{"id":439763,"date":"2021-02-19T07:03:22","date_gmt":"2021-02-19T12:03:22","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=439763"},"modified":"2021-02-19T07:03:22","modified_gmt":"2021-02-19T12:03:22","slug":"immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\/","title":{"rendered":"Immunocore\u2019s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA"},"content":{"rendered":"

\nSubmission of a Biologic License Application to FDA planned for Q3 2021
\n<\/h2>\n
\n

OXFORDSHIRE, England and CONSHOHOCKEN, Pa. and ROCKVILLE, Md., Feb. 19, 2021 (GLOBE NEWSWIRE) — Immunocore<\/a> (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).<\/p>\n

\n Bahija Jallal, Chief Executive Officer of Immunocore, said:<\/strong>
\n \u201cWe are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp based on the survival benefit from our Phase 3 clinical trial announced in November 2020. <\/em>
\n There is an urgent need for an approved treatment for this rare and aggressive form of melanoma and we look forward to continuing to work with regulators to bring tebentafusp to patients as quickly as possible.\u201d<\/em>\n <\/p>\n

In an initial pre-planned interim analysis of a randomized Phase 3 clinical trial (IMCgp100-202) in previously untreated metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies, tebentafusp demonstrated superior overall survival (OS) benefit as a monotherapy. The primary endpoint was achieved when the OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.36, 0.71); p< 0.0001, over investigator\u2019s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).<\/p>\n

The Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).<\/p>\n

Tebentafusp has also been granted Fast Track Designation and orphan drug designation from the FDA for uveal melanoma and Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme. Immunocore will be working with the FDA to facilitate submission of a BLA for tebentafusp. If approved, Immunocore believes tebentafusp would be the first new therapy for the treatment of metastatic uveal melanoma in 40 years.<\/p>\n

\n About Immunocore <\/strong>\n <\/p>\n

Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX \u2013 Immune mobilizing monoclonal TCRs Against X disease \u2013 designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore\u2019s most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.<\/p>\n

\n About ImmTAC\u00ae<\/sup>\u00a0Molecules<\/strong>\n <\/p>\n

Immunocore\u2019s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune \u201ccold\u201d low mutation rate tumours.\u00a0<\/p>\n

\n About Tebentafusp<\/strong>\n <\/p>\n

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\u2019s ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) 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<\/a> (NCT03070392).<\/p>\n

\n About Uveal Melanoma<\/strong>\n <\/p>\n

Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. 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 per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.<\/p>\n

\n Forward Looking Statements<\/strong>\n <\/p>\n

This press release contains \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp, the results, conduct, progress and timing of the Company\u2019s development programs including tebentafusp, the potential benefit of Breakthrough Therapy Designation for tebentafusp, estimates regarding the planned submission a BLA for tebentafusp and the regulatory approval path for tebentafusp. Any forward-looking statements are based on management\u2019s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company\u2019s control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company\u2019s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled \u201cRisk Factors\u201d in in the Company\u2019s final prospectus dated February 4, 2021 filed with the Securities and Exchange Commission pursuant to Rule 424(b)(4) on February 8, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company\u2019s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.<\/p>\n


\n
\n \n <\/div>\n

\n
CONTACT:\u00a0\r\n\r\nImmunocore \r\nDebra Nielsen, Head of Communications\r\nT: +1 (610) 368-8602\r\nE: debra.nielsen@immunocore.com \r\nFollow on Twitter: @Immunocore\r\n\r\nConsilium Strategic Communications (corporate and financial)\r\nMary-Jane Elliott\/ Chris Welsh\/ Sukaina Virji \r\nT: +44 (0)203 709 5700\r\nE: Immunocore@consilium-comms.com\r\n\r\nInvestor Relations\r\nClayton Robertson, Head of Investor Relations\r\nT: +1 215-384-4781\r\nE: ir@immunocore.com<\/pre>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"
Submission of a Biologic License Application to FDA planned for Q3 2021 OXFORDSHIRE, England and CONSHOHOCKEN, Pa. and ROCKVILLE, Md., Feb. 19, 2021 (GLOBE NEWSWIRE) — Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). Bahija Jallal, Chief Executive Officer of Immunocore, said: \u201cWe are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp based on the survival benefit from … <\/p>\n
Continue reading “Immunocore\u2019s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-439763","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nImmunocore\u2019s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Immunocore\u2019s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Submission of a Biologic License Application to FDA planned for Q3 2021 OXFORDSHIRE, England and CONSHOHOCKEN, Pa. and ROCKVILLE, Md., Feb. 19, 2021 (GLOBE NEWSWIRE) — Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). Bahija Jallal, Chief Executive Officer of Immunocore, said: \u201cWe are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp based on the survival benefit from … Continue reading "Immunocore\u2019s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-02-19T12:03:22+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE1NjIxMCMzOTg0OTUwIzIyMDYyNTg=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Immunocore\u2019s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA\",\"datePublished\":\"2021-02-19T12:03:22+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\\\/\"},\"wordCount\":1097,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODE1NjIxMCMzOTg0OTUwIzIyMDYyNTg=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\\\/\",\"name\":\"Immunocore\u2019s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA - 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Bahija Jallal, Chief Executive Officer of Immunocore, said: \u201cWe are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp based on the survival benefit from … Continue reading \"Immunocore\u2019s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\/","og_site_name":"Market Newsdesk","article_published_time":"2021-02-19T12:03:22+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE1NjIxMCMzOTg0OTUwIzIyMDYyNTg=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Immunocore\u2019s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA","datePublished":"2021-02-19T12:03:22+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\/"},"wordCount":1097,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE1NjIxMCMzOTg0OTUwIzIyMDYyNTg=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/immunocores-tebentafusp-granted-breakthrough-therapy-designation-for-unresectable-or-metastatic-uveal-melanoma-from-fda\/","name":"Immunocore\u2019s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA - 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