PDC*line Pharma is GMP accredited
PDC*line Pharma is delighted to announce, that the company is now accredited by the Belgian Federal Agency for Medicines and Health Products (FAMHP) for the Quality Control and Release activities of its anticancer agent PDC*lung, intended for the treatment of patients with lung cancer.
PDC*line Pharma is developing a new range of therapeutic anti-cancer vaccine using its versatile PDC*vac platform. This platform uses a plasmacytoid dendritic cell line (PDC*line) which can prime and strongly expand anti-tumor T lymphocytes against any tumorous antigen.
More specifically, this accreditation allows the company to release its batches of PDC*lung vials for treatment of patients, with quality controls ensured by laboratories located at the LabHotel of GIGA.
Since the beginning of 2017, PDC*line Pharma has developed in Liège a Research and Development and Quality Control activity of its innovative therapies within the GIGA LabHotel. The quality control analyses carried out in Liège are based on flow cytometry for identity, purity and safety, and on bioassays for the functionality of the product.
PDC*line Pharma has successfully passed the inspection of the FAMHP. The Agency inspector commented that PDC*line Pharma met the standards of Good Manufacturing Practice (GMP) for GIGA facilities, and for quality control activities related to the PDC*lung product.
This step is a great stride in PDC*line Pharma journey, and supports the rapid progress leading the Phase I / II clinical study, PDC-LUNG-101, expected to start enrolling patients in the 1 st half of 2019.
About PDC*line Pharma
Founded in 2014 as a spin-off of the French Blood Bank (EFS), PDC*line Pharma is a Belgian-French biotech company that develops an innovative class of active immunotherapies for cancers, based on a GMP-grade allogeneic therapeutic cell line of plasmacytoid dendritic cells (PDC*line). PDC*line is much more potent to prime and boost antitumor antigen-specific cytotoxic T-cells, including T cells specific for neoantigens, than conventional DC-based vaccines and is synergistic with checkpoint inhibitors. The technology can be applied to any type of cancer. After a first-in-human phase I feasibility study in melanoma, PDC*line Pharma focuses on the development of a candidate for non-small-cell lung cancer (NSCLC) (PDC*lung) and neoantigens (PDC*Neo). A phase Ib/IIa trial, aimed at evaluating safety and activity with and without anti-PD1, will be initiated with PDC*lung in Q2 2019. The company has a staff of 19, with a seasoned management team. The company so far raised 15M€ including 5,6 M€ in equity from Belgian investors (MeusInvest, InvestSud and SFPI) and several business angels, and 9,3 M€ of non-dilutive money (including grants from the Walloon region, Belgium and French entities)
About PDC*line Pharma’s technology
PDC*line’s biological features provide unique advantages:
- PDC*line is a professional antigen-presenting cell, much more potent than conventional DC in priming and expanding antitumor-specific cytotoxic CD8+ T cells (conventional tumor antigens and neoantigens).
- While allogeneic, PDC*line is not rejected and can be injected several times to boost the immune response.
- PDC*line can easily be produced on a large scale, with a fully mastered and simple manufacturing process (use of bioreactors with synthetic medium without growth, differentiation or activation factors).
- PDC*line is easy to use: after thawing, the same off-the-shelf product is used to treat the whole target population with a cancer type expressing the target antigens.
- PDC*line is very versatile: tumor antigens can be provided by peptide loading, mRNA transfection or retrovirus transduction of PDC*line, and the target population can be extended beyond HLA-A2 (currently used as it is expressed by 50% of Caucasian population) by using other HLAs, either already expressed by PDC*line or added by genetic modification. Moreover, new candidates can be validated for new cancer indications in a few weeks, with ex vivo testing using human PBMC.
- PDC*line synergizes with anti-PD-1 to activate antitumor CD8+ T cells.
