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PCI Biotech - Fundamentale forhold (PCIB)

Oppretter en egen tråd for de litt mer dyptgående innleggene om PCI Biotech.


Følgende andre tråder er relevante:

Småprat - for idle banter, kursbevegelser osv

Teknisk Analyse - for ren TA om PCI Biotech

Her er presentasjonen de la ut om selskapet i Juni 2018 for en bred gjennomgang:



Samleposter her :slight_smile:


Kryssposter denne også, høyst relevant:

En måte å tolke at de skal på konferansen er at de har positive data fra gjentatte behandlinger og vil presentere dem for å få opp interessen for PCIB slik at det blir lettere å få inn en partner eller kjøre emisjon for å gjennomføre PP2. PCIB har jo tidligere sagt at de vil presentere finansieringsløsningen samtidig som de går over til fase 2. (Ble vel sagt i en podcast, så hvis jeg husker feil, så rett meg gjerne). :slight_smile:

Høyst relevant, konferansen er 19-23 oktober 2018, jeg trodde den var tidligere. :slight_smile:


Jeg må si at noen av de beste episodene av Radium Podcasten har vært med Per Walday, CEO i PCI Biotech. :slight_smile: Fremstår rett og slett som en veldig hyggelig fyr med hodet på rett sted.


A post was merged into an existing topic: PCI Biotech Småprat (PCIB)

Fish of the day: Published: 10 Jul 2018

Photodynamic therapy mediated immune therapy of brain tumors **** Henry Hirschberg1, Kristian Berg2, Qian Peng3



"Photochemical internalization

Photochemical internalization (PCI), a derivative of PDT, has been shown to increase the efficacy of drugs, gene transfection as well as a variety of other anti-cancer agents that are taken up into cells by endocytosis[29-33]. PCI is based on the use of specially designed photosensitizers, such as AlPcS2a, TPPS2a, TPcS2a that localize preferentially in the membranes of endocytic and lysosomal intracellular vesicles. Upon exposure to light of appropriate wave lengths, the photosensitizers induce the formation of short range singlet molecular oxygen, destroying the intracellular vesicles membranes, thus leading to the release of the contents of these vesicles into the cell cytosol. The released macromolecules can now exert their full biological activity instead of being degraded by lysosomal hydrolases.

Norum et al.[34] (2017) has examined the efficacy of PCI delivery of bleomycin (BLM-PCI) and its impact on systemic anti-tumor immunity in an extra-cranial mouse model. Their results showed that both PDT and BLM-PCI were incapable of inducing a curative effect in athymic mice at the light dose tested. In contrast, 50% of the light dose of that used in athymic mice resulted in a curative effect in 90% of the animals after BLM-PCI and 70% after PDT in normal mice. Inhibition of tumor cell growth was observed when combined with co-injection of splenic T cells from mice treated and cured with BLM-PCI. The anti-tumor immunity induced by BLM-PCI was equal to that obtained with PDT treatment, but at a lower light dose. Furthermore, the induced immune response after BLM-PCI was sufficient to reject tumor re-challenge immediately after PCI and lasted for at least two months.

An additional and novel method for enhancing the efficacy of peptide vaccines in extra cranial studies has been explored by Haug et al.[35] (2018) utilizing PCI to promote the escape of trapped endocytosed peptides into the cytosol of APCs. Their results showed that PCI caused a 30-fold increase in MHC class I/peptide complex formation and surface presentation on APCs, and a subsequent 30- to 100-fold more efficient activation of antigen-specific CTLs compared to using the peptide alone. These in vitro effects of PCI were translatable in vivo by the successful induction of antigen-specific CTL responses to cancer antigens in C57BL/6 mice following intradermal peptide vaccination and local light treatment. It is noteworthy that both macrophages and DC were used as APCs with approximately equal efficacy in these experiments. If these promising PCI strategies might be translatable to post-operative HGG treatment by the use of indwelling balloon light applicators, as has been proposed and tried for both radiation and PDT treatment, remains to be determined[36-39].

PDT for the treatment of brain tumors

PDT has been investigated as an adjuvant for the treatment of malignant gliomas for approximately 35 years[39-43]. Although numerous clinical trials have been initiated, the vast majority have consisted of uncontrolled phase I/II studies containing small numbers of patients. For example, in the single center phase III trial reported by Eljamel et al.[39] using both flourecent guided resction combined with ALA and Photofrin repetitive PDT, a mean overall survival (OS) of the treatment group was 52.8 weeks compared to 24.6 weeks in the control group. In a phase II uncontrolled trial of 22 patients reported by Muragaki et al.[41], using talaporfin sodium as a PS, a median of survival of 99 weeks was observed. This compared favorably to the 54-64 weeks OS obtained from previous trials employing standard post operative treatment consisting of radiation and TMZ. Due to differences in methodology and types of malignant brain tumors treated, it has been very difficult to evaluate PDT efficacy from these limited trials. For a more detailed account of the results of a number of PDT clinical trials for HGG, Bechet et al.[42] and Quirk et al.[43] give an excellent overview. Additionally, none of these clinical trials have included an evaluation of the effects of PDT on the immune response to treatment. Overall, the results of PDT trials for malignant gliomas have been relatively modest, thus providing the rationale for alternative PDT mediated treatment approaches such as PDT induced immunotherapy"


Although the experience with PDT/PCI produced anti HGG vaccines is limited and no clinical trials have been done, PDT/PCI appears to be an inducer of immunogenic cancer cell death, an important step in the afferent phase of the immune anti-tumor response. Light activated induced immunotherapy therefore holds the potential to become a complementary therapeutic option for for patients with HGG. Taking into account the penetration limitations of light activated therapies in the brain the further development of ex vivo PDT/PCI generated APC or peptide vaccines seems the most attractive approach. A deeper and detailed understanding of the induction of the antitumor immunity induced by light activated therapies would allow in the defining of protocols which would focus and enhance the immune system to recognize and prevent the inevitable post-operative recurrence of the tumor. Combining PDT induced anti-tumor vaccines with other therapeutic modalities including check-point inhibitors, is an exciting field to explore. Although not discussed in this review both PDT and PCI have an effect on the vasculature and have been show to temporarily open the blood brain barrier in a limited site specific region[66-68]. What additional role this would play in the development of an effective and safe anti-HGG patient therapy, remains to be established.


Litt aksjonærhistorikk:


Gull fra @Investor på SeekingAlpha :slight_smile:


2 posts were merged into an existing topic: PCI Biotech Småprat (PCIB)

Jeg ser jeg har postet den feil sted. Skulle vært her: PCIB - Teknisk Analyse

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Legger denne her:


For å forlenge:


20/08-2018 09:00:00: (PCIB) PCI Biotech initiates research collaboration with Bavarian Nordic

Exploring synergies between proprietary technologies to further enhance the effect of novel therapeutic applications in cancer and infectious diseases

Oslo (Norway) 20 August 2018 . PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announced that it is initiating a preclinical research collaboration with Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) Kvistgaard, Denmark, a clinical stage biopharmaceutical corporation focused on developing state-of-the-art cancer immunotherapies and vaccines for infectious diseases.

In brief, the collaborators will evaluate technology compatibility and synergy based on in vivo studies. The companies will evaluate results achieved from this research collaboration and then explore the potential for a further partnership.

Per Walday, CEO of PCI Biotech, said: .I.m very pleased to announce another research agreement with a key player within the field of immunotherapies, which is the second collaboration initiated this year. We believe that the PCI technology has the potential to play a role in the realisation of several new therapeutic modalities, and we look forward to explore synergies with Bavarian Nordic.s unique and innovative technologies…


Legger ved børsmelding hvor PCI Biotech CEO Per Walday informerer til markedet om at de skal ha en fase 2 studie som blir en pivotal studie hvor det også blir inkludert in AA interim avlesning.

Direkte link finner en her: https://newsweb.oslobors.no/message/441218

PCI Biotech announces preliminary outcome of meetings with EMA and FDA for development of fimaporfin in inoperable cholangiocarcinoma

Oslo, 20 December 2017 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company, today announced preliminary outcome of regulatory
interactions with the European Medicines Agency (EMA) and the U.S. Food and Drug
Administration (FDA) on the development of fimaporfin in combination with
gemcitabine for treatment of inoperable cholangiocarcinoma (bile duct cancer).
The purpose of the interactions is to discuss the development programme for
fimaporfin, including the design of a pivotal study to support future marketing
authorisation applications in EU and the USA.

A common understanding has been reached on several important factors for a
pivotal study with fimaporfin in inoperable cholangiocarcinoma, including the
sufficiency of a single randomised two-arm study and importantly, the potential
for accelerated/conditional approval based on interim results. The required
randomised study will provide the opportunity to generate robust comparative
data of importance for market acceptance of fimaporfin as a first line treatment
of inoperable cholangiocarcinoma. The implications of an interim analysis for
the final pivotal study design will require further discussions with regulators.

Dr Per Walday, CEO of PCI Biotech, said: “With promising efficacy results
generated so far, orphan drug designations granted and guidance from regulators
and key opinion leaders, we are focused on finalising the preparations for the
pivotal randomised adaptive study. Patients with inoperable cholangiocarcinoma
have no approved treatment alternatives today and fimaporfin has the potential
to play a role in this area of high unmet medical need. We are therefore pleased
that the regulators are open to a potential approval based on interim results”.

Further information on the study, which is planned for initiation during the
first half of 2018, will be announced following completion of discussions with
regulators and clinical advisors.


Denne kan bli gøy, MERK:

  • cancer and infectious diseases
  • In Vivo, rett på dyreforsøk

In vivo: In the living organism. usually animals, including humans For example, an experiment that is done in vivo is done in the body of a living organism as opposed to in a laboratory method that does not use the living organism as the host of the test. In vivo is the opposite of in vitro.


Hvis det ikke blir spesifisert at det er clinical study så er det ikke mennesker…


La merke til at det er gjort en liten endring i ene statuspunktet for fimavacc fra dagens vedlegg og company presentation fra juni (uten at jeg vet om dette er av noe betydning):

(i dag)
• Initial data suggest enhancement of antigen specific T-cell response
at tolerable doses, with earlier responses and higher response rates


• Initial data suggest overall T-cell enhancement at tolerable doses,
as well as early responses and high response rates


Hvist dette er en bevidst omformulering, så har de fundet den specifikke formulering som trigger HPV T-cellerne. Og det er vigtig, da de har klart å isolere disse og trigge dem som immunforsvaret skal kunne.
Det i seg selv kan være en vanskelig. Immunforsvaret har mange typer T-celler som skal holdes styr på og kan trigges avhengig av hvilken kreft type som skal angripes.


Det kan man vel spørre om til neste uke!