Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 78 |
| INN | Tebentafusp |
| Status | Approved |
| Drug code(s) | IMCgp100 |
| Brand name | KIMMTRAK |
| mAb sequence source | mAb - source TBD |
| General Molecular Category | Bispecific, Immunoconjugate |
| Format, general category | Fragment fusion |
| Format details | scFv-TCR |
| Isotype (Fc) | None |
| Light chain isotype | TBD |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | T cell receptor |
| Discovery method/technology | None |
| Target(s) | CD3, gp100 |
| Indications of clinical studies | Uveal melanoma, malignant melanoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved EU, US, Canada, UK, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2010 |
| Start of Phase 2 | October 15, 2013 |
| Start of Phase 3 | October 16, 2017 |
| Date BLA/NDA submitted to FDA | June 23, 2021 |
| Year of first approval (global) | 2022 |
| Date of first US approval | January 25, 2022 |
| INN, US product name | Tebentafusp, tebentafusp-tebn |
| US or EU approved indications | Treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma |
| Company | Immunocore Ltd |
| Licensee/Partner | AstraZeneca |
| Comments about company or candidate | FDA approved in Jan 2022 under Priority review based on a late-stage Phase 2 clinical trial (NCT03070392); EC approved in late March or early April 2022. Aug 24, 2021: Immunocore Announces that U.S. Food and Drug Administration and European Medicines Agency accept Biologics License Application and Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma. PDUFA date Feb 23, 2022. April 2021: Immunocore will be working with the FDA to complete submission of a BLA for tebentafusp in the third quarter of 2021. March 10, 2021: Immunocore, 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, infection and autoimmune disease, announced that four abstracts highlighting the Company’s lead program, tebentafusp, were accepted at the American Association for Cancer Research (AACR) 2021 Annual Meeting, which will be held virtually from April 10-15, 2021. Two abstracts will be presented as oral presentations including, in the plenary session, Phase 3 data comparing tebentafusp (IMCgp100) with investigator’s choice in first line metastatic uveal melanoma (mUM). A second oral presentation will feature data on the kinetics of radiographic response for tebentafusp in previously treated mUM patients. Two abstracts will be poster presentations. Feb 2021: Breakthrough therapy designation granted April 3 2019: Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its development program, the investigation of tebentafusp (IMCgp100) for the treatment of patients who are HLA-A*0201-positive with previously untreated, metastatic uveal melanoma (mUM). The pivotal study IMCgp100-202 is a 2:1 randomized study of tebentafusp compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A*0201 positive adult patients with previously untreated mUM. The primary endpoint is a comparison of overall survival. Tebentafusp has previously been granted orphan drug designation for uveal melanoma by the US FDA and Promising Innovative Medicine designation under UK Early Access to Medicines Scheme. NCT02889861 terminated due to sponsor decision in Aug 2019. NCT03070392 pivotal Phase 2 study in Uveal Melanoma started in Oct 2017. Collaboration with Lilly to evaluate drug combinations in clinical studies (July 2015). Private company. NCT02535078 Phase 1/2 study in melanoma started in Nov 2015. As per press release dated 0ct 31, 2013, Phase 1 part of clinical study is complete and Immunocore has initiated a Phase IIa study in melanoma to optimize the dosing regimen and maximise the efficacy of IMCgp100. Data expected in 2015. [https://ir.immunocore.com/node/6766/pdf] January 9, 2012, FDA received initial IND submission for IMCgp100‐01. NCT01211262 Phase 1 in melanoma started Sep 28, 2010. |
| Full address of company | 92 Park Drive, Milton Park, Abingdon, Oxon, OX14 4RY, UK Europe United Kingdom https://www.immunocore.com/contact-us |
Monoclonal T Cell Receptor Anti-CD3 scFv Fusion Protein; soluble protein comprises a high- affinity T cell receptor (TCR) specific to a peptide sequence from the gp100 antigen, which is presented on melanoma tumour cells by HLA-A2, fused to an anti-CD3 single chain antibody fragment.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |