PDC*line Pharma, a clinical stage biotech company has announced the first immunological results of its PDC-LUNG-101 phase 1/2 clinical trial investigating PDC*Lung01.
The company’s lead therapeutic is the off-the-shelf cancer vaccine candidate for non-small cell lung cancer (NSCLC). PDC*line Pharma develops potent and scalable active immunotherapies for cancers.
The preliminary data was presented today at a poster display session at the ESMO Immuno-Oncology Congress 2022 (ESMO-IO) in Switzerland. Results showed that in a large proportion of subjects, PDC*lung01, in monotherapy and combined with pembrolizumab, induces a significant expansion of effector memory CD8+ T-cells specific to the tumor peptides carried by PDC*lung01.
PDC*lung01 cancer vaccine
The objectives of the phase 1/2 trial (PDC-LUNG-101) are to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC patients. PDC*lung01 will be administered to a total of 64 evaluable HLA-A*02:01 positive NSCLC patients, at two dose levels in two different settings. HLA-A*02:01 Positive is an inclusion criterion in 10 clinical trials for non-small cell lung carcinoma, of which 9 are open and 1 is closed.
PDC*lung01 is made of irradiated human plasmacytoid dendritic cells (PDC*line), loaded with HLA-A*02:01-restricted peptides, derived from NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1 and Survivin tumor antigens. Survivin, a member of the inhibitor of apoptosis protein family, is expressed in almost all types of malignancies, making this protein a useful tool for the development of broadly applicable vaccination therapies.
Safety and clinical activity
It is administered weekly by a subcutaneous and intravenous route, in six consecutive doses. Safety and clinical activity of the product were presented at ESMO 2022 in September in Paris. PDC*line is a potent professional antigen-presenting cell line that is able to prime and boost the patient’s anti-tumor cytotoxic CD8+ T-cells and is synergistic in vitro with anti-programmed death-1 (PD-1) treatment. The poster presented the analysis of the immune responses of the first three cohorts of patients.
Joël Plumas, co-founder and chief scientific officer of PDC*line Pharma, said: “We are very pleased that PDC*lung01 is found to be biologically active to trigger an anti-tumor immune response, detectable without any in vitro restimulation, in a significant number of patients in our NSCLC clinical trial. The first signal of correlation between immune and clinical responses in six metastatic patients from the B1 cohort is encouraging.”
Eric Halioua, CEO of PDC*line Pharma, said: “Presenting the first immunological data set from our lead candidate, PDC*lung01, for the treatment of NSCLC at ESMO-IO, a major immuno-oncology conference, is an important milestone for the company.
PDC*lung01 strong immune response
“We are very pleased to demonstrate that our innovative immunotherapy platform can induce a strong immune response in humans. These first results illustrate the potential targeted mechanism of action of PDC*lung01 to prime naive anti-tumor specific T-Cells and trigger effector memory T-cells in humans.”
The therapeutic cancer vaccine PDC*lung01 induces immune responses with or without anti-PD-1 treatment in patients with non-small cell lung cancer.