IMA402 / Immatics - LARVOL DELTA

TCER IMA402 (PRAME) (GlobeNewswire) - "Based on the initial signs of dose-dependent and PRAME target expression-dependent clinical activity observed during dose escalation, the Company will continue to evaluate IMA402 at higher dose levels to determine the optimal therapeutic dose....As of March 27, 2025, dose escalation remains ongoing at DL10 (8 mg) with MTD not reached....The next update on the Phase 1a trial with clinical data at relevant dose levels in second-line and later melanoma is planned in 2025."

P1 data • Trial status • Solid Tumor

…First Clinical Data on TCER IMA402 Targeting PRAME (GlobeNewswire) - P1/2 | N=145 | NCT05958121 | Sponsor: Immatics Biotechnologies GmbH | "Nine patients with tumors that tested PRAME-positive or were not tested for PRAME received a relevant dose (8 patients at DL7 and 1 patient at DL8). 78% (7/9) thereof experienced shrinkage of their target lesions, including several patients with significant ongoing tumor shrinkage: one cutaneous melanoma patient with an ongoing (at 3 months post first dose at data cut-off) confirmed partial response with -40.2% tumor shrinkage treated at DL7; two patients with ongoing (at 6+ weeks and 8+ months) stable diseases with significant tumor shrinkage (-27.5% in a patient with cutaneous melanoma at DL8 and at first scan; -25% in a patient with uveal melanoma deepening over time and treated at escalating doses starting at DL4 and currently at DL7); one ovarian cancer patient with ongoing (at 3 months) stable disease and tumor shrinkage of -13% started at DL6 and currently at DL7."

P1/2 data • Cutaneous Melanoma • Ovarian Cancer

Immatics Announces Multiple Presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on TCR-T Therapy Candidates Targeting PRAME (GlobeNewswire) - "A first update on Immatics’ Bispecific TCER IMA402 targeting PRAME and initial clinical data from the ongoing Phase 1a dose escalation trial is expected to be reported by year-end."

P1 data • Solid Tumor

Immatics Announces Second Quarter 2024 Financial Results and Business Update (GlobeNewswire) - "IMA402 (PRAME) data are planned to be announced later in 2H 2024 and will include data from at least 15 patients in early stages of dose escalation across multiple solid cancers, but initially focused on melanoma."

P1 data • Melanoma

Immatics Announces Third Quarter 2023 Financial Results and Business Update (GlobeNewswire) - "Immatics has recently received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for IMA203 GEN1 in multiple PRAME-expressing cancers, including cutaneous and uveal melanoma, and is now targeting a registration-enabling Phase 2 trial in cutaneous melanoma potentially bundled with uveal melanoma in 2024. Discussions with FDA to align on patient population, trial design and CMC aspects of the planned Phase 2 trial are ongoing. An update on the clinical development plan is expected in the first quarter of 2024....Research and Development Expenses: R&D expenses were €30.5 million ($32.3 million2) for the three months ended September 30, 2023, compared to €28.6 million ($30.3 million2) for the three months ended September 30, 2022. The increase mainly resulted from higher costs associated with the advancement of the clinical pipeline of ACTengine^® IMA203 and TCER^® IMA401 and IMA402 candidates."

Commercial • New P2 trial • Cutaneous Melanoma • Melanoma • Oncology • Skin Cancer • Solid Tumor

Immatics Announces Second Quarter 2023 Financial Results and Business Update (GlobeNewswire) - "ACTengine® IMA203:...Next update on Immatics’ IMA203 Phase 1b cohorts, including the projected clinical development path for PRAME-targeted TCR-T monotherapy towards registration-directed trials is planned for 4Q 2023....TCER® IMA402 (PRAME):...Following CTA acceptance, Immatics initiated the Phase 1/2 trial investigating the company’s fully owned TCER® candidate IMA402 in patients with recurrent and/or refractory solid tumors in August. Initial focus indications are cutaneous and uveal melanoma, ovarian cancer, lung cancer, uterine cancer and synovial sarcoma, among others. A first clinical data update is planned for 2024."

P1 data • P1/2 data • Eye Cancer • Gynecologic Cancers • Lung Cancer • Melanoma • Ocular Melanoma • Oncology • Ovarian Cancer • Sarcoma • Skin Cancer • Soft Tissue Sarcoma • Solid Tumor • Spindle Cell Sarcoma • Synovial Sarcoma • Thoracic Cancer • Uterine Cancer • Uveal Melanoma

IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors (clinicaltrials.gov) - P1/2 | N=145 | Recruiting | Sponsor: Immatics Biotechnologies GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Immatics Initiates Phase 1/2 Clinical Trial to Evaluate PRAME TCR Bispecific IMA402 in Patients with Advanced Solid Tumors (GlobeNewswire) - "Immatics N.V...today announced the initiation of a Phase 1/2 clinical trial with its proprietary Bispecific T cell engaging receptor (TCER®) IMA402....The Phase 1/2 clinical trial (NCT05958121) investigates TCER® IMA402 in HLA-A*02:01-positive patients with PRAME-expressing recurrent and/or refractory solid tumors. The dose escalation part of the study is designed as a basket trial in focus indications to accelerate signal finding. Initial focus indications are cutaneous and uveal melanoma, ovarian cancer, lung cancer, uterine cancer and synovial sarcoma, among others....Primary objectives of the IMA402 Phase 1/2 trial are to determine the maximum tolerated dose (MTD) and/or the recommended doses for trial extensions, as well as to characterize safety and tolerability of IMA402."

Trial status • Oncology • Solid Tumor

IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors (clinicaltrials.gov) - P1/2 | N=145 | Not yet recruiting | Sponsor: Immatics Biotechnologies GmbH

New P1/2 trial • Oncology • Solid Tumor

Immatics Announces First Quarter 2023 Financial Results and Business Update (GlobeNewswire) - "TCER^® IMA402 (PRAME) – Immatics submitted a clinical trial application (CTA4) to the Paul-Ehrlich-Institute (PEI) on April 14, 2023, to initiate the Phase 1/2 trial investigating IMA402 in patients with recurrent and/or refractory solid tumors. The trial is expected to commence in 2H 2023 with a first clinical data interim report planned in 2024."

New P1/2 trial • P1/2 data • Oncology • Solid Tumor

Immatics Announces Full Year 2022 Financial Results and Corporate Update (GlobeNewswire) - "TCER^® IMA402 (PRAME)...The submission of the CTA application for the Phase 1/2 trial is on track for 2Q 2023. Immatics plans to start the trial in 2H 2023 with a flexible dose escalation scheme for accelerated clinical development."

New P1/2 trial • Oncology

The PRAME opportunity - high peptide copy numbers, homogenous expression and high prevalence to address a broad patient population across different solid cancers with TCR-based therapeutics (SITC 2022) - P1 | "Here, we describe the in-depth characterization of an HLA-A*02:01-presented peptide derived from the cancer germline antigen preferentially expressed antigen in melanoma (PRAME) that opens an avenue of new opportunities for patients with solid cancers which we aim to leverage by two distinct TCR-based therapeutic modalities, TCR-engineered T cells (ACTengine® IMA203) and TCR Bispecifics (TCER® IMA402). Conclusions Here, we demonstrate comprehensive target characterization and validation data supporting the nearly ideal target properties of PRAME that can be exploited for the benefit of patients: PRAME is highly cancer-associated, homogenously expressed, presented at high target density, highly prevalent across many solid cancers and clinically validated, underlining its potential to reach a large cancer patient population. Trial Registration NCT03686124 Ethics Approval The study was approved by the institutional review board/ethics committee as required..."

Clinical • IO biomarker • Biliary Cancer • Bladder Cancer • Cholangiocarcinoma • Cutaneous Melanoma • Eye Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Synovial Sarcoma • Uveal Melanoma • HLA-A • PRAME

IMA402, an Off-the-Shelf, Next-Generation TCR Bispecific (TCER®) for Efficiently Targeting an HLA-Presented Peptide from the Pan-Cancer Antigen PRAME (ASH 2022) - "Taken together, our preclinical studies demonstrate that our novel, next-generation bispecific T cell engager IMA402 could be a promising therapeutic option for PRAME-positive patients. The phase 1 clinical trial designed as basket trial will start recruitment in 2023."

IO biomarker • Pan tumor • Acute Myelogenous Leukemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Inflammation • Leukemia • Lymphoma • Melanoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • HLA-A • PRAME

Immatics Reports Interim Clinical Data Update on ACTengine IMA203 TCR-T Monotherapy Targeting PRAME (GlobeNewswire) - P1 | N=102 | ACTengine (NCT03686124) | Sponsor: Immatics US, Inc. | "Confirmed objective response rate (cORR): 50% (6/12) at target dose or above with at least 1 billion infused TCR-T cells across Phase 1a and 1b; thereof 80% cORR (4/5) in Phase 1b patients alone with all responses ongoing at data cut-off; Confirmed responses across different solid tumor types: cutaneous melanoma, ovarian cancer, head and neck cancer, uveal melanoma, and synovial sarcoma....IMA203 TCR-T is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME; next data read-outs on IMA203 monotherapy, IMA203 in combination with a checkpoint inhibitor and 2nd generation IMA203CD8 planned during 2023....In addition, we are excited to start a first-in-human trial with our half-life extended Bispecific against PRAME, TCER^® IMA402, also in 2023."

New trial • P1 data • Cutaneous Melanoma • Gynecologic Cancers • Head and Neck Cancer • Melanoma • Ocular Melanoma • Oncology • Ovarian Cancer • Sarcoma • Skin Cancer • Solid Tumor • Synovial Sarcoma • Uveal Melanoma

Targeting solid tumors with IMA402, a next-generation bispecific T cell engaging receptor against PRAME (ESMO 2022) - "Conclusions Upon preclinical proof-of-concept for the novel bispecific T cell engager IMA402 GMP manufacturing was initiated and is currently ongoing. IMA402 directed against PRAME will be the second TCER® entering clinical development with start of the phase 1 basket trial in several solid tumor indications planned for 2023."

Gynecologic Cancers • Lung Cancer • Melanoma • Oncology • Sarcoma • Solid Tumor • HLA-A • PRAME

Immatics Presents Comprehensive Preclinical Data Set for TCR Bispecific Candidate IMA402 Targeting PRAME at European Society for Medical Oncology (ESMO) Congress 2022 (GlobeNewswire) - "TCER® IMA402 is a next-generation, half-life extended TCR Bispecific targeting an HLA-A*02:01-presented peptide derived from PRAME. In preclinical studies, IMA402 demonstrated enhanced anti-tumor activity in vivo and reduced T cell engager-associated toxicities as part of overall favorable in vitro safety profile. Pharmacokinetic characteristics of half-life extended IMA402 suggest potential for a favorable dosing regimen in patients with prolonged drug exposure at therapeutic levels. IMA402 is part of Immatics’ strategy to leverage the full clinical potential of targeting PRAME, one of the most promising targets for TCR-based therapies. Phase 1/2 clinical trial on track to start in 2023; submission of the CTA/IND1 application is planned for 2Q 2023."

European regulatory • IND • New P1/2 trial • Preclinical • Oncology • Solid Tumor

Immatics Announces First Quarter 2022 Financial Results and Business Update (GlobeNewswire) - "ACTengine® IMA203 (PRAME) – Update on Phase 1b expansion cohorts: Cohort C – IMA203CD8, a 2nd generation monotherapy where IMA203 is co-transduced with a CD8 co-receptor: IND granted by FDA, patient enrollment planned for Q2 2022; TCER® IMA402 (PRAME) – Manufacturing of the clinical batch is on track for the 2H 2022 and initiation of the Phase 1 trial is planned in 2023."

Enrollment status • New P1 trial • Oncology

Immatics Initiates Phase 1 Clinical Trial to Evaluate Lead TCR Bispecific IMA401 in Patients with Advanced Solid Tumors (GlobeNewswire) - "Immatics N.V...announced the initiation of a Phase 1 clinical trial with its T cell engaging receptor (TCER®) IMA401 for patients with recurrent and/or refractory solid tumors....The trial is planned to be conducted at up to 15 centers in Germany, with the first site already being initiated. The Phase 1 trial is designed to enroll approximately 50 patients...Immatics’ TCR Bispecific pipeline includes a second TCER® product candidate, IMA402, which targets PRAME. Manufacturing of the clinical IMA402 batch is planned for the second half of 2022 and initiation of the Phase 1 trial is planned in 2023."

New P1 trial • Trial status • Oncology • Solid Tumor

Immatics Announces Third Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "IND submission for IMA203CD8 as part of the Phase 1b study expansion cohort is expected in the first half of 2022...TCER® IMA402...Production of GMP material for a Phase 1 clinical study is planned in 2022...R&D expenses were €21.2 million ($24.5 million1) for the three months ended September 30, 2021...The increase is mainly due to expanded clinical activities for the ACTengine® IMA200 series, as well as GMP manufacturing for the TCER® compound, IMA401."

Commercial • New P1 trial • Hematological Malignancies • Oncology • Solid Tumor

Immatics Announces First Quarter 2021 Financial Results and Business Update (GlobeNewswire) - “ACTengine® IMA200 series...programs, IMA201, IMA202 and IMA203... trials continue to recruit according to plan with eight trial sites active in both Europe and the US. A data update is expected in H2 2021 with additional patients being treated, including initial data from patients treated at the target dose. The fourth program of the ACTengine® IMA200 series, IMA204…the Federal German regulatory authority, submission of a clinical trial application (CTA) remains on track for Q4 2021…The company’s first TCER® program, IMA401 remains on track for submission of a clinical trial application (CTA) by year end 2021.”

Enrollment status • European regulatory • Trial status • Oncology • Solid Tumor

Selexis and KBI Biopharma Enter into Agreements with Immatics for Integrated Approach to Advance Immatics TCR Bispecific Program Towards IND (Businesswire) - "Selexis SA and KBI Biopharma (KBI), both JSR Life Sciences companies, announced today that they have signed service agreements with Immatics N.V...The agreements focus on using integrated services from Selexis and KBI as part of Immatics’ development of TCR Bispecifics, called TCER® (T Cell Engaging Receptors), that simultaneously recruit, activate and stimulate the patient’s own T cells to detect, target and attack tumor cells. Under the agreements, Selexis will utilize its SUREtechnology Platform™ and KBI will leverage its advanced analytics, process, formulation and cGMP manufacturing for Immatics’ IMA402 program...'We are looking forward to working with them on our path towards IND for IMA402...'"

Licensing / partnership • Oncology