IMC-C103C / Immunocore, Roche - LARVOL DELTA

IMC-C103C-101: Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Immunocore Ltd | N=75 ➔ 0 | Terminated ➔ Withdrawn

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial withdrawal • Oncology • Solid Tumor • HLA-A • MAGEA4

IMC-C103C-101: Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab (clinicaltrials.gov) - P1/2 | N=75 | Terminated | Sponsor: Immunocore Ltd | N=144 ➔ 75 | Trial completion date: Feb 2024 ➔ Sep 2023 | Active, not recruiting ➔ Terminated; The Sponsor terminated the study and there is no further enrollment. Endpoints will not be assessed for this trial.

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial termination • Oncology • Solid Tumor • HLA-A • MAGEA4

IMC-C103C-101: Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab (clinicaltrials.gov) - P1/2 | N=144 | Active, not recruiting | Sponsor: Immunocore Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2025 ➔ Feb 2024 | Trial primary completion date: Jul 2025 ➔ Sep 2023

Combination therapy • Enrollment closed • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • HLA-A • MAGEA4

Phase 1 expansion of IMC-C103C, a MAGE-A4×CD3 ImmTAC bispecific protein, in ovarian carcinoma (ESMO-IO 2022) - P1/2 | "Pre-selection for MAGE-A4 expression was not required as a majority of OC express MAGE-A4 (H score ≥ 1) and tebentafusp demonstrated OS benefit and ctDNA reductions regardless of H score, although RECIST responses were enriched at higher H scores (Leach 2021). IMC-C103C is clinically active but the low MAGE expression may have resulted in few RECIST responses. Dose optimization and signal detection continue in MAGE-A4 pos pts with additional tumor types."

IO biomarker • P1 data • Oncology • Ovarian Cancer • Solid Tumor • HLA-A • IFNG • MAGEA4 • TNFA

Immunocore presents ovarian cancer expansion data for ImmTAC candidate IMC-C103C targeting MAGE-A4 (GlobeNewswire) - P1/2 | N=144 | NCT03973333 | Sponsor: Immunocore Ltd | "Immunocore Holdings plc...presented data for IMC-C103C, a bispecific T cell engager targeting MAGE-A4, in patients with ovarian cancer....At the time of data cut-off, 32 patients were evaluable for response, with one additional patient (H score 21) still on treatment and not having had first tumor assessment​. Of the 17 evaluable MAGE-A4 positive patients, one had a durable Partial Response (PR), with a duration of 12.7 months, one patient who had a Stable Disease (SD) converted to an unconfirmed PR after the poster data cutoff date and is still ongoing, and 5 had SD. Reductions in ctDNA were observed in over half of ctDNA evaluable patients (12/22), including 7 with ≥ 50% reductions, and even in those with low or zero MAGE-A4 expression."

P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Immunocore Reports Third Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Third Quarter 2022 Highlights (including post-period) - KIMMTRAK^® (tebentafusp-tebn): Total net product and net pre-product revenue arising from the sale of KIMMTRAK and tebentafusp was £36.3 million (or $40.4 million) in the three months ended September 30, 2022, an increase of 20% in USD over 2Q 2022 (converted using respective end-of-period convenience rates), and £74.5 million (or $83.0 million) in the nine months ended September 30, 2022....Anticipated Upcoming Milestones 2022 - KIMMTRAK: Q4 2022 – start the Phase 2/3 clinical trial in previously treated advanced melanoma; ImmTAC pipeline: Q4 2022 – report initial data from IMC-C103C (MAGE-A4) Phase 1 ovarian expansion arm."

P1 data • Sales • Trial status • Gynecologic Cancers • Melanoma • Oncology • Ovarian Cancer • Skin Cancer • Solid Tumor

Phase 1 dose escalation of IMC-C103C, a CD3_MAGE-A4 T cell receptor (TCR) bispecific protein (ESMO-IO 2021) - P1/2 | "Background TCR bispecific proteins (bsp) redirect polyclonal T cells to target intra/extracellular proteins in cancer, as validated by tebentafusp (CD3×gp100 TCR) with a survival benefit in metastatic uveal melanoma (HR 0.51). Legal entity responsible for the study Immunocore Ltd. Funding Immunocore Ltd."

IO biomarker • P1 data • Eye Cancer • Head and Neck Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Uveal Melanoma • CD8 • HLA-A • IFNG • IL6 • MAGEA4

Immunocore Reports Second Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Net KIMMTRAK / tebentafusp revenues of £27.7 million ($33.7 million) in Q2 2022; Anticipated Upcoming Milestones: KIMMTRAK - Q4 2022 – start randomized Phase 2/3 clinical trial in previously treated advanced melanoma. ImmTAC pipeline - Q3 2022 – report initial data from IMC-F106C (PRAME) Phase 1 trial in multiple solid tumors at ESMO Congress 2022 in September. Q4 2022 – report complete data from IMC-C103C (MAGE-A4) Phase 1 trial in multiple solid tumors and initial data from ovarian expansion arm."

P1 data • Sales • Trial status • Gynecologic Cancers • Melanoma • Oncology • Ovarian Cancer • Solid Tumor

Immunocore Reports First Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Immunocore Holdings plc...today announced its financial results for the first quarter ended March 31, 2022 and provided a business update....KIMMTRAK was added as a recommended Category 1 treatment in the latest National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for metastatic uveal melanoma (mUM)....The Company began the commercial launch of KIMMTRAK in Germany....KIMMTRAK: Q4 2022 – start randomized clinical trial in metastatic cutaneous melanoma (mCM); ImmTAC pipeline: Q3 2022 – report initial data from IMC-F106C (PRAME) Phase 1 trial in multiple solid tumors; Q4 2022 – report complete data from IMC-C103C (MAGE-A4) Phase 1 trial in multiple solid tumors and initial data from ovarian expansion arm..."

Launch Europe • NCCN guideline • New trial • P1 data • Cutaneous Melanoma • Gynecologic Cancers • Melanoma • Ocular Melanoma • Oncology • Ovarian Cancer • Skin Cancer • Solid Tumor • Uveal Melanoma

Immunocore Reports Full Year 2021 Financial Results and Provides Business Update (GlobeNewswire) - "KIMMTRAK® (tebentafusp-tebn): Immunocore anticipates launching KIMMTRAK for the treatment of mUM in Europe in the second quarter of 2022; IMC-C103C targeting MAGE-A4: The Company plans to report data from the MAGE-A4 program in the fourth quarter of 2022; IMC-F106C targeting PRAME: The Company plans to report the initial Phase 1 data in the third quarter of 2022."

Launch Europe • P1 data • P1/2 data • Breast Cancer • Endometrial Cancer • Gastric Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Uveal Melanoma

Immunocore announces initial Phase 1 data of ImmTAC candidate IMC-C103C targeting MAGE-A4 (GlobeNewswire) - December 06, 2021, 8:00 am E.T.

Live event

Immunocore announces initial Phase 1 data of ImmTAC candidate IMC-C103C targeting MAGE-A4 (GlobeNewswire) - P1/2, N=144; NCT03973333; Sponsor: Immunocore Ltd; "The most frequently enrolled patients had platinum relapsed/refractory ovarian cancer, who were enrolled regardless of their tumor MAGE-A4 protein expression. Most of these patients had low or no MAGE-A4 protein expression in their tumors as measured by IHC (median H score = 8). One ovarian cancer patient, with a very low MAGE protein expression, treated at a dose of < 90 micrograms, had a durable confirmed partial response (PR) with 8.3 months duration. An additional ovarian cancer patient at a dose of ≥ 90 micrograms, also with very low MAGE-A4 protein expression, has a confirmed partial response ongoing at 4.4+ months. One of the three non-ovarian cancer patients (head and neck squamous cell carcinoma) at a dose of ≥ 90 micrograms has a confirmed PR that is ongoing....The company plans to present additional data from this program in 2022."

P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Immunocore Reports Third Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "IMC-C103C targeting MAGE-A4: As of June 30, 2021, the Company has enrolled 39 patients in the Phase 1 study....The Company plans to report the initial Phase 1 data at the ESMO IO Congress in December."

P1 data • Non Small Cell Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] A phase I/II first-in-human study of a novel anti-MAGE-A4 TCR/anti-CD3 bispecific (IMC-C103C) as monotherapy and in combination with atezolizumab in HLA-A*02:01-positive patients with MAGE-A4-positive advanced solid tumors (IMC-C103C-101). (ASCO 2020) - P1/2 | "Tebentafusp is being further evaluated in combination with durvalumab and tremelimumab. IMC-C103C monotherapy dose escalation is in progress. Research Funding: Immunocore Ltd, Pharmaceutical/Biotech Company"

Clinical • Combination therapy • IO biomarker • Monotherapy • P1/2 data • Ocular Melanoma • Oncology • Solid Tumor • PD-1

Immunocore Reports First Quarter 2021 Financial Results (GlobeNewswire) - “IMC-C103C – MAGE-A4: The Company plans to report Phase 1 initial data from this trial in the fourth quarter of 2021.”

P1 data • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Synovial Sarcoma

Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab (clinicaltrials.gov) - P1/2; N=144; Recruiting; Sponsor: Immunocore Ltd

Clinical • Combination therapy • Monotherapy • New P1/2 trial • Oncology • Solid Tumor • MAGEA4

Safety and Efficacy of IMC-C103C as Monotherapy and in Combination With Atezolizumab (clinicaltrials.gov) - P1/2; N=144; Recruiting; Sponsor: Immunocore Ltd; Trial completion date: Apr 2023 ➔ Jul 2025; Trial primary completion date: Oct 2021 ➔ Jul 2025

Clinical • Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • MAGEA4

Immunocore Provides Business Update and Reports Full Year 2020 Financial Results (GlobeNewswire) - “Lead product candidate tebentafusp…submission of a Biologics License Application (BLA) in the third quarter of 2021. IMC-C103C…initial data expected to be presented in the second half of 2021; IMC-F106C is currently in a Phase 1 study in patients with PRAME-expressing solid tumors, with initial data expected to be presented mid-year 2022…GSK-01– NY-ESO…Immunocore plans to present the data from the Phase 1 study in 2022.”

BLA • P1 data • P1/2 data • Cutaneous Melanoma • Hematological Malignancies • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Uveal Melanoma

Immunocore announces dosing of first patient with third ImmTAC bispecific (Businesswire) - "Immunocore Limited...announced the start of the first-in-human clinical trial of IMC-C103C, the third bispecific developed using the company’s innovative ImmTAC® technology platform. IMC-C103C is focused on targeting tumours that express the protein MAGE-A4 (Melanoma-Associated Antigen A4) and is being developed in partnership with Genentech, a member of the Roche Group. The trial (IMC-C103C-101) is designed to study the safety and preliminary activity of IMC-C103C as a monotherapy and in combination with atezolizumab (Tecentriq®) in patients with MAGE-A4-expressing cancers."

Enrollment open