastic leukaemia (ALL) and adult patients with r/r diffuse large B-cell lymphoma (DLBCL), respectively. Kymriah® (tisagenlecleucel) continued to demonstrate strong efficacy with durable responses and maintained a consistent and well-characterised safety profile. These data are being presented at the 60th American Society of Hematology (ASH) annual meeting. Additionally, today, the New England Journal of Medicine published online the 14-month results from JULIET, the study led by the Abramson Cancer Center at the University of Pennsylvania 1.

In the 24-month follow-up analysis of the ELIANA study in children and young adults with r/r B-cell ALL, Kymriah demonstrated deep and durable responses without subsequent therapy in a significant portion of patients in this population. Among 79 evaluable patients, who were followed for at least three months or discontinued earlier, 82% (95% confidence interval [CI], 72% - 90%) achieved complete response (CR) or CR with incomplete blood count recovery (CRi) within three months of infusion; and among these responding patients, 98% had negative minimal residual disease (MRD). The relapse-free survival rate was 62% at 24 months; and the median duration of remission (mDOR) and median overall survival (mOS) remained unreached, signifying responses are deep and sustained, and further reinforcing the potential for Kymriah to be a definitive therapy for many patients. The probability of OS was 76% (95% CI, 65% - 85%) at 12 months and 66% (95% CI, 58% - 79%) at 24 months. The safety profile observed in this updated analysis was consistent with previously reported results, with no emergence of new safety signals. Grade 3/4 cytokine release syndrome (CRS) – as defined by the rigorous Penn Grading Scale – occurred in 49% of patients. Within eight weeks of infusion, 13% of patients experienced grade 3 neurological events, with no grade 4 events or cerebral oedema2. These updated data will be presented in an oral session at the ASH annual meeting (Abstract # 895; Monday, December 3, 4:30PM PST).

Results from the 19-month analysis from the JULIET study of Kymriah in adult patients with r/r DLBCL (n=99) indicated prolonged durability of response in patients who had previously been through multiple rounds of chemotherapy and unsuccessful stem cell transplants (Abstract # 1684). The overall response rate (ORR) after a median of 19 months of follow-up was 54% (95% CI, 43% - 64%; CR, 40%; partial response [PR], 13%) among patients who were followed for at least 3 months or discontinued earlier. The mDOR was not reached at the time of analysis indicating most responders were still experiencing a response at the time of analysis; and the relapse-free probability, which was 66% (95% CI, 51%-78%) at 6 months, remained consistent at 64% (95% CI, 48%-76%) between 12-month and 18-month analyses. Further, 54% (15/28) of patients who had achieved a PR converted to CR. Median OS for all infused patients was 11.1 months (95% CI, 6.6 months-NE) and not reached (95% CI, 21 months-NE) for patients in CR. The OS probability was 48% (95% CI, 38%-57%) at 12 months and 43% (95%CI, 33%-53%) at 18 months (max follow-up, 29 months). Analyses of ORR, DOR and OS data showed consistent results across all patient subgroups, regardless of relapsed/refractory status, age and high-risk cytogenetics.

The safety profile observed in the 19-month follow-up from JULIET continued to be consistent with previous reports and no deaths occurred due to causes other than disease progression in this longer-term follow up analysis. Within eight weeks of infusion with Kymriah, Grade 3/4 CRS, as defined by the Penn Grading Scale, was reported in 23% of patients. CRS management was conducted per the Penn CRS management algorithm, which is specific to Kymriah. Tocilizumab and steroids were used in 16% and 11% of patients, respectively, to treat CRS. Eleven percent of patients had Grade 3/4 neurologic adverse events, which were managed with supportive care3.

Oxford BioMedica is the sole manufacturer of the lentiviral vector used in Kymriah. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate Kymriah and other undisclosed CAR-T products. This collaboration has reached important milestones in 2018 with the US FDA approval of Kymriah to treat adult patients with r/r DLBCL, and the approval of Kymriah in these two distinct indications in the European Union, Canada and Switzerland. These important achievements follow the initial US launch of Kymriah in paediatric and young adult patients with r/r B-cell ALL in 2017. Oxford BioMedica signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate CTL019 and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years.

Notes for editors

About the ELIANA Trial

ELIANA is the first paediatric global CAR-T cell therapy registration trial, examining patients in 25 centres in 11 countries across the US, Canada, Australia, Japan and the EU, including: Austria, Belgium, France, Germany, Italy, Norway and Spain, demonstrating effective distribution of Kymriah across four continents using a global supply chain. In 2012, Novartis and Penn entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers.

About the JULIET Trial

JULIET is the first multi-centre global registration study for Kymriah in adult patients with r/r DLBCL. JULIET, led by researchers at the University of Pennsylvania, is the largest and only global registration study examining a CAR-T cell therapy in DLBCL, enrolling patients from 27 sites in 10 countries across the US, Canada, Australia, Japan and Europe, including Austria, France, Germany, Italy, Norway and the Netherlands.

About Kymriah

In August 2017, Kymriah became the first available chimeric antigen receptor T cell (CAR-T) therapy when it received FDA approval for children and young adults with B-cell acute lymphoblastic leukaemia (ALL) that is refractory or has relapsed at least twice. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer. Kymriah uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular expansion and persistence.

About Oxford BioMedica

Oxford BioMedica (LSE:OXB) is a leading 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 and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Bioverativ, Sanofi, Axovant, Orchard Therapeutics, Boehringer Ingelheim/UK Cystic Fibrosis Gene Therapy Consortium/Imperial Innovations and GC LabCell, 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 360 people. Further information is available at www.oxb.com.

________________________
1 Schuster S., et. al. Tisagenlecleucel in Adult Relapsed/Refractory Diffuse Large B-Cell Lymphoma. New England Journal of Medicine. December 2018.
2 Grupp S., et al. Updated Analysis of the Efficacy and Safety of Tisagenlecleucel in Pediatric and Young Adult Patients with Relapsed/Refractory (r/r) Acute Lymphoblastic Leukemia. 60th American Society of Hematology Annual Meeting and Exposition. Abstract #112599.
3 Schuster S., et. al. Sustained Disease Control for Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma: An Updated Analysis of Juliet, a Global Pivotal Phase 2 Trial of Tisagenlecleucel, Acute Lymphoblastic Leukemia. 60th American Society of Hematology Annual Meeting and Exposition. Abstract #: 11525.

Contact information

Oxford BioMedica plc:
John Dawson, Chief Executive Officer
Stuart Paynter, Chief Financial Officer
Sarah MacLeod, Head of Communications
Tel: +44 (0)1865 783 000
media@oxb.com

Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal/Laura Thornton
Tel: +44 (0)20 3709 5700

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Blue Danube Systems Coherent Massive MIMO Delivers Industry’s Highest Capacity Gains in Multiple Commercial Networks22.2.2019 02:00:00Tiedote

Blue Danube Systems, a provider of intelligent wireless access solutions that help mobile operators address the challenge of explosive data growth, is today announcing significant results from multiple new FDD deployments in commercial networks with live traffic. These multi-unit installations show more than 2.5 times higher cellular capacity and significantly increased user throughputs for both legacy LTE terminals as well as new generation smartphones. Blue Danube’s BeamCraft™ 500 antennas were deployed in 4G LTE networks in dense urban megacities and other areas with high traffic load nearing full bandwidth utilization. The systems exploited intelligent analytics-based multi-site optimization, and the performance was measured directly from the operators’ network performance management systems. The results exhibit increasing gains with the number of units deployed and highlight the benefits of multi-site optimization and coordination. Consistent performance improvements were observed

Blue Danube Systems Expands Operations in India and Welcomes Sundeep Raina to the Global Sales Management Team22.2.2019 01:00:00Tiedote

Blue Danube Systems, a provider of intelligent wireless access solutions that help mobile operators address the challenge of explosive data growth, is announcing that Sundeep Raina has joined the company as the Country Sales Director of India. Mr. Raina joins Blue Danube with over 19 years of industry experience in telecommunications equipment sales and key account management most recently with ZTE Corporation and previously at Ericsson India. Mr. Raina will be responsible for developing new business relationships, managing current engagements and sales expansion in India. He will be based in Mumbai close to Blue Danube’s customers and partners. “We are excited to have Sundeep on board and look forward to Blue Danube’s continued progress in India,” said John Shelnutt, Blue Danube’s Vice President of Sales. “With the recent positive developments and increasing interest towards our solutions we decided to increase our presence in India to better serve our key customers. Sundeep has demon

Blue Danube Systems Enhances BeamPlanner™ Software Including Artificial Intelligence and Machine Learning Capabilities21.2.2019 23:00:00Tiedote

Blue Danube Systems, a provider of intelligent wireless access solutions that help mobile operators address the challenge of explosive data growth, is today announcing new capabilities into its BeamPlanner™ cloud software suite. BeamPlanner is the world’s first network planning and optimization tool for beamforming antenna systems. With the new and enhanced artificial intelligence (AI) and machine learning (ML) functionalities, BeamPlanner becomes the automated platform for network-wide operation of Blue Danube’s Coherent Massive MIMO systems. BeamPlanner utilizes an intelligent analytics-based, data-driven multi-site optimization engine that now has been enhanced with 3D ray tracing capabilities for improved prediction results accuracy. The simulation platform provides actionable beamforming recommendations and expected capacity results matching the real-world performance results validated through drive tests, network statistics data and standard key performance indicators (KPIs). In

Recipients of HCL GRANT 2019 Felicitated by Amitabh Kant & Sourav Ganguly21.2.2019 22:06:00Tiedote

Mr. Amitabh Kant, CEO, Niti Aayog and Mr. Sourav Ganguly, Former captain of the Indian National Cricket Team felicitated the winners of HCL Grant 2019 at a ceremony held today at HCL Technologies Campus, Noida, in the presence of Mr. Shiv Nadar, Founder & Chairman, HCL, Ms. Roshni Nadar Malhotra, Vice Chairperson, HCL Technologies and Chairperson, CSR Committee, HCL Technologies, along with senior dignitaries, bureaucrats, NGO-partners and the HCL leadership. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005822/en/ L to R - Ms. Roshni Nadar Malhotra, Vice Chairperson, HCL Technologies and Chairperson, CSR Committee, HCL Technologies; Mr. Sourav Ganguly, Former Captain of Indian National Cricket Team; Mr. Amitabh Kant, CEO, NITI Aayog and Ms. Robin Abrams, former president of Palm Computing and longest-serving Board member of HCL Technologies along with the HCL Grant 2019 recipients - Environment - Wildlife Trust of In

International Indigenous Languages Conference Set for June in British Columbia21.2.2019 20:48:00Tiedote

In celebration of the United Nations 2019 International Year of Indigenous Languages, the First Peoples’ Cultural Foundation (FPCF) and the First Peoples’ Cultural Council (FPCC), in partnership with the Canadian Commission for UNESCO, will host a major international conference on Indigenous language revitalization in British Columbia this summer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005758/en/ WHAT: The HELISET TŦE SḰÁL – ‘Let the Languages Live’ – 2019 International Conference on Indigenous Languages will bring together Indigenous leaders and language experts, speakers, learners and advocates from around the globe to celebrate, honour and share expertise in Indigenous language reclamation, revitalization and maintenance and to learn about successful language projects in B.C. The goal of the conference is to provide participants with practical skills and knowledge to support the Indigenous language revitaliz

Axilum Robotics Announces U.S. FDA 510(k) Clearance for TMS-Cobot21.2.2019 20:00:00Tiedote

Axilum Robotics, specializing in the development of medical robots, announces that, 2 weeks after the CE mark, the Company has received 510(k) clearance from the U.S. Food and Drug Administration to market the TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the treatment coil of the MagVenture TMS Therapy system. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190221005667/en/ Axilum Robotics TMS-Cobot (Photo: Business Wire) After having successfully developed and launched outside of the United States (OUS) the TMS-Robot, the first robot designed to assist health care professionals in delivering Transcranial Magnetic Stimulation (TMS), based on an invention of ICube laboratory in Strasbourg, Axilum Robotics has reinforced its expertise in medical robotics with the development of a new platform based on collaborative robot technology. TMS-Cobot, the first medical device built on this platform, allows

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme