PDC* therapeutic vaccine clears first hurdle

Encouraging new clinics for Liege biotech PDK*line Pharma, specializes in immuno-oncology: Its therapeutic vaccine candidate to treat lung cancer has received its first positive results in human trials.

Called PDC-lung-01, this product candidate is a therapeutic vaccine against non-small cell lung cancer (NSCLC), the most common lung cancer (80% of cases). Unlike traditional vaccines that prevent disease, therapeutic vaccines are intended for treat cancer that is already present and reduce its potential growth. The PDC* line primarily targets cancers that are already advanced, metastatic, and unresectable, in combination with existing cancer treatments.

A phase I/II clinical trial was conducted. in 17 clinical sites in France, Belgium, Germany, the Netherlands and Poland, in 67 patients 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) shows that high doses of the vaccine in combination with Keytruda produce immunological activity in most patients. and promising antitumor response in NSCLC with a moderate safety profile. The final analysis of the clinical trial will be conducted in the third quarter of 2024.

“Given the current state of published materials, these are very good results. And that’s why.“We were selected to give an oral presentation at the AACR conference in San Diego along with other companies such as BioNTech.”, says CEO and co-founder of the company Eric Halioua. But you always need to be vigilant, because it is obvious that you are very good until there are others better than you. We then need to confirm the interim data because we have presented 19 of the 45 patients. Finally, we are still in phase I/II, so the next trial, a randomized phase II trial, will be important,” he continues.

The next clinical trial is scheduled to begin in the second quarter of 2025 and enroll approximately 200 patients. according to the CEO. Currently, PDC*line is the only company working on a first-line therapeutic vaccine against lung cancer. On the other hand, there are other approaches based on various therapeutic methods in clinical development, for example, the so-called “anti-Tigit”.

Which doesn’t bother Eric Halioua. “Lung cancer is so common that there is a place. In addition, if we confirm our results, we will have the advantage of very good safety data in our clinical trial. This is not the case with other drugs, which often have serious side effects. The more exogenous products you add, the more toxicity will accumulate. In vaccination approaches, the immune system itself is stimulated, which degrades and eats the tumor. The safety of cancer vaccines is very high. We are also seeing significant dynamism around cancer vaccines in the health sector.”

The Liege biotech company, based in Legiapark and employing 44 people, is itself working on a second project to create a therapeutic vaccine. targeting colorectal cancer. This is an initiative that is part of an innovative partnership for innovative treatments. which the Walloon region launched a few months ago. PDC*line Pharma has joined forces on this project with the Walloon sequencing and biopsy specialist OncoDNA, the technology company salamanderU and the research institutes UCLouvain-IREC and ULB-BCTL.

“The lung vaccine is a ready-to-use vaccine. The fight against colorectal cancer is personalized medicine.”– Eric Haliua further clarifies. “We’re going to look for specific mutations in a patient’s tumor that will be much more immunogenic than common mutations. This means taking a tumor, sequencing it and identifying immunogenic peptides, then synthesizing them to create a personalized vaccine. It is clear that this will be much more difficult and expensive. Indeed, there must be an extremely attractive benefit to justify the prices of these products.”