Esmo abstract

Aakam
PCIB 11.12.2019 kl 23:38 2370

109P - 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
Presentation Number

109P

Lecture Time

12:15 - 12:15

Speakers

P. Selbo (Oslo, Norway)
Authors

P. Selbo (Oslo, Norway)

S. Janetzki (Fort Lee, NJ, United States of America)

M. Welters (Leiden, Netherlands)

M. Håkerud (Oslo, Norway)

A. Nedberg (Oslo, Norway)

V. Edwards (Oslo, Norway)

H. Olivecrona (Oslo, Norway)

S. Van der Burg (Leiden, Netherlands)

T. Otterhaug (Oslo, Norway)

A. Hogset (Oslo, Norway)

Abstract

Background
FimaVacc is a vaccine formulated by the photosensitising compound fimaporfin and a toll-like receptor (TLR) agonist, and is administered intradermally followed by illumination of the vaccination site. In preclinical studies, fimaVacc has been shown to improve MHC class I antigen presentation, resulting in strongly enhanced cytotoxic and helper T-cell responses to various types of peptide and protein vaccines.

Methods
A phase I clinical study with fimaVacc has been performed in healthy volunteers to study the safety and immunogenicity of this novel vaccine. The subjects were vaccinated with HPV16 E7 peptides and Keyhole Limpet Hemocyanin (KLH) protein, serving as model antigens for peptide- and protein-based vaccines. Both antigens were formulated with fimaporfin and the TLR3 agonist poly-ICLC (Hiltonol) and administered in up to three vaccinations. Local and systemic adverse effects were assessed for safety, and cellular and humoral immune responses were analysed by ELISPOT, flow cytometry and ELISA assays to determine the immunogenicity of fimaVacc.

Results
The principle of the fimaVacc technology will be presented, together with preclinical results showing that fimaVacc strongly enhances both cellular and humoral immune responses and improves anti-tumour effects in mouse models. The clinical study showed that intradermal vaccination with fimaVacc was well tolerated, with no systemic side effects and generally only mild local reactions. Elispot analysis showed that fimaVacc can significantly increase the number of healthy donors displaying a T-cell response to HPV peptide vaccination. Furthermore, Elispot and flow cytometry analyses demonstrated an enhancement of both HPV-specific CD4+ and CD8+ T cells upon fimaVacc treatment.

Conclusion
The photochemically based fimaVacc vaccination technology can be applied safely in humans, and enhances T-cell responses to an HPV peptide vaccine over what is achieved in a control group which received antigen + adjuvant without fimaVacc.

Clinical trial identification
NCT02947854.

Legal entity responsible for the study
PCI Biotech AS.

Funding
PCI Biotech AS.

Disclosure
S. Janetzki: Advisory / Consultancy: PCI Biotech AS. V.T. Edwards: Full / Part-time employment: PCI Biotech AS. H. Olivecrona: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment: PCI Biotech AS. S.H. van der Burg: Advisory / Consultancy: PCI Biotech AS. T. Otterhaug: Shareholder / Stockholder / Stock options, Full / Part-time employment: PCI Biotech AS. A. Hogset: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment: PCI Biotech AS. All other authors have declared no conflicts of interest
Redigert 20.01.2021 kl 23:45 Du må logge inn for å svare
ToffeeMan
12.12.2019 kl 08:08 2177

Dette er vanvittig bra!!
https://newsweb.oslobors.no/message/491448
Redigert 20.01.2021 kl 23:45 Du må logge inn for å svare
Fljo
12.12.2019 kl 08:18 2091

Kunne du si to ord om hvorfor den børsmeldingen er "vanvittig bra"?
Redigert 20.01.2021 kl 23:45 Du må logge inn for å svare
ToffeeMan
12.12.2019 kl 08:57 1877

Dette kan jo bli verdensledende innen vaksine! Hvor stort er ikke dette??
"and the fimaVacc technology
has proven excellent preclinical efficacy with protein- and peptide-based
vaccines. The technology has shown particularly strong CD8 T-cell immune
responses, which are important for therapeutic vaccination, as well as enhanced
helper (CD4) T-cell and antibody responses."
Redigert 20.01.2021 kl 23:45 Du må logge inn for å svare
Slettet bruker
12.12.2019 kl 09:26 1713

Ja, vi har vel sett disse hengelåsene og disse mer eller mindre ubrukelige skissene lenge nok
Redigert 20.01.2021 kl 23:45 Du må logge inn for å svare
Fljo
12.12.2019 kl 09:32 1645

Kursen faller så første reaksjon fra markedet var ikke så stor begeistring.
Redigert 20.01.2021 kl 23:45 Du må logge inn for å svare
Slettet bruker
12.12.2019 kl 09:32 1641

Er du bitter, merida1? Normale folk slutter å følge/kommentere aksjer de har solgt pga mistro
Redigert 20.01.2021 kl 23:45 Du må logge inn for å svare
ToffeeMan
12.12.2019 kl 10:03 1460

Bare selg unna...Budet kommer plutselig og brutalt😊
Redigert 20.01.2021 kl 23:45 Du må logge inn for å svare
Newsman
12.12.2019 kl 10:18 1369

Dette fallet i dag morges, vil bli hentet inn igjen.
Redigert 20.01.2021 kl 23:45 Du må logge inn for å svare
Odeven
12.12.2019 kl 10:32 1295

Denne går i pluss før lunch og med pen gevinst før stengetid.
Til glede for mange og til skuffelse for et par.

O.
Redigert 20.01.2021 kl 23:45 Du må logge inn for å svare