COMPANY

Gradalis, Inc.

HQ: Carrollton, TX source · gradalisinc.com ↗ · Southwest

Also known as Gradalis · 18 sources

Keywords: oncology cancer Ovarian Cancer Ewing Sarcoma Ewing's Tumor Metastatic Ewing's Sarcoma Metastatic Advanced Gynecological Cancers Cervical Cancer Uterine Cancer Ewing's Sarcoma Ewing Family of Tumors Ewing's Tumor Recurrent Rare Diseases Sarcoma Stage III Ovarian Cancer Stage IV Ovarian Cancer Ovarian Neoplasms Connective and Soft Tissue Neoplasms Neoplasms by Histologic Type Bone Tissue Neoplasms Connective Tissue Neoplasms Non Small Cell Lung Cancer Liver Cancer Colon Cancer Advanced Melanoma Melanoma Recurrent Malignant Melanoma Melanoma Advanced Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Lung Neoplasms Vigil Vigil™ Vaccine Vigil™ pbi-shRNA™ EWS/FLI1 Type 1 Lipoplex pbi-shRNA STMN1 LP

Location: Carrollton, TX · source · Oct 15, 2026

Profile checked Oct 10, 2026

15Trials (company is sponsor)4NIH grants

Timeline

Aug 21, 2018 Trial start Phase 3: A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide source ↗
May 31, 2017 Trial start Phase 2: A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers source ↗
2016-10 Trial start Phase 1: Pbi-shRNA™ EWS/FLI1 Type 1 LPX in Subjects With Advanced Ewing's Sarcoma source ↗
2016-03 Trial start Phase 2: Vigil™ + Nivolumab in Advanced Non-Small Cell Lung Cancer source ↗
Feb 10, 2016 Trial start II: A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma source ↗
2015-10 Trial start Phase 1: Pilot Study of Vigil™ + Pembrolizumab for Advanced Melanoma source ↗
2015-02 Trial start Phase 2: A Trial of Vigil for Participants With Ovarian Cancer source ↗
2013-06 Trial start Phase 2: Salvage Ovarian FANG™ Vaccine + Carboplatinum source ↗
2012-03 Trial start II: Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver Metastases source ↗
2012-03 Trial start Phase 2: Salvage Ovarian FANG™ Vaccine + Bevacizumab source ↗
2012-02 Trial start I: Phase I Intratumoral Pbi-shRNA STMN1 LP in Advanced and/or Metastatic Cancer source ↗
2011-10 Trial start II: Phase II FANG™ in Advanced Melanoma source ↗
Mar 8, 2011 Trial start Phase 2: A Trial of FANG™ Vaccine for Participants With Ovarian Cancer source ↗
2009-12 Trial start Phase 1: Trial of Bi-shRNA-furin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer source ↗

Upcoming milestones

2028-12 (ESTIMATED) · Phase 2 · A Trial of Vigil for Participants With Ovarian Cancer · NCT02346747

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 15

Record	Title	Phase	Status	Start	Primary completion
NCT02346747	A Trial of Vigil for Participants With Ovarian Cancer	Phase 2	Active, not recruiting	2015-02	2028-12 (estimated)
NCT01309230	A Trial of FANG™ Vaccine for Participants With Ovarian Cancer	Phase 2	Completed	Mar 8, 2011	Feb 2, 2022 (actual)
NCT03842865	Expanded Access of Vigil in Solid Tumors	Not listed	Temporarily not available	Not listed	Not listed
NCT02736565	Pbi-shRNA™ EWS/FLI1 Type 1 LPX in Subjects With Advanced Ewing's Sarcoma	Phase 1	Completed	2016-10	Aug 12, 2019 (actual)
NCT03495921	A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide	Phase 3	Terminated	Aug 21, 2018	Jan 20, 2022 (actual)
NCT03073525	A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers	Phase 2	Completed	May 31, 2017	May 22, 2019 (actual)
NCT02511132	A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma	II	Completed	Feb 10, 2016	Nov 12, 2018 (actual)
NCT01061840	Trial of Bi-shRNA-furin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer	Phase 1	Completed	2009-12	Dec 6, 2018 (actual)
NCT01505166	Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver Metastases	II	Terminated	2012-03	2016-08 (actual)
NCT01551745	Salvage Ovarian FANG™ Vaccine + Bevacizumab	Phase 2	Completed	2012-03	2016-04 (actual)
NCT01867086	Salvage Ovarian FANG™ Vaccine + Carboplatinum	Phase 2	Completed	2013-06	2016-04 (actual)
NCT01453361	Phase II FANG™ in Advanced Melanoma	II	Terminated	2011-10	Mar 22, 2016 (actual)
NCT01505153	Phase I Intratumoral Pbi-shRNA STMN1 LP in Advanced and/or Metastatic Cancer	I	Completed	2012-02	2017-03 (actual)
NCT02574533	Pilot Study of Vigil™ + Pembrolizumab for Advanced Melanoma	Phase 1	Completed	2015-10	2017-09 (actual)
NCT02639234	Vigil™ + Nivolumab in Advanced Non-Small Cell Lung Cancer	Phase 2	Withdrawn	2016-03	2017-03 (estimated)

NIH awards 4

Annual award amounts. Total $524K.

2012 NIH contract (government contract; not a grant and not an investment round) 261201100055C-1-0-1 FY2012: $150,021 awarded for that fiscal year; activity N43 (OTHER_NIH); PI TEMPLETON, NANCY; recipient as written: GRADALIS, INC., CARROLLTON, TX. SBIR PHASE I AWA source ↗
2011 NIH contract (government contract; not a grant and not an investment round) 261201100055C-0-0-1 FY2011: $50,000 awarded for that fiscal year; activity N43 (OTHER_NIH); PI TEMPLETON, NANCY; recipient as written: GRADALIS, INC., CARROLLTON, TX. SBIR PHASE I AWAR source ↗
2010 NIH contract (government contract; not a grant and not an investment round) 261201000108C-0-0-1 FY2010: $199,045 awarded for that fiscal year; activity N43 (OTHER_NIH); PI TONG, ALEX; recipient as written: GRADALIS, INC., CARROLLTON, TX. TAS::75 0849::TAS ANTI source ↗
Sep 13, 2006 NIH award 1R41CA108039-01A2 FY2006: $124,640 awarded for that fiscal year; activity R41 (STTR); PI TONG, ALEX W; recipient as written: GRADALIS, INC., CARROLLTON, TX. Oncolytic Viral Delivery of Oncogene siRNA source ↗