Liège-based biotechnology company PDC*line Pharma reports good interim clinical results from the last cohort of Non-Small Cell Lung Cancer patients in its phase I/II clinical trial. Intermediary results of high dose PDC*lung01 combined with pembrolizumab show mild safety profile, immunological activity and promising tumor response.
Called PDC-lung-01, PDC*Line’s lead product candidate is a therapeutic vaccine against non-small cell lung cancer (NSCLC), the most common lung cancer (80% of cases). Unlike traditional vaccines, which prevent disease, therapeutic vaccines are designed to treat a cancer that is already present and reduce its potential growth. PDC*line targets advanced, metastatic and non-operable cancers in the first line of treatment, in combination with an existing anti-cancer therapy.
First clinical results show immunological activity in a majority of patients
The phase I/II clinical trial was conducted at 17 clinical sites in France, Belgium, Germany, the Netherlands and Poland, and involved 67 patients, either as monotherapy or in combination with Merck's Keytruda, the reference first-line treatment. Preliminary data presented at the annual meeting of the American Association for Cancer Research (AACR) showed that the high-dose vaccine, combined with Keytruda, produced immunological activity in a majority of patients and a promising anti-tumor response in NSCLC, with a moderate safety profile. The final analysis of the clinical trial will be carried out in the third quarter of 2024.
"In the current state of what has been published, these are very good results. And that's why we've been selected for an oral presentation at the AACR in San Diego, alongside other companies like BioNTech", enthuses the company's CEO and co-founder, Eric Halioua. “But you always have to be vigilant, because you are obviously very good as long as there are no others who are better than you. Secondly, we need to confirm the interim data, because what we have presented is 19 of the 45 patients. Finally, we're still in phase I/II, so the next study, a randomized phase II, is going to be important," he continues.
The only company working on a first-line therapeutic vaccine for lung cancer
This next clinical trial should start in the second quarter of 2025 and include around 200 patients, according to the CEO. At present, PDC*line is the only company working on a first-line therapeutic vaccine for lung cancer. Though other approaches based on different therapeutic modalities are currently in clinical development, PDC*Line has the advantage of having very good safety data in their clinical study.
“Other products often have significant side-effects. The more exogenous products you add, the more toxicities will accumulate. With vaccines, it is the immune system itself that is stimulated to break down and eat the tumor. The safety of cancer vaccines is very good. In fact, we can see that in the healthcare sector, there is a great deal of momentum around cancer vaccines", explains Halioua.
Towards an autologous approach in colorectal cancer?
PDC*Line Pharma is also working on a second therapeutic vaccine project, this time targeting colorectal cancer. This initiative is part of the innovation partnership for advanced therapies launched by the Walloon Region a few months ago. In this project, PDC*line Pharma has joined forces with the Walloon sequencing and biopsy specialist OncoDNA, the technology company salamanderU and the research institutes UCLouvain-IREC and ULB-BCTL.
"The lung cancer vaccine is a ready-to-use vaccine. The colorectal cancer vaccine is personalized medicine," adds Eric Halioua. "We're going to look for specific mutations in the patient's tumor that are much more immunogenic than general mutations. This means sampling the tumor, sequencing it and identifying immunogenic peptides, and then synthesizing them to produce a personalized vaccine ”.
