IMA201 / Immatics - LARVOL DELTA

TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101) (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Immatics US, Inc. | Active, not recruiting ➔ Completed | N=22 ➔ 7 | Trial completion date: Dec 2024 ➔ Sep 2023

Enrollment change • IO biomarker • Trial completion • Trial completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Immatics Announces Full Year 2022 Financial Results and Corporate Update (GlobeNewswire) - "ACTengine® IMA201 (MAGEA4/8) – The Phase 1a dose escalation cohort at target dose is ongoing. Immatics plans to discontinue this program after treatment of the remaining patients already enrolled in the clinical trial in order to focus on its TCR Bispecific program TCER^® IMA401 addressing the identical target peptide derived from MAGEA4/8 as IMA201."

Trial status • Oncology • Solid Tumor

Phase I trial evaluating genetically modified autologous T cells (ACTengine IMA201) expressing a T-cell receptor recognizing a cancer/germline antigen in patients with squamous NSCLC or HNSCC. (ASCO-SITC 2018) - P1; "The translational objectives include: i) the persistence and functionality of IMA201 in vivo, ii) correlative biomarkers for clinical success, and iii) target expression levels in the tumor. Enrollment to the study is currently ongoing."

Clinical • P1 data • Head and Neck Cancer • Non Small Cell Lung Cancer

TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101) (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Immatics US, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2022 ➔ Apr 2023

Enrollment closed • IO biomarker • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Immatics Announces Second Quarter 2022 Financial Results and Business Update (GlobeNewswire) - "ACTengine^® IMA203 (PRAME): The next data readout for the IMA203 monotherapy cohort at RP2D is expected for 2H 2022 and an initial data readout for Cohort B and Cohort C is planned for YE2022; ACTengine® IMA201 (MAGEA4/A8) – The Phase 1a dose escalation cohort is ongoing and is expected to be completed by YE2022."

P1 data • Trial completion date • Oncology • Solid Tumor

IMA201: Completion of dose escalation part of P1a ACTengine trial (NCT03247309) for solid tumors in 2022 (immatics) - Corporate Presentation

Trial completion date • Solid Tumor

Immatics Reports Clinical Responses across Multiple Solid Tumor Types in Ongoing ACTengine IMA203 Phase 1a Trial Targeting PRAME (GlobeNewswire) - P1, N=12; "At data cut-off on September 17, 2021, 12 heavily pretreated patients have been treated; 8 out of 12 patients showed disease control. Tumor shrinkage was observed in 6 patients. All treatment-emergent adverse events (TEAEs) for both IMA201 and IMA202 continue to be transient and manageable. No dose limiting toxicities (DLT) or higher grade CRS/ICANS have been observed. The next step in the IMA201 and IMA202 trials is to complete dose escalation including target dose (DL3)."

P1 data • Oncology

Immatics Announces Second Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - ACTengine® IMA200 series: The next data update, which will cover safety, biological activity, and the assessment of anti-tumor activity across different cancer indications, including patients treated at higher dose levels (dose levels 2 and 3), will be provided by the company within the second half of 2021; IMA401 remains on track for submission of a CTA in the fourth quarter of 2021 and patient recruitment will be initiated in the first half 2022."

Enrollment status • P1 data • Regulatory • 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

TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101) (clinicaltrials.gov) - P1; N=22; Recruiting; Sponsor: Immatics US, Inc.; N=15 ➔ 22

Clinical • Enrollment change • IO biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

[VIRTUAL] First Anti-Tumor Activity Associated with Robust Biological Activity Observed in Early Phases of Dose Escalation Across Three TCR-T Trials (CIMT 2021) - "Safety, biological activity and anti-tumoral efficacy are closely monitored throughout and following lymphodepletion with Fludarabine and Cyclophosphamide, T cell infusion and low dose IL-2 treatment. Taken together, treatment-emergent adverse events for ACTengine® product candidates were transient and manageable and in line with published data for autologous cell therapy in solid cancers. First anti-tumor activity in heavily pre-treated patients after infusion of low cell doses was unexpected, and together with robust biological activity warrants exploration of IMA201, IMA202 and IMA203 product candidates at target dose."

IO biomarker • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Oncology • Solid Tumor • CD8 • MAGEA1 • MAGEA4 • PRAME • TMB

IMA201: “Tumor shrinkage observed in 8 of 10 Patients at low dose levels”; Solid tumors (immatics) - Kempen Life Science Conference

P1 data • Solid Tumor

IMA201: Expiry of patents in US, Morocco, Colombia, Argentina, Australia, Brazil, Canada, Chile, China, Costa Rica, Algeria, Eurasia, Egypt, Europe, Hong Kong, Indonesia, Israel, India, Japan, South Korea, Mexico, Malaysia, New Zealand, Peru, Philippines, Singapore, Thailand, Taiwan, the Ukraine, Vietnam and South Africa in 2037 (immatics) - Annual Report 2020

Patent

Immatics Announces Full Year 2020 Financial Results and Corporate Update (GlobeNewswire) - “Adoptive Cell Therapy Programs: An additional Phase 1a read-out for IMA201 and IMA203 and initial Phase 1b data for IMA202 from the dose expansion cohort is planned for H2 2021. Submission of a clinical trial application (CTA) for the fourth IMA200 series program, IMA204, remains anticipated for H2 2021; TCR Bispecifics Programs: IMA401 –Submission of a CTA for IMA401 remains on track by the end of 2021; IMA402 – Immatics plans to announce preclinical proof-of-concept data for its second TCER® program, IMA402 in Q2 2021....Scientific Advisory Board Update...Patrick Hwu...will co-chair the SAB."

Clinical data • Preclinical • Regulatory • Oncology • Solid Tumor

Immatics Presents Data Update on Dose Escalation from Ongoing ACTengine Cell Therapy Programs (GlobeNewswire) - “The treatment of patients with ACTengine product candidates IMA201, IMA202 and IMA203 at initial dose levels below one billion transduced cells, intended to establish safety and first biological activity, showed first anti-tumor activity with 9 out of 10 evaluable patients showing disease control as well as tumor shrinkage observed in 8 out of 10 patients including one partial response…Clinical and biological activity: Data from 10 patients dosed at the first or second dose level with an ACTengine product candidate – IMA201 (n=1), IMA202 (n=5) and IMA203 (n=4) – and who concluded the observation period for efficacy analysis with at least one tumor response assessment post-baseline as of the data cut-off showed…”

P1 data • Trial status • Oncology • Solid Tumor

IMA201: Data from P1 trial (NCT03247309) for r/r solid tumors in H2 2021 (immatics) - Corporate Presentation

P1 data • Solid Tumor

Immatics Announces Third Quarter 2020 Financial Results and Business Update (GlobeNewswire) - "ACTengine® IMA200 Series: These patients are expected to be treated within the fourth quarter this year, moving Immatics towards delivering the clinical milestones for ACTengine® in the coming year. Combined initial data readout for ACTengine® programs, IMA201, IMA202 and IMA203, continues to be expected in Q1 2021. Reported initial data will focus on safety and pharmacodynamic data including engraftment level, persistence and molecular phenotype of infused T cells as well as clinical change of target tumor lesions."

Clinical data • Oncology

IMA_Detect: Mass spectrometry guided development and clinical application of a companion diagnostic for adoptive cellular therapy against tumor associated HLA peptides (AACR 2018) - "IMA101-101 uses autologous T-cell products (ACTolog) for patients with solid cancers while IMA201-101 is based on TCR-engineered T Cells (ACTengine) in NSCLC and HNSCC patients. We will present first results of the patient screening and the personalized target selection."

Clinical • Companion Diagnostic • IO Biomarker • IO Companion Diagnostic • Head and Neck Cancer • Non Small Cell Lung Cancer

TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101) (clinicaltrials.gov) - P1; N=15; Recruiting; Sponsor: Immatics US, Inc.; Trial completion date: Dec 2033 ➔ Dec 2024; Trial primary completion date: Dec 2020 ➔ Dec 2022

Clinical • IO Biomarker • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

TCR-engineered T Cells in Solid Tumors With Emphasis on NSCLC and HNSCC (ACTengine) (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Immatics US, Inc.; Initiation date: Sep 2017 ➔ Dec 2018; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • IO Biomarker • Trial initiation date • Trial primary completion date