IMA202 / Immatics - LARVOL DELTA

First-in-human dose escalation trial to evaluate the clinical safety and efficacy of an anti-MAGEA1 autologous TCR-transgenic T cell therapy in relapsed and refractory solid tumors. (PubMed, J Immunother Cancer) - P1/2 | "In conclusion, IMA202 had a manageable safety profile, and it was associated with biological and potential clinical activity of MAGEA1-targeting genetically engineered TCR-T cells in a poor prognosis, multi-indication solid tumor cohort."

Journal • P1 data • Hematological Disorders • Hematological Malignancies • Leukopenia • Melanoma • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CD8 • IL2 • MAGEA1

ACTengine: TCR-engineered T Cells in Solid Tumors: IMA202-101 (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Immatics US, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Mar 2023

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

ACTengine: TCR-engineered T Cells in Solid Tumors: IMA202-101 (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Immatics US, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • IO biomarker • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

IMA 202: Completion of dose escalation part of P1a ACTengine trial (NCT03441100) for solid tumors in Q1 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

[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

IMA202: Expiry of patents in US, Germany, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Algeria, Eurasia, Egypt, Europe, Gulf Cooperation Council, Hong Kong, Indonesia, Israel, India, Japan, South Korea, Mexico, Malaysia, New Zealand, Peru, Philippines, Singapore, Thailand, Taiwan, the Ukraine, Vietnam and South Africa between 2036 and 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

IMA202: Initial data from dose expansion P1b trial (NCT03441100) 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

Immatics Announces European Clinical Expansion of its Adoptive Cell Therapy Programs (GlobeNewswire) - "Immatics N.V…announced today the treatment of the first patient in the IMA202-101 trial in Europe following the Clinical Trial Application (CTA, the equivalent of an IND approval by FDA) approval by Paul-Ehrlich-Institute (PEI), the regulatory body for cell and gene therapies in Germany. In addition, Immatics has been granted regulatory approval by PEI to initiate another phase I clinical trial in Germany to evaluate safety, tolerability and initial signs of clinical efficacy of IMA203. The clinical trials of the IMA200 series will investigate up to three novel cancer immunotherapies, which include IMA202 (NCT03441100) and IMA203 (NCT03686124). IMA202 and IMA203 are designed to target unique peptides derived from either melanoma-associated antigen 1 ('MAGEA1') or preferentially expressed antigen in melanoma ('PRAME'), respectively"

Enrollment open • European regulatory • Melanoma • Oncology • Solid Tumor

ACTengine: TCR-engineered T Cells in Solid Tumors: IMA202-101 (clinicaltrials.gov) - P1; N=15; Recruiting; Sponsor: Immatics US, Inc.; Trial completion date: Jun 2022 ➔ Jun 2024; Trial primary completion date: Sep 2020 ➔ Jun 2022

Clinical • IO Biomarker • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ACTengine: TCR-engineered T Cells in Solid Tumors Including NSCLC and HCC Patients (clinicaltrials.gov) - P1; N=16; Recruiting; Sponsor: Immatics US, Inc.; Trial completion date: Jun 2033 ➔ Jun 2022; Trial primary completion date: Sep 2019 ➔ Sep 2020

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