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PCI Biotech - Småprat 2019 (PCIB)

Preclinical publication in high-impact immunology journal
Preclinical results were recently published in the high-impact immunology journal “Frontiers in Immunology” (Combined Photosensitation and vaccination enable CD8 T-Cell Immunity and Tumor Suppression independent of CD4 T-Cell help, Varypataki et al. Front.Immunol. 10:1548). The study provided evidence of strong activation of CD8 T-cells and tumour regression after vaccination with fimaVACC in melanoma bearing mice, including mice with impaired T-helper cell function. The study thereby demonstrate that therapeutic cancer vaccination with fimaVACC can be effective independent of T-helper cell functionality.

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Likte best avsnittet om patentsøknaden og svar på denne for NAC :slight_smile:

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Jeg likte best ALT​:partying_face::partying_face:. Dette er tidenes rapport og resultater. Leverer gang etter gang og finansiert.

PROMISING INITIAL RESPONSE ON PATENT APPLICATION ► Patent application on mRNA delivery with fimaNAC
► The International Search Authority has provided a positive International Search Report on an mRNA delivery patent
► May give valuable intellectual property for fimaNAC mRNA delivery until 2039
► mRNA therapeutics is an emerging field with massive investments and broad
potential applicability
► Sufficient intracellular delivery remains a major hurdle to realise the potential
► The majority of fimaNAC collaborations concern mRNA therapeutics

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Her må noen spørre om hvor mye dette koster og hvor pengene kommer fra

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VEELDIG MYE BRA!!!
Da ser vi vel 20 blank i dag :joy::joy:

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Per Walday og resten av ledelsen, ansatte, styret og advisory board! Takk for en glitrende utført jobb​:+1::+1::+1:

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Gratulerer til alle,dette går veien så det suser.

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Har ikke lest rapporten da jeg har språklige utfordringer men høres jo fantastisk ut det som beskrives her da. Var det ikke noe negativt ? Alt på skinner?

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Super q2 rapport! Da er det klart at Hegnar og E24 har overskrifter om underskudd og elendighet :frowning:

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Hegnar er bra for biotek-Norge! :sweat_smile:Da blir det vel sell on news som vanlig…

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Haha. For noen idioter

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Svært positivt at de nå bekrefter at det blir studie i Asia, og at de etter et grundig feasability-studie, som de jo også gjorde for EU og US vil inkludere første pasient i Asia i 2020.

Dette mener jeg er utrolig viktig for fremtidig forhandlingsposisjon for partnering på GGK.

Skulle de Feks få med Asan Medical Center i Seoul, har det et pasientgrunnlag tilsvarende UK og Tyskland tilsammmen.

Asan er verdens beste sykehus på lever-sykdommer og man vil da ha et stykk sykehus som ville kunne PCI-prosedyren til fingerspissene og enkelt kunne håndteres av PCI Biotech alene. En fantastisk forhandlingsposisjon å ha ren pengemaskin på hånda.

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De som er investert og investerer i biotek vet innhold i rapporten. Den var innertier. Innfridde Asia sites, flere sites åpnet, USA klar for første pasient, levetid øker, mRNA patent, fimavacc strategi!

For å spøke med Hegnar med det underskuddet ser det ut til at PCIB blir biotek stjerne internasjonalt!:stuck_out_tongue_winking_eye:

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Vil det ikke da bli vesentlig enklere å behandle pasienter i Asia hvis RELEASE får markedsgoskjennelse? Ikke bare landet(ene) som har sites i RELEASE, men andre asiatiske land.

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Last ned Google Chrome da får du oversettelse.

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Says it all: SALUTE PW!

Per Walday, CEO of PCI Biotech, comments: ”The initiation of the pivotal RELEASE study in inoperable extrahepatic bile duct cancer is progressing very well. The first patient was included in May and we now have regulatory and ethics approvals in two thirds of the countries including USA, and almost half of the planned sites open for enrolment and actively screening for patients. Additionally, a feasibility study is ongoing in Asia to ensure that we select and establish relationships with the most appropriate sites for patient recruitment and market impact. The company is now focused on successful completion of this transforming study. The encouraging fima VACC Phase I results provide proof-of-concept and efficacy in terms of dosing in humans as well as an overall characterisation of tolerability. We will now use these data to guide further development in a clinical disease setting and in seeking partnerships. It was encouraging to receive the promising initial response on a patent application for mRNA delivery, which may prove highly valuable for the fima NAc programme. We have also agreed a final six months extension of the current research collaboration with the undisclosed big pharma to complete in vivo work, including an additional six months thereafter for evaluation of potential next steps.”

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En strålende rapport! :ok_hand:

Likevel, jeg håper noen kan spørre Per Walday, på en ryddig og ordentlig måte, om hvorfor de ikke har meldt om oppstart i USA når «regulatory approval achieved in the USA».

Skjønner de ikke at dette ville kunne gitt akskjekursen en fin boost? Eller bryr de som overhodet ikke om det? :thinking:

Og hvorfor «I will get back to you by end of H1…» etterfulgt av øredøvende taushet, når strategien for asia jo tydeligvis ER fastlagt og at de nå går for siter her.

Dette er jo BIG NEWS!!! Og de burde helt klart ha meldt om dette, for å promotere selskapet og oppnå litt blest.

Jeg vil kalle det sidrumpa, rett og slett.

Når de gjør en så fantastisk bra jobb og leverer så strålende, gang på gang, så MÅ de for svingende kunne være noen hakk mer offensive i media og ovenfor markedet!!! :grinning:
Håper noen tør å meddele dette på Q&A.

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Regulatory and ethics approvals have been received for USA
** A** total of 15 sites in 7 different European countries were open for enrolment by mid-August 2019. (Norway, Germany, France, Spain, Belgium, Poland, Sweden and Denmark)

The median overall survival in the fourth dose cohort in the dose-escalation part ended at 21.7 months, with half of the patients exceeding 30 months survival including one patient still being alive more than three years after treatment.

The overall development strategy for fimaVACC is two-pronged, both utilising the current Phase I results in direct partnering efforts and plan for clinical proof-of-concept in a disease setting.

FimaVACC
Preclinical results were recently published in the high-impact immunology journal “Frontiers in
Immunology”

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He He, Hegnar-artikkelen vil få Jonas Einarsson til å rive seg i håret, økt ressursbruk betyr selvsagt at de har steppet opp investeringer og pace.

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Rank Investor Andel Verdi 26.08.2019 +/-
1 FONDSAVANSE AS 10.10% 3 760 443
2 MP PENSJON PK 7.14% 2 658 805
3 MYRLID AS 6.49% 2 415 000
4 RADIUMHOSPITALETS FORSKNINGSSTIFT. 3.44% 1 281 415
5 NORDNET LIVSFORSIKRING AS 2.87% 1 067 668 -11 681
6 Privat investor 1.69% 630 000
7 NORDNET BANK AB 1.59% 593 145 12 663
8 JANDERSEN KAPITAL AS 1.44% 535 000
9 Privat investor 1.31% 485 900 1 979
10 VESLIK AS 1.00% 371 690 -27 614
11 KLP AKSJENORGE INDEKS 0.89% 332 029
12 Privat investor 0.89% 330 261
13 ESTI AS 0.82% 303 795 1 640
14 MYNA AS 0.81% 303 019 3 019
15 OLAV OLSEN HOLDING AS 0.81% 300 000
16 Privat investor 0.78% 291 000
17 FORENEDE FORVALTNING AS 0.76% 282 666 2 500
18 DANSKE BANK A/S 0.73% 273 181
19 LGJ INVEST AS 0.71% 262 503
20 Privat investor 0.70% 260 000
21 NUNATAK INVEST AS 0.55% 203 149
22 RAVI INVESTERING AS 0.54% 200 000
23 AKK INVEST AS 0.52% 195 149
24 Privat investor 0.51% 191 400
25 PETROCK II AS 0.51% 191 000
26 ELAMA AS 0.51% 190 118
27 Privat investor 0.51% 189 107 2 500
28 HASJØ HOLDING AS 0.50% 185 000
29 Privat investor 0.50% 185 000 -54 000
30 Privat investor 0.48% 179 001
31 BASIC I AS 0.46% 170 850
32 BAKELITTFABRIKKEN HOLDING AS 0.45% 167 859
33 KIRITEC A/S 0.41% 151 860
34 Privat investor 0.40% 150 000
35 Privat investor 0.37% 138 000
36 Privat investor 0.37% 137 000
37 NORDANG GEOHOLDING AS 0.36% 132 500
38 Privat investor 0.33% 123 662
39 Privat investor 0.33% 122 499 3 865
40 Privat investor 0.32% 120 000
41 LUCELLUM AS 0.32% 120 000
42 BEELINE AS 0.32% 117 814
43 VERDIPAPIRFONDET NORDEA AVKASTNING 0.30% 112 000
44 Privat investor 0.29% 108 668
45 ABN AMRO GLOBAL CUSTODY SERVICES N 0.28% 105 833
46 UBS SWITZERLAND AG 0.28% 103 879
47 Privat investor 0.27% 102 000
48 Privat investor 0.27% 101 897 832
49 Privat investor 0.27% 100 105
50 SAXO BANK A/S 0.26% 96 743 INN
51 Øvrige investorer 43.24% 16 096 274 -32 446
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