NeoTCR-P1 / PACT Pharma - LARVOL DELTA

A phase I study of personalized adoptive TCR T cell therapy in patients with solid tumors: safety, efficacy, and T cell trafficking to tumors of non-virally gene edited T cells (SITC 2022) - P1a/1b | "Background NeoTCR-P1 is a personalized autologous T cell therapy for treatment of patients with solid tumors...Conclusions This study demonstrates the feasibility of isolating and manufacturing NeoTCR-T cells using non-viral precision genome engineering, the safety of infusing up-to-three gene edited NeoTCR-T cell products, and T cell persistence and trafficking to a variety of solid tumors. Trial Registration NCT03970382 Ethics Approval Ethics approvals have been obtained from each clinical site enrolling patients: City of Hope, Duarte California; University of California Los Angeles, Los Angeles California; University of California, Irvine Medical Center, Orange, California; University of California, Davis, Sacramento California; University of California, San Francisco, San Francisco California; Northwestern University Medical Center, Chicago Illinois; Memorial Sloan Kettering Cancer Center, New York, New York; Tennessee Oncology, Nashville, Tennessee; and..."

Clinical • IO biomarker • Late-breaking abstract • P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CD8 • IL2

Monitoring of neoantigens and adoptively transferred personalized neoTCR T cell populations in the tumor and PBMCs of patients with solid tumors (AACR 2023) - P1a/1b | "Background: NeoTCR-P1 is a personalized autologous T cell therapy for treatment of patients with solid tumors... These case studies illustrate for the first time tracking of 3 unique personalized T cell products within a single patient. Shifts in the T cell phenotype of the neoTCR T cell products post-infusion for some, but not all, of the products suggest early signs of T cell engagement with the target."

Clinical • IO biomarker • Tumor-specific neoantigens • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • CD8 • GZMB • HLA-B • HLA-C

[VIRTUAL] A high-throughput platform to produce neoE-HLA libraries for capturing neoE-specific T cells from the peripheral blood of patients with solid tumors (AACR-II 2020) - P1a/1b | "This fully personalized NeoTCR-P1 cell therapy is manufactured in fully enclosed, automatable systems for each individual patient with solid tumors. These breakthrough technologies support the on-going Phase 1 clinical trial of personalized engineered autologous NeoTCR-P1 T cell therapies for patients with six different solid tumor types (NCT03970382)."

Clinical • Oncology • Solid Tumor • CD8

[VIRTUAL] Non-viral genome engineering method allows highly efficient, single-step removal and precise insertion of multiple large genes (AACR-II 2020) - P1a/1b | "Despite multi-locus editing, no evidence of off-target insertion or unexpected genomic rearrangements were observed.In summary, these results demonstrate the applicability of a single step, highly efficient method for manufacturing fresh human T cells into neoTCR-T cell therapies, engineered with multiple functionalities. This proprietary precision genome engineering technology supports the on-going Phase 1 clinical trial of personalized autologous, NeoTCR-P1 engineered T cell therapies for patients with solid tumors (NCT03970382)."

Oncology • Solid Tumor • CD8

PACT Pharma to Present New Data Highlighting First-of-its-Kind Personalized Neoantigen TCR T Cell Therapy Platform at SITC 2022 (PRNewswire) - "PACT Pharma...announced that new data highlighting its first-of-its-kind adoptive T cell therapy platform will be featured in multiple presentations at the upcoming 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2022). The company, along with academic research collaborators, will deliver oral and poster presentations, including a late-breaking oral presentation, providing the latest clinical and preclinical findings from its pioneering research in the field of personalized neoantigen TCR T cell therapies."

Late-breaking abstract • P1 data • Preclinical • Oncology • Solid Tumor

"Pact Pharma's NeoTCR-P1 trial is suspended (business decision), presumably owing to the asset sale https://t.co/xLMZCoB3S6" (@JacobPlieth)

A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors (clinicaltrials.gov) - P1a/1b | N=21 | Suspended | Sponsor: PACT Pharma, Inc. | Trial completion date: Dec 2024 ➔ Aug 2022 | Active, not recruiting ➔ Suspended | Trial primary completion date: Dec 2022 ➔ Aug 2022

Combination therapy • Trial completion date • Trial primary completion date • Trial suspension • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hormone Receptor Breast Cancer • Melanoma • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • IL2

A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors (clinicaltrials.gov) - P1a/1b | N=21 | Active, not recruiting | Sponsor: PACT Pharma, Inc. | Recruiting ➔ Active, not recruiting | N=148 ➔ 21

Combination therapy • Enrollment change • Enrollment closed • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hormone Receptor Breast Cancer • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • IL2

[VIRTUAL] A Phase 1a/1b, open-label first-in-human study of the safety, tolerability, and feasibility of gene-edited autologous NeoTCR-T cells (NeoTCR-P1) administered to patients with locally advanced or metastatic solid tumors (AACR-I 2020) - P1a/1b | "This is the first clinical study of an autologous, fully personalized adoptive T cell therapy directed against private tumor-exclusive mutations, generated without using recombinant viral vectors."

Clinical • P1 data • CD8 • IL2

[VIRTUAL] A phase Ia/Ib, open-label first-in-human study of the safety, tolerability, and feasibility of gene-edited autologous NeoTCR-T cells (NeoTCR-P1) administered to patients with locally advanced or metastatic solid tumors. (ASCO 2020) - P1a/1b | "The combination of NeoTCR-P1 dosing plus nivolumab will be tested in a Phase 1b study. This is the first clinical study of an autologous, fully personalized adoptive T cell therapy directed against private tumor-exclusive mutations, generated without using recombinant viral vectors. Research Funding: PACT Pharma"

Clinical • P1 data • Bladder Cancer • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Melanoma • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Urothelial Cancer • CD8 • IL2

A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors (clinicaltrials.gov) - P1a/1b; N=148; Recruiting; Sponsor: PACT Pharma, Inc.; Trial completion date: Dec 2023 ➔ Dec 2024; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • IL2

[VIRTUAL] Fully personalized mutation-targeted NeoTCR-T cell therapies for patients with solid tumors (FOB-USA 2021) - "Precision genome engineering (non-viral) of patient T cells. First-in-human clinical trials of NeoTCR-P1 cell therapy for patients with solid tumor."

Clinical • Oncology • Solid Tumor

"Yuman Fong, MD on Safety of Gene-Edited Autologous NeoTCR-P1 #AACR2020 https://t.co/832VPsbHj6" (@oncologytube)

Clinical • Oncology