On December 6, 2023 PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancers, reported completion of enrolment of the fourth cohort of patients in its PDC-LUNG-101 phase I/II clinical trial (NCT03970746) with PDC*lung01, the company’s therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC) (Press release, PDC Line Pharma, DEC 6, 2023, View Source [SID1234638213]). This cohort, B2, was designed to assess PDC*lung01 at ‘high dose’, added to pembrolizumab in monotherapy in a first-line stage IV setting. It includes 45 patients.

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The objectives of the phase I/II trial (PDC-LUNG-101) were to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC patients. The trial was conducted at 17 clinical sites in France, Belgium, Germany, the Netherlands and Poland. PDC*lung01 has been administered to a total of 67 evaluable HLA-A*02:01 positive NSCLC patients, at two dose levels in two different settings:

As a single agent to patients in the adjuvant setting (A1: Low Dose, A2: High Dose)
Added to standard of care anti-PD-1 monotherapy to patients with first-line stage IV (metastatic) NSCLC disease with a PD-L1 tumor proportion score of ≥50% and no targetable driver mutation (B1: Low Dose, B2: High Dose)
Safety and clinical activity results of the first three cohorts of patients (A1, A2 and B1), which included a total of 22 patients, were presented at ESMO (Free ESMO Whitepaper) 2022 in September 2022 in Paris (France) and ESMO (Free ESMO Whitepaper)-IO in December 2022 in Geneva (Switzerland). Preliminary results with PDC*lung01 in monotherapy and at low dose with pembrolizumab show a mild safety profile, immunological activity and promising tumor response in Non-Small Cell Lung Cancer.

"It is a privilege to be the global principal investigator in the PDC*lung01 cancer vaccine program. I am thrilled that we have reached this significant milestone in its development. Most advanced stage NSCLC patients eligible for pembrolizumab as a monotherapy in the first line of treatment still show high unmet need. It makes sense to combine anti-PD-1, which works to unleash anti-tumor cytotoxic T cells, with PDC*line to prime and boost T-cells. PDC*lung01 is the only therapeutic vaccine currently in development in this setting, providing great hope for patients," said Prof Johan Vansteenkiste, emeritus professor in respiratory oncology at KU Leuven in Belgium and chair of the Data and Safety Monitoring Board (DSMB).

"We are pleased to have achieved full patient enrolment in the PDC-LUNG-101 clinical trial, a key step in the product’s clinical development and another important milestone for PDC*line Pharma. We look forward to presenting our interim report on the clinical trial at international conferences next year including the promising safety, immunological and clinical results we have observed in the first 19 evaluable patients of the B2 cohort," said Eric Halioua, CEO of PDC*line Pharma.

"I would like to extend my gratitude to the investigators and patients across the five countries included in our clinical trial. Their commitment has been invaluable. We eagerly anticipate the next steps in our development process and look forward to continuing our collaboration with all the trial sites," said Dr. Beatrice De Vos, chief medical director at PDC*line Pharma.

PDC*lung01 is made of irradiated human Plasmacytoid Dendritic Cells (PDC*line), loaded with HLA-A*02:01-restricted peptides, derived from NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1 and Survivin tumor antigens. It is administered weekly by a subcutaneous and intravenous route, in six consecutive doses. PDC*line is a potent professional antigen-presenting cell line that primes and boosts the patient’s antitumor cytotoxic CD8+ T-cells and is synergistic in vitro with anti-Programmed Death-1 (PD-1) treatment.

In October 2023, the Data and Safety Monitoring Board (DSMB) confirmed the mild safety profile of PDC*lung01 at high dose in association with pembrolizumab in the B2 cohort.