
A DNA vaccine targeting a specific cancer marker
Cancer cells produce an enzyme which is key to their unlimited proliferation, but is nearly never expressed in normal cells. This enzyme is the telomerase.
Our lead product, INVAC-1 is a human telomerase DNA-based anti-cancer vaccine. It aims at mobilizing the immune system against the human telomerase complex (named hTERT), which is overexpressed in 90% of human tumors, but is virtually absent from normal cells. The vaccine activates the CD8+ Cytotoxic T cells, also called killer T Cells, which are capable of killing cancer cells. It also turns on CD4+ T helper cells, which regulate the immune response and stimulate the cytotoxic T cells.
INVAC-1 has completed its Phase I trial in various advanced cancer indications, demonstrating satisfying safety and immune response. The Phase II trial in Chronic Lymphocytic Leukemia (CLL) began in August 2018.
Invectys uses electroporation to intradermally inject INVAC-1 into the patient, and a needle-free injection system is also being evaluated.
In addition to its development, Invectys is working on combining INVAC-1 and other anti-cancer therapies. INVAC-1 could significantly increase the efficiency of other anti-cancer products, particularly Immune Checkpoint Inhibitors.
Below is additional information on INVAC-1:
INVAC-1 Phase I clinical information
The product INVAC-1 completed its Phase I trial in various cancers in June 2018 (last patient last visit). Below is a brief summary of the study design and results:
- Study design
- 20 advanced cancer patients injected monthly with electroporation
- 3 cohorts with 100, 400 and 800 µg doses of INVAC-1
(n=3 per cohort) - Extension cohort 800 µg (n=11)
- 3 cycles per protocol
- 3 cohorts with 100, 400 and 800 µg doses of INVAC-1
- 6 additional patients injected with needle-free injection device
- 20 advanced cancer patients injected monthly with electroporation
- Objectives
- Toxicity, tolerance, safety and immune responses
- Efficiency and immune response duration
- Safety
- Vaccine treatment was safe and well tolerated
- No Dose Limiting Toxicity observed
- Efficacy
- 1-year survival reached for 65% of patients
- 60% of patients demonstrated stabilized disease
- Overall median survival of 15 months
- Overall PFS was 2,7 months
Preliminary results were presented at ASCO 2017 and ESMO 2018.
Full results were published in an article titled « A First-in-Human Phase I Study of INVAC-1, an Optimized Human Telomerase DNA Vaccine in Patients with Advanced Solid Tumors » in Clinical Cancer Research.
Phase II clinical study design
The Phase II trial for INVAC-1 started in August 2018 (first patient first visit) in CLL, at the MD Anderson Cancer Center in Houston, TX, USA. 84 patients are expected to be enrolled along this study.
The study is divided into two groups (42 patients each):
Group 1: « watch and wait » | Group 2: Ibrutinib-treated patients as 1st or 2nd line treatment | |
|
|
Outcome measures:
- #1: Efficacy of INVAC-1 on MRD eradication rate in bone marrow, in Group 1 and/or Group 2
- #2 : Progression free survival – impact on emergence of secondary tumors
Early read-out results for Phase II are expected in Q2 2020.
INVAC-1 Mechanism of Action