PDC*line Pharma Advances Cancer Vaccine Results at ESMO-IO 2024

Promising Clinical Results for PDC*line Pharma’s Cancer Vaccine

PDC*line Pharma, an innovative biotech company, has presented its primary results from a phase I/II clinical trial focused on PDC*lung01, an advanced therapeutic cancer vaccine. This milestone was reached during the ESMO-IO 2024 conference. The results highlight the significant impact this treatment can have on patients with stage IV Non-Small Cell Lung Cancer (NSCLC) who exhibit high PD-L1 expression, showing exciting clinical benefits when combined with pembrolizumab.

Key Findings from the Phase I/II Trial

The clinical trial, known as PDC-LUNG-101, assessed the safety and effectiveness of PDC*lung01 among a group of 67 NSCLC patients. These individuals were HLA-A02:01 positive and were treated across five European countries. They received a series of six doses of the vaccine either subcutaneously or intravenously, evaluating its efficacy both alone and in conjunction with pembrolizumab.

Breakthrough Immune Response

One of the standout findings from this trial was the significant immune response observed in 56% of the patients. They showed tumor antigen-specific CD8+ T-cell responses, suggesting that PDC*lung01 can effectively stimulate the body's immune system against cancer. This immune activation correlated positively with progression-free survival (PFS), further emphasizing the vaccine's potential therapeutic value.

Impressive Efficacy Metrics

The high-dose cohort (B2) in the trial, which included 42 evaluable patients, reported an objective response rate (ORR) of 55%. This result not only surpassed expectations but also compared favorably against previously established benchmarks in similar trials, such as the KEYNOTE-042 study. Specifically, patients receiving PDC*lung01 in combination with pembrolizumab experienced an 8.9-month median progression-free survival, indicating a marked improvement compared to conventional therapies.

A Focus on Patient Safety

In terms of safety, PDC*lung01 demonstrated a favorable profile with mild side effects mainly categorized as grades 1-2. Notably, only one severe adverse event was recorded, underscoring the vaccine’s tolerability among patients. This aspect is crucial in the context of cancer therapies, where patient safety often poses significant challenges.

Future Directions for PDC*line Pharma

Encouraged by these promising outcomes, PDC*line Pharma is laying the groundwork for a pivotal phase IIb study targeting untreated stage IV NSCLC patients. This study, set to start in the near future, is designed to further evaluate the efficacy of PDC*lung01 when combined with pembrolizumab. If successful, it could lead to a new standard of care for patients suffering from this aggressive form of lung cancer.

CEO's Vision and Company’s Mission

Eric Halioua, the CEO of PDC*line Pharma, expressed enthusiasm for the trial results, remarking on the potential of PDC*lung01 to act as the first of its kind—a cancer vaccine catering specifically to metastatic NSCLC cases with high PD-L1 expression. The company remains committed to exploring further opportunities for their innovative vaccine technology across various cancer types, establishing partnerships to facilitate market introduction.

About PDC*line Pharma

Founded in 2014, PDC*line Pharma focuses on developing cutting-edge cancer immunotherapies harnessing its proprietary PDC*line technology. The company continues to advance its product pipeline, which includes PDC*lung01 for lung cancer and PDC*neo targeting neoantigens. With over €62 million raised to date, PDC*line Pharma collaborates with strategic partners like LG Chem to broaden the clinical availability of their therapies.

Frequently Asked Questions

What is PDC*lung01?

PDC*lung01 is an innovative therapeutic cancer vaccine developed by PDC*line Pharma designed to treat stage IV Non-Small Cell Lung Cancer.

How does PDC*lung01 work?

The vaccine utilizes irradiated human Plasmacytoid Dendritic Cells loaded with tumor antigens to stimulate the immune system, enhancing the body’s defense against cancer cells.

What were the key results from the recent trial?

The trial showed an impressive 55% objective response rate and significant immune responses in treated patients, demonstrating its potential efficacy in cancer treatment.

When will the next phase of trials begin?

PDC*line Pharma is planning to initiate a randomized phase IIb study in 2026 focusing on untreated stage IV NSCLC patients.

What other projects does PDC*line Pharma have?

Aside from PDC*lung01, the company is also developing PDC*neo, which targets neoantigens for cancer treatment, indicating its commitment to expanding therapeutic options.

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