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IMMUNOCORE Immunocore Reports First Quarter 2021 Financial Results May 12 , 2021 PRESS RELEASE Immunocore Reports First Quarter 2021 Financial Results Biologics License Application ( BLA ) submission to the U.S. Food and Drug Administration ( FDA ) is expected to be completed in third quarter of 2021 Launched a global early access program for tebentafusp in metastatic uveal melanoma Cash position of $ 431 million as of March 31 , 2021 includes $ 287 million in net proceeds from initial public offering and concurrent private placement in February 2021 ( OXFORDSHIRE , England & CONSHOHOCKEN , Penn . & ROCKVILLE , Md . , US , 12 May 2021 ) Immunocore Holdings Plc ( 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 its results for the quarter ended March 31 , 2021 . Highlights for the quarter included the presentation of the Phase 3 randomized data from the Company's lead candidate tebentafusp in the plenary clinical trial session at the American Association for Cancer Research ( AACR ) Annual Meeting , the launch of a global early access program for tebentafusp , and the successful completion of the Company's initial public offering resulting in net proceeds of $ 287 million . Bahija Jallal , Chief Executive Officer of Immunocore , said : " Tebentafusp has been demonstrated to prolong survival in patients with metastatic uveal melanoma , a cancer that has historically proven insensitive to chemotherapy and immunotherapies . These data , recently presented at AACR , represent the first positive Phase 3 clinical trial for a TCR therapeutic and the first time that a bispecific T cell engager has demonstrated a survival benefit in a solid tumor , representing a significant breakthrough in the field of oncology . " First Quarter 2021 Highlights ( including post - period ) Tebentafusp In April , one oral presentation and three posters on tebentafusp were accepted at the 2021 American Society of Oncology ( ASCO ) Annual Meeting being held virtually from June 4-8 , 2021. Per ASCO's Embargo & Release Information , full abstracts will be released to the public on ASCO's Meeting Library at 5:00 p.m. ET on May 19 , 2021 . In April , the Company launched a global early access program for tebentafusp in metastatic uveal melanoma ( mUM ) . In April , the Company's Phase 3 data of tebentafusp in metastatic uveal melanoma was also the subject of an oral presentation in the Phase 3 clinical trials plenary session at the AACR Virtual Annual Meeting 2021. Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival ( OS ) as a first - line treatment in mUM . In the intent - to - treat population , tebentafusp demonstrated a median overall survival of 21.7 months compared to 16.0 months for investigator's choice and with 73 % of patients alive at 1 year for tebentafusp vs. 58 % for investigator's choice . The OS Hazard Ratio ( HR ) favored tebentafusp , HR = 0.51 ( 95 % CI : 0.37 , 0.71 ) ; p < 0.0001 , over investigator's choice ( 82 % pembrolizumab ; 12 % ipilimumab ; 6 % dacarbazine ) . In addition , tebentafusp resulted in a statistically significant longer PFS . Treatment - related adverse events were manageable and consistent with the proposed mechanism . In February , tebentafusp was granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration ( FDA ) for unresectable or metastatic uveal melanoma . Additionally , the European Commission , upon recommendation of the European Medicines Agency's ( EMA ) Committee for Orphan Medicinal Products ( COMP ) awarded tebentafusp Orphan Drug Designation for the treatment of uveal melanoma . Medicines that meet the EMA'S Orphan Drug Designation criteria qualify for several incentives , including 10 years of market exclusivity , protocol assistance , and potentially reduced fees for regulatory activities . Immunocore will be working to complete its BLA submission to the FDA in the third quarter of 2021 , followed by submission of a Marketing Authorization Application to the EMA . Additional Clinical Programs IMC - C103C MAGE - A4 In the first quarter , the Company continued to advance , IMC - C103C , an ImmTAC molecule targeting an HLA - A * 02 : 01 MAGE - A4 antigen , in a first- in - human , Phase 1/2 dose escalation trial in patients with solid tumor cancers including non - small - cell lung cancer ( NSCLC ) , gastric , head and neck , ovarian and synovial sarcoma . The Company plans to report Phase 1 initial data from this trial in the fourth quarter of 2021 . IMC - F106C - PRAME In the first quarter , the Company continued to advance IMC - F106C , an ImmTAC molecule targeting an HLA - A * 02 : 01 PRAME antigen , in a first- in - human , Phase 1/2 dose escalation trial in patients with multiple solid tumor cancers . PRAME is overexpressed in many solid tumors including NSCLC , SCLC , endometrial , ovarian , and breast cancers . The Company plans to report Phase 1 initial data from this trial in mid - 2022 . IMC - 1109V - HBV In the first quarter , the Company continued to advance IMC - 1109V , an ImmTAV molecule targeting a conserved Hepatitis B virus ( HBV ) , envelope antigen , in a global Phase 1 single ascending dose trial . The Company plans to initiate dosing mid - year 2021 .