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IMMUNOCORE Immunocore Reports Third Quarter 2021 Financial Results and Provides Business Update November 10 , 2021 PRESS RELEASE Immunocore Reports Third Quarter 2021 Financial Results and Provides Business Update Biologics License Application ( BLA ) and Marketing Authorisation Application ( MAA ) submissions accepted for tebentafusp in metastatic uveal melanoma ; FDA set a PDUFA date of February 23 , 2022 Over 150 patients have accessed tebentafusp through the global early access program across 14 countries Dose escalation of IMC - C103C targeting MAGE - A4 continues as planned ; investor call planned for initial Phase 1 MAGE - A4 data scheduled for presentation at the ESMO IO Congress in December Cash position of approximately $ 346 million as of September 30 , 2021 ( OXFORDSHIRE , England & CONSHOHOCKEN , Penn . & ROCKVILLE , Md . , US , 10 November 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 financial results for the quarter and nine months ended September 30 , 2021 and provides a business update . Immunocore's recent and third quarter highlights include the acceptance of tebentafusp regulatory submissions in the US , EU and UK ; the publication of Phase 3 tebentafusp data in the New England Journal Medicine ; and the continued dose escalation of MAGE - A4 and PRAME targeting ImmTACS® with data to be presented from IMC - C103C targeting MAGE - A4 at the European Society of Medical Oncology Immuno - Oncology Congress in December of this year ( ESMO IO Congress ) . Bahija Jallal , Chief Executive Officer of Immunocore , said : " We continue to be encouraged by the interest in our tebentafusp data in metastatic uveal melanoma , including the publication of our Phase 3 data in the New England Journal of Medicine . We have now activated our early access program in fourteen countries and have treated over 150 patients with metastatic uveal melanoma over the last six months . As we advance our ImmTAC programs in other solid tumors , we look forward to continuing to update on our progress at upcoming medical meetings . " Third Quarter 2021 Highlights ( including post - period ) Tebentafusp Earlier this month , the Company presented new clinical data from the metastatic uveal melanoma ( mUM ) tebentafusp monotherapy program and a Phase 1b study of tebentafusp in combination with durvalumab ( anti - PDL1 ) and / or tremelimumab ( anti - CTLA4 ) in metastatic cutaneous melanoma ( mCM ) in poster presentations at the Society for Immunotherapy of Cancer ( SITC ) 36th Annual Meeting . In a phase 1b trial in mCM of tebentafusp in combination with checkpoint inhibitors , in which the majority of patients had previously received prior anti - PD ( L ) 1 treatments , the maximum target doses of tebentafusp ( 68 mcg ) plus durvalumab ( 20 mg / kg ) with and with / out tremelimumab ( 1 mg / kg ) were tolerated in both doublet and triplet arms of the study . Preliminary evidence of tebentafusp clinical activity in mCM patients who had prior anti - PD ( L ) 1 therapy , currently an unmet medical need , included 1 - year overall survival ( OS ) rate of 76 % . In mCM patients who were refractory ( defined as best response of progressive disease ) to prior anti - PD ( L ) 1 , the 1 - year OS rate was 61 % . In addition , the Company presented a new analysis of baseline gp100 protein tumor expression by immunohistochemistry of tumor biopsies from the phase 2 and phase 3 tebentafusp monotherapy mUM trials , where OS benefit was observed for both high and low gp100 protein tumor expression . Four additional posters depicting new analyses from tebentafusp in metastatic uveal melanoma , as well th as the Company's proprietary soluble TCR bispecific ImmTAC platform were also accepted for presentation at the upcoming SITC 36 Annual Meeting and will be made available for on - demand viewing throughout the meeting . In October , the Company announced an exclusive multi - regional agreement for Medison Pharma Ltd. to help seek regulatory authorization and commercialize Immunocore's tebentafusp ( IMCgp100 ) , for the treatment of patients with mUM , in Canada , twenty markets across Central Eastern Europe and Israel . Under the agreement , Medison Pharma would also provide assistance with commercialization activities , assuming regulatory approval is received . In the third quarter , the Australian Government Department of Health granted tebentafusp Orphan Drug Designation . Additionally , the Australian Government Department of Health has accepted the Marketing Application for tebentafusp in mUM , and the company ( through the Adjutor Healthcare Party Ltd. ) has also received a Priority Review of its application for approval . In September , The New England Journal of Medicine ( NEJM ) published online data from the IMCgp100-202 Phase 3 randomized clinical trial in mUM where the OS Hazard Ratio ( HR ) in the intent - to - treat population favored tebentafusp , HR = 0.51 ( 95 % CI : 0.37 , 0.71 ) . The NEJM paper concluded that tebentafusp prolonged OS compared to investigator's choice in previously untreated mUM . In September , the Company presented new data and analysis from tebentafusp at the ESMO Congress . The findings presented in an oral presentation , by Alexander N. Shoushtari MD , medical oncologist at Memorial Sloan Kettering Cancer Center , demonstrated that 70 % of evaluable patients had a reduction in circulating tumor DNA ( ctDNA ) by Week 9 and the degree of reduction was strongly associated with OS . In September , the Company announced the United Kingdom's Medicines and Healthcare products Regulatory Agency has accepted a MAA seeking the approval of tebentafusp for the treatment of patients with mUM .