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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 ...
Immunocore (IMCR) Investor Presentation - Slideshow
2023-03-10 12:33
▸ CM: all received prior anti-PD1 and anti-CTLA4 IMC-F106C was well tolerated Most frequent related AE was Grade 1/2 CRS, consistent with proposed mechanism | --- | --- | --- | --- | |----------------------------------------------|--------------------------------|-----------------------|------------| | Preferred Term (MedDRA v23.1) | 0.3 – 10 mcg † N=18 | 20 – 320 mcg † N=37 | Total N=55 | | All grades events in ≥ 25% of patients , n % | | | | | At least one event | 18 (100) | 34 (92) | 52 (95) | | Pyrexia* ...