Page 1

IMMUNOCORE Immunocore Reports Second Quarter 2021 Financial Results and Provides Business Update August 11 , 2021 PRESS RELEASE Immunocore Reports Second Quarter 2021 Financial Results and Provides Business Update Biologics License Application ( BLA ) submission for tebentafusp in metastatic uveal melanoma remains on track for completion in Q3 ; FDA has granted tebentafusp Real Time Oncology Review ( RTOR ) and the application will be part of the Project Orbis initiative Submission of a Market Authorization Application ( MAA ) to the European Medicines Agency ( EMA ) , and the United Kingdom's Medicines and Healthcare Regulatory Agency ( MHRA ) accelerated to Q3 ; EMA granted tebentafusp accelerated assessment procedure for this MAA Dose escalation of IMC - C103C targeting MAGE - A4 and IMC - F106C targeting PRAME continues as planned ; initial Phase 1 MAGE - A4 data planned for Q4 Cash position of approximately $ 385 million as of June 30 , 2021 ( OXFORDSHIRE , England & CONSHOHOCKEN , Penn . & ROCKVILLE , Md . , US , 11 August 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 six months ended June 30 , 2021 and provides a portfolio update . Immunocore's recent and second quarter highlights include the acceleration of tebentafusp regulatory submissions in the EU and UK ; continued dose escalation of MAGE - A4 and PRAME targeting ImmTACsⓇ ; and the initiation of a single ascending dose trial for its ImmTAVⓇ bispecific molecule for chronic hepatitis B ( HBV ) . Bahija Jallal , Chief Executive Officer of Immunocore , said : " The team at Immunocore is focused on bringing our pioneering science to patients as quickly as possible . We remain on track to complete the tebentafusp BLA submission in the US in the third quarter and are pleased to have accelerated our submissions in Europe , while also initiating our global early access program to make tebentafusp available to patients who need it now . " " With the positive phase 3 results for tebentafusp in metastatic uveal melanoma , we now have demonstrated the first ever overall survival benefit for any TCR therapeutic , " said David Berman , Head of Research and Development . " Our Phase 1 programs targeting MAGE - A4 and PRAME continue to dose escalate , with both now at biologically active doses . The start of our first clinical trial in chronic hepatitis B further highlights our confidence in the potential of our ImmTAX platform across a broad range of indications including cancer and infectious disease . " Second Quarter 2021 Highlights ( including post - period ) Tebentafusp In July , the European Medicines Agency ( EMA ) granted tebentafusp accelerated assessment procedure for this Marketing Authorization Application ( MAA ) . Accelerated assessment potentially reduces the time frame for the EMA Committee for Medicinal Products for Human Use ( CHMP ) and Committee for Advanced Therapies ( CAT ) to review a MAA for an Advanced Therapy Medicinal Product ( ATMP ) . The U.S. Food and Drug Administration ( FDA ) will review the Biologics License application ( BLA ) for tebentafusp ( IMCgp100 ) under the Real - Time Oncology Review ( RTOR ) pilot program , an initiative of the FDA's Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients . Tebentafusp is also being reviewed under the FDA's Project Orbis initiative , which enables concurrent review by the health authorities in partner countries that have requested participation . Previously , the FDA has 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 ) . In June , the Company presented a subset analysis from the Phase 3 study exploring the overall survival benefit from tebentafusp in patients with best RECIST * response of progressive disease ( PD ) at the American Society of Clinical Oncology ( ASCO ) Annual Meeting . In patients with a best response of PD in the Phase 3 trial , the overall survival ( OS ) was superior for the tebentafusp arm versus the investigator's choice arm with a hazard ratio ( HR ) of 0.43 ( 95 % CI 0.27-0.68 ) . More than half of tebentafusp patients with best response PD were treated beyond initial progression and no new safety signals were observed . In addition , analysis from the Phase 2 tebentafusp trial suggests that at least one - third of patients on tebentafusp with a best response of PD have a reduction in circulating tumor DNA and that this may be associated with longer OS . In April , the Company launched a global early access program for tebentafusp in mUM . In April , the Company's Phase 3 data of tebentafusp in mUM 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 . The Company remains on track to complete submission of a BLA to the FDA in the third quarter of 2021. Additionally , the Company has accelerated the submission of a MAA to the EMA , and the United Kingdom's Medicines and Healthcare Regulatory Agency , or MHRA , to the third quarter of 2021 . Additional Clinical Programs