Diskusjon Triggere Porteføljer Aksjonærlister

PCI Biotech - Småprat 2019 (PCIB)

Fimavacc :

Jeg sitter i vårsolen og går igjennom Q4 presentasjonen. Forsøker å lese meg opp på de foreløpige resultatene fra Fimavacc. Det har vell blitt diskutert frem og tilbake en rekke ganger, men så langt ser vell dette veldig lovende ut? Om videre kohorter viser tilsvarende økning med Fimavacc, forstår jeg at de ønsker å publisere dette, og sørge for å ha all nødvendig dokumentasjon, patenter, osv på plass før endelige resultater kommer ut.

«The interim clinical results reported so far have shown enhanced T-cell responses (CD3), with both earlier responses and higher response rates in groups treated with well tolerated fimaVACC dosing regimens compared to the control group, which is treated with a state-of-the-art adjuvant technology (Hiltonol).

In the two dose groups analysed to date and which were demonstrated to be well tolerated, the numbers of volunteers showing CD8 responses upon completion of the vaccination schedule were higher in the two fimaVACC treated groups (5 of 6 subjects) than in the control group (2 of 6 subjects). Analyses of further groups will be completed with the aim of confirming these preliminary positive findings prior to publication.»

http://pcibiotech.no/wp-content/uploads/2019/02/PCI-Biotech-Q4-2018-Interim-Report.pdf

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Potensiale fimaVACC:

http://pcibiotech.no/vaccination/

Professor Sjoerd van der Burg ble medlem av PCIB’s Scientific Advisory Committee samtidig med arbeidet han gjennomfører for tolking og innsamling av dataene i avsluttede fimaVACC studie.
En kan jo kanskje spekulere litt i det forholdet. :thinking:

http://pcibiotech.no/scientific-advisory-committee/

Indications: potentially all cancers”

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Beklager at du tydeligvis har fått “rockpus” i vrangstrupen.
Hensikten med mine siste innlegg har kun vært å belyse det jeg mener er årsaken til avstanden mellom optimismen på dette forum og den faktiske aksjekurs. Jeg mener det er fordi aksjen i for liten grad har vært fristende for de som er mer kortsiktige, og at denne gruppen betyr mer for kursen enn det vi kanskje liker å tro. Det er jo mange på dette forum som undrer seg over lav kurs?
Når jeg samtidig nevner min egen grunn for relativ kortsiktighet, er det fordi jeg har planer om å gå av med alderspensjon om et snaut år. Min plan har vært å avslutte “karrieren” som investor samtidig som jeg slutter i arbeidslivet. Jeg ønsker dermed å disponere mine sparepenger til meg selv og mine barn før jeg blir så alt for gammel. Hvorfor jeg i det hele tatt nevner det?: For at bl.a. du ikke skal angripe meg for å være en simpel, troløs og sleip trader.
Håper det er mulig med en mer vennlig og høflig tone mellom oss i det videre løp?

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Jeg påpekte bare et faktum som jeg mener er et viktig element å ha i tankene for folk her på forumet når man skal vurdere innspillene du kommer med. Du trader og veksler mellom positiv og negativ vinkling på dine innlegg slik jeg ser det og for meg så synes det å være en agenda bak det. Ingen grunn til å bli krenka av den grunn.
For øvrig enig i at det er mye kortsiktighet blant markedsaktører og at det kan forklare kursbevegelsene som ses og at dette er ekstra gjeldende for biotek-sektoren hvor man ikke har inntjening ennå. Ingen tvil om at det er lenge til 2022 og fimachem-avlesing… Dog er firmaet godt finansiert i lang tid fremover nå og det gir ihvertfall en sikkerhet som kanskje burde kunne dempe noe av den største/verste kortsiktigheten.

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Her er det bakkekontakt🥳.
For det første må vi se resultater før det kan snakkes om verdenssensasjon. For det andre hvem har bedre resultater? Har Fimavacc best resultater i verden per i dag etter resultater er kjent er det verdenssensasjon. Enkelt og greit er du best i verden er det sensasjon for norsk biotek. Eller verdenssensasjon om du vil!

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Hvis det er definisjonen på verdenssensasjon, så sitter den alt for løst.

Hvis PCIB kan vise til bedre resultater (med statistisk signifikans) for iGGK enn SoC har vi altså en verdenssensasjon. Jeg syntes ikke det er beskrivende.

FimaVacc blir nok ingen verdenssensasjon det heller…

Men at det er lovende og ser lyst ut er jeg helt enig i. Det holder med suksess for at vi skal bli rikelig belønnet, det trenger ikke være en verdenssensasjon.

Med den hallelujastemningen her, så så jeg savner jeg trollingen til @anon21766851. Overdreven og urealistisk haussing bør kompenseres med overdreven og urealistisk baissing.

På tide å gjøre jobben din @anon21766851!

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Føler meg ikke spesielt kallet til å baisse PCIB, men jeg har lyst til å påpeke et par utfordringer jeg tror PCIB har:

  1. Jeg kan ikke minnes å ha hørt av PW noen gang før presentasjonen av 4Q-2018-tallene har gitt uttrykk for at uttestingen av fimaVACC på et spesielt protein fra HPV, innebar at de satte listen høyt. Jeg er redd dette er en oppdagelse de har gjort når nå SvdB har gjort sitt analysearbeid, og da som en overraskende negativ nyhet. Dette kan være med å ha redusert effekten av fimaVACC i betydelig grad og mer enn det PCIB tidligere har forutsett. Jeg kan ta feil her, men kan ikke minnes å ha sett noe av dette omtalt tidligere.

  2. Jeg er redd at PCIB ikke har sterkt nok apparat til å sørge for en tilstrekkelig effektiv rekruttering til sitt RELEASE-studie. Dette er åpenbart den største risikoen for PCIB i mine øyne. Forsinkelser her gjør at konkurrenter kan komme tidligere, at nye emisjoner må gjennomføres, og at investorene mister tiltroen til selskapet. Første pasient vil nok være en norsk pasient, med god hjelp fra OUS-systemet, men å rekruttere hele pasientmassen tror jeg kan by på store utfordringer for å så liten organisasjon. I motsetning til NANO har ikke PCIB gjort samme effektive arbeide med å bygge en slik organisasjon.

Noen som har noen innspill?

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Jeg er enig med begge to her.

@Chrkni det er mulig vi ikke står ovenfor en verdenssensasjon. Gode og/eller fantastiske resultat i “bare” gallegang gjør ikke dette til en sensasjon som hele verden vil legge merke til.

@Jubel , får vi fimachem til å fungere er det en god mulighet til at dette også vil enhance andre typer medisiner. Får fimaChem mange andre medisiner også til å enhances så kan vi faktisk stå ovenfor en verdenssensasjon, men det er selvfølgelig langt fram dit…

fimaVacc kan også ha et potensial til å bli en verdenssensasjon hvis teknologien kan brukes til å forsterke mange vaksiner…

" PCI – An innovative CTL induction technology based on the use of a proprietary photosensitizer
Effective induction of CTLs (Cytotoxic T Lymphocytes) is key to realize the huge potential of therapeutic cancer vaccination, but this has been difficult to achieve with today’s vaccination technologies. PCI Biotech’s CTL induction technology may provide a solution to this problem, thereby substantially improving the potential to trigger the immune system to fight both cancers and infectious diseases."

http://pcibiotech.no/vaccination/

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Vi er så enig så enig. Skrev det samme som deg før deg😜

Det holder med suksess for at vi skal bli rikelig belønnet, det trenger ikke være en verdenssensasjon.

Hvem har sagt at det ER en verdenssensasjon og hvem har sagt at det ikke er det før noen har sett resultatene. Det er mitt poeng!

La nå van der burgh og teamet i Leiden som kan det komme med sin konklusjon. Hva som skrives på forum er revnende likegyldig.

Tar Leiden glimrende resultater i sin munn er det nyanser fra sensasjon / verdensrommetsensasjon🚀

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Side 5 i årsrapport for 2018

In a nutshell, immunotherapy utilises the body’s own immune system to fight cancer, which is a radically different approach to treating cancer than chemotherapy. The armamentarium of the field of cancer immunotherapy includes many different therapeutic approaches including antibody-based treatments, cell-based therapies, and therapeutic vaccines. The pharmaceutical industry has long recognised the potential of therapeutic cancer vaccination and the objective of a therapeutic vaccine is to treat an existing disease using the body’s natural defences. Whereas in a traditional anti- infectious vaccine, the main component of the vaccine is a disease antigen, in the case of a cancer vaccine the main component can be a peptide or protein found on the surface of tumour cells. By vaccinating with such tumour-specific antigens, the body’s natural defences can be trained to recognise and destroy cancers cells.

Peptide and protein based vaccines are a subgroup of therapeutic cancer vaccines. There is a broad consensus that therapeutic peptide and protein based cancer vaccines have so far not been able to elicit sufficiently strong immune responses. A fundamental challenge for most existing therapeutic vaccine approaches is to produce a strong and relevant cellular immune response (T-cell activation). A potent induction of Cytotoxic T-cells is considered paramount for successful therapeutic vaccination. This is a main need in the market, which could be addressed by using the fimaVACC technology. In addition to the use in therapeutic vaccination for cancer, fimaVACC also has the potential to be used for both therapeutic and prophylactic vaccination for several infectious diseases.
fimaVACC is an endosomal escape technology that may realise the true benefit of innovative therapeutic vaccines by modifying the intracellular machinery of immune cells in such a way that antigens are more efficiently processed and induce antigen specific cytotoxic T-cells. The innovative and well characterised mode of action of fimaVACC can be applied to a wide range of cancer vaccine technologies and provide PCI Biotech with a strategic opportunity to enter the field of cancer immunotherapy at a time where the understanding of cancer biology and the potential of modulating the immune response to fight cancer is growing at a rapid pace.
In terms of type of vaccination, fimaVACC is also a versatile technology that can be used in multiple settings including, intradermal, intranodal, and intratumoural administration. Preclinical research has shown that it could also be developed in conjunction with ex vivo vaccination. Another promising way forward in the development of therapeutic vaccines is to combine vaccination with other cancer immunotherapy modalities such as checkpoint inhibitors (CPIs). There is a strong scientific rationale for combining CPIs with the fimaVACC technology: fimaVACC increases the number of T-cells induced by cancer vaccines while the CPIs prevent the tumour from evading the immune response. This potentially powerful combination could be summarised with a car analogy where the immune system is the engine, the vaccine is the fuel, the CPIs release the brakes, and fimaVACC is the turbocharger.

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Vaccine technologies commonly utilise adjuvants to enhance immune responses, but the consensus is that each one of the adjuvants available today has shortcomings, like variation in efficacy and toxicity issues. fimaVACC is expected to increase vaccines’ efficacy and generate the immune response faster, and to be user-friendly since illumination of the target area is overall considered to be a minor inconvenience. fimaVACC has the potential to increase patient safety if it can reduce the antigen payload and adjuvant volume per treatment and reduce the number of treatments needed. Increased efficacy for a broad range of peptide and protein based vaccines and patient safety are fimaVACC’s key competitive differentiators.
The proprietary fimaVACC technology has entered clinical development after having demonstrated strong preclinical efficacy. The translation of this technology into humans by demonstrating immunogenicity of vaccines is a main priority to establish the Company in the immunotherapy field. It is anticipated that a significant number of the cancer vaccines in development could use fimaVACC to boost their activation of T-cells and increase their efficacy. There are competing peptide vaccine enhancing technology platforms; for example adjuvants, liposomes and nanoparticles. For some of these technologies fimaVACC has shown synergistic effects in the preclinical setting.

Unlocking the potential of innovative medicines
In 2018 there were close to 90 different cancer indications targeted in clinical trials by peptide based therapeutic cancer vaccines across Europe and US. Most players clinically active in the peptide based vaccine area are small and the big pharma players are underrepresented.

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Side 10 og 11

fimaVACC - Vaccination program
Encouraging initial clinical results
The fimaVACC technology has proven excellent preclinical efficacy with protein and peptide based vaccines, with particularly strong CD8 T-cell immune responses that are considered important for therapeutic vaccination, but also enhanced helper T-cell and antibody responses. The initial clinical translation of this preclinical efficacy is done through a Phase I study in healthy volunteers, designed to determine immune responses, safety and tolerability. The study is performed with two model vaccines; both a large immunogenic protein (KLH) and two smaller less immunogenic peptides (HPV).
To date more than 90 subjects have been included, and tolerability of intradermal treatment with fimaVACC is established. The interim clinical results reported so far have shown that fimaVACC may enhance T-cell responses, especially the response to the less immunogenic HPV peptide. Both earlier responses and higher response rates are seen in groups treated with well tolerated fimaVACC dosing regimens compared to the control group, which is treated with a state-of-the-art adjuvant technology (Hiltonol).
The two HPV peptide antigens chosen for the Phase I study were derived from the E7 protein of the human papillomavirus (HPV). A very high response hurdle was set by this choice, as it is notoriously difficult to induce CD8 T-cell responses in man with peptides from the HPV E7 protein. In the two groups analysed to date and which were demonstrated to be well tolerated, the number of volunteers showing CD8 responses upon completion of the vaccination schedule was higher in the two fimaVACC treated groups than in the control group.
Overall the initial data suggest that fimaVACC trigger high response rates and early responses, which are highly sought-after features of vaccination platforms. Analyses of further groups will be completed with the aim of confirming these preliminary positive findings prior to publication. Next steps for the Phase I study and the overall development strategy for fimaVACC will be assessed following completion of these analyses.
Collaboration with international immunotherapy experts
The in-depth characterisation of the T-cells (CD4 and CD8) involved in the fimaVACC immune response is done in collaboration with a renowned international expert institute; the laboratory of Experimental Cancer Immunology and Therapy of the department of Medical Oncology at Leiden University Medical Center in the Netherlands under the leadership of Professor Sjoerd van der Burg.
New US patent granted
A patent application filed in 2013 for a “band-aid-like“ illumination/injection device for fimaVACC vaccination, as well as other potential skin applications, has been granted in the US in October 2018.
Research and development supported by a grant
The fimaVACC programme is supported by a government grant from the Research Council of Norway (BIA-programme) of up to NOK 13.8 million distributed over the course of three and a half years, 2017- 2020.

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An important value-creating step for the fimaVACC programme is a successful clinical translation of the promising preclinical data, through the ongoing Phase I study in healthy volunteers. A successful clinical validation would provide substantial risk reduction for the fimaVACC asset, as well as significant value enhancement and opening up for new partnering opportunities enabling PCI Biotech to enter into the immunotherapy field. Next steps for the overall development strategy for fimaVACC will be assessed following completion of Phase I.

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OUTLOOK
PCI Biotech believes that the proprietary PCI technology has the possibility to unlock the true potential of certain classes of innovative medicines. Supported also by external collaboration partners opinion, the PCI technology has the opportunity of playing a significant role in the realisation of several new therapeutic modalities, including immunotherapy (fimaVACC) and nucleic acid therapeutics (fimaNAc).
Although the company’s focus is three-pronged, divided over the three programmes, most resources are currently spent on progressing the lead project of fimaCHEM, which is the clinical development programme of fimaporfin with gemcitabine for the treatment of inoperable extrahepatic bile duct cancer; a rare disease with high unmet medical need. Based on the encouraging early signs of efficacy in Phase I, the company worked with the key regulators in Europe and the U.S. receiving important guidance which informs the design for a pivotal phase study. The final pivotal study design has thus been determined and funding expected to finance the study beyond interim read-out is now in place. During this next step, the company will maintain its full commitment of advancing the programme with the ambition of helping the patients currently left without effective treatment options achieve a good quality of life.
In parallel, the two other programmes, fimaVACC and fimaNAc, are proceeding in accordance with the established development strategy. The clinical validation of the fimaVACC technology is essential for PCI Biotech’s role within the immunotherapy space and the Phase I study in healthy volunteers will provide results on clinical translation of the technology into humans. The initial results are encouraging, and the study is expected to provide key data to support decisions of the programme’s further development strategy. The fimaNAc programme continues to follow a collaborative approach, by pursuing out-licensing opportunities.
In short, the main priorities of PCI Biotech at this time are to:
 Effectively drive the fimaCHEM development programme in inoperable extrahepatic bile duct cancer towards the market;
 Complete the clinical translation of the fimaVACC technology and determine the further development strategy
 Manage alliance and partnering activities across all commercially interesting areas for the PCI platform.

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Har problemer med å skjønne logikken din her Nille.

Du mener at PW uten å skjønne det selv har lagt listen høyt for fimaVACC, og når man likevel kommer over med soleklar margin så er det en negativ nyhet??

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Liten påskequiz mens vi venter

Når blir fimaVacc dybdeanalysen presentert (1. Gang)

De som foreslår andre konferanser jeg har glemt må gjerne legge dem inn i tråden så legger jeg ut som er alternativ.

  • CIMT (21-23/5)
  • ASCO(31/5-4/6)
  • IPA(28/6-4/6)
  • ESMO(11-14/12)
  • Annen konferanse

0 stemmegivere

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Mulig årsak til at vi ikke får melding om fimaVacc før abstract release…

Fra Asco guidelines(min utheving)

Once an abstract is submitted to an ASCO Meeting, the abstract and any study data to be presented at the meeting are confidential. This includes late-breaking data submission abstracts (a.k.a. placeholder abstracts), even if not yet updated with late-breaking results.

After the abstract is submitted to and prior to the abstract information being publicly released in conjunction with an ASCO Meeting, the author, coauthors, sponsor of the research, journalists, and others must not:

  • make the information public, or provide it to others who may make it public (such as news media),
  • publish or present the information or provide it to others who may publish or present it,
  • use the information for trading in the securities of any issuer, or provide it to others who may use it for securities trading purposes.

If information from the abstract or additional study data are disclosed after abstract submission and in advance of public release in conjunction with an ASCO Meeting, the abstract may be subject to rejection or removal unless an official Confidentiality Policy Exception applies (see below).

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https://meetings.asco.org/am/abstract-submission

Abstract Submission

Important Dates

April 17, 2019
Abstract titles released online via ASCO iPlanner

May 15, 2019
Abstracts are released on Meeting Library at 5:00 PM (ET)

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Dersom fimaVACC kommer med på Asco 2019 er det en sensasjon. Som vi i tilfelle får vite om om bare et par dager. Ingen downside, kun upside.

INGEN forventer at fimaVACC skal komme med. Og kommer det med er det en svært positiv, overraskende nyhet som gir akselerasjon i fremdriften for PCIB.

Muligheten er til stede. Plutselig forsvant jo nyheten som skulle komme før årsskiftet. Ikke unaturlig at munnkurvreglene i forbindelse med legekonferanser var årsaken.

Og timingmessig skulle Asco passe perfekt. Deadline var i februar, altså etter at hollenderne var forventet å bli ferdig med sin analyse.

Hva ville passet bedre enn Asco da?

Deltagelse på Asco er et kvalitetsstempel med en kvalitetssikring innebygget.

Kursen vil i tilfelle kunne gjøre et kjempebyks. Kanskje lurt å ta et bet i dag eller morgen på at det stemmer med Asco abstract?

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Snøffelen,

Logikken i min bekymring er at ingen vet at man “kommer over med soleklar margin” som du sier. Vi håper at marginene er soleklar.

Sagt med andre ord - hadde for eksempel resultatene blitt vesentlig bedre om man hadde valgt en annen kilde for proteinet? Poenget mitt er at jeg frykter at PCIB ikke forstod at de valgte et spesielt vanskelig utgangspunkt for sin undersøkelse når studien ble igangsatt. I så fall tror jeg vi hadde hørt PW snakke om hvor høyt lista var på et tidligere tidspunkt.

Men jeg er enig i at hvis resultatet, selv med dette utgangspunktet, blir svært godt, skal vi alle være fornøyde.

Og jeg tror da vi er enige om at PW aldri tidligere har nevnt at man i studien av de friske frivillige hadde lagt listen høyt…:wink:

Veldig nysgjerrig i å høre hva ditt syn er på mitt andre punkt Snøffelen. Har du gjort deg noen tanker om dette?

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