Business Wire

New IMCgp100-102 Data Show Durable Response and Robust Overall Survival Rate in Patients with Metastatic Uveal Melanoma

Jaa

Patients with metastatic uveal melanoma (mUM) treated with IMCgp100 continued to experience a durable tumour response with a median follow up of 19.1 months, without yet reaching median overall survival (OS), according to new Phase I research to be presented today at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.2 IMCgp100 is the wholly-owned, lead programme from Immunocore Limited, a leading T-cell receptor (TCR) company focused on delivering first-in-class biological therapies that transform lives.

Although rare, uveal melanoma is the most common form of adult eye cancer.3 When it metastasises beyond the eye, less than half of patients will survive for one year.4 Of the 19 HLA-A*0201+ patients enrolled in Phase I of the Phase I/II dose escalation trial, 17 were evaluated for efficacy. Among these patients, treatment with IMCgp100 was associated with an objective response rate of 18% (90% confidence interval [4,30]) and a one-year overall survival rate of 74% (95% confidence interval [48,88]) at the time of data cut-off.2

Survival rates in uveal melanoma have remained largely unchanged for decades, and it is difficult to treat once it advances to metastatic disease,” said Dr. Takami Sato, Department of Medical Oncology, Kimmel Cancer Center, Thomas Jefferson University and lead investigator. “These data provide compelling evidence that IMCgp100 may offer hope to this underserved patient population.”

Additional exploratory survival analyses also indicated prolonged OS was associated with a number of pharmacodynamic outcomes, including lymphocyte trafficking, providing encouraging evidence supporting the proposed mechanism of action of IMCgp100.2

Immunocore is focused on transforming the lives of patients with some of the most challenging diseases, such as metastatic uveal melanoma, for which there is currently no standard of care,” said Andrew Hotchkiss, Chief Executive Officer at Immunocore. “Although these are early findings, we are encouraged by the emerging clinical data and focused on advancing our pivotal trials.”

The most common adverse events in the Phase I arm included pruritus (severe itching of the skin; 90%), pyrexia (fever) and fatigue (84%), and hypotension (74%).2 Dose limiting toxicities were observed in 3 patients; all were reversible abnormalities in liver function tests (Grade 3 or 4 ALT/AST changes). There were no IMCgp100-related AEs that resulted in discontinuation or death.2

About Metastatic Uveal Melanoma

Uveal melanoma is an aggressive form of melanoma which affects the eye, with a poor prognosis and no standard of care.5 Although it is the most common primary intraocular malignancy in adults,3 the diagnosis is rare, with approximately 4,000 new patients diagnosed globally each year (1,500 cases/year in US).1 Up to 50% of people with uveal melanoma will eventually develop metastatic disease.5,6 When the cancer spreads beyond the eye, only approximately 40% of patients will survive for one year.4

About the IMCgp100-102 Phase I/II Trial

In this study, IMCgp100 is administered on a weekly basis with an intra-patient escalation dosing regimen. The dose escalation portion of the study has been completed, which identified the recommended Phase II intra-patient dose. The Phase II portion of the study is ongoing evaluating both the safety and efficacy in patients with metastatic uveal melanoma. The currently enrolling cohort is assessing IMCgp100 in patients who have experienced disease progression after 1 or 2 prior lines of therapy, which may include up to 1 line of liver directed therapy. Approximately 150 patients will be enrolled in the Phase II portion and the estimated enrolment completion date is September 2019.

About the IMCgp100 Programme

IMCgp100 is a novel bi-specific biologic T cell redirection therapy that specifically targets the melanoma-associated antigen gp100, and which is now in pivotal studies for mUM. IMCgp100 was granted Orphan Drug Designation by the US Food and Drug Administration in 2016 and Promising Innovative Medicine designation under UK Early Access to Medicines Scheme in 2017. For more information about enrolling IMCgp100 clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT02570308 , NCT03070392).

About ImmTAC® Molecules

Immunocore’s proprietary TCR (T Cell Receptor) technology generates a novel class of bi-specific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that enable the immune system to recognise and kill cancerous cells. ImmTAC molecules are based on synthetic, 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. ImmTAC molecules can access up to nine-fold more target antigens than typical antibody-based approaches, including monoclonal antibodies. 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 Immunocore

Immunocore, a leading T Cell Receptor (TCR) biotechnology company, is focused on delivering first-in-class biological therapies that have the potential to transform the lives of people with serious diseases. The Company’s primary therapeutic focus is oncology and it also has programs in infectious and autoimmune diseases. Immunocore has a pipeline of proprietary and partnered programs in development and the lead programme, IMCgp100, has entered pivotal clinical studies as a treatment for patients with metastatic uveal melanoma. Partners include Genentech, GlaxoSmithKline, AstraZeneca, Lilly, and the Bill and Melinda Gates Foundation. Immunocore is headquartered at Milton Park, Oxfordshire, UK, with an office outside Philadelphia, USA. The Company is privately held by a broad international investor base. For more information, please visit www.immunocore.com.

   
1 Data on file
2

Sato, T. et al. Redirected T cell lysis in patients with metastatic uveal melanoma with gp100-directed TCR IMCgp100: Overall survival findings. Presented at ASCO 2018 (abstract 9521).

3

Mahendraraj K, Lau CS, Lee I, et al., 2016. Trends in incidence, survival, and management of uveal melanoma: a population-based study of 7,516 patients from the surveillance, epidemiology, and end results database (1973–2012). Clinical Ophthalmology, 10, 2113.

4

Khoja L, Atenafu E, Joshua A, and The International Rare Cancer's Initiative-Ocular Melanoma Group. 2016. Meta-analysis of phase II trials in metastatic uveal melanoma (MUM) to determine progression-free (PFS) and overall survival (OS) benchmarks for future phase II trials: An irci-ocular melanoma initiative. Journal of Clinical Oncology 34:15_suppl, 9567-9567.

5

Carvajal, RD, Schwartz, GK, Tezel, T, et al., 2017. Metastatic disease from uveal melanoma: treatment options and future prospects. British Journal of Ophthalmology, 101(1), 38-44.

6

Kujala E, Mäkitie T, Kivelä T. 2003. Very long-term prognosis of patients with malignant uveal melanoma. Investigative Ophthalmology & Visual Science, 44, 4651.

 

Contact information

Immunocore
Andrew Hotchkiss, +44 (0) 1235 438600
Chief Executive Officer
info@immunocore.com
Follow on Twitter: @Immunocore
or
Syneos Health Communications (IMCgp100)
Hannah Silver, 212-849-9483
ImmunocorePR@syneoshealth.com
or
Consilium Strategic Communications (corporate and financial)
Mary-Jane Elliott/Jessica Hodgson/Laura Thornton
+44 (0) 203 709 5700
Immunocore@consilium-comms.com

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 jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

BioNTech Signs Collaboration Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza16.8.2018 08:00Tiedote

BioNTech AG, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease, today announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. (NYSE: PFE) to develop mRNA-based vaccines for prevention of influenza (flu). Under the terms of the agreement, BioNTech and Pfizer will jointly conduct research and development activities to help advance mRNA-based flu vaccines. Pfizer will assume sole responsibility for further clinical development and commercialization of mRNA-based flu vaccines, following BioNTech’s completion of a first in human clinical study. BioNTech will receive $120 million in upfront, equity and near-term research payments and up to an additional $305 million in potential development, regulatory and commercial milestone payments. In addition, BioNTech will receive up to double-digit tiered royalty payments associated with worldwide sales if the program reac

Maxion Wheels to Showcase Market-Leading Light Weight Commercial Vehicle Wheels at REIFEN 201816.8.2018 07:05Tiedote

Maxion Wheels, the world’s largest producer of wheels, announced today its participation in REIFEN, the leading tire and wheel industry event in Europe, from Sept. 11 – 15, 2018 in Hall 12.1 / Stand D24. For the first time, REIFEN will be co-located with Automechanika Frankfurt at the Messe Frankfurt. “REIFEN is the premier event for European tire and wheel manufacturers and resellers, bringing us together to meet and collaborate on the important aftermarket themes of innovation, service and delivery,” stated Mark Gerardts, Vice President of Global Sales and Marketing, Maxion Wheels. “After a highly popular launch to truck and trailer OEMs in 2017, we’re excited to have the industry’s lightest mass production steel wheel now available to our aftermarket distributors. This wheel, along with several others, including our new 10.00W-20 wide base tubetype and tubeless heavy duty armored vehicles wheel are great examples of our continued efforts to bring our OE multi-application innovations

Lenovo Accelerates Turnaround with Back-to-Back, Double-Digit Quarterly Revenue Growth16.8.2018 02:40Tiedote

Lenovo Group (HKSE: 0992) (PINK SHEETS: LNVGY) today announced results for its first fiscal quarter ended June 30, 2018. For the second straight quarter, Lenovo achieved strong double-digit growth in revenue year-on-year. Group revenue reached US$11.91 billion, up 19% year-on-year. The company also reported strong pre-tax income during the quarter of US$113 million, an improvement of US$182 million year-on-year, as profitability improved across all businesses. In the first fiscal quarter, Lenovo’s profit attributable to equity holders grew to US$77 million, up US$149 million year-over-year. Basic earnings per share in the first fiscal quarter was 0.65 US cents or 5.10 HK cents. “As we persistently execute our 3-wave strategy, all our businesses made solid improvements in both revenue and profitability. Lenovo has passed the turning point and entered a phase of ‘acceleration’ - accelerating the execution of our transformation strategy and accelerating the rising momentum in business per

CORRECTING and REPLACING Ebola Successfully Neutralized by Latest Generation Polyclonal Immunotherapy16.8.2018 01:37Tiedote

Please replace the release with the following corrected version due to multiple revisions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005602/en/ New Ebola immunotherapy developed by SAB Biotherapeutics uses natural human polyclonal antibodies to combat disease. (Photo: SAB Biotherapeutics) The corrected release reads: EBOLA SUCCESSFULLY NEUTRALIZED BY LATEST GENERATION POLYCLONAL IMMUNOTHERAPY Promising new platform can rapidly respond to emerging infectious diseases Sioux Falls, SD, August 15, 2018 – SAB Biotherapeutics, Inc. (SAB), a clinical-stage biopharmaceutical company, today announced that its anti-Ebola immunotherapy (SAB-139) provided “100% protection against a lethal dose of the Ebola virus” in a recent animal study published in The Journal of Infectious Diseases . The study was conducted at the Integrated Research Facility, National Institute of Allergy and Infectious Diseases, National Institutes of He

QConnect – Markkinoiden älykkäin, erittäin kompakti ja lujatekoinen viestintälaite15.8.2018 23:23Tiedote

Quake Global, Inc. (QUAKE), yksi maailman johtavista IoT-markkinoiden toimittajista, julkaisi QConnect™, uuden sukupolven kehittyneen telematiikkalaitteen. Äärimmäisen kompakti QConnect integroituu kiinteisiin ja liikkuviin omaisuuksiin niiden seuraamiseksi, valvomiseksi ja hallitsemiseksi reaaliajassa mistä ja milloin tahansa. Laite tarjoaa useita pitkälle kehitettyjä langattomia kommunikaatiovaihtoehtoja, mukaan lukien LTE/2G/3G, kaksitaajuus-Wi-Fi, Bluetooth/BLE, V2X ja satelliitti. Laite on suunniteltu vastaamaan moniin eri vaatimuksiin yksinkertaisista ja edullisista seurantasovelluksista aina korkean suorituskyvyn monikanavaisiin videon suoratoistosovelluksiin. Tämä lehdistötiedote sisältää multimediaa. Katso koko julkaisu täällä: https://www.businesswire.com/news/home/20180815005706/fi/ Quake Global’s new QConnect, the most intelligent, global, ultra-compact and rugged communication device available (Photo: Business Wire) QConnect tarjoaa joustavuutta sen ainutlaatuisilla sovell

Ebola Successfully Neutralized by Latest Generation Polyclonal Immunotherapy15.8.2018 20:43Tiedote

SAB Biotherapeutics, Inc. (SAB), a clinical-stage biopharmaceutical company, today announced that its anti-Ebola immunotherapy (SAB-139) provided “100% protection against a lethal dose of the Ebola virus” in a recent animal study published in The Journal of Infectious Diseases . The study was conducted by the National Interagency Confederation for Biological Research and other collaborators including United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Naval Medical Research Center (NMRC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005602/en/ New Ebola immunotherapy developed by SAB Biotherapeutics uses natural human polyclonal antibodies to combat disease. (Photo: SAB Biotherapeutics) According to the World Health Organization, Ebola virus disease (EVD), formerly known as Ebola hemorrhagic fever, is a severe, often fatal illness in humans with an average fatality rate around 50%.

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