DEVELOPING POWERFUL, SAFE, VERSATILE IMMUNOTHERAPIES

A Clinical Trial Combining a Tumor Targeting Immunocytokine (PDS01ADC) and Enzalutamide

IMMUNOCERV 2024 ASTRO Presentation

ESMO poster

2023 HPV16+ Head and Neck KOL Roundtable

Floudas et al. 2025: Novel Combination Immunotherapy and Clinical Activity in Patients With HPV-Associated Cancers
A Nonrandomized Clinical Trial. JAMA Oncol. doi:10.1001/jamaoncol.2024.6998

Seo et al. 2025: Human Papilloma Virus Circulating Cell-Free DNA Kinetics in Patients with Cervical Cancer Undergoing Definitive
Chemoradiation. Clin Cancer Res 2025;31:697–706; doi: 10.1158/1078-0432.CCR-24-2343

Minnar CM, Lui G, Gulley JL, Schlom J and Gameiro SR (2024) Preclinical and clinical studies of a tumor targeting IL-12 immunocytokine. Front. Oncol. 13:1321318. doi: 10.3389/fonc.2023.1321318

Harrington K, et al. 2023. Polyfunctional HPV16-Specific T cell responses in subjects receiving PDS0101 and pembrolizumab combination treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). Presented at European Society for Medical Oncology (ESMO). October 20-24, 2023. Madrid, Spain. Abstract Number: 924P.

Madan R, et al. 2023. Combining an IL-12-based Immunocytokine (PDS01ADC) with Docetaxel in Metastatic Prostate Cancer: Preliminary Safety and Immune Data. Presented at the Annual Meeting of the International Cytokine & Interferon Society. October 15-18, 2023. Athens, Greece. Abstract Number: 249.

Seo A, et al. 2023. HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation. Presented at American Society for Therapeutic Radiology and Oncology. October 1-4, 2023. San Diego, California. Abstract Number: 55593.

Allen J, et al. 2023. Influenza pre-immune ferrets vaccinated with computationally optimized recombinant HA proteins generate sero-protective antibody responses against H1N1 and H3N2 viruses from the last decade. Presented at European Scientific Working Group on Influenza Annual Meeting. September 17-20, 2023. Valencia, Spain. Abstract Number: SCS09.

Price KAR et al. 2023. Safety and efficacy of immune checkpoint inhibitor (ICI) naïve cohort from study of PDS0101 and pembrolizumab in HPV16-positive head and neck squamous cell carcinoma (HNSCC). Presented at American Society of Clinical Oncology Annual Meeting. June 2-6, 2023. Chicago, IL. Abstract 6012.

Toney NJ, Gatti-Mays ME, Tschernia NP, Strauss J, Gulley JL, Schlom J, Donahue RN. Immune correlates with response in patients with metastatic solid tumors treated with a tumor targeting immunocytokine NHS-IL12. International Immunopharmacology. 2023. 116; 109736. ISSN 1567-5769.

Henson TR, Richards KA, Gandhapudi SK, Woodward JG, Sant AJ. R-DOTAP Cationic Lipid Nanoparticles Outperform Squalene-Based Adjuvant Systems in Elicitation of CD4 T Cells after Recombinant Influenza Hemagglutinin Vaccination. Viruses. 2023; 15(2):538.

Gandhapudi SK, Shi H, Ward MR, Bush JP, Avdiushko M, Sundarapandiyan K, Wood LV, Dorrani M, Fatima A, Dervan J, Bedu-Addo F, Conn G, Ross TM, Woodward JG. 2023. Recombinant Protein Vaccines Formulated with Enantio-Specific Cationic Lipid R-DOTAP Induce Protective Cellular and Antibody-Mediated Immune Responses in Mice. Viruses; 15(2):432.

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Goswami M, et al. 2022. Immune correlates associated with clinical benefit in patients with checkpoint refractory HPV-associated malignancies treated with triple combination immunotherapy. Presented at: Society for Immunotherapy of Cancer; November 8-12, 2022. Boston, MA. Abstract: 695.

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Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: American Society of Clinical Oncology 2021 Annual Meeting; June 4-8, 2021; Virtual. Abstract: 2501.

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