News & Press

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March 2025

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Press Release

Gradalis Announces Development of Clinically Relevant Exome Sequencing Bioinformatics Pipeline to Determine Clonal Tumor Mutation Burden Gradalis Announces Development of Clinically Relevant Exome Sequencing Bioinformatics Pipeline to Determine Clonal Tumor Mutation Burden

February 2025

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Press Release

Gradalis Secures FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Vigil® (Gemogenovatucel-T)Gradalis Secures FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Vigil® (Gemogenovatucel-T)

January 2024

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Press Release

Gradalis’ GRAD1405 bi-shRNAi Candidate First to Show Positive Impact on Three Key KRAS Mutations Identified in Drug Resistant Lung, Colon and Pancreatic Cancers Gradalis’ GRAD1405 bi-shRNAi Candidate First to Show Positive Impact on Three Key KRAS Mutations Identified in Drug Resistant Lung, Colon and Pancreatic Cancers

December 2023

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Press Release

Gradalis Highlights Importance of Targeting Clonal Neoantigens in Achieving Durable Benefit in Cancer Treatment Gradalis Highlights Importance of Targeting Clonal Neoantigens in Achieving Durable Benefit in Cancer Treatment

November 2023

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News Article

Texas backs Carrollton firm working on ovarian cancer drug with $10 million grant Texas backs Carrollton firm working on ovarian cancer drug with $10 million grant

November 2023

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Press Release

Gradalis Awarded $9.9 Million Grant From the Cancer Prevention and Research Institute of Texas Gradalis Awarded $9.9 Million Grant From the Cancer Prevention and Research Institute of Texas

October 2023

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Press Release

Gradalis hosted KOL Discussion: Vigil® Platform Entering Phase 2 for Platinum-Sensitive Recurrent Ovarian Cancer Gradalis hosted KOL Discussion: Vigil® Platform Entering Phase 2 for Platinum-Sensitive Recurrent Ovarian Cancer

October 2023

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Press Release

Gradalis to Host Virtual KOL Discussion on the Vigil® Platform Entering Phase 2 for Platinum Sensitive Recurrent Ovarian Cancer on October 25, 2023 Gradalis to Host Virtual KOL Discussion on the Vigil® Platform Entering Phase 2 for Platinum Sensitive Recurrent Ovarian Cancer on October 25, 2023

September 2023

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Press Release

Gradalis Highlights Importance of Clonal Neoantigen Targeting for Clinical Benefit of Vigil® in Oncology Reviews Publication Gradalis Highlights Importance of Clonal Neoantigen Targeting for Clinical Benefit of Vigil® in Oncology Reviews Publication

June 2023

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Press Release

Gradalis Announces Peer-Reviewed Publication Demonstrating Potential of Novel 3D Scaffold Tissue Technology to Expand Vigil Platform Gradalis Announces Peer-Reviewed Publication Demonstrating Potential of Novel 3D Scaffold Tissue Technology to Expand Vigil Platform

March 2023

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Press Release

Gradalis to Participate in the Cantor Fitzgerald Future of Oncology Symposium Gradalis to Participate in the Cantor Fitzgerald Future of Oncology Symposium

March 2023

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Press Release

Gradalis Announces Publication in Clinical Cancer Research Featuring Positive Results from a Study Evaluating Vigil® in Combination Therapy for Patients with Recurrent Ewing's Sarcoma Gradalis Announces Publication in Clinical Cancer Research Featuring Positive Results from a Study Evaluating Vigil® in Combination Therapy for Patients with Recurrent Ewing's Sarcoma

February 2023

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Press Release

Gradalis to Present at the 2023 BIO CEO & Investor Conference Gradalis to Present at the 2023 BIO CEO & Investor Conference

December 2022

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Press Release

Gradalis Receives Clearance to Begin Pivotal Phase 3 Clinical Trial of Vigil® (gemogenovatucel-T) in Patients With Advanced Ovarian Cancer in the U.S.Gradalis Receives Clearance to Begin Pivotal Phase 3 Clinical Trial of Vigil® (gemogenovatucel-T) in Patients With Advanced Ovarian Cancer in the U.S.

December 2022

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Press Release

Gradalis Appoints Eric Hall as Chief Financial Officer Gradalis Appoints Eric Hall as Chief Financial Officer

October 2022

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Press Release

Gradalis to Present at the 2022 Cell & Gene Meeting on the Mesa Gradalis to Present at the 2022 Cell & Gene Meeting on the Mesa

October 2022

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Press Release

Gradalis Announces Publication of Two Studies Demonstrating the Positive Results of Vigil® in Combination with Checkpoint Inhibitors Gradalis Announces Publication of Two Studies Demonstrating the Positive Results of Vigil® in Combination with Checkpoint Inhibitors

September 2022

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Press Release

Gradalis to Host Key Opinion Leader Webinar on Unmet Medical Needs in Ovarian Cancer and the Company's Immuno-Oncology Treatment, Vigil Gradalis to Host Key Opinion Leader Webinar on Unmet Medical Needs in Ovarian Cancer and the Company's Immuno-Oncology Treatment, Vigil

September 2022

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Press Release

Gradalis KOL Webinar on Unmet Medical Needs in Ovarian Cancer and the Company’s Immuno-Oncology Treatment, Vigil®Gradalis KOL Webinar on Unmet Medical Needs in Ovarian Cancer and the Company’s Immuno-Oncology Treatment, Vigil®

September 2022

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News Article

Gradalis' Autologous Immunotherapy Shows Promise in Certain Ovarian Cancer Patients Gradalis' Autologous Immunotherapy Shows Promise in Certain Ovarian Cancer Patients

August 2022

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Press Release

Gradalis Announces Publication in Nature Communications Medicine Identifying Survival Predicting Biomarker in Patients with Ovarian Cancer Treated with Vigil®Gradalis Announces Publication in Nature Communications Medicine Identifying Survival Predicting Biomarker in Patients with Ovarian Cancer Treated with Vigil®

June 2022

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Press Release

Gradalis Appoints Steven Engle as Chief Executive Officer Gradalis Appoints Steven Engle as Chief Executive Officer

February 2022

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Press Release

Gradalis and University of Michigan collaboration to utilize a patient's cancer cells to create personalized therapeutics to treat cancer Gradalis and University of Michigan collaboration to utilize a patient's cancer cells to create personalized therapeutics to treat cancer

March 2021

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Press Release

Phase 2b VITAL study of Gemogenovatucel-T (Vigil™) immunotherapy demonstrates clinical benefit in homologous recombination (HR) proficient ovarian cancer Phase 2b VITAL study of Gemogenovatucel-T (Vigil™) immunotherapy demonstrates clinical benefit in homologous recombination (HR) proficient ovarian cancer

January 2021

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Press Release

Gradalis Announces Publication of Phase 2b VITAL trial of Vigil® demonstrating RFS and OS advantage in women with first-line platinum-responsive BRCA1 and BRCA2 wild-type advanced ovarian cancer in The Lancet Oncology Gradalis Announces Publication of Phase 2b VITAL trial of Vigil® demonstrating RFS and OS advantage in women with first-line platinum-responsive BRCA1 and BRCA2 wild-type advanced ovarian cancer in The Lancet Oncology

December 2020

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News Article

Dr. Rod Rocconi on Med School Watercooler: Significant Results for Ovarian Cancer Patients Dr. Rod Rocconi on Med School Watercooler: Significant Results for Ovarian Cancer Patients

December 2020

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News Article

Lancet Oncology: Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial Lancet Oncology: Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial

June 2020

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News Article

Gradalis at ASCO Virtual Scientific Forum - Randomized double-blind placebo-controlled trial of primary maintenance GMCSF/bi-shRNA(furin) DNA-transfected autologous tumor immunotherapy (VITAL study) in stage III/IV ovarian cancer Gradalis at ASCO Virtual Scientific Forum - Randomized double-blind placebo-controlled trial of primary maintenance GMCSF/bi-shRNA(furin) DNA-transfected autologous tumor immunotherapy (VITAL study) in stage III/IV ovarian cancer

April 2020

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News Article

Frontline Maintenance Vigil Immunotherapy Improves RFS in Ovarian Cancer Frontline Maintenance Vigil Immunotherapy Improves RFS in Ovarian Cancer

June 2019

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News Article

Cancer Vaccine Developed In North Texas Could Be 'As Simple As A Flu Shot'Cancer Vaccine Developed In North Texas Could Be 'As Simple As A Flu Shot'

March 2019

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Press Release

Gradalis Announces Medical Leadership Team Promotion Gradalis Announces Medical Leadership Team Promotion

November 2018

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Press Release

Gradalis® Presents Initial Data from Phase II U.S. Trial for Ewing’s sarcoma at the Annual Meeting of the Children’s Oncology Group Gradalis® Presents Initial Data from Phase II U.S. Trial for Ewing’s sarcoma at the Annual Meeting of the Children’s Oncology Group

October 2018

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News Article

Gradalis® implements L7 Informatics’ Enterprise Science Platform as part of initiating their Phase 3 Study of Vigil™ in Ewing’s sarcoma Gradalis® implements L7 Informatics’ Enterprise Science Platform as part of initiating their Phase 3 Study of Vigil™ in Ewing’s sarcoma

August 2018

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Press Release

Gradalis® Announces Initiation of Phase 3 Study of Vigil™ in Ewing’s sarcoma Gradalis® Announces Initiation of Phase 3 Study of Vigil™ in Ewing’s sarcoma

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