PCI Biotech - Fundamentale forhold (PCIB)

Jubel · november 30, 2021, 8:13am

PCI BIOTECH AND IMMUNICUM ANNOUNCE AN EXTENSION TO THEIR RESEARCH COLLABORATION TO EXPLORE NOVEL CANCER VACCINATION TREATMENTS

Oslo, Norway, November 30, 2021 - PCI Biotech Holding ASA (OSE: PCIB), a cancer focused biopharmaceutical company with a unique intracellular delivery technology via Photochemical Internalisation and Immunicum AB (publ; IMMU.ST), a biopharmaceutical company focused on hard-to-treat established tumors and the prevention of cancer recurrence, announced today an extension of their current collaboration.

The companies jointly research the possibility to overcome current hurdles in cancer immunotherapy by introducing tumor independent immune targets into the tumor microenvironment, in combination with vaccination or adoptive immunotherapies. The so-called Tumor Independent Antigen concept, which has been invented by Immunicum, could benefit from PCI Biotech’s antigen delivery technologies based on Photochemical Internalisation. Following the encouraging results of the first set of in vitro experiments, during which the delivery protocol of the combination treatment has been optimized, the companies have decided to move ahead to evaluate the novel therapeutic concept in animal models. While the first experiments were conducted by Immunicum, this further in vivo evaluation will be carried out by PCI Biotech.

Commenting on the announcement PCI Biotech’s CEO, Per Walday said: “The results of the initial collaborative experiments are encouraging, supporting the immune response enhancing capability of the fimaVacc platform technology. We are committed to this collaboration and are looking forward to the next series of experiments in animal models, which are aimed to generate data that could pave the way to a potential joint development program.”

Erik Manting, CEO of Immunicum added: “At Immunicum, we are continuously studying novel immunotherapy concepts aimed to address hard-to-treat established tumors and to overcome the limitations of currently available cancer therapies. In this collaboration, we are combining our know-how and technology basis with that of PCI Biotech to design potential novel therapeutic concepts and we look forward to advancing the collaboration through in vivo studies as an important next step.”

Tekspert · desember 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 (965 likes)

@Jubel (813 likes)

@bamse (494 likes)

Resten av topp 10:

@abacus (443 likes)
@StockDZ (258 likes)
@Gautosaur (222 likes)
@anon6994212 (203 likes)
@nordpolen (195 likes)
@Logdec (195 likes)
@Sorlendingen (152 likes)

Gratulerer!

Jubel · desember 3, 2021, 9:44pm

ufo · desember 7, 2021, 4:41pm

Dette innlegget ble rapportert og er midlertidig skjult.

TekBot · desember 7, 2021, 5:45pm

PCI Biotech: Update on regulatory interactions for the RELEASE trial

Oslo (Norway), 7 December 2021 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company, today announced that the company has concluded on the
interactions with regulatory authorities in the US (US Food and Drug
…

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Administration, FDA) and Europe (European Medicines Agency, EMA) held during
2H 2021.

The interactions with the FDA and EMA were initiated to explore the opportunity
for a modified study design to address the retention risk in the control arm of
the RELEASE study. PCI Biotech argued that enrichment of the control arm of
RELEASE with external control data, using existing patient-level data from past
clinical trials and real-world data from a patient registry for patients with
extra-hepatic cholangiocarcinoma receiving gemcitabine-cisplatin, could address
the potential retention issue and that this approach may also benefit
recruitment. The company has previously reported that initial responses from the
authorities suggested significant challenges for using external control data in
a pivotal trial of a first line treatment. The authorities have now reiterated
their position and given more granularity on their concerns.

Both regulatory authorities recognised the retention and recruitment challenges
for RELEASE in bile duct cancer, a rare disease with high unmet medical need.
The authorities’ main concern is that the proposed modification would introduce
a risk for uncontrolled bias. The feedback suggests that the validity of
external control data for inferential statistical tests is not yet sufficiently
corroborated for the settings of a global pivotal trial with registration
intent.

PCI Biotech acknowledges the feedback from the authorities and has concluded not
to further pursue adoption of real-world data to supplement experimental control
arm data in a randomised first line setting under the current regulatory
environment. The company continue with full focus on RELEASE assessing all
opportunities to address retention and recruitment.

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:
Per Walday, CEO
pw@pcibiotech.no
Mobile: +47 917 93 429

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

Jubel · desember 7, 2021, 6:10pm

Dette ble kjent på siste Q for få dager uker siden.
De samme spydde av kommentarer fra ledelsen om slim hvis noen mulighet og nu ble det bekreftet. Må det spys for andre gang. Det ble jo allerede spydd etter Q!!!

The company has previously reported that initial responses from the authorities suggested significant challenges for using external control data in a pivotal trial of a first line treatment.

The company continue with full focus on RELEASE assessing all opportunities to address retention and recruitment.

Fra Q:

Strategies:
• Working with clinical sites to strengthen the commitment of patients to the trial
• Support patients in all aspects of taking part in the study
• Evaluate the possibility to convert the randomised control arm to a hybrid control arm by adding external patients’ data
• Evaluate options to decentralise the study, allowing treatment in nearer clinics and replacing site visits with home visits

Antar siste punkt er aktuelt fortsatt. Det var vel her Snapir greiet ut om faktiske muligheter. Selskapet ble slaktet av enkelte på fora etter Q for at ledelsen i PCIB ikke var spesielt positive til mulighet hos regulatoriske for bruk av ekstern kontroll data.

Det er meget bra at selskapet kommuniserer aktivt til markedet som lovet fra selskapet og som ønsket fra aksjonærene.

Kreft · desember 7, 2021, 6:06pm

Litt pussig å SPY av dette?

« PCI Biotech erkjenner tilbakemeldingene fra myndighetene og har konkludert med ikke for å fortsette å ta i bruk virkelige data for å supplere eksperimentell kontroll arm data i en randomisert førstelinjeinnstilling under gjeldende regulering miljø. Selskapet fortsetter med fullt fokus på RELEASE vurderer alle muligheter til å ta tak i oppbevaring og rekruttering.
…fimaVacc bruker en unik virkemåte for å forbedre det essensielle cellegift av terapeutiske kreftvaksiner, som fungerer i synergi med flere andre toppmoderne vaksinasjonsteknologier. fimaNAc bruker endosomal frigjøring for å gi intracellulær levering av nukleinsyrer, som f.eks mRNA- og RNAi-terapi, og adresserer dermed en av de største flaskehalsene man står overfor dette nye og lovende feltet. «

pdx · desember 9, 2021, 9:17am

La oss holde småprat til småprat

TekBot · desember 13, 2021, 4:12pm

PCI Biotech: Independent Data Monitoring Committee recommends continuation of two treatments in the RELEASE trial

Oslo (Norway), 13 December 2021 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company, today announced that the Independent Data Monitoring
Committee (IDMC) has reviewed the safety data collected thus far in the RELEASE
…

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trial and recommends that the trial continues with up to two fimaChem treatments
as stated in the protocol.

The ongoing pivotal RELEASE trial with registration intent was initiated with a
planned safety review for the first eight patients receiving two fimaChem
treatments. In the previously completed Phase I study a total of five patients
received two treatments and now with additional eight patients reviewed for
safety after two treatments, the RELEASE trial seamlessly continues to enrol
patients for up to two fimaChem treatments.

Per Walday, CEO of PCI Biotech, said: “With this positive initial safety
clearance for repeated treatments, PCI Biotech continue to focus on execution of
the pivotal trial and we are eager to see the benefits fimaChem hopefully can
provide to the patients in need of better local treatment options. So far, a
clear majority of patients eligible to receive two treatments in RELEASE opted
for the second treatment, which is an early encouraging sign on the
acceptability of the treatment modality, both from a patient- and clinician
perspective.”

The IDMC consists of international experts in bile duct cancer and medical
statistics and is chartered to monitor the safety of participants in the RELEASE
trial. The primary purpose of the IDMC is the protection of participants in the
trial and the maintenance of trial integrity. The IDMC recommendation is based
on a review of the available trial safety data, including data from eight
patients that had undergone two fimaChem treatments.

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 perihilar and
distal 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:
Per Walday, CEO
pw@pcibiotech.no
Mobile: +47 917 93 429

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 · desember 14, 2021, 10:45am

PCI Biotech to present at DNB Nordic Healthcare Conference 2021

Oslo (Norway), 14 December 2021 - PCI Biotech (OSE: PCIB), a clinical-stage
biopharma company developing innovative therapeutics that address significant
unmet medical needs in cancer today announced that it has been invited to
…

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present at the DNB Nordic Healthcare Conference 2021, an Oslo based online event
hosted by DNB.

On Thursday, 16 December 2021 at 11:10 (CET), Dr. Per Walday, CEO, will present
an overview of PCI Biotech’s proprietary platform technology via a general
company presentation. The Company is also available for 1:1 meetings with
potential partners and investors.

The presentation slides will be made available on PCI Biotech’s website
(www.pcibiotech.com) under “Other presentations”.

Contact information:
Per Walday, CEO
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 perihilar and
distal 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

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

Jubel · desember 15, 2021, 10:47pm

Tekspert · januar 1, 2022, 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 (1352 likes)

[quote=“lenny, post:1476, topic:30365”]

@Jubel (1101 likes)

@bamse (710 likes)

Resten av topp 10:

@abacus (596 likes)
@TyrionIV (434 likes)
@Oxion (308 likes)
@anon6994212 (287 likes)
@StockDZ (276 likes)
@olafalo (261 likes)
@Gautosaur (222 likes)

Gratulerer!

TekBot · januar 5, 2022, 6:01am

PCI Biotech and MDimune announce research collaboration agreement

Oslo, Norway and Seoul, South Korea 5 January, 2022 - PCI Biotech (OSE: PCIB), a
Norwegian cancer focused biopharmaceutical company and MDimune Inc. (“MDimune”),
a private South Korean biotech company developing innovative drug delivery
…

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technologies for modifying cellular and disease processes in many areas of human
disease, today announced a preclinical research collaboration that would offer
several opportunities for future development.

Commenting on the announcement, Per Walday, CEO of PCI Biotech, said: “We are
very pleased to initiate a collaboration with MDimune. This collaboration is an
additional mark of interest from a cutting-edge biotech company developing
therapies with emerging advanced technologies, with a large potential in future
medicine.”

Seung Wook Oh, Chief Scientific Officer of MDimune added: “We are excited to
launch this collaboration with PCI Biotech. PCI Biotech’s versatile
photochemical technologies have the potential to enhance several aspects of our
technologies, to make future therapies more efficient and more specific.”

Please see the attachment for the full press release.

Contact information:
Per Walday, CEO
pw@pcibiotech.no
Mobile: +47 917 93 429

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

1987 · januar 5, 2022, 11:45am

Dette innlegget ble rapportert og er midlertidig skjult.

erikaak · januar 5, 2022, 11:45am

Dette innlegget ble rapportert og er midlertidig skjult.

urban66 · januar 5, 2022, 11:45am

Dette innlegget ble rapportert og er midlertidig skjult.

1987 · januar 5, 2022, 11:45am

Dette innlegget ble rapportert og er midlertidig skjult.

Jubel · januar 5, 2022, 9:57am

Rydde litt i fundamental tråden @Savepig ?

TekBot · januar 11, 2022, 8:02am

PCI Biotech: Publication of preclinical tuberculosis results

Oslo (Norway), 11 January 2022 - PCI Biotech (OSE: PCIB), a cancer focused
biopharmaceutical company, today announced that results from preclinical studies
on tuberculosis performed in collaboration with The University of Zurich and ETH
…

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Zurich are accepted for publication in Frontiers in Immunology, a high impact
immunology journal. The article title is “Photochemically-mediated inflammation
and cross-presentation of Mycobacterium bovis BCG proteins stimulates strong CD4
and CD8 T-cell responses in mice” and the abstract of the publication is
available through this link:
www.frontiersin.org/articles/10.3389/fimmu.2022.815609/abstract.

Anders Høgset, CSO of PCI Biotech, comments: “Infectious diseases are not within
PCI Biotech’s core focus areas, but these positive results support our general
understanding of fimaVacc’s mode of action and further demonstrate the broad
potential of the technology.”

Contact information:
Per Walday, CEO
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

polygon · januar 11, 2022, 8:03am

FimaBACC!