Key Takeaways:
- Successful Enrollment Completion: PDC*line Pharma completes enrolment for four patient cohorts in groundbreaking PDC-LUNG-101 phase I/II clinical trial.
- Innovative Cancer Vaccine Candidate: PDC*lung01 emerges as a promising therapeutic cancer vaccine for Non-Small Cell Lung Cancer (NSCLC).
- Pioneering Immunotherapy Approach: Utilizing a novel class of active immunotherapies, PDC*line Pharma paves the way for advanced cancer treatment.
Introduction: A Leap Forward in Cancer Immunotherapy
PDCline Pharma, a clinical-stage biotech company, has made a significant stride in cancer treatment with the completion of enrolment for its PDC-LUNG-101 phase I/II clinical trial. This trial evaluates the efficacy and safety of PDClung01, a novel therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC).
The PDC-LUNG-101 Clinical Trial: A Detailed Overview
The PDC-LUNG-101 trial, which includes 67 evaluable HLA-A02:01 positive NSCLC patients, is conducted across 17 clinical sites in multiple European countries. The trial’s objectives include assessing the safety, tolerability, immunogenicity, and preliminary clinical activity of PDClung01, both as a single agent and in combination with anti-PD-1 treatment.
Cohort B2: High Dose Exploration
The recently completed Cohort B2 focuses on assessing ‘high dose’ PDC*lung01 in combination with pembrolizumab monotherapy in first-line stage IV NSCLC patients. This cohort includes 45 patients, contributing significantly to the trial’s comprehensive patient data.
Preliminary Results and Patient Safety
Preliminary results from the first three cohorts (A1, A2, and B1) presented at major oncology conferences in 2022 have shown a mild safety profile and promising tumor response. This showcases PDC*lung01’s potential as a safe and effective treatment option for NSCLC.
The Vision of PDC*line Pharma
Under the leadership of global principal investigator Prof. Johan Vansteenkiste, PDCline Pharma aims to address the unmet needs of advanced stage NSCLC patients. The combination of PDClung01 with anti-PD-1 treatment represents a novel approach in enhancing the efficacy of cancer immunotherapy.
Eric Halioua, CEO of PDC*line Pharma, on the Trial’s Progress
CEO Eric Halioua expressed excitement about the full patient enrolment and the anticipated presentation of the interim report, highlighting the promising safety, immunological, and clinical results observed in the B2 cohort.
Dr. Beatrice De Vos, Chief Medical Director, on the Collaborative Effort
Dr. Beatrice De Vos extended gratitude to the investigators and patients involved in the trial, emphasizing the collaborative effort across five countries. She expressed eagerness for the upcoming development phases of the trial.
PDC*lung01: A Potent Therapeutic Agent
PDClung01 consists of irradiated human Plasmacytoid Dendritic Cells (PDCline), loaded with specific peptides to target tumor antigens. This unique formulation is designed to prime and boost the patient’s antitumor cytotoxic CD8+ T-cells, showcasing synergy with anti-PD-1 treatment.
The DSMB’s Confirmation of Safety
The Data and Safety Monitoring Board (DSMB) confirmed the mild safety profile of PDC*lung01, especially at high doses in association with pembrolizumab, reinforcing the vaccine’s potential as a safe therapeutic option.
PDC*line Pharma’s Technological Innovation
PDC*line’s technology stands out with its ability to effectively present antigens and activate antitumor T-cells. The technology is versatile, scalable, and aligns with regulatory compliance, making it a groundbreaking addition to cancer immunotherapy.
PDC*line Pharma: A Leader in Immunotherapy
Founded as a spin-off of the French Blood Bank (EFS), PDC*line Pharma has emerged as a leader in developing active immunotherapies for cancers. The company’s experienced team and significant funding have propelled its innovative approach in cancer treatment.
PDC*line Pharma’s Global Reach
PDCline Pharma’s collaboration with LG Chem Life Sciences for the development and commercialization of PDClung01 in Asian markets underscores its global impact in the fight against cancer.
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