PRGN-3007 / Precigen - LARVOL DELTA

MCC-21622: Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=3 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Jan 2026 ➔ Mar 2025

CAR T-Cell Therapy • Metastases • Trial primary completion date • Acute Lymphocytic Leukemia • B Cell Lymphoma • Breast Cancer • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

MCC-21622: Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=3 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | N=88 ➔ 3

CAR T-Cell Therapy • Enrollment change • Enrollment closed • Metastases • Acute Lymphocytic Leukemia • B Cell Lymphoma • Breast Cancer • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

Precigen Strategically Prioritizes Portfolio to Focus on First Potential Gene Therapy Launch (PRNewswire) - "PRGN-2009 AdenoVerse Gene Therapy Clinical Trials: The Company plans to continue PRGN-2009 Phase 2 trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer. PRGN-2009 clinical trial enrollment at non-NCI clinical sites will be paused. UltraCAR-T Clinical Programs: The Company has completed enrollment of the Phase 1b trial for PRGN-3006 in acute myeloid leukemia (AML), which received Fast Track designation from the US Food and Drug Administration (FDA), and is preparing for an end of Phase 1b meeting with the FDA to discuss next steps. The Company will pause all other UltraCAR-T clinical programs, including PRGN-3005 and PRGN-3007."

Discontinued • Pipeline update • Cervical Cancer • Gynecologic Cancers • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Precigen Reports Second Quarter and First Half 2024 Financial Results and Business Updates (PRNewswire) - "Key Program Highlights:...(i) PRGN-2009 AdenoVerse Gene Therapy Clinical Trials: The Company plans to continue PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the...NCI in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer. PRGN-2009 cervical cancer clinical trial enrollment at non-NCI clinical sites will be paused; (ii) UltraCAR-T Clinical Programs: The Company has completed enrollment of the Phase 1b trial for PRGN-3006 in acute myeloid leukemia (AML)...and is preparing for an end of Phase 1b meeting with the FDA to discuss next steps. The Company will pause the PRGN-3005 and PRGN-3007 clinical trials. The Company will minimize UltraCAR-T spend and focus on strategic partnerships to further advance UltraCAR-T programs."

FDA event • Trial status • Acute Myelogenous Leukemia • Cervical Cancer • Fallopian Tube Cancer • Oropharyngeal Cancer • Ovarian Cancer • Peritoneal Cancer

Precigen Reports Full Year 2023 Financial Results and Business Updates - "PRGN-3006 in AML/MDS: An interim Phase 1b dose expansion data presentation is anticipated in the second half of 2024; PRGN-3007 in Advanced ROR1+ Hematological and Solid Tumors: A preliminary Phase 1 dose escalation data presentation is anticipated by the end of 2024."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Precigen Highlights Pipeline Updates to be Presented at the 42nd Annual J.P. Morgan Healthcare Conference (PRNewswire) - "PRGN-3007 in Advanced ROR1+ Hematological and Solid Tumors....The Phase 1 dose escalation portion of the Phase 1/1b study is ongoing (clinical trial identifier: NCT05694364); A preliminary Phase 1 dose escalation data presentation is anticipated by the end of 2024."

P1 data • Hematological Malignancies • Oncology • Solid Tumor

Precigen Reports Third Quarter 2023 Financial Results and Progress of Clinical Programs (PRNewswire) - "Precigen, Inc...today announced third quarter 2023 financial results and progress of clinical programs...The Phase 2 (NCT05996523) combination arm (PRGN-2009 in combination with pembrolizumab) in OPSCC is enrolling patients...As previously communicated, based on portfolio reprioritization efforts, the Company will not add an extensive number of new sites this year. Instead, a new site will be activated under the Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to continue the advancement of the PRGN-3005 Phase 1b dose expansion study without incurring major clinical/contract research organization (CRO) costs...The Company presented additional preclinical data (Abstract# P469) for PRGN-3007 at the ESGCT 30th Annual Congress in a poster presentation..."

Enrollment status • Preclinical • Trial status • Fallopian Tube Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Oncology • Oropharyngeal Cancer • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Precigen Announces Further Advancement of UltraCAR-T Platform with First Patient Dosed in Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 in Advanced ROR1+ Hematological and Solid Tumors (PRNewswire) - "Precigen, Inc...announced that the first patient has been dosed in the Phase 1/1b dose escalation/dose expansion study (clinical trial identifier: NCT05694364) of PRGN-3007 in advanced ROR1-positive (ROR1+) hematological and solid tumors. The target patient population for the study includes chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), and diffuse large B-cell lymphoma (DLBCL) and solid tumors, including breast adenocarcinomas encompassing triple negative breast cancer (TNBC). There are estimated to be more than 100,000 patients diagnosed in both the hematological and TNBC target populations in the United States, European Union and Japan in 2023."

Trial status • Acute Lymphocytic Leukemia • Breast Cancer • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Mantle Cell Lymphoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

Preclinical Evaluation of Prgn-3007, a Non-Viral, Multigenic, Autologous ROR1 Ultracar-T® Therapy with Novel Mechanism of Intrinsic PD-1 Blockade for Treatment of Hematological and Solid Cancers (ASH 2021) - P1 | "Data shown is from 8 mice/group at the start of the study. * p<0.05, ***p<0.001; log rank test."

IO biomarker • Preclinical • Gene Therapies • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • Solid Tumor • IL15 • PD-L1 • ROR1

Precigen Reports Fourth Quarter and Full Year 2022 Financial Results and Business Updates (PRNewswire) - "PRGN-3007 UltraCAR-T® in Advanced ROR1+ Hematological and Solid Tumors: Manufacturing technology transfer was completed for initiation of the Phase 1 umbrella trial in ROR1+ hematological cancers (chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), acute lymphoblastic leukemia (ALL), and diffuse large B-cell lymphoma (DLBCL)) and solid tumors (triple negative breast cancer (TNBC)). The Phase 1 trial is open for enrollment and the Company expects to dose the first patient in the first quarter of 2023."

Trial status • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Mantle Cell Lymphoma • Oncology • Solid Tumor

Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute

CAR T-Cell Therapy • Metastases • New P1 trial • Acute Lymphocytic Leukemia • Breast Cancer • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

Precigen Provides Pipeline and Corporate Updates at the 41st Annual J.P. Morgan Healthcare Conference (PRNewswire) - "PRGN-3007 Next Generation UltraCAR-T® with Intrinsic PD-1 Inhibition...Program Status:...Tech transfer was completed for initiation of the Phase 1 umbrella trial in ROR1+ hematological (CLL, MCL, ALL, DLBCL) and solid tumors (TNBC). The trial is currently open for enrollment and the Company expects to dose the first patient in the first quarter of 2023."

Trial status • Acute Lymphocytic Leukemia • Breast Cancer • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Phase1/1b Dose Escalation/Dose Expansion Study of Prgn-3007 Ultracar-T Cells in Patients with Advanced Hematologic and Solid Tumor Malignancies (ASH 2022) - "Study subjects undergo leukapheresis followed by lymphodepletion with either fludarabine 30mg/m2 and cyclophosphamide 500mg/m2 for 3 days (Arm 1) or 60 mg/kg cyclophosphamide for 2 days (Arm 2). All subjects will be followed for adverse events, CAR-T-related toxicities, disease response and PRGN-3007 cell expansion and persistence. In addition, the mechanisms of safety and effectiveness of PRGN-3007 cells will be evaluated with correlative assays of specific immune response pathways."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Breast Cancer • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Ewing Sarcoma • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Hepatology • Indolent Lymphoma • Leukemia • Lung Adenocarcinoma • Lung Cancer • Lymphoma • Mantle Cell Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Sarcoma • Solid Tumor • Triple Negative Breast Cancer • CCND1 • IL15 • PD-L1 • ROR1

Precigen Reports Third Quarter 2022 Financial Results and Progress of Clinical Programs (PRNewswire) - "PRGN 2009 AdenoVerse™ Immunotherapy in HPV-associated Cancers: The Company expects Phase 1 data to be presented in the first half of 2023; PRGN-3005 UltraCAR-T® in Ovarian Cancer: Patient follow up is ongoing and the Company expects Phase 1 data to be presented in the first half of 2023; PRGN-3007 UltraCAR-T® in Advanced ROR1+ Hematological and Solid Tumors: The Phase 1/1b umbrella study of PRGN-3007 in advanced receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) hematological and solid tumors is on track to initiate dosing in the fourth quarter of 2022."

P1 data • Trial status • Gynecologic Cancers • Hematological Malignancies • Oncology • Ovarian Cancer • Solid Tumor

Precigen Reports Second Quarter and First Half 2022 Financial Results (PRNewswire) - "PRGN-3007 UltraCAR-T in Advanced ROR1+ Hematological and Solid Tumors: The Phase 1/1b umbrella study of PRGN-3007 in advanced receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) hematological tumors...is on track to initiate dosing in the second half of 2022....PRGN 2009 AdenoVerse™ Immunotherapy in HPV-associated Cancers: Patient follow up is ongoing. The Company expects Phase 1 data to be presented in the first half of 2023."

P1 data • Trial status • Hematological Malignancies • Leukemia • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Precigen Provides Pipeline and Corporate Updates at the 40th Annual J.P. Morgan Healthcare Conference (PRNewswire) - "Precigen plans to initiate dosing in the Phase 1 study in ROR1+ hematological (CLL, MCL, ALL, DLBCL) and solid (TNBC) tumors in 2022."

New P1 trial • Acute Lymphocytic Leukemia • Breast Cancer • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

Precigen Achieves Significant Clinical Progress for UltraCAR-T and AdenoVerse Therapies (PRNewswire) - "An abstract highlighting PRGN-3007 preclinical data (Abstract# 1694)...will be presented as a poster presentation at the 63rd ASH Annual Meeting and Exposition."

Preclinical • Hematological Malignancies • Oncology

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"$PGEN PRGN-3007 #ASH21 trial design" (@Biotech2050)

Precigen Announces Clearance of IND to Initiate Phase 1/1b Study for PRGN-3007 UltraCAR-T in Advanced ROR1+ Hematological and Solid Tumors (PRNewswire) - "Precigen, Inc...announced that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate the Phase 1/1b clinical trial of PRGN-3007 in advanced receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) hematological and solid tumors."

IND • Hematological Malignancies • Oncology • Solid Tumor