Phase I Clinical Study for Validation of Fimaporfin-Based Photochemical Internalisation: A Novel Technology for Enhancing Cellular Immune Responses Important for Therapeutic Effect of Peptide-and Protein-Based Vaccines

Selbo, Pål Kristian; Janetzki, Sylvia; Welters, Marij J.P.; Håkerud, Monika; Nedberg, Anne Grete; Edwards, Victoria Tudor; Olivecrona, Hans; Burg, Sjoerd H. van der; Otterhaug, Tone

doi:10.1093/annonc/mdz451.018

Cited by 4 publications

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“…The primary objective was to study the incidence of AEs after a single administration of the photosensitizer and light. The first results thereof were presented at the ESMO Immuno-Oncology Congress in December 2019 [92]. The induction of HPV-specific immune response in blood showed an increase in the number of healthy donors with HPV-specific CD4+ and CD8+ T-cell responses to PCI-based vaccination compared to baseline levels.…”

Section: Pci In Immunotherapymentioning

confidence: 99%

Photochemical Internalization: Light Paves Way for New Cancer Chemotherapies and Vaccines

Šošić

Selbo

Kotkowska

et al. 2020

Cancers

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Photochemical internalization (PCI) is a further development of photodynamic therapy (PDT). In this report, we describe PCI as a potential tool for cellular internalization of chemotherapeutic agents or antigens and systematically review the ongoing research. Eighteen published papers described the pre-clinical and clinical developments of PCI-mediated delivery of chemotherapeutic agents or antigens. The studies were screened against pre-defined eligibility criteria. Pre-clinical studies suggest that PCI can be effectively used to deliver chemotherapeutic agents to the cytosol of tumor cells and, thereby, improve treatment efficacy. One Phase-I clinical trial has been conducted, and it demonstrated that PCI-mediated bleomycin treatment was safe and identified tolerable doses of the photosensitizer disulfonated tetraphenyl chlorin (TPCS2a). Likewise, PCI was pre-clinically shown to mediate major histocompatibility complex (MHC) class I antigen presentation and generation of tumor-specific cytotoxic CD8+ T-lymphocytes (CTL) and cancer remission. A first clinical Phase I trial with the photosensitizer TPCS2a combined with human papilloma virus antigen (HPV) was recently completed and results are expected in 2020. Hence, photosensitizers and light can be used to mediate cytosolic delivery of endocytosed chemotherapeutics or antigens. While the therapeutic potential in cancer has been clearly demonstrated pre-clinically, further clinical trials are needed to reveal the true translational potential of PCI in humans.

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Section: Pci In Immunotherapymentioning

confidence: 99%

Photochemical Internalization: Light Paves Way for New Cancer Chemotherapies and Vaccines

Šošić

Selbo

Kotkowska

et al. 2020

Cancers

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“…Furthermore, the authors demonstrated the presence of a strong increase (greater than 10-fold increase in the median percentage) in HPV-directed CTLs in mice vaccinated with PCI and the HPV16 E7 peptide compared to mice vaccinated with the HPV16 E7 peptide alone [ 116 ]. In a first phase I study (NCT02947854) [ 117 ], the fimaVacc vaccine, combining PCI therapy, a TLR agonist, and an HPV16 E7 peptide, was well tolerated in healthy participants. ELISpot and flow cytometry demonstrated the presence of CD4+- and CD8+-specific HPV T cells following vaccination.…”

Section: Challenges and Future Perspectives Of Vaccines In Hnsccmentioning

confidence: 99%

Vaccine-Based Immunotherapy for Head and Neck Cancers

Beyaert

Machiels

Schmitz

2021

Cancers

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In 2019, the FDA approved pembrolizumab, a monoclonal antibody targeting PD-1, for the first-line treatment of recurrent or metastatic head and neck cancers, despite only a limited number of patients benefiting from the treatment. Promising effects of therapeutic vaccination led the FDA to approve the use of the first therapeutic vaccine in prostate cancer in 2010. Research in the field of therapeutic vaccination, including possible synergistic effects with anti-PD(L)1 treatments, is evolving each year, and many vaccines are in pre-clinical and clinical studies. The aim of this review article is to discuss vaccines as a new therapeutic strategy, particularly in the field of head and neck cancers. Different vaccination technologies are discussed, as well as the results of the first clinical trials in HPV-positive, HPV-negative, and EBV-induced head and neck cancers.

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“…The clinical trial found the combination to be safe, and it enhanced the T-cell response to HPV antigens. 156 A recently completed Phase I study (NCT02526316) combined the peptide vaccine P6_37-63 with chemotherapy in order to modulate the effect of the vaccine. The results have not yet been presented.…”

Section: Therapeutic Hpv Vaccines In Combination With Other Therapeutmentioning

confidence: 99%

<p>Therapeutic Vaccines for HPV-Associated Malignancies</p>

Rumfield

Roller

Pellom

et al. 2020

ITT

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Human papillomavirus (HPV)-related malignancies are responsible for almost all cases of cervical cancer in women, and over 50% of all cases of head and neck carcinoma. Worldwide, HPV-positive malignancies account for 4.5% of the global cancer burden, or over 600,000 cases per year. HPV infection is a pressing public health issue, as more than 80% of all individuals have been exposed to HPV by age 50, representing an important target for vaccine development to reduce the incidence of cancer and the economic cost of HPVrelated health issues. The approval of Gardasil ® as a prophylactic vaccine for high-risk HPV 16 and 18 and low-risk HPV6 and 11 for people aged 11-26 in 2006, and of Cervarix ® in 2009, revolutionized the field and has since reduced HPV infection in young populations. Unfortunately, prophylactic vaccination does not induce immunity in those with established HPV infections or HPV-induced neoplasms, and there are currently no therapeutic HPV vaccines approved by the US Food and Drug Administration. This comprehensive review will detail the progress made in the development of therapeutic vaccines against high-risk HPV types, and potential combinations with other immunotherapeutic agents for more efficient and rational designs of combination treatments for HPV-associated malignancies.

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Phase I Clinical Study for Validation of Fimaporfin-Based Photochemical Internalisation: A Novel Technology for Enhancing Cellular Immune Responses Important for Therapeutic Effect of Peptide-and Protein-Based Vaccines

Cited by 4 publications

References 0 publications

Photochemical Internalization: Light Paves Way for New Cancer Chemotherapies and Vaccines

Photochemical Internalization: Light Paves Way for New Cancer Chemotherapies and Vaccines

Vaccine-Based Immunotherapy for Head and Neck Cancers

<p>Therapeutic Vaccines for HPV-Associated Malignancies</p>

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