IMA101 / Immatics - LARVOL DELTA

AutoDPS: An unsupervised diffusion model based method for multiple degradation removal in MRI. (PubMed, Comput Methods Programs Biomed) - "In this paper, we propose an unsupervised method that removes multiple corruptions, mainly motion with undersampling, in MRI images which are essential for accurate diagnosis. The experiments show promising results on realistic and composite artifacts with higher improvement margins as compared to other methods. Our code is available at https://github.com/arunima101/AutoDPS/tree/master."

Journal

Autologous engineered T cell receptor therapy in advanced cancer. (PubMed, Hum Vaccin Immunother) - "Of 214 screened patients, 14 were treated (6, IMA101; 8, IMA101 and atezolizumab). Target-specific T cells expanded to constitute up to 78.7% of CD8+ cells. In conclusion, IMA101 was feasible and well tolerated, leveraging the potential of multi-targeted ACT that warrants further investigation."

IO biomarker • Journal • Metastases • Review • Hematological Disorders • Oncology • CD8 • COL6A3 • CTAG1B • IL2 • MAGEA1 • MAGEA4 • MMP1 • MXRA5 • PRAME

Feasibility and Safety of Personalized, Multi-Target, Adoptive Cell Therapy (IMA101): First-In-Human Clinical Trial in Patients with Advanced Metastatic Cancer. (PubMed, Cancer Immunol Res) - P1 | "Patients received lymphodepletion (fludarabine, cyclophosphamide), followed by T-cell infusion and low-dose interleukin-2 (Cohort 1). Patients in Cohort 2 received atezolizumab for up to 1 year (NCT02876510)...This study demonstrates the feasibility and tolerability of an actively personalized ACT directed to multiple defined pHLA cancer targets. Results warrant further evaluation of multi-target ACT approaches using potent high-avidity TCRs."

Journal • Metastases • P1 data • Hematological Disorders • Oncology • Solid Tumor • CD8 • HLA-A

[VIRTUAL] Results of the first-in-human clinical trial with personalized multi-target adoptive cell therapy (ACTolog IMA101) (SITC 2020) - P1 | "Patients received lymphodepletion (fludarabine 40 mg/m² and cyclophosphamide 500 mg/m² on days -6 to -3) followed by up to 4 × 1010 cells (day 0), and IL-2 (1 × 106 IU/m² SC twice daily, 14 days) (Cohort 1). In addition, cohort 2 received atezolizumab (1200 mg IV) every 21 days upon hematologic recovery...Conclusions This is the first reported trial demonstrating the feasibility and tolerability of a personalized ACT approach using multiple defined T-cell products directed to multiple precisely defined pHLA cancer targets. These results support further exploration of a multi-target ACT approach, particularly in the context of T-cells expressing high-avidity TCRs to such defined pHLA targets."

Clinical • P1 data • Oncology • Solid Tumor • CD8 • IL2

The first personalized adoptive cellular therapy trial using defined multiple targets (ACTolog IMA101-101) (SITC 2019) - No abstract available.

Phase I adoptive cellular therapy trial with ex-vivo stimulated autologous CD8+ T-cells against multiple targets (ACTolog IMA101) in patients with relapsed and/or refractory solid cancers. (ASCO-SITC 2018) - P1; "The translational objective is to assess the in vivo persistence and ex vivo functionality of transferred T cells in addition to evaluation of target expression in tumors. Enrollment to the study is currently ongoing."

P1 data • Solid Tumor

Whole Genome Sequence Analysis of Lactiplantibacillus plantarum Bacteriophage P2. (PubMed, Pol J Microbiol) - "Phage P2 was isolated from failed fermentation broth carried out by Lactiplantibacillus plantarum IMAU10120...Cell wall adsorption experiments showed that the adsorption receptor component of phage P2 might be a part of the cell wall peptidoglycan. This research might enrich the knowledge about genomic information of lactobacillus phages and provide some primary data to establish phage control measures."

Journal

Whole genome sequence analysis of bacteriophage P1 that infects the Lactobacillus plantarum. (PubMed, Virus Genes) - "plantarum) IMAU10120...Moreover, it was observed that L. plantarum phage P1 utilized the 'cohesive ends' DNA packaging mechanism. This study furthered the genomic knowledge of L. plantarum phages and provided some basis for the control of L. plantarum phages in the dairy fermentation industry."

Journal

ACTolog in Patients With Solid Cancers (clinicaltrials.gov) - P1; N=38; Completed; Sponsor: Immatics US, Inc.; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion • Oncology • Solid Tumor

Phase I adoptive cellular therapy trial with ex-vivo stimulated autologous CD8+ T-cells against multiple targets (ACTolog IMA101) in patients with relapsed and/or refractory solid cancers. (ASCO 2018) - P1; "The translational objective includes the assessment of in vivo persistence and ex vivo characterization of transferred T cells in addition to evaluation of target expression in tumors. Enrollment in the study is currently ongoing."

IO Biomarker • P1 data • Oncology • Solid Tumor

Phase I adoptive cellular therapy trial with actively personalized, multi-targeted CD8+ T-cells in patients with relapsed and/or refractory solid cancers (ACTologIMA101-101) (AACR 2018) - "The actively personalized ACTolog approach is unique in that it addresses the scarcity of suitable tumor antigens by using novel tumor targets identified via the MS-guided XPRESIDENT technology. In addition, it is a multi-target approach intended to generate broad anti-tumor activity with decreased risk of tumor relapse due to loss of target expression."

Clinical • IO Biomarker • P1 data • Solid Tumor

[VIRTUAL] Results of the first-in-human clinical trial with personalized multi-target adoptive cell therapy (ACTolog IMA101) (SITC 2020) - P1 | "Patients received lymphodepletion (fludarabine 40 mg/m² and cyclophosphamide 500 mg/m² on days -6 to -3) followed by up to 4 × 1010 cells (day 0), and IL-2 (1 × 106 IU/m² SC twice daily, 14 days) (Cohort 1). In addition, cohort 2 received atezolizumab (1200 mg IV) every 21 days upon hematologic recovery...Conclusions This is the first reported trial demonstrating the feasibility and tolerability of a personalized ACT approach using multiple defined T-cell products directed to multiple precisely defined pHLA cancer targets. These results support further exploration of a multi-target ACT approach, particularly in the context of T-cells expressing high-avidity TCRs to such defined pHLA targets."

Clinical • P1 data • Oncology • Solid Tumor • CD8 • IL2

Phase I adoptive cellular therapy trial with ex-vivo stimulated autologous CD8+ T-cells against multiple targets (ACTolog® IMA101) in patients with relapsed and/or refractory solid cancers (ESMO 2018) - P1; "Treatment consists of lymphodepletion (Fludarabine/Cyclophosphamide) followed by IMA101 infusion of up to 4 Ag-specific T cell products and IL-2. In the 3 pts treated, treatment was tolerable. To our knowledge, this is the first time that pts received multiple defined Ag-specific products. Initial T-cell persistence data demostrated high prevalence and the expected T-cell phenotype, which are important prerequisites for clinical activity."

P1 data • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Sarcoma

Feasibility of a phase I personalized adoptive T-cell therapy in patients with relapsed/refractory solid tumors (SITC 2019) - P1; "Patients who meet criteria for treatment receive lymphodepletion with Fludarabine 40 mg/m2 i.v. and Cyclophosphamide 500 mg/m2 i.v. (Days, -6 to -3). ACTolog IMA101 is well-tolerated and no safety issues have been noted to date. The study is ongoing."

Clinical • IO biomarker • P1 data • Anal Carcinoma • Breast Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • IL2

ACTolog in Patients With Solid Cancers (clinicaltrials.gov) - P1; N=38; Active, not recruiting; Sponsor: Immatics US, Inc.; Trial completion date: Sep 2022 ➔ Sep 2021

Clinical • Combination therapy • Trial completion date • Oncology • Solid Tumor

ACTolog in Patients With Solid Cancers (clinicaltrials.gov) - P1; N=38; Active, not recruiting; Sponsor: Immatics US, Inc.; Trial completion date: Dec 2021 ➔ Sep 2022; Trial primary completion date: Jun 2021 ➔ Sep 2021

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

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

Immatics Announces Third Quarter 2020 Financial Results and Business Update (GlobeNewswire) - "ACTengine® IMA204: Submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for IMA204 remains anticipated for 2021; IMA401: Submission of the IMA401 IND/IMPD application remains expected by the end of 2021."

IND • Oncology

Immatics Presents Phase I Data from ACTolog Multi-Target Pilot Study IMA101 at the 35th Annual SITC Conference (GlobeNewswire) - P1, N=38; NCT02876510; Sponsor: Immatics US, Inc; “Immatics N.V…announced today that the Company will present Phase I results from their ACTolog® program IMA101 at the 35th Annual SITC Meeting, held virtually from November 9-14, 2020…The data to be presented demonstrate the feasibility of the approach while also showing the therapy is well tolerated. In addition, case studies within the treated patient population support further exploration of a personalized ACT approach using potent high-affinity TCRs…The target positivity rate of 90% demonstrated that such a multi-target approach leads to minimal patient attrition during screening due to lack of target expression. Each product combination in the ACTolog® multi-target approach was guided by confirmed target expression in patient-derived biopsies.”

P1 data • Oncology • Solid Tumor

Immatics Announces Second Quarter 2020 Financial Results and Business Update (GlobeNewswire) - "IMA301 – A preclinical data update is expected to be presented in Q4 2020. IND-enabling studies are ongoing and Immatics expects to submit the IND in 2022....Immatics intends to report updated clinical trial results for its multi-target cell therapy pilot clinical trial, IMA101-101, in Q4 2020."

IND • P1 data • Preclinical • Oncology • Solid Tumor

ACTolog in Patients With Solid Cancers (clinicaltrials.gov) - P1; N=38; Active, not recruiting; Sponsor: Immatics US, Inc.; Recruiting ➔ Active, not recruiting; N=20 ➔ 38; Trial completion date: Jun 2020 ➔ Dec 2021; Trial primary completion date: Dec 2019 ➔ Jun 2021

Clinical • Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

ACTolog in Patients With Solid Cancers (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Immatics US, Inc.; Trial completion date: Sep 2019 ➔ Jun 2020; Trial primary completion date: Jun 2019 ➔ Dec 2019

Clinical • Combination therapy • Trial completion date • Trial primary completion date

Characterization and adsorption of a Lactobacillus plantarum virulent phage. (PubMed, J Dairy Sci) - "...A virulent bacteriophage was isolated from an abnormal fermentation liquid of Lactobacillus plantarum IMAU10120...Divalent ions and chloramphenicol did not have a significant influence on the adsorption of this phage. The information obtained in this study will enrich the database of lactobacilli virulent phages and provide a basis of information for the control of phages in the food fermentation industry."

Journal

Cellular Immunomonitoring for the personalized adoptive cellular therapy trial ACTolog® IMA101-101 (CIMT 2019) - "In summary, product characterization and initial persistence data of the first five treated patients revealed a high prevalence, with up to 50% of CD8+ T cells in the blood being target-specific two weeks after transfer, persistence of cells for up to 3 months after infusion as well as a favorable phenotype of target-specific cells. Taken together, our data show the high potential of the personalized, multi-target ACTolog® approach to generate autologous and long-persisting tumor-specific T cells with different target-specificities for the treatment of cancer patients."

IO Biomarker • PD(L)-1 Biomarker

Cellular Immunomonitoring for the personalized adoptive cellular therapy trial ACTolog® IMA101-101 (CIMT 2019) - "In summary, product characterization and initial persistence data of the first five treated patients revealed a high prevalence, with up to 50% of CD8+ T cells in the blood being target-specific two weeks after transfer, persistence of cells for up to 3 months after infusion as well as a favorable phenotype of target-specific cells. Taken together, our data show the high potential of the personalized, multi-target ACTolog® approach to generate autologous and long-persisting tumor-specific T cells with different target-specificities for the treatment of cancer patients."

IO Biomarker • PD(L)-1 Biomarker