PDC*lung / PDC line Pharma, LG Chem - LARVOL DELTA

Innovative therapeutic cancer vaccine PDC∗lung01 with or without anti-PD-1: an open-label, dose-escalation phase I/II study in non-small-cell lung cancer. (PubMed, ESMO Open) - "PDC∗lung01 was immunogenic and had a manageable safety profile in all cohorts and met the predefined clinical objectives when combined with anti-PD-1 in metastatic NSCLC. Median PFS was positively correlated with antigen-specific T-cell expansions."

Journal • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BIRC5 • CTAG1B • MAGEA4 • MUC1 • PD-L1

Impact of anti-PD-1 Treatment on DSA Generation in Cancer Patients (EFI 2025) - P1/2 | "PDC*lung01 product, based on an irradiated plasmacytoid dendritic cell line (PDC*line) loaded with 7 HLA-A*02:01-restricted tumour peptides, was injected intravenously and subcutaneously (140 million cells) on 6 occasions one week apart in stage II/IIIA (Cohort A (n = 10), monotherapy) or stage IV (Cohort B (n = 42); in combination with pembrolizumab) patients. In addition, we showed that PDC*line cells were resistant to complement-dependent killing mediated by the patient's anti-HLA Ab independently of the cohorts, due to a high expression of membrane-bound complement-regulatory proteins. Taken together, these results show that anti-PD-1 treatment does not appear to alter the specificities and dynamics of DSA induced by a cancer cell vaccine in lung cancer patients."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HLA-A • HLA-DPB1 • HLA-DRB1

Humoral response in lung cancer patients treated with a plasmacytoid dendritic allogeneic cell line-based cancer vaccine in combination with or without anti-PD1 (CIMT 2025) - P1/2 | "PDC*lung01 is injected 6 times intravenously and subcutaneously at two dose levels, 14 million, or 140 million cells in stage II/IIIA (cohort A1 & A2, monotherapy) or stage IV (cohort B1 & B2; in combination with pembrolizumab) patients. Importantly, anti-PD1 treatment does not seem to modify the nature, the functionality and the dynamics of anti-HLA IgG response. Altogether, these results show the innocuity and the absence of deleterious effect of anti-HLA Ab on allogeneic PDC*line cells used as a cancer vaccine platform."

Combination therapy • Preclinical • Lung Cancer • Oncology • Solid Tumor • CD46 • CD55 • CD59 • HLA-A

Primary analysis of safety, efficacy and immunogenicity of the therapeutic cancer vaccine PDC*lung01 with or without pembrolizumab in NSCLC: A multicenter phase I/II study (ELCC 2025) - P1/2 | "PDC*lung01 combined with pembrolizumab provides meaningful clinical activity, with a mild safety profile, and a confirmed correlation between the immune response intensity and the PFS."

Clinical • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • HLA-A • PD-L1

PDC*line Pharma Presents Primary Clinical Results From Phase I/II Trial on PDC*lung01 Cancer Vaccine at ESMO-IO 2024 (Businesswire) - P1/2 | N=73 | NCT03970746 | Sponsor: PDC*line Pharma SAS | "In the high-dose (B2) cohort consisting of 42 evaluable patients, PDC*lung01 combined with pembrolizumab achieved a confirmed objective response rate (ORR) of 55% (80% CI 43.7%; 65.4%), surpassing the trial's predefined success criteria (15% absolute increase compared to 39% for external comparator KEYNOTE-042). The Best Overall Response (BOR) according to RECIST 1.1 included 23 confirmed Partial Response (55%) and 12 Stable Disease (29%). Median progression-free survival (mPFS) was 8.9 months, a 36% improvement (2.4 months longer) compared to pembrolizumab alone (KEYNOTE-042)....Further data from the trial will become available at the end of 2025, once all patients have reached two years of follow-up....PDC*line Pharma is preparing a randomized phase IIb study in untreated stage IV NSCLC (and PD-L1 ≥50%) in combination with pembrolizumab, with initiation planned in 2026."

New P2b trial • P1/2 data • Non Small Cell Lung Cancer

Phase I/II trial evaluating the innovative therapeutic cancer vaccine PDC*lung01 in combination with anti-PD-1 in patients (pts) with untreated stage IV non-small cell lung cancer (ESMO-IO 2024) - P1/2 | "Background PDC*lung01 (IMP) is an innovative therapeutic cancer vaccine, synergistic with anti-PD-1, based on an irradiated plasmacytoid dendritic cell line loaded with HLA-A*02:01-restricted peptides (NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1, Survivin and Melan-A), able to prime and expand antigen-specific CD8+ T cells in vitro and in vivo.Methods This phase I/II study (NCT03970746) enrolled HLA-A*02 positive NSCLC pts in 4 cohorts: 2 cohorts with IMP in resected stage II/IIIA in adjuvant setting following SoC (low A1 and high dose A2) and 2 cohorts with IMP plus pembrolizumab 200 mg q3w in untreated stage IV NSCLC with PD-L1≥50% and no targetable driver mutation (low B1 and high-dose B2). PDC*lung01 is biologically active inducing strong immune response in a significant proportion of pts. Table: 119MO B2 cohort: Efficacy parameters B2 cohort (Designed per protocol population) N=42 Keynote-042 De Castro, JCO 2022 (PD-L1≥50% cohort) N=299 Confirmed ORR, N..."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BIRC5 • CD8 • CTAG1B • HLA-A • MAGEA4 • MLANA • MUC1 • PD-L1

PDC-LUNG-101: Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (clinicaltrials.gov) - P1/2 | N=73 | Active, not recruiting | Sponsor: PDC*line Pharma SAS | Trial primary completion date: Dec 2025 ➔ Jul 2024

Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • HLA-A

Evaluation of the immune response using TCR repertoire analysis in patients with non-small cell lung cancer treated with a PDC*line cell-based cancer vaccine in combination or not with an anti-PD-1 (CIMT 2024) - P1/2 | "This strategy enabled us to clearly identify some CD8+ T cells clonotypes presenting significant variations over time in the patients assessed. We will present this strategy and the characterization of this evolution in patients receiving PDC*lung01 in combination or not with pembrolizumab."

Clinical • Infectious Disease • Influenza • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • CD8 • HLA-A • TRB

Evaluation of the immune response using TCR repertoire analysis in patients with non-small cell lung cancer treated with a PDC*line cell-based cancer vaccine in combination or not with an anti-PD-1 (CIMT 2024) - P1/2 | "This strategy enabled us to clearly identify some CD8+ T cells clonotypes presenting significant variations over time in the patients assessed. We will present this strategy and the characterization of this evolution in patients receiving PDC*lung01 in combination or not with pembrolizumab."

Clinical • Infectious Disease • Influenza • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • CD8 • HLA-A • TRB

Preliminary clinical results of a therapeutic cancer vaccine PDC*lung01 in combination with anti-PD-1 in patients (pts) with stage IV NSCLC (AACR 2024) - "Background PDC*lung01 (IMP) is a therapeutic cancer vaccine based on an irradiated plasmacytoid dendritic cell line loaded with HLA-A*02:01-restricted peptides (NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1, Survivin and Melan-A), able to prime and expand peptide-specific CD8+ T cells in vitro and in vivo, and is synergistic with anti-PD-1.Methods In this phase I/II study, HLA-A*02 positive NSCLC pts were enrolled in 4 cohorts: resected stage II/IIIA in adjuvant setting treated with low dose (A1) or high dose (A2) of IMP following SOC; or untreated stage IV NSCLC with measurable disease, PD-L1≥50% and no targetable driver mutation, treated with low dose (B1) or high dose (B2) of IMP in combination to pembrolizumab 200mg q3w, continuously. Thirteen pts experienced a serious AE, of which 3 were considered causally related to the IMP.Conclusions The BOR, ORR, DCR, PFS, duration of response and safety of PDC*lung01 in combination with anti-PD-1 showed encouraging signals..."

Clinical • Combination therapy • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BIRC5 • CD8 • CTAG1B • HLA-A • MAGEA4 • MLANA • MUC1 • PD-L1

PDC*lung01: An innovative therapeutic cancer vaccine induces specific immune responses in combination with anti- PD-1 treatment in patients with non-small cell lung cancer (AACR 2024) - P1/2 | "The TME features will also be illustrated. To conclude, treatment with PDC*lung01 induces an anti-tumor immune response in a significant number of patients which appears to be enhanced by the combination with pembrolizumab."

Clinical • Combination therapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BIRC5 • CD4 • CD8 • CTAG1B • HLA-A • ICAM1 • IL2RA • MAGEA4 • MUC1

AACR 2024: PDC line Pharma Presents Interim Clinical Results From Last Cohort of Patients in Phase I/II Trial with PDC*lung01 Cancer Vaccine (Businesswire) - P1/2 | N=73 | NCT03970746 | Sponsor: PDC*line Pharma SAS | "PDC*line Pharma...announces the interim results from the last cohort of patients in its phase I/II clinical trial (PDC-LUNG-101, NCT03970746) with PDC*lung01....With the 19 evaluable patients, the median follow-up at the database lock was 12.5 months (95% CI: 9.9, 14.2). The Best Objective Response (BOR) included 12 Partial Response (63.2%) and 7 Stable Disease (36.8%) with ORR of 63.2% (80% CI 45.9 - 78.2) and a Disease Control Rate (DCR) of 94.7% (80% CI: 81, 99.4). The 9-month PFS according to the Kaplan-Meier estimate was 52.1% (80% CI 36.5 - 65.56). The median PFS was 10.9 months (95% CI 5.6 – Not Reached). The median duration of response was 9.49 months (95% CI: 4.4, -)."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Preliminary clinical results of a therapeutic cancer vaccine PDC*lung01 in combination with anti-PD-1 in patients (pts) with stage IV NSCLC (ELCC 2024) - No abstract available

Clinical • Combination therapy • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

PDC*line Pharma Completes Enrolment of Four Cohorts of Patients in PDC-LUNG-101 Phase I/II Clinical Trial (Businesswire) - "PDC*line Pharma...announces 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). 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...'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'..."

Enrollment closed • Non Small Cell Lung Cancer

PDC-LUNG-101: Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (clinicaltrials.gov) - P1/2 | N=73 | Active, not recruiting | Sponsor: PDC*line Pharma SAS | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2025 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • HLA-A

Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (clinicaltrials.gov) - P1/2 | N=64 | Recruiting | Sponsor: PDC*line Pharma SAS | Trial completion date: Aug 2024 ➔ Sep 2025 | Trial primary completion date: Aug 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • HLA-A

Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (clinicaltrials.gov) - P1/2 | N=64 | Recruiting | Sponsor: PDC*line Pharma SAS | Trial primary completion date: Aug 2022 ➔ Aug 2024

Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • HLA-A

The therapeutic cancer vaccine PDC*lung01 induces immune responses with or without anti- PD-1 treatment in patients with non-small cell lung cancer (ESMO-IO 2022) - P1/2 | "Detailed findings will be graphically presented at the meeting. Conclusions Treatment with PDC*lung01 induces an anti-tumour immune response in a significant number of patients which appears to be enhanced by the combination with pembrolizumab."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BIRC5 • CD4 • CTAG1B • HLA-A • ICAM1 • IL2RA • MAGEA4 • MUC1 • PD-L1

PDC*line Pharma Presents First Immunological Results From Phase I/II Trial With PDC*lung01 at ESMO-IO 2022 (Businesswire) - P1/2 | N=64 | NCT03970746 | Sponsor: PDC*line Pharma SAS | "The preliminary data was presented today at a poster display session at the ESMO Immuno-Oncology Congress 2022 (ESMO-IO)... Results showed that in a large proportion of subjects PDC*lung01, in monotherapy and combined with pembrolizumab, induces a significant expansion of effector memory CD8+ T-cells specific to the tumor peptides carried by PDC*lung01....A specific and memory CD8+ T-cell response was induced against the antigens from which are derived the peptides loaded on PDC*lung01 in 33%, 45% and 67% of evaluable patients in, respectively, A1 (six patients), A2 (eleven patients) and B1 (six patients) cohorts....The best overall response in six evaluable patients of the B1 cohort, according to RECIST criteria, included four partial responses, one stable disease and one progressive disease."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Open-label, dose escalation, phase I/II study to assess safety, tolerability, immunogenicity and preliminary clinical activity of the therapeutic cancer vaccine PDC*lung01 with or without anti-programmed death-1 (PD-1) treatment in patients with non-small cell lung cancer (NSCLC) (ESMO 2022) - P1/2 | "Clinical trial identification NCT03970746. Interestingly, a very promising ORR was observed in combination with pembrolizumab in first line setting in stage IV patients. Updated results will be presented."

Clinical • IO biomarker • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BIRC5 • CD8 • CTAG1B • HLA-A • MAGEA4 • MLANA • MUC1 • PD-L1

PDC*line Pharma Presents First Clinical Results From Phase I/II trial With PDC*lung01 at ESMO 2022 (Businesswire) - P1/2 | N=64 | PDC-LUNG-101 (NCT03970746) | Sponsor: PDC*line Pharma SAS | "PDC*line Pharma...announces the first results of PDC-LUNG-101 phase I/II clinical trial (NCT03970746) with PDC*lung01....The preliminary data was presented today at a poster discussion session at the 2022...ESMO Annual Meeting. This showed that PDC*lung01, in monotherapy and combined with pembrolizumab, evokes an acceptable safety profile, immunological activity and a promising tumour response in Non-Small Cell Lung Cancer, with the caveat of low numbers at the present time....The best overall response in six evaluable patients of the B1 cohort, according to RECIST criteria, included four partial responses, one stable disease and one progressive disease, leading to an objective response rate of 66.7% (80% CI 33.3% - 90.7%). Progression Free Survival at nine months for the same patient population is 66.7% (80% CI 36.4% - 85%)."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

[VIRTUAL] An open-label, dose escalation, phase I/II study to assess safety, tolerability, immunogenicity and preliminary clinical activity of the therapeutic cancer vaccine PDC*lung01 with or without anti-programmed death-1 (PD-1) treatment in patients with non-small cell lung cancer (NSCLC) (ELCC 2021) - P1/2 | "Additional clinical endpoints of cohort B2 are response rate and 9-month progression-free survival per RECIST v1.1 and iRECIST. Patient enrolment is ongoing."

Clinical • IO biomarker • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BIRC5 • CD8 • CTAG1B • MAGEA4 • MLANA • MUC1 • PD-L1

Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (clinicaltrials.gov) - P1/2; N=64; Recruiting; Sponsor: PDC*line Pharma SAS; Trial completion date: Aug 2022 ➔ Aug 2024; Trial primary completion date: Nov 2020 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8

PDCline Pharma doses first patient with high dose in ongoing PDC-LUNG-101 clinical trial (PharmiWeb) - “PDC*line Pharma…announces today that two new cohorts have been opened in the PDC-LUNG-101 phase I/II clinical trial with its therapeutic cancer vaccine candidate PDC*lung01 for non-small cell lung cancer (NSCLC) (NCT03970746)…one assessing PDC*lung01 as a single agent in adjuvant setting at 'high dose', which already includes one patient, and one assessing PDC*lung01 at 'low dose' added to the pembrolizumab monotherapy in first line Stage IV setting....'We have been very active in the clinical trial and are pleased to begin patient dosing in the A2 cohort of the PDC*line Pharma phase I/II trial at our clinical center,' said Pr. Jaafar Bennouna...”

Media quote • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology

PDC*line Pharma announces the administration of a first patient with its therapeutic cancer vaccine candidate (PDC*lung01) targeting non-small cell lung cancer (Businesswire) - "PDC*line Pharma...announces...that the first patient was dosed with its innovative medicinal product candidate PDC*lung01 in a phase I/II trial in non-small cell lung cancer (NSCLC). This patient is under the supervision of Dr. Anne Sibille, principal investigator for the Liege University Hospital (Belgium)."

Enrollment open