Thank you @thosolb ! This collaboration agreement is exciting as well as the other ones. What is also a good sign for FimaNac is that none of the collaboration agreements were terminated, on the contrary we are adding more every time, knowing that these are costing us peanuts. All the doors that have opened to us so far are still opened, this is great, rest to convert these opportunities into licensing agreements, something that will have to happen, a matter of waiting for the partners to conclude the preclinical studies, some of which we know are already in invivo stages.
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PCI Biotech’s first half year 2018 audiocast
(available from 30 August, at 08:30 am CEST (local time):
http://pcibiotech.no/q4-2016-presentation/
Update on the 3 strong Brothers Vacc, Nac & Chem
and do they get a little brother Bacc soon !? 
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PCI Biotech: Second quarter and first half-year 2018 results
Oslo (Norway), 30 August 2018 - PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announces its interim second quarter and first half-year 2018 result. Please find enclosed the report and presentation.
The proposed fully underwritten rights issue of NOK 360 million provides PCI Biotech with the funds needed for the pivotal fima_Chem_ study until interim read-out for potential accelerated approval. The established underwriting syndicate shows that we both have a supportive shareholder base and significant interest from external investors, including a reputable international specialist investor.
The Phase I efficacy data at the dose selected for the fima_Chem_ pivotal study is now mature enough for presentation. Median overall survival is currently 21.2 months in this cohort, and three of the five patients with measurable tumours show tumour response. Although the data sample is small, the results indicate a clear improvement over the best comparable published data. Our focus is now to bring fima_Chem_ to the market as quickly as possible, through successful performance of the pivotal study, which is expected to start early 2019.
The dose-finding part of the fima_Vacc_ Phase I study is completed with more than 90 subjects included, and a well-tolerated dosing regimen is identified. The focus in the coming months will be on in-depth analysis and characterisation of the immune responses.
Continued positive development in the fima_NAc_ programme, with two new research collaborations established over the past couple of months and the top-10 pharma collaboration extended to end of 2018.
Per Walday, CEO of PCI Biotech, comments: .The apparent strong emerging survival and response results from the last cohort in the fima_Chem_ Phase I study in bile duct cancer verify the selection of this dose for the pivotal study. With the recently proposed fully underwritten rights issue that was supported by both major shareholders and an international specialist investor, we are now all set to execute the pivotal study to interim readout and potential accelerated approval. The near-term focus for the fima_Vacc_ Phase I study will be to further characterise the promising clinical immune responses and strategic assessment of the most value-enhancing path forward. We see a continued strong interest in the fima_NAc_ programme and are pleased to see the addition of two new research collaborations with key players in the immunotherapy field…
Highlights
*Proposed fully underwritten rights issue of NOK 360 million
*Encouraging data from the Phase I study at the dose level selected for the fima_Chem_ pivotal study
*Initial data suggests that two fima_Chem_ treatments are well tolerated and preparation for pivotal study progressing towards initiation early 2019
*Phase I fima_Vacc_ interim data suggests enhancement of several parameters of importance for vaccination . near-term focus is on analysis and characterisation of the clinical immune responses
*Extension of the top-10 pharma fima_NAc_ collaboration and new research collaborations established with the immunotherapy focused companies IMV in Canada and Bavarian Nordic in Denmark
A presentation in English will be held today, Thursday 30 May 2018, at Oslo Cancer Cluster Innovation Park.
Time: Thursday 30 May 2018, 08.30am - 09.30am CEST (local time).
Venue: Jónas Einarsson aud. (2nd floor, entrance 2B), Oslo Cancer Cluster
Innovation Park, Ullernchausséen 64, Oslo.The presentation can be followed as a live audiocast (access through link ) or the company.s website under .Investors . Reports and presentations . Webcasts… It will be possible to post questions through the audiocast console.
About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fima_Chem_ (enhancement of chemotherapeutics for localised treatment of cancer), fima_Vacc_ (T-cell induction technology for therapeutic vaccination), and fima_NAc_ (nucleic acid therapeutics delivery).
Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company.s lead fima_Chem_ programme consists of a Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fima_Vacc_ applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies. fima_NAc_ utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and siRNA therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.
For more information visit:Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo
Ronny Skuggedal, CFO, [email protected], Mobile: +47 9400 5757Forward-looking statements
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. PCI Biotech disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
Attachments
PCI Biotech Q2 2018 Interim Reporting
PCI Biotech Q2 2018 Presentation
Nyheten er levert av GlobeNewswire.
http://www.netfonds.no/quotes/release.php?id=20180830.GlobeNewswire.GNW1000097428-en
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De tar hensyn bare til de 5 pasientene med respons:
Deilig å få det endelig bekreftet. Best case scenario 
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Initial data suggests=endelig bekreftet? 
At ikke det har vært problemer med sikkerheten. Betyr jo ikke at det ikke kan bli på de som ikke er ferdig med behandlingen enda. Her snakker jeg ikke om at det er sikkert at pivotale fasen går med 2 behandlinger, men ser veldig bra ut 
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Helt enig!
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Dette så meget bra ut!!
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Likte denne om “large catchment areas”:
Preparations for pivotal phase progressing towards initiation early 2019
Extensive feasibility study ongoing to aid in the selection of high quality sites with large catchment areas 
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Muligens litt dumme spørsmål her på morgenkvisten, men dette er vel et forum for å lære så here goes:
Det står at “interim analysis of progression free survival and objective response rate for potential accelerated/conditional approval”
Hva vil dette praktisk si når FDA evaluerer mulig AA? Kreves begge parametre oppfylt, vektlegges en mer enn den andre? Vi har per dags dato ORR på 60% i arm4, kan noen minne meg på ORR på SoC? Har vi fått tall på PFS for arm 4 eller noen armer forøvrig?
Sterk melding fra selskapet. Uten tvil gode data. Alt i alt en veldig positiv melding. Spent på å høre presentasjonen 8.30! Som de sier i presentasjonen:
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De tar hensyn bare til de 5 pasientene med respons:
Hvis de kun beregner median med 5 pasienter, så ville 21.2 mnd vært overlevelse til en av pasientene. Det er ingen i cohort 4 som har OS= 21.2 mnd. Jeg tolker dette som at de har oppdaterte data siden sist rapportering.
(Forøvrig ville det jo være juks med statistikk å utelate en pasient som ikke viste respons. Alt skal med når man rapporterer overall survival, om de dør i bilulykke eller annet).
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En spennende detalj jeg plukket opp i prestasjonen. Pasienter med metastaser er med i PF2, betyr det da at vi kan utvide markedet betydelig utover de 3000 inoperable?
Denne lille detaljen her kan bety at det potensielle markedet brått økte med ca 8200 pasienter fra 3000 til ca 11000!
Hørte jeg noen si blockbuster?
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Har ikke PCIB operert med 1500 personer tidligere? Mens Stuffers 3000 i sin analyse
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dere hørte vel på Podcasten om hva de sa om akkurat dette.!?
At behandlings opplegget for PF2 blir dosen som vi har i Cohort IV samt gjentatt behandling.
Men selvfølgelig noen pasienter vil bare få 1 dose, da deres sykdoms og allmenntilstand vil tilsi det. DVS en pasient tilpassning underveis i behandlingsløpet.
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Enig. Men begge tallene er pr august og 4 av 6 pasienter var døde da vi fikk oppgitt 19.4 måneder. Skal ikke være mulig å få forlenget median med mindre en har stått opp fra de døde…
Data har gått fra promising til encouraging.
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Hehe, var litt kjapt ut der, lesefeil;)
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JAXI
Bare for å korrigere, jeg er ikke garantist. Jeg har nok selv bidraget til den missforståelse fordi jeg skrev til abacus at jeg garanterede resultatene, men jeg er altså ikke garantist.
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Jeg tolker dette som at de inkluderer inoperable pasienter med metataser. Det positive med dette er at man får flere pasienter å ta av for å rekruttere inn i studien(og kanskje det er her stuffers 3000 kommer inn?), det negative er at man sannsynligvis får inn pasienter som er vanskeligere å behandle.