Diskusjon Triggere Porteføljer Aksjonærlister

Pcib fimaVacc (PCIB)

En ting jeg liker med PCIB sine tre ben er at de ikke kjører noen veldig “vi har mange skudd på mål” kommunikasjon rundt dette. Dette var en ting jeg spesifiserte at jeg ikke likte veldig med targovax fra de ble børsnotert.

PCIB har et spydspissprogram, et som er nr 2, og et som er nr 3, i veldig klart kommunisert prioritet og ressurstildeling.

At de klarer å kjører fimavacc såpass fort fremover på lavbluss fortjener de stor kudos for.

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Det skal bli interessant å se resultatene fra fase l/ll i vaksinestudien i lys av dette:

"Lessons from previous cancer vaccine expeditions are teaching us the type and magnitude of immune responses needed, as well as vaccine technologies that can achieve these responses. For example, we are learning which vaccine approaches elicit the potent, balanced, and durable CD4 plus CD8 T cell expansion necessary for clinical efficacy. Exploration of interactions between the immune system and cancer has elucidated the adaptations that enable cancer cells to suppress and evade immune attack. "

https://www.nature.com/articles/s41541-019-0103-y?WT.ec_id=NPJVACCINES-201903&sap-outbound-id=041C1027E2BBCE9E732AF02DF36F9BC61F5B2E74

(publisert 8. februar 2019)

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Og denne

https://www.researchgate.net/publication/329267925_Nanoparticle_Systems_for_Cancer_Vaccine

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I still believe that fimavacc study will be presented in the CIMT meeting. The deadline for abstract is passed and the conference will send out abstract notifications around 04/04/2019. (I expect after this date pci biotech will update the website with the conference)

http://www.meeting.cimt.eu

The interesting thing is that among the conference speakers there is a person by the name of Thorbald van Hall ( http://www.meeting.cimt.eu/speakers ) i tried to look him up and i found out that he is a member of Sjoerd van der burg lab (the wanted man :slight_smile: )

another intersting thing is that the late breaking abstract deadline was extended to march 15/03 … mmmmmm :grin:, may be for fimavacc, we dont kow but definetly works for pci biotech if they are part of this

Thorbald van Hall

Leiden University Medical Center

short bio

Thorbald van Hall (PhD) is faculty member of the Medical Oncology Department at the Leiden University Medical Center, the Netherlands. He received his PhD in 2000 from Leiden University on tumorimmunology and was visiting scientist at the Karolinska Institutet, Stockholm in 2005. His main research interest centers around immune escape mechanisms of cancers with the aim to counter these for improved efficacy of immunotherapy. His group identified a new category of cancer antigens: TEIPP. These CD8 T-cell antigens are of non-mutated self-origin and emerge on tumors with deficiencies in their antigen processing machinery. We are currently in the process to bring these novel targets forward for clinical testing. Furthermore, his research group studies the role of HLA-E (a non-classical MHC) in cancer immune escape and recently reported that its observed upregulation in cancers might constitute a barrier for CD8 T cell immunity via NKG2A. This inhibitory receptor is expressed on NK cells and CD8 T cells and might represent the new kid on the block of checkpoint therapy for cancer.

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2019 CIMT Annual Meeting

SCIENTIFIC PLANNING COMMITTEE

Mustafa Diken
TRON-Translational Oncology, Mainz/Germany; CIMT Scientific Secretary

Harpreet Singh
immatics Biotechnologies/USA

Sine Reker Hadrup
Denmark Technical University, Copenhagen/Denmark

Marij Welters
Leiden University Medical Center, Leiden/The Netherlands

Sebastian Kreiter
TRON-Translational Oncology, Mainz/Germany; Head CIMT Management Board

Leiden University i scientific planning commitee i 2019👍

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Let´s hope… no sure although. Thanks for sharing @StockDZ !

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it is rather an educated guess :wink: and it is the best we can do for now since he company is applying a “radio silence” policy

you missed out Christoph Huber, who knows pci biotech inside out and who recently retired from our scientific advisory board, he is also a member of CIMT scientific palnning committee :wink:

image

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Takker for fine innlegg ang CIMT, når finner CIMT meeting sted?

The deadline for abstract is passed and the conference will send out abstract notifications around 04/04/2019

Om fimaVacc skal bli presentert ved denne eventen, vil vi da få vite det ved å sjekke abstract notifications?

4 April kan da bli meget spennende.

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CIMT 2019 Annual Meeting

May 21 – 23, 2019

Rheingoldhalle Congress Center
Mainz, Germany

Kan jo svare meg selv på denne da.

https://www.cimt.eu/meetings

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Fra Artic analysen angående Fimavacc:

To date, more than 80 subjects have been included. Preliminary data has indicated initial clinical support of fimaVACC’s potential to enhance the cellular immune response at well-tolerated dose levels, as well as early responses and high response rates.
Interestingly and somewhat unexpectedly, best responses were found at the lowest fimaporfin dose that was tested. Therefore, the study needed additional expansion to include lower doses. This led to more subjects being recruited and a slight delay to the study timelines than originally planned. The study was initiated in 3Q16 and completion is expected in 2H18.

Strategic positioning To improve the immunogenicity of vaccines is of great importance for vaccine-based immunotherapeutics. Most vaccines are depending on enhancement by adjuvants, which boost uptake of antigens and immune response, but are still considered somewhat suboptimal. The development of better adjuvants has shown to be demanding, costly and time consuming. Therefore, PCI enhancement should be an interesting opportunity for companies developing cancer vaccines. Fimaporfin is stable in solution and at room temperature, with cost-effective synthesis and is used in combination with a user-friendly, disposable “band-aid-like” device for illumination at the vaccination site.

PCI Biotech reports it has previously attempted to out-license the technology on the back of preclinical data, but instead saw the opportunity for substantial upside by gaining quick clinical validation of concept, optimization of the protocol and confirmation of safety at relatively limited cost.

After completion of the phase I study, the company’s main strategy is to out-license the fimaVACC technology to vaccine companies, likely on a non-exclusive basis, in resemblance with adjuvants. The technology has a broad application, as it can be combined with peptide and protein antigens, as well as with particulate antigen formulations and prophylactic and therapeutic vaccination.

Due to PCIB’s strong patent situation and positioning, it could also decide to utilize the platform and develop vaccine candidates by itself. The strategy of non-exclusive out-licensing agreements could give PCI Biotech some revenue stream from late 2018 or early 2019. These types of deals are usually backend loaded and could be imagined to include lower single-digit upfront payments, sober development and regulatory milestones and lower single-digit royalties on sales.

The total global cancer vaccines market (preventative and therapeutic vaccines) was valued at some USD 4bn in 2016, mostly driven by prophylactic cancer vaccines. The market is projected to reach a value somewhere between USD 7.5 - 12.5bn by 2023, but includes a wide range of cancer vaccines and “affiliated” technologies, like CAR-T treatments that are expected to generate blockbuster revenues within that time period. Few therapeutic cancer vaccines have received clinical approval so far, but more than 120 vaccine assets are currently in clinical development, of which some 40 in combination with PD-1/L1 checkpoint inhibitors.

is worth noting that for vaccines already in clinical development, companies would need to start clinical development from scratch if combining with a new adjuvant and/or delivery technology. On the other hand, many companies are aware of their suboptimal technology platform and are shopping around to optimize efficacy of their approach.

Sales projections and considerations

After completion of the phase I study, PCIB’s main strategy is to out-license the fimaVACC technology to vaccine companies, likely on a non-exclusive basis. The technology has a broad application, and a substantial “rescue value” for vaccine technologies that now generate suboptimal efficacy, due to delivery challenges.
The strategy of non-exclusive out-licensing agreements could give PCI Biotech some revenue stream from late 2018 or early 2019. These types of deals are usually backend loaded and could be imagined to include lower single-digit upfront payments, sober development and regulatory milestones and lower single-digit royalties on sales.

We find it particularly challenging to estimate the potential revenue stream fimaVACC could generate and we therefore model revenue from 1-2 out licensing agreements per year between 2019-2025 to a total of ten deals, with the following assumptions:
Each deal is based on an upfront of some USD 0.5-1m, additional milestones of some USD 2.53m and royalties of some 2%. We assume slightly higher milestone based payments for later deals, as the platform may be validated by earlier deals by then

 We assume 5 - 10,000 vaccines per year (peak sales) at USD 50,000 per vaccine per deal, which amounts to an average of USD 7.5m per deal per year in royalties for 7 years (note: gradual ramp up of peak sales in line with industry statistics)

 We assume all vaccine are developed from pre-clinical to clinical assets, all are successful and all have meaningful market uptake and sales

We acknowledge our assumptions are highly speculative and only reflect one possible scenario for fimaVACC. We do however think the total value for out-licensing of fimaVACC could be realistic

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Med bare få uker igjen før lansering er det spennende å få vite om prognose i qty og i $$$ er riktig, overestimert eller undervurdert. :crossed_fingers:

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it is interesting that the CIMT conference has added a new speaker from Leiden who was not on the list 2 days ago by the name of Ferry Ossendorp (now they have 2 speakers from Leiden)

what is interesting about the new speaker is that if you look at my post in the main forum about the upcoming PDT conference end june/july

you can notice that Ferry Ossendorp has a special interest in light targeted therapies and will be participating in the PDT conference along side with pci biotech.

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Dævelen , der satt den i sikringsboksen.

PCIB burde børsmelde dette straks.
Siste setning er musikk i mine ører :bomb::zap::boom:

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Rart ikke volumet kommer :wink:

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http://pcibiotech.no/partnering/

Vienna, March 25-27, 2019

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der ble det 5888 nye pcib på meg idag :wink:
and tnx @StockDZ for ure digging and shearing :hugs:

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Hehe, starter og bli alvorlig mange nå :joy:

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Vi har vel fått bekreftet at resultatene fra fase1 studiet fimaVACC er kjent for markedet senest 1 juli 2019.

Men resultatene kan kanskje være publisert før denne dato (1 juli) i et tidsskrift eller et annet videnskapelig forum.
Jeg kan aldri tenke meg at en ikke skal melde til markedet fimaVACC resultatene dersom de allerede er ferdige i nederland.
Det er vel over 3 måneder til 1 juli så dersom ferdige så venter en ikke over 3 måneder før publisering.
Tid er penger.

Ser at prestasjonen også skal inneholde resultatene fra preklinisk også for fimaVACC.

Men nå vet vi ihvertfall at siste dato for publisering av vacc’n er 1 juli.

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From CIMT 2019 conference program, all other speakers have communicated what they ll speak about except for Ferry

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limer inn denne fra trigger lista fra småprat tråden :wink:

#6 fimaVACC - Final analasys presented or published by mr.Burg

FimaVACC results can be presented at CIMT Germany :de: 21-23 May
http://www.meeting.cimt.eu/program

Abstract deadline March 8
http://www.meeting.cimt.eu/call_for_abstracts

Abstract Presentation 14Mai
Accepted abstracts will be posted in full length on this website and on the conference app one week prior to the conference.

if you look at the committee for scientific planning, you ll see that Leiden university is well represented. Also interesting to see Pci biotech ex member of the scientific advisory board professor Christop Huber who is also part of this.

Worth mentioning that fimavacc animal study was also presented in this conference back in 2016.
Tnx @StockDZ :handshake:

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