Business Wire

New Biomarker Research Builds Further Understanding of Tebentafusp (IMCgp100) Mechanism of Action, Link to Clinical Activity in Advanced Melanoma

Del

Monotherapy treatment with the first-in-class ImmTAC® molecule tebentafusp (IMCgp100) induced an immunologically potent response in patients with advanced uveal and cutaneous melanoma, according to new data presented today by Immunocore Limited at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. The biomarker research provides additional insight into the mechanism of action of tebentafusp in patients with advanced melanoma and demonstrates the potential association with clinical outcomes.

“We are pleased to share new biomarker data from our tebentafusp clinical trial programme, which add to the growing body of evidence supporting the investigational agent’s clinical activity and reinforce the potential applicability of our ImmTAC technology,” said Bahija Jallal, Chief Executive Officer of Immunocore. “We recognise the immediate need for new treatment options for people living with metastatic uveal melanoma and are working to advance tebentafusp as quickly and safely as possible.”

Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect T cells to recognise and kill tumour cells. Pivotal tebentafusp clinical trials are currently underway in metastatic uveal melanoma, a rare form of eye cancer.

“Biomarker research is critical to informing the development of new immunotherapy agents, particularly in difficult-to-treat cancers like uveal melanoma,” said Mark R Middleton, MD, lead study investigator and Head of the Department of Oncology at the University of Oxford. “These data build a deeper understanding of how the immune system responds to tebentafusp and provide insights needed to inform future enhancements.”

ASCO Presentations

Researchers analysed data from the Phase 1 first-in-human clinical trial assessing the safety and tolerability of tebentafusp in 84 HLA-A2+ patients with metastatic melanoma (n=61 cutaneous, n=19 uveal, n=4 other) resistant to standard treatment regimens or for which no standard treatments exist.

Pharmacodynamic Effect of IMCgp100 (TCR–CD3 bispecific) on Peripheral Cytokines and Association with Overall Survival in Patients with Advanced Melanoma

The goal of this analysis was to understand the biological effects of tebentafusp and an association with anti-tumour activity. The findings showed an association between a greater increase in serum CXCL10, a chemokine for T cells expressing CXCR3 receptor, and a greater transient reduction in peripheral CXCR3+CD8+ T cells, tumour shrinkage and longer overall survival (OS). A greater reduction in peripheral CXCR3+ CD8+ T cells also appeared to be associated with tumour shrinkage and longer OS, and changes in tumour biopsies were consistent with T cell infiltration and immune activation.

Relationship Between Clinical Efficacy and AEs of IMCgp100, a Novel Bispecific TCR–anti-CD3, in Patients with Advanced Melanoma

In this analysis, adverse events (AEs) were consistent with tebentafusp’s proposed mechanism of action with most AEs relating to on-target (gp100) off-tumour activity (e.g., rash, pruritus), or were cytokine mediated (e.g., pyrexia, hypotension). There appears to be an association between the timing of onset and resolution of these AEs and certain cytokines in the blood. AEs were generally manageable with standard clinical interventions. An association was also observed between OS and LDH ≤ULN and any-grade rash occurring within 21 days.

“Further understanding of the potential association of mechanism of action with safety and activity is important in the success of novel immune therapies,” said Omid Hamid, MD, study investigator and Chief of Translational Research and Immunotherapy at The Angeles Clinic. “These data support the continued investigation of tebentafusp in cutaneous melanoma in addition to the pivotal trials in metastatic uveal melanoma already underway.”

More information about the tebentafusp clinical trials can be found at https://www.clinicaltrials.gov.

- Ends -

About Tebentafusp

Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect T cells to recognise and kill tumour cells. Tebentafusp has Fast Track Designation and Orphan Drug Designation in the US and Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

About Immunocore

Immunocore is a leading T cell receptor (TCR) biotechnology company working to create first-in-class biological therapies that have the potential to transform patients’ lives. The Company’s primary therapeutic focus is oncology and it also has programmes in infectious and autoimmune diseases. Immunocore has a pipeline of proprietary and partnered programmes in development and the lead tebentafusp is being investigated in pivotal clinical studies as a treatment for patients with metastatic uveal melanoma. Collaboration partners include Genentech, GlaxoSmithKline, AstraZeneca, Lilly, and the Bill and Melinda Gates Foundation. Immunocore is headquartered at Milton Park, Oxfordshire, UK, with offices in Conshohocken, PA and Rockville, MD, US. The Company is privately held by a broad international investor base. For more information, please visit www.immunocore.com.

About ImmTAC® Molecules

Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that can potentially enable the immune system to recognise and kill cancerous cells. ImmTAC molecules are based on soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill cancer cells via an anti-CD3 immune-redirecting effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to tackle solid “cold” low mutation rate tumours, the majority of tumours that do not adequately respond to currently available immunotherapies.

About Uveal Melanoma

Uveal melanoma is an aggressive form of melanoma which affects the eye, with a poor prognosis and no standard of care.1 Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases/year in the US).1,2,3,4 Up to 50% of people with uveal melanoma will eventually develop metastatic disease.1 When the cancer spreads beyond the eye, only approximately 40% of patients will survive for one year.1

For more information, please contact:

1 Carvajal, RD, Schwartz, GK, Tezel, T, et al., 2017. Metastatic disease from uveal melanoma: treatment options and future prospects. British Journal of Ophthalmology101(1), 38-44.

2 Pandiani C, Béranger GE, Leclerc J, Ballotti R, Bertolotto C. Focus on cutaneous and uveal melanoma specificities. Genes Dev. 2017;31(8):724-743.

3 Jovanovic P, Mihajlovic M, Djordjevic-Jocic J, Vlajkovic S, Cekic S, Stefanovic V. Ocular melanoma: an overview of the current status. Int J Clin Exp Pathol. 2013;6(7):1230-1244.

4 About ocular melanoma. Ocular Melanoma Foundation website. www.ocularmelanoma.org /about-om.htm. Accessed May 2019.

Contact information

Immunocore
Louise Conlon,
External Affairs and Brand Communications Manager
T: +44 (0) 1235 438600
E: info@immunocore.com
Follow on Twitter: @Immunocore

Syneos Health Communications (Tebentafusp/IMCgp100)
Stephanie Bukantz
T: +973 477 1814
E: ImmunocorePR@syneoshealth.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Three Finalists Selected Following GA-ASI’s Blue Magic Belgium Event15.6.2019 11:00:00 CESTPressemelding

Three finalists have been selected from GA-ASI’s Blue Magic Belgium event with the goal of supporting GA-ASI and the development of MQ-9B SkyGuardian Remotely Piloted Aircraft (RPA) for Belgium. The three Belgian companies selected are AIRobot, ALX Systems, and Hexagon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190615005003/en/ "We were very impressed by the many talented companies and particularly by the innovative concepts presented by these three finalists," said Linden Blue, CEO, GA-ASI. (Photo: Business Wire) AIRobot, a company based at DronePort in Sint Truiden, Belgium, focuses on developing drone performance equipment for easy, precise and safe professional operations, while specializing in Artificial Intelligence (AI) for processing hyper-spectral imagery. ALX Systems is an Unmanned Aircraft System (UAS) solution provider based in Liège, Belgium and specializing in AI for processing Full Motion Video. Hexagon’s

World’s First E-Money License for Blockchains Issued to Monerium15.6.2019 08:35:00 CESTPressemelding

Monerium ehf. has received a license from the Financial Supervisory Authority of Iceland to issue e-money on blockchains through its subsidiary, Monerium EMI ehf. The full license is the world’s first e-money license for blockchains issued under EU e-money regulations. The license is passportable within the largest global economic zone, the European Economic Area, and to external jurisdictions subject to regulatory approval and destination country regulations. Designed as a digital alternative to cash, e-money is a proven framework for digital fiat currency already in use for pre-paid cards and mobile wallets. By issuing e-money on blockchains, Monerium removes the need for intermediaries and provides the ability to automate financial transactions in many sectors, including payments, trade finance, securities settlement, and ecommerce. At the same time, e-money on blockchains extends Satoshi Nakamoto’s vision of online peer-to-peer currency transactions to a regulated form of digital f

Mattel® Unveils Hot Wheels™ id, Groundbreaking New Play System Bringing Together Physical and Digital Play, Available Exclusively at Apple.com, Select Apple Stores and on the App Store14.6.2019 13:00:00 CESTPressemelding

Mattel, Inc. (NASDAQ: MAT) today announced the launch of Hot Wheels id, the evolution of the beloved brand that generations of kids have played with to ignite their challenger spirit. Through innovative vehicle play, Hot Wheels id brings together physical and digital in a Mixed Play experience with uniquely identifiable vehicles, a smart Race Portal, Smart Track, and digital hub, so you can build your personalized fleet, measure your performance, and compete like never before. Hot Wheels id is available starting June 14th exclusively at Apple.com, select Apple stores and on the App Store. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190614005084/en/ Hot Wheels Race Portal™ scans your Hot Wheels id vehicles into the app, tracks speed and counts laps via infrared sensors, and easily connects with your classic Hot Wheels track. (Photo: Business Wire) For the first time in history, kids can scan their Hot Wheels id cars digita

S BLOCK Co-host With World Blockchain Forum Singapore & World Blockchain Award Asia14.6.2019 12:45:00 CESTPressemelding

Asia's highly anticipated blockchain event World Blockchain Forum · Singapore & World Blockchain Award · Asia will be held on June 22-23, 2019 at the Marina Bay Sands in Singapore. The conference will bring together more than 4,000 global elites from government, associations, regulatory agencies, investment institutions, blockchain project parties, financial technology, and media to discuss industry trends and innovations, jointly recognizing industry pioneers and contributions to promote the industry and achieve healthy and rapid development! The World Blockchain Forum Singapore & World Blockchain Award Asia will be co-hosted by S BLOCK. As a fast-growing digital asset management platform, S BLOCK was developed for the blockchain industry. This rapidly growing platform aims to serve the digital financial ecosystem and aims to commercialize by the end of 2019. The slogan of S BLOCK is “unleash your digital asset.” The platform also provides investors access to mainstream cryptocurrenci

Janssen Reports Top-Line Phase 3 Results for TREMFYA® (guselkumab) in Adults with Active Psoriatic Arthritis14.6.2019 11:39:00 CESTPressemelding

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced top-line results from the Phase 3 DISCOVER 1 and 2 studies, which evaluated the efficacy and safety of guselkumab compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary endpoints of American College of Rheumatology 20% improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER programme were consistent with previous studies of guselkumab and current prescribing information.1 The DISCOVER programme comprises the first-ever Phase 3 studies evaluating an IL-23 p19 inhibitor for the treatment of psoriatic arthritis, and data will be presented at upcoming scientific medical meetings. Data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for

Velodyne Features Advanced Lidar for Port Terminal Automation at TOC Europe14.6.2019 10:00:00 CESTPressemelding

Velodyne Lidar, Inc. (Stand A50) will demonstrate how its smart, powerful lidar solutions can advance port terminal automation at TOC Europe in Rotterdam, 18-20 June. Velodyne will highlight customer applications that show how its lidar sensors can be used in crane steering, container handling, internal terminal vehicles (ITV), automated guided vehicles (AGV), forklifts, and terminal security/yard monitoring systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190614005040/en/ DGWorld solutions demonstrate how Velodyne’s intelligent lidar sensors are helping port and terminal operators deliver consistent service quality and achieve increased safety. (Photo: Business Wire) DGWorld (Stand B21A), a Dubai-based Velodyne integrator, will showcase autonomous taxis, ITVs, AGVs, and terminal operation vehicles that use Velodyne lidar sensors to run autonomously. These vehicles use advanced artificial intelligence (AI), automation