INVAC-1 / Invectys - LARVOL DELTA

Clinical response and pharmacodynamic assessment of INVAC-1, a DNA plasmid encoding an inactive form of human telomerase reverse transcriptase (hTERT), on immune responses, immune tolerability, tumor burden and circulating tumor DNA (ctDNA) in patients with advanced solid tumors. (ESMO 2018) - P1; "Results indicate that INVAC-1 was well tolerated and immunogenic at the doses and schedule tested. Disease stabilization was obtained for the majority of pts, according to RECIST criteria or ctDNA levels. Phase II studies of INVAC-1 in solid tumors and hematologic malignancies, preferably in pts with early diseases and adequate immune functions, are starting."

Clinical • PK/PD data • Leukemia • Solid Tumor

[VIRTUAL] INVAC-1, an optimized telomerase DNA vaccine in patients with advanced solid tumors: Final results of first-in-human phase I study (AACR 2021) - P1 | "Disease stabilization was observed for the majority of patients during the treatment period and beyond. Clinical trial identification #NCT02301754"

Clinical • IO biomarker • P1 data • Oncology • Solid Tumor • CD4 • CD8

Final results of A Phase I study evaluating INVAC-1, a novel DNA vaccine expressing an inactive form of human telomerase reverse transcriptase (hTERT) in patients with advanced solid tumors. (ASCO 2019) - P1; "This specific anti-hTERT immune response was enhanced ex vivo by adding the immune checkpoint inhibitor nivolumab. Results indicate that INVAC-1 was well tolerated and immunogenic at the doses and schedule tested. Disease stabilization was obtained for the majority of pts (58%) according to RECIST criteria or ctDNA levels. Clinical trial information: NCT02301754"

Clinical • IO Biomarker • P1 data • PD(L)-1 Biomarker

EXPLORATORY STUDY Addendum to INVAC1-CT-101 (NCT02301754) (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Invectys; Not yet recruiting ➔ Completed

Clinical • Trial completion • Oncology • Solid Tumor

A First-in-Human Phase I Study of INVAC-1, an Optimized Human Telomerase DNA Vaccine in Patients with Advanced Solid Tumors. (PubMed, Clin Cancer Res) - "INVAC-1 vaccination was safe, well tolerated and immunogenic when administered intradermally at the three tested doses in patients with relapsed or refractory cancers. Disease stabilization was observed for the majority of patients (58%) during the treatment period and beyond."

Clinical • Journal • P1 data • Oncology • Solid Tumor

Building on the promise of cancer vaccines for solid tumors. (PubMed, Clin Cancer Res) - "A novel telomerase vaccine (INVAC-1) has been evaluated in a phase I clinical trial (n = 26). It induced CD8+ and CD4+ T cell responses and reduced circulating regulatory T cells. The findings support further development, especially in combination with vaccine adjuvants, plus therapies to increase immune infiltrates into solid tumor metastases."

Journal • Oncology • Solid Tumor

EXPLORATORY STUDY Addendum to INVAC1-CT-101 (NCT02301754) (clinicaltrials.gov) - P1; N=6; Not yet recruiting; Sponsor: Invectys

Clinical • New P1 trial • Oncology • Solid Tumor

DNA Plasmid Encoding a Modified Human Telomerase Reverse Transcriptase (hTERT), Invac-1 in Chronic Lymphocytic Leukemia (clinicaltrials.gov) - P2; N=26; Terminated; Sponsor: Invectys; N=90 ➔ 26; Trial completion date: Mar 2022 ➔ Jun 2020; Recruiting ➔ Terminated; Trial primary completion date: Dec 2020 ➔ Jun 2020; sponsor decision

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Phase I clinical trial results published for Invectys DNA vaccine for cancer using PharmaJet needle-free injector (PRNewswire) - "PharmaJet...announced that the results of the Invectys Phase I clinical trial of its therapeutic cancer vaccine, INVAC-1, using the PharmaJet needle-free injection system, were recently published. The study entitled A First-in-Human Phase I Study of INVAC-1, an Optimized Human Telomerase DNA Vaccine in Patients with Advanced Solid Tumors was published in Clinical Cancer Research on November 19, 2019....Invectys has chosen the PharmaJet Tropis for its ongoing Phase II study for Chronic Lymphocytic Leukemia in the US and Europe, in addition to solid tumor studies in 2020."

P1 data • Trial status

INVAC-1 Anti-Cancer hTERT DNA Immunotherapy (clinicaltrials.gov) - P1; N=26; Completed; Sponsor: Invectys; Active, not recruiting ➔ Completed; Trial completion date: Dec 2018 ➔ Jun 2018

Clinical • Trial completion • Trial completion date

INVAC-1 Anti-Cancer hTERT DNA Immunotherapy (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: Invectys; Trial primary completion date: Jan 2016 ➔ Jun 2016

Clinical • IO Biomarker • Trial primary completion date

INVAC-1 Anti-Cancer hTERT DNA Immunotherapy (clinicaltrials.gov) - P1; N=27; Not yet recruiting; Sponsor: Invectys

Clinical • IO Biomarker • New P1 trial

INVAC-1 Anti-Cancer hTERT DNA Immunotherapy (clinicaltrials.gov) - P1; N=26; Recruiting; Sponsor: Invectys; Active, not recruiting ➔ Recruiting; N=20 ➔ 26; Trial primary completion date: Dec 2016 ➔ Dec 2017

Clinical • Enrollment change • Enrollment open • IO Biomarker • Trial primary completion date

INVAC-1 Anti-Cancer hTERT DNA Immunotherapy (clinicaltrials.gov) - P1; N=26; Active, not recruiting; Sponsor: Invectys; Recruiting ➔ Active, not recruiting; Trial primary completion date: Dec 2017 ➔ Feb 2018

Clinical • Enrollment closed • IO Biomarker • Trial primary completion date

INVAC-1 Anti-Cancer hTERT DNA Immunotherapy (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: Invectys; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • IO Biomarker

INVAC-1 Anti-Cancer hTERT DNA Immunotherapy (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Invectys; N=27 ➔ 18

Clinical • Enrollment change • IO Biomarker

INVAC-1 Anti-Cancer hTERT DNA Immunotherapy (clinicaltrials.gov) - P1; N=20; Active, not recruiting; Sponsor: Invectys; Recruiting ➔ Active, not recruiting; Trial primary completion date: Aug 2016 ➔ Dec 2016

Clinical • Enrollment closed • IO Biomarker • Trial primary completion date

Strong antigen-specific T-cell immunity induced by a recombinant human TERT measles virus vaccine and amplified by a DNA/viral vector prime boost in IFNAR/CD46 mice. (PubMed, Cancer Immunol Immunother) - "The 4 kb hTERT transgene did not impact MV replication or induction of cell-mediated responses. These findings validate the MV-TERT vector to boost cell-mediated responses following DNA priming in humans."

Journal • Preclinical