PCI Biotech - Fundamentale forhold (PCIB)

TyrionIV · mai 18, 2021, 7:16pm

Dersom det virker så godt første gang slik at det ikke er noe å lyse på, så er jeg enig i at det ikke vil bli belysning mer enn en gang. Jeg tror ikke over 50 % av de som opplever effekt vil oppnå CR ved første gangs belysning - langt ifra - og derfor er jeg overbevist om at flertallet av de som får respons får 2 behandlinger og også at de vil gjennomføre alle 8 gem/cis-behandlinger. Men jeg er enig i at ikke alle pasienter vil få 2 fimachem-behandlinger og da i størst grad de som blir for syke til det og derfor velger å avslutte behandlingen.

FiloD · mai 18, 2021, 7:34pm

Jeg tror ikke nødvendigvis at de vil opnå CR, men de vil få en god nokk respons, altså en PR eller en SD.

Pasienterne dør fordi galdegangen lukkes av en cancer striktur, og de vil overleve hvis denne fjernes (CR), de vil også overleve hvis denne minkes (PR), eller hvis de kan holde denne stabil (SD).

Alle disse grupper vil være reprecenteret i RELEASE studien, og legerne vil kunne se etter første behandling (fimachem1) om de har noen respons. Har de CR, får pasienten ingen andre behandling (fimachem2). Har de PR eller SD, så kan det være at legen vurderer en fimachem2 behandling. Men dette kommer an på hvor stor PR responsen er og om de har erfaring for at SD ikke vil gi en PR eller en CR. Dette er ikke noe vi kan vite noe om.

Men når jeg jobber med elektroporation, så ser jeg at det ofte at det er nok med en behandling, fordi når cellegiften kommer inn i cellen, så responderer de fleste pasienter på denne.

Pci må ikke forveksles med alm cellegift behandling, hvor man får mange cyklusser, ganske enkelt fordi pasientern får mange cyklusser FORDI cellegiften har vanskelig for å komme inn i cellen. Det er nettop dette som pci har løst.

Det er derfor min antagelse, og jeg understreker antagelse, at det er langt fra alle pasienter som får 2 behandlinger (fimachem1 og fimachem2).

Derfor tror jeg at vi vil se avbrytelse av Soc armen lenge før de fleste venter det.

Inkognito666 · mai 18, 2021, 8:08pm

Angående antall sykluser så virker det som at man av og til avviker litt fra protokoll.

I publikasjonen hvor man fikk informasjon om tre av pasientene så fremkommer det at case 3 fikk 2 fimaCHEM-behandlinger selv om han bare klarte 3 sykluser med gem+cis. Etter 3 måneder hadde han PR, så kanskje ikke rart han ønsket en andre runde med fimaCHEM.

På tross av få sykluser med cellegift så overlevde han likevel 17 måneder etter han fikk diagnosen (og 14 måneder etter han ble inkludert i studiet).

bilde

Link:

TyrionIV · mai 18, 2021, 8:04pm

Jeg tror ikke mange av PR vil gi seg med en Fimachem-behandling og tilnærmet ingen med SD vil det. Jeg ser ingen gode grunner for at det skulle være aktuelt.

Jeg tror forsåvidt kan bli aktuelt med en avbrytelse av SOC-armen, men tidligst ifbm avlesing av planlagt interrim av 120 pasienter. Har ingen illusjoner om at det vil skje noe før det.

Det er for øvrig ingen forveksling av alminnelig cellegift fra min side og jeg er fullt klar over at Pci hjelper cellegiften inn i kreftcellene.

abacus · mai 19, 2021, 9:07am

Når vi snakker om cellegift og den belastningen slik behandling betyr for pasientene, kan det være grunn til å minne om at studiedesignet for RELEASE er satt opp med samme cellegiftdoser i kontrollarmen (SoC) og den eksperimentelle armen (PCI) - og det av én grunn: Presis og vitenskapelig dokumentasjon av hvor mye bedre PCIBs løsning er enn SoC.

Imidlertid skal vi slett ikke ze bort fra at når behandlingsløsningen først er godkjent og ute i markedet, så vil noen klinikker prøve ut om man kan redusere giftdosene.

Dersom den lokale virkningen på belyste tumorer da skulle vise seg å gi tilnærma samme effekt, har men oppnådd en betydelig gevinst for pasientene ved at den nedbrytende systemiske virkningen blir klart mindre.

Skulle denne “nedgiftningen” vise seg god nok, vil den ved behov kunne åpne for flere gjentatte behandlinger over tid.

Ansar · mai 18, 2021, 8:15pm

Hadde det ikke vært fint å diskutere dette på småprat tråden?

solo · mai 18, 2021, 8:21pm

Veldig leit og hoere, og synes du er sprek som er saa oppegaaende at du fortsetter og skrive her i en saa vanskelig stund. I USA sier rundt 60% av legene at de ikke vil ta cellegift i det hele tatt. Og da maa det vaere ille.

Det er og haape at fimaChem for alvor kommer paa banen snart, slik at man kan helbrede foer man kommer saa langt at man maa gjenomgaa saa mange sykluser.

Geoinvestor · mai 18, 2021, 8:45pm

Enig. Om resultatene viser seg å være i nærheten av det vi har sett hittil, så forventer jeg at SOC avbrytes. Det vil komme som et sjokk på markedet, men ikke på meg

TekBot · mai 27, 2021, 7:03am

Disclosure of voting rights for Chairman of the Board

Oslo, 27 May 2021. PCI Biotech Holding ASA (“PCI Biotech” or the “Company”)
issue this notification on behalf of its chairman, Hans Peter Bøhn.

…

Vis børsmeldingen

Hans Peter Bøhn is chairman of PCI Biotech and shall open the annual general
meeting of the Company on 28 May 2021. Mr. Bøhn holds 123,662 shares,
representing 0.3 per cent of the share capital of PCI Biotech. Mr. Bøhn has
received powers of attorney to represent and vote for 5,887,479 additional
shares. In total, Mr. Bøhn will represent and vote for 16.1 per cent of the
share capital. A major part of the powers of attorney are without voting
instructions. The powers of attorney are only valid at the annual general
meeting on 28 May 2021.

This information is subject to the disclosure requirements pursuant to section
4 -3, cf. section 5-12 of the Norwegian Securities Trading Act.

Contact information:
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo
Ronny Skuggedal, CFO, [email protected], Mobile: +47 9400 5757

Kilde

TekBot · mai 28, 2021, 9:24am

PCI Biotech Minutes from Annual General Meeting 2021

TekBot · mai 28, 2021, 12:52pm

PCI Biotech receives Orphan Drug Designation in South Korea for fimaporfin in the treatment of bile duct cancer

Oslo, 28 May 2021 - PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical
company today announced that the Ministry of Food and Drug Safety (MFDS) in
South Korea has granted Orphan Drug Designation to its lead product candidate,
…

Vis børsmeldingen

fimaporfin, for combination treatment with gemcitabine in patients with
inoperable locally advanced or metastatic bile duct cancer (cholangiocarcinoma).
No approved treatment alternatives exist today for the first-line treatment of
patients with this disease and fimaChem (fimaporfin) has the potential to play a
role in this area of high unmet medical need.

“The RELEASE trial has in general shown promise with good recruitment activity
in South Korea despite the Covid-19 pandemic. Receiving orphan status from the
South Korean authorities is a key step in the development of this important new
medicine for Asian cancer patients in need of better local treatments. PCI
Biotech’s fimaChem treatment is well suited for treatment of bile duct cancer,
with easy light access through routine endoscopic methods.” said Dr. Per Walday,
CEO of PCI Biotech. “Orphan designation in South Korea, in addition to the
already granted orphan designations in EU and USA, are all significant
regulatory milestones and recognises the therapeutic benefits we seek to bring
to the patients.”

Contact information:
Per Walday, CEO
[email protected]
Mobile: +47 917 93 429

About bile duct cancer and the fimaChem technology
The bile duct drains bile from the liver into the small intestine. Bile duct
cancer (cholangiocarcinoma) is a cancer that affects the cell lining of the bile
duct and represents a patient population with a high unmet medical need. Surgery
is the only potential curative option for these patients, but most patients are
inoperable at presentation. Inoperable patients are treated with stenting to
keep the bile duct open and with chemotherapy. Median survival of inoperable
patients is between 11 and 12 months with the current standard of care
treatment, which is a chemotherapy combination of gemcitabine and cisplatin.
Biliary tract sepsis, liver failure and/or malnutrition and cachexia due to
locoregional effects of the disease are the most important causes of death, so
there is a high need for better locoregional treatments. The locoregional anti-
cancer effect of gemcitabine is significantly enhanced by the fimaChem
technology in preclinical studies, and early clinical treatment data suggest
encouraging tumour response and survival in bile duct cancer patients.

Bile duct cancer is a rare disease with an incidence rate of 1-2 per 100,000 in
the western world. The incidence rates are increasing worldwide and are
generally higher in Asian countries. The immediate target for PCI Biotech is
first-line treatment of inoperable patients with extrahepatic disease. The
fimaChem treatment regimen consists of an intravenous injection of fimaporfin,
followed four days later by an intravenous infusion of gemcitabine and a laser
light application in the bile duct easily administered through endoscopic
methods used routinely in these patients. The patients then follow the standard
background treatment with up to 8 chemotherapy cycles of gemcitabine +
cisplatin. The fimaChem treatment may be repeated during the background
chemotherapy treatment cycles.

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: fimaChem (enhancement of
chemotherapeutics for localised treatment of cancer), fimaVacc (T-cell induction
technology for therapeutic vaccination), and fimaNAc (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 fimaChem programme consists of a clinical Phase I/II clinical
study in bile duct cancer, an orphan indication with a high unmet need and
without approved products. fimaVacc 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. fimaNAc
utilises the endosomal release to provide intracellular delivery of nucleic
acids, such as mRNA and RNAi therapeutics, thereby addressing one of the major
bottlenecks facing this emerging and promising field.

For further information, please visit: www.pcibiotech.com
(http://www.pcibiotech.com)

Forward-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.

Kilde

anon99163478 · mai 28, 2021, 1:39pm

Børsen ble ikke lamslått…

Andor · mai 28, 2021, 1:45pm

Feil tråd.

ufo · mai 28, 2021, 4:23pm

Hvor i huleste er PCIB’s småprat blitt av?
Er den flyttet innenfor insider betalingsmur?

Dagens melding kom beleilig ettersom covid har stoppet hele programmet til favorittaksjen min men det er kanskje ikke så galt allikevell?

Utdrag fra dagens melding:

“The RELEASE trial has in general shown promise with good recruitment activity
in South Korea despite the Covid-19 pandemic”

Slike utsagn er kolosalt beroligende og får en til å fortsatt være optimist.

PCIB , best there is

PcibPhoSerlyset · mai 28, 2021, 4:26pm

https://tekinvestor.no/tag/pcib_ol

LCY · mai 29, 2021, 8:27pm

Synest denne druknet litt paa smaaprat-traaden, kan vaere greit aa ha lettere tilgjengelig her:

TekBot · mai 31, 2021, 9:18am

PCI Biotech: US patent for the vaccine technology (fimaVacc) in combination with checkpoint inhibitors

Oslo (Norway), 31 May 2021 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company, today announces that the U.S. Patent and Trademark
Office (USPTO) has informed the company that a new US patent will be granted
…

Vis børsmeldingen

early June 2021. The US patent covers the use of fimaVacc in combination with
immune checkpoint inhibitors (ICIs).

The use of ICIs has revolutionised cancer immunotherapy, as this class of drugs
may induce long-lasting effects in those patients responding to treatment.
Unfortunately, most patients do not respond to ICI therapy and different
treatment combination strategies are explored with the aim to increase the
number of patients responding. Combining ICIs with therapeutic cancer vaccines
that induce relevant immune responses against the tumour cells is regarded as
one of the most promising strategies. The patent that soon will be granted in
the US covers the use of PCI Biotech’s fimaVacc vaccination technology in
combination with important classes of ICIs and an important type of
immunological adjuvants (a class of so-called Toll like receptor agonists).

“Increasing the response rates to ICI’s is one of the pharma industry’s main
priorities in cancer and therapeutic cancer vaccination is a rational approach
to this aim. The fimaVacc technology has delivered encouraging immune responses
in early phase clinical trials and this US patent provides relevant intellectual
property for the further development of this technology.” said Dr. Per Walday,
CEO of PCI Biotech.

As part of PCI Biotech’s strategy for applying the PCI technology for
therapeutic cancer vaccines, several global patent applications were filed in
2013-2016. Today’s announced US patent secure protection until 2036 and this
patent application is still pending in Europe and key Asian markets.

About fimaVacc
This novel vaccine technology applies a unique mode of action, triggered
endosomal release of antigens or antigen-encoding nucleic acids, to enhance
immune responses essential for therapeutic cancer vaccines as well as for
several types of vaccines against viral and parasitic infections. fimaVacc works
in synergy with several other state-of-the-art vaccination technologies, and is
especially effective in combination with some types of TLR agonists. The
fimaVacc programme aims to enhance the cellular immune responses that are
important for the therapeutic and prophylactic effect of vaccines, and the
fimaVacc technology has proven excellent preclinical efficacy with protein- and
peptide-based vaccines. The technology has shown particularly strong CD8 T-cell
immune responses, which are important for therapeutic vaccination, as well as
enhanced helper (CD4) T-cell and antibody responses.

PCI Biotech successfully translated the vaccination technology into humans
through a Phase I study in healthy volunteers that was completed in May 2019.
The study covered more than 90 subjects and established the tolerability of
fimaVacc across a wide range of doses. The immune results provided proof-of-
concept and demonstrates fimaVacc’s potential to enhance overall T-cell
responses, by demonstrating improvement of the immunogenicity of vaccines in
healthy volunteers.

The results from the successful Phase I proof of concept study for the fimaVacc
technology were recently published in Frontiers in Immunology, a high impact
immunology journal. The article title is “Photochemical internalization enhanced
vaccination is safe, and gives promising cellular immune responses to an HPV
peptide-based vaccine in a phase I clinical study in healthy volunteers” and the
publication is available through this link:
https://www.frontiersin.org/articles/10.3389/fimmu.2020.576756/full

Effective induction of proper cellular immune responses will be critical to
realise the huge potential of therapeutic cancer vaccines, and is also important
for vaccination against some viral and parasitic infections. With present
technologies vaccines often fail to generate such responses, and especially
cytotoxic T-cell responses are often inappropriate. Insufficient delivery of
vaccine antigens to the appropriate presentation pathway in the immune cells may
be one of the main reasons for weak cytotoxic T-cell responses. The fimaVacc
technology has the potential to effectively enhance vaccine presentation through
these pathways.

Contact information:
Per Walday, CEO
[email protected] (mailto:[email protected])
Mobile: +47 917 93 429

About PCI Biotech
PCI Biotech is a biopharmaceutical late stage clinical development 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:
fimaChem (enhancement of chemotherapeutics for localised treatment of cancer),
fimaVacc (T-cell induction technology for therapeutic vaccination), and fimaNAc
(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 programme fimaChem consists of a pivotal study in bile duct
cancer, an orphan indication with a high unmet need and without approved
products. fimaVacc 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. fimaNAc utilises the
endosomal release to provide intracellular delivery of nucleic acids, such as
mRNA and RNAi therapeutics, thereby addressing one of the major bottlenecks
facing this emerging and promising field.

For further information, please visit: www.pcibiotech.com
(http://www.pcibiotech.com)

Forward-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.

Kilde

Tekspert · juni 1, 2021, 10:00am

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

@lenny (2146 likes)

@Investor (1155 likes)

@FiloD (1093 likes)

Resten av topp 10:

@Jubel (1067 likes)
@StockDZ (904 likes)
@Snoeffelen (834 likes)
@abacus (822 likes)
@olafalo (503 likes)
@polygon (496 likes)
@anon6994212 (433 likes)

Gratulerer!

Jubel · juni 7, 2021, 9:48pm

Tekspert · juli 1, 2021, 10:00am

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

@lenny (1354 likes)

@StockDZ (1231 likes)

@Jubel (1103 likes)

Resten av topp 10:

@Investor (1077 likes)
@Snoeffelen (976 likes)
@FiloD (928 likes)
@abacus (687 likes)
@anon6994212 (481 likes)
@polygon (433 likes)
@Logdec (320 likes)

Gratulerer!