Immunocore(IMCR) - 2024 Q4 - Annual Results

KIMMTRAK Performance and Market Potential - KIMMTRAK Q1-Q3 2024 net sales reached $226M, with potential to help up to 6K patients per year in the US and Europe[11] - KIMMTRAK has been launched in 45 countries as of December 31, 2024, with Q1-Q3 2024 net revenue from these launches[13] - KIMMTRAK active in cutaneous melanoma (CM) with Phase 1/2 study showing durable disease control in patients who progressed on prior anti-PD1 therapy[15] - KIMMTRAK's dosing frequency in CM patients shows durable response regardless of time since last dose of anti-PD1 therapy[15] - KIMMTRAK (tebentafusp) is being evaluated in a Phase 3 trial for adjuvant uveal melanoma, targeting ~1,200 patients[47] - The company's preliminary, unaudited year-end cash position is $820M, with $226M in commercial revenues from KIMMTRAK[43] Clinical Trials and Pipeline Development - TEBE-AM Phase 3 trial in 2L+ cutaneous melanoma targets a market opportunity of up to 4,000 patients, with expected enrollment completion in 1H 2026[18][19] - ATOM Phase 3 trial for KIMMTRAK in adjuvant uveal melanoma shows 88% ctDNA reduction in 1st line treatment and 71% in 2nd+ line treatment[21] - HIV STRIVE Phase 1 trial for IMC-M113V has enrolled 15 people living with HIV (PLWH) as of June 2024, with biologically active dose reached and Phase 1 MAD data planned for 1Q 2025[30] - Immunocore's pipeline includes candidates across oncology, autoimmune diseases, and infectious diseases, with multiple Phase 1/2 and Phase 3 trials ongoing[6][7] - PRISM-MEL-301, a Phase 3 trial for first-line advanced cutaneous melanoma, is enrolling ~10,000 HLA-A02+ patients annually in the US and Europe[72] - The company is evaluating brenetafusp in combination with standard-of-care therapies for ovarian and NSCLC, with enrollment expected in 2025[54] - PRAME franchise expansion opportunities include HLE and A24 programs, with IND/Phase 1 trials planned[54] Therapeutic Potential and Innovation - Immunocore's TCR therapeutics can target >90% of the human proteome, offering a broad therapeutic potential[5] - Immunocore's vision for autoimmunity includes tissue-specific downmodulation of the immune system, aiming to suppress activation only in inflamed tissues[33] - IMC-S118AI for type 1 diabetes (T1D) is expected to submit CTN for Phase 1 trial by end of 2025, targeting 160,000 newly diagnosed T1D patients annually in the US and EU5[35] - IMC-U120AI is a non-HLA restricted bispecific candidate for dermatology, addressing a broader patient population beyond HLA-A02[43] - PRAME-A02-HLE targets 20,000 PIWIL+ CRC patients, expanding the addressable patient population[43] Brenetafusp Clinical Data - Brenetafusp monotherapy in cutaneous melanoma showed a median H-score of 215 for PRAME expression, with 89% of patients being PRAME positive[58] - Brenetafusp monotherapy demonstrated a durable disease control rate (DCR) of 58% in PRAME+ patients, with a median progression-free survival (mPFS) of 3.7 months[69] - Median age of patients in monotherapy group is 63 years (range 40-80) and in chemo combo group is 65 years (range 47-72)[75] - 51% of monotherapy patients had ECOG PS 0, compared to 25% in chemo combo group[75] - 94% of monotherapy patients were PRAME positive, while 81% in chemo combo group were PRAME positive[75][77] - Disease Control Rate (DCR) for monotherapy was 58% with a median Progression-Free Survival (mPFS) of 3.3 months[82] - 6-month Overall Survival (OS) rate for monotherapy was 73%[82] - Treatment-related adverse events (TRAE) occurred in 97% of monotherapy patients and 100% of chemo combo patients[78] - Grade 3/4 TRAE were reported in 19% of monotherapy patients and 50% of chemo combo patients[78] - Cytokine Release Syndrome (CRS) was observed in 57% of monotherapy patients and 75% of chemo combo patients[78] - ALT increased in 11% of monotherapy patients and 50% of chemo combo patients[78] - AST increased in 5% of monotherapy patients and 50% of chemo combo patients[78]