DEVELOPING POWERFUL, SAFE, VERSATILE IMMUNOTHERAPIES

2023 HPV16+ Head and Neck KOL Roundtable

Versamune^®: A New Generation of Cancer Immunotherapies

White Paper

A Simplified Overview of How the Versamune^® Platform Overcomes Key Limitations of Immuno-Oncology

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 (PDS0301) 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.

Wood LV, et al. 2023. HPV16-specific CD4 and CD8 T-cell activation and functionality in patients receiving combination PDS0101 immunotherapy. Presented at: European Society for Medical Oncology Targeted Anticancer Therapies; March 6-8, 2023. Paris, France. Abstract: P44.

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.

Klopp A, et al. 2022. IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers. Presented at: Society for Immunotherapy of Cancer; November 8-12, 2022. Boston, MA. Abstract: 674.

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.

Gandhapudi SK, et al. 2022. Development of targeted T-cell cancer immunotherapies based on a novel enantiomeric cationic lipid that promotes antigen cross-presentation and upregulation of type I interferons. Presented at: American Association of Clinical Research Tumor Immunology and Immunotherapy; October 21-24, 2022. Boston, MA. Abstract: B24.

Shi H, et al. 2022. Infectimune™ enhances antibodies elicited by computational optimized broadly reactive antigen (COBRA) hemagglutinin influenza vaccine. Presented at American Society of Virology Annual Meeting. July 16-20, 2022. Madison, WI. Abstract 3733830.

Weiss J, et al. 2022. PDS0101 a novel Type 1 interferon and CD8+ T cell activating immunotherapy in combination with pembrolizumab in subjects with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). Presented at American Society of Clinical Oncology Annual Meeting. June 3-7, 2022. Chicago, IL. Abstract 6041.

Strauss J, et al. 2022. Phase II evaluation of the combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV16-positive malignancies. Presented at American Society of Clinical Oncology Annual Meeting. June 3-7, 2022. Chicago, IL. Abstract 2518.

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.

Sun W, McCroskery s, Liu WC, Leist SR, Liu Y, Albrecht RA, Slamanig S, Oliva J, Amanat F, Schafer A, Dinnon KH III, Innis BL, Garcia-Sastre A, Krammer F, Baric RS, Palese P. 2020. A Newcastle Disease Virus (NDV) Expressing a Membrane-Anchored Spike as a Cost-Effective Inactivated SARS-CoV-2 Vaccine. Vaccines. 8(4): 771.

Smalley Rumfield C, Pellom ST, Morillon II YM, Schlom J, Jochems C. 2020. Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. J. for ImmunoTherapy of Cancer 8:e000612.

Gandhapudi SK, Ward M, Bush JPC, Bedu-Addo F, Conn G, Woodward JG. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel induction of a Type I IFN response. J Immunol. 202 (12): 3524-3536.

Vasievich EA, Ramishetti S, Zhang Y, Huang L. 2012. Trp2 peptide vaccine adjuvanted with (R)-DOTAP inhibits tumor growth in an advanced melanoma model. Mol Pharmaceutics. 9(2): 261-268.

Vasievich EA, Chen W, Huang L. 2011. Enantiospecific adjuvant activity of cationic lipid DOTAP in cancer
vaccine. Cancer Immunol Immunother. 60(5): 629-638.

Chen W, Yan W, Huang L. 2008. A simple but effective cancer vaccine consisting of an antigen and a
cationic lipid. Cancer Immunol Immunother. 57(4): 517-530.

Yan W, Chen W, Huang L. 2007. Mechanism of adjuvant activity of
cationic liposome: phosphorylation of a MAP kinase, ERK and induction
of chemokines. Molecular Immunology 44(15): 3672-3681.

Vangasseri DP, Cui Z, Chen W, Hokey DA, Falo LD Jr, Huang L. 2006. Immunostimulation of dendritic cell
by cationic liposomes. Mol Membr Biol. 23(5): 385-395.

Zelphati, O., Y. Wang, S. Kitada, J. C. Reed, P. L. Felgner, and J. Corbeil. 2001. Intracellular delivery of proteins with a new lipid-mediated delivery system. J Biol Chem 276: 35103-35110.

Felgner, P. L., T. R. Gadek, M. Holm, R. Roman, H. W. Chan, M. Wenz, J. P. Northrop, G. M. Ringold, and M. Danielsen. 1987. Lipofection: a highly efficient, lipid-mediated DNA-transfection procedure. Proc Natl Acad Sci U S A 84: 7413-7417.

Science

Scientific Presentations and Publications

2023 HPV16+ Head and Neck KOL Roundtable

White Paper