DUBLIN – PDC*line Pharma SAS could earn up to €108 million (US$122.7 million) in up-front and milestone payments from a license and option agreement with LG Chem Ltd. for its cell-based cancer vaccine, PDC*lung, which is in development for non-small-cell lung cancer.

Seoul, South Korea-based LG Chem is acquiring a license to the product that covers South Korea initially, as well as an exclusive option for other Asian countries, while Liège, Belgium-based PDC*line retains rights for the rest of the world. It would receive royalties on whatever sales LG Chem generates.

The deal represents important validation for PDC*line as it embarks on its first company-sponsored clinical trial of the allogeneic human-leukocyte-antigen (HLA)-matched cell therapy, which it hopes to start later this year.

"We have submitted an IND file to France and Belgium," CEO Eric Halioua told BioWorld Asia. "We are awaiting an approval from the regulatory authorities." That could come by the end of the second quarter – it has already received cGMP validation for its manufacturing process.

PDC*line Pharma, a 2014 spinout from the l'Etablissement Français du Sang (EFS), the French national blood transfusion service, is developing a proprietary cell line of plasmacytoid dendritic cells (PDCs) that combine professional antigen presentation with potent CD8-positive cytotoxic T lymphocyte (CTL) activation. Although the cell line is immunologically silent, it is HLA-restricted, having been originally isolated from a patient with an HLA-A*0201 genotype. That covers about 50 percent of Caucasians, about 30 to 40 percent of the U.S. population and about 20 to 25 percent of the Asian population, Halioua said. "We know we can add an additional HLA to the cell line," he said.

PDC*lung comprises the PDC line pulsed with six HLA-A*02:01-restricted peptides derived from common lung cancer antigens, including Mage family members and Muc1. The cells are also exposed to gamma irradiation, which stops proliferation without affecting their biological function.

The PDC*line therapy has already been tested in patients. Prior to the company's formation, its scientific founder and chief scientific officer, Joel Plumas, conducted a feasibility study in nine melanoma patients. "We decided to focus on lung cancer – the unmet need is bigger," Halioua said.

The forthcoming trial will recruit 66 patients. It will test low and high doses of the cell therapy, both as a monotherapy and in combination with Keytruda (pembrolizumab), the PD-1 inhibitor marketed by Merck & Co. Inc., of Kenilworth, N.J. Preliminary data could become available in the first half of 2020.

LG Chem will undertake its own clinical trial in South Korea. PDC*line Pharma is also in preclinical development with a version of the vaccine based on patients' neoepitopes.

In the long term, PDC*line is positioning its lung cancer vaccine as a combination therapy to boost patient responses to PD-1 inhibitor therapy. It has already observed synergy in ex vivo experiments conducted with blood samples from lung cancer and melanoma patients, Halioua said.

It's almost a decade since Dendreon Corp. (now part of Nanjing, China-based Sanpower Group Co. Ltd.) gained FDA approval for treating prostate cancer with Provenge (sipuleucel-T), an autologous dendritic cell therapy that was difficult to manufacture and provided modest survival benefits. The product never fulfilled the extravagant sales forecasts that heralded its approval, even if it has managed to carve out a small market niche. (See BioWorld Today, Jan. 12, 2017.)

PDC*lung is a different proposition, because of its allogenicity, which eliminates costly individualized manufacturing processes, while ensuring greater batch-to-batch consistency. Its production is straightforward. "The manufacturing process takes two weeks," Halioua said. Whether it will pass muster in terms of its ability to prime and boost the immune response against cancer is still an open question – but not for much longer.

PDC*line has raised €17 million since its formation, including €7.6 million in equity and loans from a consortium of Belgian investors and €9.3 million in grant funding from the Walloon region in Belgium and from other Belgian and French agencies. It aims to close an €11 million financing round this year, part of which is already secured. The present deal should help its completion.

"This license deal was an important milestone," Halioua said.