Diskusjon Triggere Porteføljer Aksjonærlister

PCI Biotech - Småprat 2019 (PCIB)

Jeg tror de kommer til å lande en partneravtale for Asia rett etter at bekreftende gode data fra exstensionstudiet foreligger.

En partner/lisensavtaler for FimaVacc kan oxo komme om ikke lenge, det er ikke bare vi og ultimovacs som venter på dybdeanalysen ref. PW

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Good point, forhandlingsstyrken til PCIB er nå solid forbedret etter emisjonen, og som du sier, ingen som leker butikk, ei heller PCIB.

Abacus har vært inne på det tidligere, og har spekulert i at PCIB avslo en avtale i sommer da en emisjonen vi hadde i høst vil gi aksjonærene mye mer igjen for pengene.

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Skråblikk; Om en bransje i Norge kan bli internasjonal stor-industri er det innen biotek. Blockbuster muligheter og marginer få forunt. «Skaperen» av PCIB teknologien bør kunne bli rikelig belønnet ved suksess (som Fortnite skaperen).

Fortnite-skaperen er god for 63 milliarder kroner.

Spillindustrien håver inn milliarder. Nå rykker Fortnite-skaperen opp på listen over verdens rikeste.

Kan PCIB rykke opp i denne ligaen? Oslo Cancer Cluster selskap?

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Positive fimaVACC data er jo “end of the road” for PCIB uansett.
Produktet fimaVACC er således klart for utlisensiering NÅ.

Hva BP vet på nåværende tidspunkt???
Er resultatene for fimaVACC fase 1 studiet “vanntett” frem til publisering?

Var der ikke en CEO som nesten forsnakket seg … :no_mouth:

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Tror neppe at ting er ‘‘vanntett’’ :frowning:

this is from Q-3 Q&A:

Unidentified Analyst, [59]


Yes, but I do think that you failed to find a partner that you wanted for the fimaCHEM because that was when you raised money the last time, NOK 70 million, it was clearly said that the next bile duct program would be too expensive to go alone, and still you do. So why should we trust that you will be able to find any good solution for the big 10 pharma, for instance? How should you guys be able to do that because you clearly failed on your objective on the first – on the main area?


Per Walday, PCI Biotech Holding ASA - CEO [60]


I wouldn’t say that. There was an opportunity to take this forward by ourselves or to do it with a partner, and you look strategically what is the best option going forward. And the best option with the results we had was to actually raise funds and take this because we – when we went to the regulatory authorities, we discussed with them what is needed. And what is needed here is not 2 randomized big Phase III studies. It is one single Phase III study of a moderate size even with an interim read that can get approval. So that changed the picture and that makes it possible for a company like us to actually take that all the way to the pivotal phase.

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La oss være enige om en ting til: Det var ikke en partneravtale for CHEM i Europa/USA @ufo håpet på.

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@geiran

Det som kan komme i dette halvåret er dette:

2019-01-03_13-08-49

Man skriver ikke noe sånt inn i et prospekt uten at det pågår konkret diskusjoner. Når det kommer vet vi ikke, men det KAN komme i morgen. Eller 30. juni.

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En skal ikke gjenta seg sjøl i tide og utide, men denne synes jeg kan bli med over på den nye tråden. For 24 dager siden skrev jeg på den forrige tråden:

"Så lenge vi befinner oss i informasjonsvakuum, passer det å spekulere litt. Her er mine ville gjetninger:

  • Samarbeidsavtalen med “Den store ukjente kjempen” blir enda en gang forlenga.
  • Første kommersielle avtale innenfor fimaNAc vil enten være med PHIO Pharmaceuticals (tidl. RXi) eller med Bavarian Nordic.
  • Det vil bli undertegna partneravtale med en asiatisk partner i løpet av de nærmeste to-tre månedene (fimaCHEM / pCCA / øst-asiatiske land)
  • Første kommersielle avtale basert på fase 1-resultatene i vaksinestudien, kommer i løpet av Q1/2019."

Den første gikk jo greit inn. Så får vi se hva dd neste kvartalene bringer.

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Fimavacc har et enormt bruksområde (om resultatene som blir presentert fra fimavacc innen kort tid er suksess).

Det er årlig så store summer innen vacc at det er hinsides. Blir antakelig tatt for å være useriøs om en lirer av seg alle milliardene i årlig mulig omsetning innen bruksområde!

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Celgene blir nå solgt til Bristol-Myers for 74 milliarder dollar. Det er 650 PCIBer det :wink:

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At this point we shall all agree that the financial risk is almost not there, since the funding should last beyond interim results, so this box is checked.

What we are left with now is the final data risk in terms of efficacy and safety, I would say the safety risk can also be checked based on the latest double treatment safety reporting. so we are now kind of left with treatment efficacy risk: when PW says the following (from transcript): “And the best option with the results we had was to actually raise funds and take this”. my interpretation of this is that the efficacy risk perceived by the company is a lot less than we investors perceive, and this is most likely due to all fimachem results including other indication (H&N). it has been documented before that +70 patient have been treated with pci.

I interpret PW answer as of the company decided to go with this independent of any partner right after the discussions with EMA and FDA were concluded. and a partner agreement was a back up option to signing in a special investor to help raise the funds. it is also natural to still go on partnering discussions as those parties could be your future partners so you keep the door open.

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K### Alliances and partnering opportunities

PCI Biotech is an oncology-focused company developing innovative products for cancer treatment. The products are based on PCI Biotech’s patented technology, photochemical internalisation (“PCI”). The PCI technology can enhance the effect of anticancer drugs by targeted, light-directed drug delivery into cancer cells, and can also be used as a platform that may both potentiate the effect of vaccines and enable macromolecules such as RNA therapeutics to reach intracellular targets. Our objective is to deliver value to cancer patients through the development of products within three major anticancer treatment paradigms:

  • fima CHEM – Enhancement of existing therapeutics for localised treatment of cancer, for indications with a clear unmet medical need; pivotal phase II ready opportunity in an orphan cancer indication, cholangiocarcinoma (bile duct cancer).
  • fima VACC – Novel mechanism of action of the PCI technology to be used as a CTL induction technology for therapeutic and prophylactic vaccination with potential value creation in both cancer and infectious diseases; phase I in healthy volunteers initiated.
  • fima NAc – Novel delivery Technology for pharmaceutical and biotechnology companies looking to overcome the challenge of introducing nucleic acid therapeutics into cells; preclinical programme.

To fully exploit the potential of our three major PCI applications, we are looking for partnerships with renowned pharmaceutical and biotech Companies.
Together, we will unlock the potential of your drug candidates. We continue to commit to partners with synergistic ideas to develop innovative drug candidates.
Partners should share our vision to develop and commercialize the next generation of anti-cancer therapeutics.

Collaborations
PCI Biotech has an excellent track record in its partnering activities. These successful scientific collaborations are not only contributing towards the validation of Our technology platform but are also bringing value to our partners.

Where to meet us:
List of all events where we are planning to attend during current half year, with a link to the event:

Kommet til flere konferanser, tre bare første kvartal 2019👍. Salt Lake City lukter fugl, her bør det kunne presenteres chem data/nyheter?

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Fra clinicaltrials.org med søk Pci biotech:

Recruiting A Phase I/II Study Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas
Conditions: * Cholangiocarcinoma
Interventions: * Drug: Amphinex and Gemcitabine
* Drug: Gemcitabine and Cisplatin
Locations: * National Center for Tumor Diseases

Heidelberg, Baden-Württemberg, Germany

  • Klinikum rechts der Isar
    Munich, Bayern, Germany
  • Klinikum der Ludwig-Maximilians-Universität
    München, Bayern, Germany
  • (and 13 more…)||

Kan dette bety at PCIB nå har 16 sites i sin pivotal fase studie? Noen som kan dette?

Det her er jo fase 1 studiet

De har ikke oppdatert studien sin på clinicaltrials.gov siden oktober 2016 så tror ikke informasjonen der er så oppdatert.

https://patents.justia.com/assignee/pci-biotech-as

Patents Assigned to PCI Biotech AS

Patent number: 10166401

Abstract: A device for activating light-induced rupture of endocytic vesicles in target cells of a patient so as to effect delivery of an administered antigen to cytosol in the target cells, is described. The device is adapted to be worn by a patient over a region of skin where an antigen and a photosensitising agent are to be administered. The device comprises a rear surface that is rounded or otherwise configured to be worn against the patient’s skin. It has a retaining part for retaining the device in place over the region of the patient’s skin during an activation cycle. A light source is arranged to illuminate the patient’s skin from the rear of the device. A control system is configured to vary the output of the light source with respect to time in accordance with a pre-configured output sequence.

Type: Grant

Filed: August 28, 2014

Date of Patent: January 1, 2019

Assignee: PCI BIOTECH AS

Inventors: Anders Hogset, Per Edvard Walday, Kristin Eivindvik

Patent granted 1 Jan 2019!! Grunnet vacc resultater?

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Jeg kjenner meg nogenlunde trygg på effekt- og finansrisk. Bare å kunne oppnå CR i en andel av pasienter med gallegangsobstruksjon vil være en stor forbedring på standard of care, og vil kunne forlenge livene og forbedre livskvaliteten betydelig for de pågjeldende pasienter. For meg er safety risk den største når vi skal behandles et større antall pasienter, tiltross for godkjent safety studie.

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Bristol-Myers kjøper Celgene for 647 milliarder kroner

7 minutter siden · Martin Hagh Høgseth

Legemiddelselskapet Bristol-Myers Squibb har inngått en avtale om å kjøpe opp bioteknologiselskapet Celgene i en avtale verdt rundt 74 milliarder dollar, tilsvarende 647 milliarder kroner.

Nyheten her viser at det er tull at det ikke er midler tilgjengelig i biotek. Ikke første gang en har sett verdsettelse av patenter, teknologi, studier og partnersamarbeid. PCIB markedsverdi omtrentlig en milliard kroner.

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Jubel, det der høres jo VACC-aktig ut, antigener er spesifikt nevnt.

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