PCI Biotech - Fundamentale forhold (PCIB)

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
pw@pcibiotech.no (mailto:pw@pcibiotech.no)
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!

StockDZ · juli 9, 2021, 9:07am

this is an interesting article about CCA

Cholangiocarcinoma_2020_the_next_horizon_in_mechan.pdf (3,9 MB)

pci not necessarily mentioned but helps to understand the clinical benefits of pci treatment and the commercial potential

Surprising to see high rates in Austria, probably patients can be recruited from there by german Release sites

interesting to see that the relapse from resection surgery is about 60%, could suggest that pci biotech can play a role in post surgery management of the disease?

Jubel · juli 28, 2021, 6:09am

Tekspert · august 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:

@StockDZ (1180 likes)

@Jubel (1024 likes)

@FiloD (915 likes)

Resten av topp 10:

@Snoeffelen (837 likes)
@Investor (711 likes)
@abacus (708 likes)
@lenny (618 likes)
@polygon (513 likes)
@anon6994212 (492 likes)
@Logdec (301 likes)

Gratulerer!

olafalo · august 18, 2021, 10:16am

This article is a preprint and has not been certified by peer review
Posted August 13, 2021.
Light-controlled elimination of PD-L1+ cells
Judith Jing Wen Wong, Pål Kristian Selbo
[…]
In this study, we show that the intracellular light-controlled drug delivery method photochemical internalization (PCI) induce specific and strongly enhanced cytotoxic effects of the PD-L1-targeting immunotoxin, anti-PD-L1-saporin (Anti-PDL1-SAP), in the PD-L1+ triple-negative breast cancer MDA-MB-231 cell line, while no enhanced efficacy was obtained in the PD-L1 negative control cell line MDA-MB-453. Using fluorescence microscopy, we reveal that the anti-PD-L1 antibody binds to PD-L1 on the surface of the MDA-MD-231 cells and overnight accumulates in late endosomes and lysosomes where it co-localizes with the PCI photosensitizer fimaporfin (TPCS2a).

TekBot · august 23, 2021, 8:01am

PCI Biotech: Invitation to first half-year 2021 result presentation

Oslo, Norway, 23 August 2021 - PCI Biotech’s (OSE: PCIB) first half-year 2021
interim report will be released on 31 August 2021 at 07.00 CEST. The interim
report and presentation will be made available on www.newsweb.no and on the
…

Vis børsmeldingen

company’s webpage, www.pcibiotech.com.

A results presentation (in English) will be held through a live webcast at
08.30 CEST the same day. The webcast can be accessed through www.pcibiotech.com.
There will be a Q&A session at the end of the presentation. It will be possible
to post written questions through the webcast console or through a
teleconference facilitated for investors intending to ask questions verbally
during the Q&A session.

For further information, please contact:
Ronny Skuggedal, CFO
Email: rs@pcibiotech.no
Mobile: +47 9400 5757

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)
Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, N-0379
Oslo

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

TekBot · august 31, 2021, 5:01am

PCI Biotech first half-year 2021 interim results

Oslo (Norway), 31 August 2021 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company, today announces its interim first half-year 2021
results. Please find enclosed the report and presentation.
…

Vis børsmeldingen

Highlights

fimaChem
*The implementation of the amended protocol and the opening of Asian sites
provided increased screening and enrolment to RELEASE in Q1, but the activity
declined significantly in Q2 with only three patients included. The expected
timeline for the interim analysis for potential accelerated approval is revised
to 2H 2023

*Recruitment in Q3 started stronger with four patients included in July and the
company continues to focus on enrolment of patients into the RELEASE study, with
the emphasis on regular trial management, including overall performance
evaluation and site replacement

*First US patient enrolled in the RELEASE study

*Orphan drug designation granted in South Korea

fimaVacc
*Successful Phase I vaccination proof of concept study published in the high
impact immunology journal, Frontiers in Immunology, demonstrating that fimaVacc
enhances the immune response to peptide- and protein-based vaccines in healthy
volunteers

*US patent granted for the use of fimaVacc in combination with immune checkpoint
inhibitors

fimaNAc
*Encouraging data on enhanced delivery of mRNA for various medical applications
was presented at the UK based 12th Annual RNA Therapeutics Virtual Conference

*Established extensive research collaboration with the South Korean company OliX
Pharmaceuticals, a leading developer of RNAi therapeutics

Corporate
*Significantly strengthening the organisation with three highly skilled
individuals; an experienced operational leader for RELEASE, and two key
employees within clinical science and business development focusing on fimaVacc
and fimaNAc

Per Walday, CEO of PCI Biotech, comments: “The organisation has been focused on
the implementation of all the initiatives to recoup delays to the RELEASE study
inflicted by the Covid-19 pandemic. On the positive side, South Korea has
contributed strongly to the recruitment in 2021. Asia is a region with higher
prevalence of bile duct cancer and South Korea is a key market in this region.
The granting of orphan drug designation for fimaporfin in South Korea was an
important step in the development of fimaChem for bile duct cancer and a
recognition of the therapeutic benefits we seek to bring to the patients. The
pandemic situation is however still fluid in 2021 and we have seen fluctuating
recruitment this year, which unfortunately means that we need to revise our
estimated timelines. The situation is expected to improve as the vaccination
rates increase going forward. We are fully focused on optimal study performance
and progress, with attention to site performance and proactive management of
study specific risks. The focused efforts needed for RELEASE during the pandemic
has unfortunately reduced available resources for fimaVacc and fimaNAc. We have
strong confidence in the commercial potential of all our programmes and have
therefore strengthened the organisation significantly, with three highly skilled
employees that will play key roles in driving the progress of all programmes.
For fimaVacc, the US patent granted for the use in combination with immune
checkpoint inhibitors (ICI’s) provides important intellectual property for the
further development of this programme. Increasing the response rates to ICI’s is
a main priority in the pharma industry and therapeutic cancer vaccination is a
rational approach to this aim, with well-suited characteristics of the fimaVacc
technology. For fimaNAc, we were pleased to announce a broad and exciting
collaboration with OliX Pharmaceuticals in South Korea, and we continue to
pursue new and value-adding collaborative opportunities.”

An online presentation in English will be held today, Tuesday 31 August 2021, at
08.30am CEST (local time). The presentation can be followed as a live webcast,
access through link
https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20210831_1
(https://channel.royalcast.com/hegnarmedia/) or the company’s website under
“Investors - Reports and presentations - Webcasts”.

Q&A session
There will be a Q&A session at the end of the presentation and it will be
possible to post written questions through the webcast console. The presentation
will also be presented through a teleconference, mainly facilitated for
investors intending to ask questions verbally during the Q&A session.

Dial-in details for teleconference, mainly facilitated for verbal questions
during Q&A session:
If you plan to use this facility, please join the event 5-10 minutes prior to
the scheduled start time using the dial-in numbers below. A line mediator will
provide information on how to ask questions.

Norway +47 2195 6342 / Sweden +46 4 0682 0620 / Denmark +45 7876 8490 / United
Kingdom +44 20 3769 6819 / United States +1 646 787 0157. If your country is not
listed, we recommend that you use the dial-in details for UK.

When prompted, provide the confirmation code or event title.

Confirmation Code: 436187
Event title: PCI Biotech Holding conference call Q2

The interim report and the presentation will also be available on www.newsweb.no
and on the company’s webpage, www.pcibiotech.com from 07:00am (CEST) on 31
August 2021.

For further information, please contact:
Ronny Skuggedal, CFO
Email: rs@pcibiotech.no
Mobile: +47 9400 5757

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)
Contact information: PCI Biotech Holding ASA, Ullernchausséen 64, N-0379
Oslo

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 considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act. This stock exchange
announcement was published by Ronny Skuggedal, CFO, PCI Biotech Holding ASA, on
31 August 2021.

Kilde

TekBot · august 31, 2021, 10:40am

Financial calendar

Tekspert · september 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:

@StockDZ (1040 likes)

@Jubel (738 likes)

@abacus (546 likes)

[quote=“abacus, post:6393, topic:24197”]

Resten av topp 10:

@Logdec (493 likes)
@FiloD (417 likes)
@Investor (413 likes)
@Snoeffelen (407 likes)
@anon6994212 (396 likes)
@lenny (298 likes)
@neuro (269 likes)

Gratulerer!

TekBot · september 6, 2021, 4:22pm

PCI Biotech: Employee share option scheme

Oslo, 6 September 2021

In accordance with the authorisation granted and the remuneration policy adopted
…

Vis børsmeldingen

by the Annual General Meeting 28 May 2021, the Board of Directors of PCI Biotech
Holding ASA (“PCI Biotech”) has awarded a total of 485,000 share options to key
employees. Each share option gives the right to subscribe for or acquire one
share per option (after PCI Biotech’s choice), at a strike price of NOK 19.41,
equal to the volume weighted average share price (VWAP) for the last 5 days of
trade prior to the grant date. The share options are granted without
consideration and are subject to service based vesting conditions, with a three
year vesting term and one third vested each year. The share options are lapsing
in Q3 2026. Further details about the share option program are described in PCI
Biotech’s remuneration policy, available on https://www.pcibiotech.no/s/PCI-
Biotech-Remuneration-Policy-6-May-2021.pdf.

To ensure long term ownership by executive management, shares obtained by
exercise of share options shall be held for at least one year, except shares to
be sold immediately to cover transaction costs and tax under a so-called cash
less exercise. Through the long-term incentive program the board expects members
of the executive team to build up and maintain share ownership with a market
value equal to at least one-year gross base salary, before any shares may be
sold.

Of the 485,000 share options, 340,000 share options were allotted to the
following primary insiders:

70,000 share options were allotted to Per Walday, CEO. After the allotment, Per
Walday holds a total portfolio of 295,000 unexercised share options and 72,700
shares.

60,000 share options were allotted to Amir Snapir, CMO. After the allotment,
Amir Snapir holds a total portfolio of 150,000 unexercised share options and 0
shares.

50,000 share options were allotted to Ronny Skuggedal, CFO. After the allotment,
Ronny Skuggedal holds a total portfolio of 190,000 unexercised share options and
55,000 shares.

40,000 share options were allotted to Anders Høgset, CSO. After the allotment,
Anders Høgset holds a total portfolio of 190,000 unexercised share options and
64,800 shares.

40,000 share options were allotted to Ludovic Robin, CBO. After the allotment,
Ludovic Robin holds a total portfolio of 130,000 unexercised share options and
0 shares.

40,000 share options were allotted to Lucy Wabakken, CDO (acting). After the
allotment, Lucy Wabakken holds a total portfolio of 160,000 unexercised share
options and 0 shares. Her related parties holds 10,008 shares.

40,000 share options were allotted to Kristin Eivindvik, CDO. After the
allotment, Kristin Eivindvik holds a total portfolio of 110,000 unexercised
share options and 25,200 shares.

Primary insider notifications pursuant to the market abuse regulation article
19 are attached.

The current authorisation, as of 28 May 2021, allows for a total of 2,790,000
share options, of which 1,615,000 now have been granted by the Board of
Directors.

For more information, please contact:
Per Walday, CEO, pw@pcibiotech.no, Mobile: +47 917 93 429

This information is subject to the disclosure requirements pursuant to the
market abuse regulation article 19 and to section 5-12 of the Norwegian
Securities Trading Act.

Kilde

Kreft · september 6, 2021, 6:17pm

"…til en pris på 19,41 kroner,

Av de 485 000 aksjeopsjonene ble det tildelt 340 000 aksjeopsjoner til følgende primære innsidere:

70 000 aksjeopsjoner ble tildelt konsernsjef Per Walday. Etter tildelingen ble PerWalday en total portefølje på 295 000 uutnyttede aksjeopsjoner og 72 700 aksjer.

60 000 aksjeopsjoner ble tildelt Amir Snapir, CMO. Etter tildelingen,
har Amir Snapir har en total portefølje på 150 000 uutnyttede aksjeopsjoner og 0 aksjer.

50 000 aksjeopsjoner ble tildelt Ronny Skuggedal, finansdirektør. Etter tildelingen,
Ronny Skuggedal har en total portefølje på 190 000 uutnyttede aksjeopsjoner og 55.000 aksjer.

40 000 aksjeopsjoner ble tildelt Anders Høgset, CSO.
Anders Høgset har en total portefølje på 190 000 uutnyttede aksjeopsjoner og 64 800 aksjer.

40 000 aksjeopsjoner ble tildelt Ludovic Robin, CBO.
Ludovic Robin har en total portefølje på 130 000 uutnyttede aksjeopsjoner og 0 aksjer.

40 000 aksjeopsjoner ble tildelt Lucy Wabakken, CDO (fungerende). Etter tildeling, har Lucy Wabakken en total portefølje på 160 000 uutnyttet andelopsjoner og 0 aksjer. Nærstående parter eier 10 008 ak sjer.

40.000 aksjeopsjoner ble tildelt Kristin Eivindvik, CDO. Kristin Eivindvik har en total portefølje på 110 000 uøvede
aksjeopsjoner og 25.200 aksjer. "

Investor · september 22, 2021, 9:31pm

Begynner å bli lenge siden vi diskuterte AstraZeneca og avtalen som ikke ble noe av.

Men ifølge Anders Høgset i podcasten i mai i år er kanskje ikke døra lukket for alltid
“Da vi kom dit vi kom drev ikke AstraZeneca med mRNA til tumorer men det de driver med er å levere mRNA inn i hjertemuskel. Det kan vi kanskje også forbedre, men AstraZeneca kjører en klinisk studie som allerede er igangsatt. De var ikke interessert i å gjøre noe med den studien, de ville avvente resultatene i den studien og så kunne vi evnt komme tilbake å gjøre noe etterpå”.

Nå har det seg sånn at den studien nå har avsluttet rekruttering og det er grunn til å vente resultater any minute

"At Visit 3 patients will receive either AZD8601 or placebo as epicardial injections and will then be followed up at 14 days (telephone visit) and 1, 3 and 6 months (on-site) post-surgery.
"

Det ville vært den største oppstandelsen siden år 0, hvis PCIB skulle smelle til med en deal med AstraZeneca nå. Kanskje lav sannsynlighet, men ikke 0% og i seg grunn nok til å holde noen PCIB aksjer.

polygon · september 22, 2021, 9:52pm

Men så er det jo den andre applikasjonen vi trodde på da…

Det siste fra Moderna/AZ om AZD8601 som er to uker gammelt:
https://investors.modernatx.com/static-files/c65fc37f-5528-478d-823d-10458749058b

Jeg håper fortsatt at det var COVID som satte en stopper for en studie i denne pasientgruppen, som jo er en veldig klart definert risikogruppe. Bare det at de ikke har gått videre med diabetiske sår på egenhand uten PCIB tar jeg som et godt signal.

Andor · september 23, 2021, 6:45am

Det blir penger om vi skulle få en avtale med AZ som de her,195 mill Dollar avtale nå hadde gjort susen.
https://www.avanza.se/placera/telegram/2021/09/23/astra-zeneca-astra-zeneca-inleder-samarbete-med-vaxequity-inom-sarna.html

abacus · september 25, 2021, 9:18am

Ved Q1-presentasjonen fikk vi guiding om at “sikkerhetsvinduet” (safety review) ville nås i andre halvår 2021.

Dette tror jeg var en tryggere guiding enn de fleste selskapet har gitt; rett og slett fordi de aktuelle åtte pasientene på det tidspunktet enten allerede hadde vært gjennom dobbel behandling - eller i det minste enkel behandling.

NB! Her snakker vi om pasienter I den eksperimentelle armen. Med andre ord rammes ikke denne prosessen av “retention-problematikken”.

Ut fra at safety og toxicity ikke var noe problem verken i doseeskaleringsstudien eller den utvida studien med dobbel behandling, tar nok de fleste av oss for gitt at det heller ikke vil være noe problem i RELEASE.

Men sånn er det ikke uten videre i markedet generelt - og, viktigst, heller ikke blant eventuelle partnere. For klarert safety review er en viktigere klinisk milepæl enn vi gjerne går rundt og tror.

Slik jeg ser det, kan det godt være slik at potensielle partnere setter klarert safety (ingen dosebegrensende toksisitet) som et minstekrav til videre partnerskapsdrøftinger.

Wait and see.

Tekspert · oktober 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:

@StockDZ (919 likes)

@Jubel (759 likes)

@Investor (601 likes)

Resten av topp 10:

@Logdec (557 likes)
@abacus (509 likes)
@lenny (496 likes)
@bamse (454 likes)
@Snoeffelen (386 likes)
@neuro (360 likes)
@anon6994212 (323 likes)

Gratulerer!

Logdec · oktober 18, 2021, 8:16am

Kjære forumsvenner.

Viser til @Gunnersaurus mail fra HP.

The joint feedback from you all was shared with the BoD and discussed at a non-executive session at a recent BoD meeting. Without going into details here, the Board decided on a number of steps aimed at improving our communication. These will be gradually implemented and noticed over the coming months.

Siden vi har lite å diskutere for tiden, så legger jeg ut en liten liste med mulige triggere.
Vi får ta opp listen om ett år og sjekke om noen av disse har materalisert seg

Vennligst ta diskusjonen på småprat.

Oppdatering:
Trigger 13 info om status (18.102021)

Generelt

Trigger 1 Ny CEO (tidslinje <3mnd)
Trigger 2 Nytt medlem i BoD (tidslinje <3mnd)

FimaCHEM

Trigger 3: Åpenhet ang innrullering (tidslinje <3mnd)
Trigger 4: Mer synlig i verden (tidslinje <3mnd)
Trigger 5: Phase 1 paper ang studien (tidslinje <3mnd)
Trigger 6: Safety 8 pasienter - Release (tidslinje <3mnd)
Trigger 7: Avklaring med FDA ang kontroll arm (tidslinje < 3mnd)
Trigger 8: Økt takt i innrullering (tidslinje < 6mnd)
Bytte av CRO, fra PPD til IQVIA
Trigger 9: Partner i Asia

FimaNAC and FimaVACC

Trigger 10: Paper med AZ (tidslinje <3mnd)
Trigger 11: Klinisk basert på AZ samarbeid (tidslinje <6mnd)
Arpan Desai (AZ) som deltok på samarbeidet med Anders har fått seg ny tittel:Associate Director, Nucleic Acid Therapeutics, Pharmaceutical Sciences. Arpan kjenner PCIB godt. I hans PhD fra 2014 så får vi en smakebit: http://eprints.nottingham.ac.uk/14146/1/Thesis_AD_vFinal.pdf “Photochemical membrane disruption Photosensitsors are delivered to the endosomal pathway, exposure to light results in the release in formation of reactive oxygen species which destroy the endosomal membrane”. Viser til TPPS4, TPPS2A,AlPcS2a.

Trigger 12: Hvem eier den hemmelige medisin x? Partner avtale? (tidslinje <3mnd)
Forskningsprosjekter
«I 2019 rapporterte vi også lovende resultater som viser at lysaktivering av PCI-fotosensitiseren TPCS2a/fimaporfin i kombinasjon med legemiddel X (på dette stadiet vil vi ikke oppgi navn da prinsippet vurderes for patentering) fører til kraftig hemming av vekst og økt drap av tykktarm- og brystkreftceller. I 2020 ble dette arbeidet bekreftet i en xenograft musemodell og arbeidet er nå i sluttfasen og vil bli sendt inn for publikasjon. Medisin X benyttes klinisk og testes ut som en lovende behandling av ulike kreftformer. Relevant for oss er at medisin X har vist seg å gjøre kreftstamceller mer sensitiv til ulike kreftterapier».
Trigger 13 Judith Jing Wen Wong Phd avhandling (tidslinje <3mnd) ref over. 17.10.2021 Avhandling innlevert. Disputas ca mid desember 2021
Trigger 14: Klinisk VACC med UZH (tidslinje <6mnd)
“As the overall goal of our project is to assess feasibility and to pave the way for human testing of PCI-based vaccination, we will also make first preparations for clinical translation of this novel vaccination method.” SNF | P3 Forschungsdatenbank | Project 162773

image1566×544 105 KB
Trigger 15: Klinisk basert på Olix samarbeid (tidslinje <6mnd)
Trigger 16: Klinisk basert på Academisch Medisch Centrum samarbeid (tidslinje?)
Xiaolin ZHANG Academisch Medisch Centrum er med på en av PCIB sine patentsøknader (COMPOSITION FOR THE TREATMENT OF INTRACELLULAR BACTERIAL INFECTION)

image1547×397 84.3 KB
Trigger 17: Klinisk basert på eTheRNA samarbeid (tidslinje?)
Trigger 18: Klinisk basert på Immunicum samarbeid (tidslinje?)
Trigger 19: Klinisk basert på Aposense samarbeid (tidslinje?)
Trigger 20: Klinisk basert på IMV samarbeid (tidslinje?)

FimaLICE

Trigger 21: Fiskelus prosjektet skal ende i publikasjon(er) (tidslinje +1år)
Trigger 22: Fiskelus patentsøknad (tidslinje +1år)

FimaSONIC

Trigger 23: Klinisk basert på ultrasonisk PCI (tidslinje?)
Trigger 24: Klinisk basert på forsking hos Laser institutt i California (tidslinje?)

Patentsøknader (USA)

Trigger 25 Patentsøknad som enda ikke er offentlig - > basert på medisin x… (tidslinje <3mnd)
Forskningsprosjekter
Trigger 26: METHOD (mRNA) Publication date: February 25, 2021 - Anders Høgset
Denne bør vel kunne godkjennes relativt raskt siden dette er opplagt del av PCIBs patentfamilien, samt den er ganske så unik mhp dosering
Trigger 27: TREATMENT OF CHOLANGIOCARCINOMA WITH TPCS-2A INDUCED PHOTOCHEMICAL INTERNALISATION OF GEMCITABINE Publication date: October 29, 2020 - Anders HØGSET, Per Edvard WALDAY, Pål Kristian SELBO, Kristin EIVINDVIK, Lena FINNESAND
Trigger 28: COMPOSITION FOR THE TREATMENT OF INTRACELLULAR BACTERIAL INFECTION Publication date: August 27, 2020 Anders HØGSET, Sebastian A.J. ZAAT, Xiaolin ZHANG Academisch Medisch Centrum
Trigger 29: METHOD Publication date: February 22, 2018 - Anders HØGSET
Trigger 30: METHOD Publication date: February 11, 2016 - Pål JOHANSEN, Anders HØGSET
Trigger 31: METHOD OF VACCINATION Publication date: December 12, 2013 - Kristian Berg, Torunn E. Tjelle, Anders Hogset, Lina Prasmickaite

Har sikkert glemt noen …