Immunocore(IMCR)
Search documents
Immunocore presents KIMMTRAK clinical data demonstrating that patients with stable disease and confirmed tumor reduction have similar clinical outcomes to patients with partial response
Newsfilter· 2024-06-01 12:00
Immunocore presents KIMMTRAK clinical data demonstrating that patients with stable disease and confirmed tumor reduction have similar clinical outcomes to patients with partial response Data were presented at ASCO 2024, where Immunocore also presented Phase 1 data from its PRAME trial with brenetafusp (IMC-F106C) in advanced cutaneous melanoma "In both Phase 2 and Phase 3 KIMMTRAK trials, patients with stable disease and durable tumor reduction, regardless of depth, had similar benefit as patients with RECI ...
Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous melanoma patients at ASCO 2024
Newsfilter· 2024-05-31 20:05
Core Insights - Immunocore has reported updated Phase 1 data for brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, showing promising clinical activity in late-line cutaneous melanoma patients previously treated with immune checkpoint inhibitors [1][2][3] Phase 1 Clinical Data - Monotherapy with brenetafusp demonstrated a disease control rate (DCR) of 56%, with 4 patients achieving partial response (ORR 11%) and 16 patients showing stable disease [6] - The median progression-free survival (mPFS) for all patients was 4.2 months, with a notable difference in mPFS between PRAME positive (4.2 months) and PRAME negative patients (2.1 months) [7] - Among ctDNA-evaluable PRAME positive patients, 42% exhibited a molecular response, while no PRAME negative patients showed ctDNA reduction [7] Patient Population and Treatment Tolerance - A total of 47 patients received brenetafusp monotherapy, all of whom had prior exposure to immune checkpoint inhibitors, with 100% having received anti-PD1 and 81% anti-CTLA4 [4] - Brenetafusp was well tolerated, with manageable treatment-related adverse events (TRAEs) primarily consisting of Grade 1 or 2 cytokine release syndrome (CRS) and rash [5][8] Combination Therapy Insights - In a cohort of 9 patients receiving brenetafusp in combination with anti-PD1 (pembrolizumab), 4 achieved disease control, including 1 ongoing partial response [9] - The combination therapy was also well tolerated, with manageable TRAEs consistent with the mechanisms of both agents [8] Gene Expression and T Cell Fitness - A gene signature indicating systemic T cell fitness was identified, with patients above the median expression level showing a median PFS of 6 months and a DCR of 69% compared to 2 months and 42% for those below the median [10] Upcoming Trials and Presentations - Immunocore is currently enrolling patients in a Phase 3 clinical trial (PRISM-MEL-301) for brenetafusp combined with nivolumab in first-line advanced cutaneous melanoma, with the primary endpoint being progression-free survival [12][17] - The advanced cutaneous melanoma data from the ongoing Phase 1/2 trial will be presented at the 2024 ASCO Annual Meeting [11]
Immunocore converts Phase 2/3 TEBE-AM clinical trial into registrational Phase 3 trial evaluating KIMMTRAK for previously treated advanced cutaneous melanoma
Newsfilter· 2024-05-29 11:00
Immunocore converts Phase 2/3 TEBE-AM clinical trial into registrational Phase 3 trial evaluating KIMMTRAK for previously treated advanced cutaneous melanoma Following recent consultation with FDA, all patients randomized from start of TEBE-AM Phase 2/3 trial will be included in the Phase 3 intent-to-treat population Phase 3 will continue three arms: KIMMTRAK monotherapy, KIMMTRAK in combination with pembrolizumab, and control Expected to accelerate time to final Phase 3 overall survival analysis (OXFORDSHI ...
Immunocore converts Phase 2/3 TEBE-AM clinical trial into registrational Phase 3 trial evaluating KIMMTRAK for previously treated advanced cutaneous melanoma
globenewswire.com· 2024-05-29 11:00
Immunocore converts Phase 2/3 TEBE-AM clinical trial into registrational Phase 3 trial evaluating KIMMTRAK for previously treated advanced cutaneous melanoma Following recent consultation with FDA, all patients randomized from start of TEBE-AM Phase 2/3 trial will be included in the Phase 3 intent-to-treat population Phase 3 will continue three arms: KIMMTRAK monotherapy, KIMMTRAK in combination with pembrolizumab, and control Expected to accelerate time to final Phase 3 overall survival analysis (OXFORDSHI ...
Immunocore(IMCR) - 2024 Q1 - Quarterly Results
2024-05-08 11:13
Exhibit 99.1 Immunocore reports first quarter financial results and provides a business update KIMMTRAK® (tebentafusp-tebn) net revenues of $70.3 million in Q1 2024; continuing to expand global access with 7 additional launches since January 2024 Phase 1/2 brenetafusp (IMC-F106C; PRAME-A02) clinical data in post-checkpoint late-line cutaneous melanoma selected for oral presentation at ASCO 2024 (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, May 8, 2024) Immunocore Holdings plc (Nasdaq: IM ...
Immunocore(IMCR) - 2024 Q1 - Quarterly Report
2024-05-08 11:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Commission File Number: 001-39992 Immunocore Holdings plc (Exact name of registrant as specified in its charter) | England and Wales | Not Applicable | | --- | --- | | (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | | 92 Park Drive Milton Park | | | Abingdon, Oxfordshire, United Kingdom | OX14 4RY | | (Address of principal executive offices) | (Zip Code) | | +44 1235 4386 ...
Immunocore(IMCR) - 2023 Q4 - Annual Report
2024-02-28 12:33
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the period from ________ to ________ Commission File Number 001-39992 Immunocore Holdings plc (Exact name of registrant as specified in its charter) England and Wales Not Applicable (State o ...
Immunocore(IMCR) - 2023 Q3 - Quarterly Report
2023-11-07 12:09
Unaudited Condensed Consolidated Statements of Profit / (Loss) and Comprehensive (Loss) / Income Exhibit 99.1 Immunocore Holdings plc Unaudited Condensed Consolidated Interim Financial Statements | | | Three Months Ended | | Nine Months Ended | | | --- | --- | --- | --- | --- | --- | | | | September 30, | | September 30, | | | | | 2023 | 2022 | 2023 | 2022 | | | Notes | £'000 | £'000 | £'000 | £'000 | | Product revenue, net | 3 | 49,719 | 33,252 | 137,285 | 64,926 | | Pre-product revenue, net | 3 | — | 3,05 ...
Immunocore(IMCR) - 2023 Q2 - Earnings Call Transcript
2023-08-10 17:26
Financial Data and Key Metrics Changes - Net KIMMTRAK revenue increased to $57.8 million in Q2 from $52 million in Q1, representing an 11% quarter-over-quarter growth and a year-to-date revenue of $111 million [7][22][46] - The net loss for the period was approximately $18 million, with SG&A expenses year-to-date around $60 million [8][49] - The cash position of the company increased to $435 million, driven by KIMMTRAK revenue and disciplined expense management [49] Business Line Data and Key Metrics Changes - KIMMTRAK sales in the U.S. saw a 14% demand growth, increasing first-line market share from approximately 50% in Q1 to 60% in Q2 [10][22] - The company launched KIMMTRAK in four additional countries, including Italy, Austria, Finland, and Israel, expanding its market presence [22] Market Data and Key Metrics Changes - KIMMTRAK is now approved in over 35 countries, with reimbursement agreements reached in Germany, expected to be published in September [20][22] - The company anticipates further growth in the U.S. and Italy, with plans to launch in additional European countries by the end of the year [23][64] Company Strategy and Development Direction - The company is committed to expanding its oncology pipeline, with plans to submit three INDs or CTAs over the next 18 months, starting with PIWIL-targeted candidates in Q4 [18][64] - The first Phase 3 trial for the PRAME-targeted therapy is set to begin by Q1 2024, focusing on advanced cutaneous melanoma patients [37][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing educational efforts to support KIMMTRAK therapy, which is expected to drive further growth [23] - The company remains focused on making KIMMTRAK available to over 1,000 patients per year by 2025 [25] Other Important Information - The company is exploring a less frequent dosing regimen for KIMMTRAK based on insights from clinical data, which may enhance patient compliance [80][102] - The company is also investigating the potential for a functional cure for HIV and HBV through ongoing clinical trials [18][65] Q&A Session Summary Question: Plans for Phase 3 in melanoma - Management confirmed that the decision to start the Phase 3 study was based on positive data from ESMO and ongoing expansion cohort data [40][41] Question: Market size comparison for gp100 versus PRAME - Management highlighted that the accessible market for PRAME in first-line treatment is greater than 10,000 patients per year, compared to 2,000 to 4,000 for KIMMTRAK in second-line treatment [73] Question: Efficacy changes based on Phase 2 data - Management indicated that the Phase 2 data could inform changes to the Phase 3 design, including potential discontinuation of less effective arms [79] Question: Less frequent dosing rationale - The decision for less frequent dosing was influenced by KIMMTRAK's experience and the observation that most progression occurs within the first 12 weeks of treatment [80][102] Question: Initial data expectations for HIV program - Management outlined that initial data will include safety and biomarkers during the first 12-week treatment period, followed by a virus rebound assessment after ART withdrawal [96]
Immunocore(IMCR) - 2023 Q2 - Quarterly Report
2023-05-10 11:27
Exhibit 99.1 Immunocore Holdings plc Unaudited Condensed Consolidated Interim Financial Statements | | Notes | £'000 | £'000 | £'000 | £'000 | £'000 | £'000 | £'000 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | At January 1, 2022 | | 88 | 212,238 | 89 | 54,357 | 386,167 | (481,392) | 171,547 | | Loss for the period | | — | — | — | — | — | (16,128) | (16,128) | | Other comprehensive | | | | | | | | | | income | | — | — | 205 | — | — | — | 205 | | Total comprehensive | | | | | | | | | | loss for ...