Immunocore announces strategic priorities for 2023

Immunocore Holdings announces the addition of three new ImmTAC product candidates to its pipeline and preliminary unaudited KIMMTRAK 2022 year-end net sales. Preliminary Year-End 2022 KIMMTRAK and tebentafusp net sales: The preliminary unaudited total net product and net pre-product revenue arising from the sales of KIMMTRAK and tebentafusp was ~$50 million in Q4 2022, an increase of ~25% compared to the previous quarter, and ~$140 million for full year 2022. Preliminary unaudited cash and cash equivalents were ~$400 million USD year end 2022. In 2023, the Company will continue to launch in additional countries and establish KIMMTRAK globally as first line treatment for metastatic uveal melanoma, while exploring how to enhance patient convenience. In addition, the Company is enrolling patients into a Phase 2/3 trial to investigate the potential of tebentafusp in advanced cutaneous melanoma. Expansion of ImmTAC franchise targeting PRAME: IMC-F106C: Initial Phase 1 data with IMC-F106C targeting PRAME, in the context of HLA-A02, presented in September 2022 at the ESMO Congress 2022, demonstrated multiple durable confirmed RECIST responses and a reduction in circulating tumor DNA in multiple solid tumors. As previously announced, and following the promising initial data, patient enrollment is ongoing in the four monotherapy expansion arms and multiple combination arms of the trial: cutaneous melanoma, ovarian, non-small cell lung cancer, and endometrial cancers. The IMC-F106C-101 trial is adaptive and enables combinations with standards-of-care including checkpoint inhibitors, chemotherapy, and tebentafusp. These combinations will position the Company to explore IMC-F106C in earlier lines of treatment. In 2023, the Company plans to continue to expand the clinical trial footprint globally; enrolling additional patients in the expansion arms to understand the breadth of clinical activity across multiple tumor types. The Company expects to report initial data from the monotherapy and combination arms by the first half of 2024. IMC-T119C & IMC-P115C: IMC-F106C is an ImmTAC targeting PRAME for patients with HLA-A02, which is expressed in approximately 40% of Western populations. In order to expand the potential of TCR therapy targeting PRAME, the Company is developing IMC-T119C, a first-in-class ImmTAC product candidate targeting a PRAME peptide presented by HLA-A24. HLA-24 is an HLA-type that is estimated to be present in 60% of people in Japan and 15-20% in Western populations. In addition, the Company is developing IMC-P115C, a half-life extended ImmTAC product candidate targeting PRAME-A02, with the aim of improving patient convenience. IMC-P115C targets the same PRAME-A02 peptide and uses the same CD3 end and TCR specificity as IMC-F106C. First-in-class ImmTAC candidate – IMC-R117C for colorectal and other gastrointestinal cancers: The Company has leveraged its proprietary peptidomic database to validate a novel target, PIWIL1. PIWIL1 is believed to play a role in tumor progression and is expressed across a range of tumors including colorectal, which is historically insensitive to immune checkpoints, as well as gastro-esophageal, and pancreatic cancer. PIWIL1 is also reported to be a negative prognostic marker. The Company believes IMC-R117C is the first PIWIL1 targeted immunotherapy and plans to submit an IND in Q4 2023. Enrolling ImmTAV candidates for a functional cure in HIV & HBV: The Company continues to enroll patients in the HIV and HBV global Phase 1 clinical trials. The Company plans to report data from the Single Ascending Dose portion of the Phase 1 HIV trial in 2023.