PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancers, has revealed the first results of its PDC-LUNG-101 phase I/II clinical trial with PDC*lung01.
PDC*lung01 is the company’s therapeutic off-the shelf cancer vaccine candidate for non-small cell lung cancer (NSCLC).
The preliminary data was presented at a poster discussion session at the 2022 European Society for Medical Oncology (ESMO) annual meeting.
The data showed that PDC*lung01, in monotherapy and combined with pembrolizumab, evokes an acceptable safety profile, immunological activity and a promising tumor response in NSCLC, with the caveat of low numbers at the present time.
The objectives of the trial are to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate PDC*lung01, associated with, or not, anti-PD-1 treatment in NSCLC patients.
It is planned to administer PDC*lung01 to 64 evaluable HLA-A*02:01 positive NSCLC patients at two dose levels in two different settings.
PDC*lung01 is a cell suspension of seven active agents – 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.
PDC*line is an antigen-presenting cell that is able to prime and boost the patient’s antitumor cytotoxic CD8+ T-cells and is synergistic with anti-programmed death-1 (PD-1) treatment. It is administered weekly by a subcutaneous and intravenous route, in six consecutive doses. Clinical activity is assessed only for B cohorts. Results are reported on the first three cohorts that have been completed (A1/A2/B1).
“I am very pleased that we have been able to present this encouraging data from the PDC-LUNG-101 trial, evaluating PDC*lung01 in combination with a checkpoint blockade. This is a very encouraging step for the company and we are looking forward to sharing a more mature set of data when the B2 cohort is completed,” said Channa Debruyne, medical director of PDC*line Pharma.
“These new results reinforce our differentiating data package for PDC*lung01.They support the potency of our platform to trigger anti-tumor specific and effector memory T-cells against lung antigens in a large proportion of subjects, with a dose effect and a combined effect with anti-PD-1,” said Eric Halioua, CEO of PDC*line Pharma.
About PDC*line Pharma
Founded in 2014 as a spin-off of the French Blood Bank (EFS), PDC*line Pharma is a Belgian-French clinical-stage biotech company developing a class of active immunotherapies for cancers, based on a GMP-grade allogeneic therapeutic cell line of Plasmacytoid Dendritic Cells (PDC*line).
The company has a staff of 30. It has raised more than €52 million ($52.6 million) in equity and non-dilutive funding. In March 2019, PDC*line Pharma granted an exclusive license to the LG Chem Life Sciences company in South Korea and an exclusive option in other Asian countries, for the development and commercialization of the PDC*lung01 cancer vaccine for lung cancer.
The total deal is worth $123 million, plus tiered royalties on net sales in Asia.