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PCI Biotech - Småprat 2019 (PCIB)

https://patents.justia.com/assignee/pci-biotech-as

Patents Assigned to PCI Biotech AS

Patent number: 10166401

Abstract: A device for activating light-induced rupture of endocytic vesicles in target cells of a patient so as to effect delivery of an administered antigen to cytosol in the target cells, is described. The device is adapted to be worn by a patient over a region of skin where an antigen and a photosensitising agent are to be administered. The device comprises a rear surface that is rounded or otherwise configured to be worn against the patient’s skin. It has a retaining part for retaining the device in place over the region of the patient’s skin during an activation cycle. A light source is arranged to illuminate the patient’s skin from the rear of the device. A control system is configured to vary the output of the light source with respect to time in accordance with a pre-configured output sequence.

Type: Grant

Filed: August 28, 2014

Date of Patent: January 1, 2019

Assignee: PCI BIOTECH AS

Inventors: Anders Hogset, Per Edvard Walday, Kristin Eivindvik

Patent granted 1 Jan 2019!! Grunnet vacc resultater?

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Jeg kjenner meg nogenlunde trygg på effekt- og finansrisk. Bare å kunne oppnå CR i en andel av pasienter med gallegangsobstruksjon vil være en stor forbedring på standard of care, og vil kunne forlenge livene og forbedre livskvaliteten betydelig for de pågjeldende pasienter. For meg er safety risk den største når vi skal behandles et større antall pasienter, tiltross for godkjent safety studie.

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Bristol-Myers kjøper Celgene for 647 milliarder kroner

7 minutter siden · Martin Hagh Høgseth

Legemiddelselskapet Bristol-Myers Squibb har inngått en avtale om å kjøpe opp bioteknologiselskapet Celgene i en avtale verdt rundt 74 milliarder dollar, tilsvarende 647 milliarder kroner.

Nyheten her viser at det er tull at det ikke er midler tilgjengelig i biotek. Ikke første gang en har sett verdsettelse av patenter, teknologi, studier og partnersamarbeid. PCIB markedsverdi omtrentlig en milliard kroner.

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Jubel, det der høres jo VACC-aktig ut, antigener er spesifikt nevnt.

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Det er ikke umulig at det kan komme efficiacy data fra extension studien rundt dette tidspunktet. I en av podcastene snakker Per Walday om Dose-Limiting Toxicity, DLT-vinduet som han vel kaller det. Det er da man avleser safety. Slik jeg tolket meldingen 20/12 hadde minst 6 pasienter (les: safety endpoint) passert dette vinduet. I podcasten, jeg husker ikke hvilken, fortalte PW at safety leses av ca 30 dager etter FimaChem 2 behandlingen.

Hvis pasient nr 6 hadde passert DLT vinduet per 20/12 kan man lese ut fra figuren over at vedkommende ble dosert ca 120-140 dager før 20/12, dvs i starten av August. Vi vet at efficiacy leses av etter hhv. 3 og 6 mnd, men er normalt kun blitt rapportert etter 6 mnd. Pasient nr 6 vil være veldig nær avlesning på 6 mnd efficiacy i starten av februar.

Tipper likevel på en liten lag pga at dataene skal kvalitetssikres, så at vi får efficicay data i mars en gang.

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Er vel denne her, og innvilgelsen av patent er neppe timet med resultater fra VACC-studien. Oppfinnelser er forøvrig beskyttet fra det tidspunktet man sender inn en patentsøknad. Og denne ble altså sendt inn i 2014.

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I remember JE discussing in one of the podcasts about having to wait for patents and things like that sometimes before being able to release data. Maybe he was referring to this fimavacc patent when he was discussing this…?

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You never know polygon. This device is clearly combined with antigen. Anyway delighted that the company now is in control of the valuechain» by given this grant at the new year! Happy new year!

A device for activating light-induced rupture of endocytic vesicles in target cells of a patient so as to effect delivery of an administered antigen to cytosol in the target cells, is described. The device is adapted to be worn by a patient over a region of skin where an antigen and a photosensitising agent are to be administered
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Kanskje det nye patentet er for en ny versjon av lyskilden.

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Jeg er virkelig ingen ekspert på patenter, men jeg mener det er slik: Man sender inn en patentsøknad når man har en oppfinnelse man ønsker å beskytte. Søknaden og innholdet i søknaden forblir hemmelig i en periode for at man skal kunne jobbe videre med den. Etter en tid som i utgangspunktet defineres av de patentmyndighetene (når man forhåpentligvis har et produkt klart for markedet) så innvilges og offentliggjøres innholdet i patentet. Evt. patenter som PCIB har søkt om det siste året i forbindelse med fimaVACC er derfor opp til selskapet om de vil dele med omverdenen.

Som nevnt er dette doseeskaleringsstudiet. I tillegg har ikke siden blitt oppdatert siden 2016. Det syns jeg er litt pussig.

In view of the time and money required to obtain patent protection for a biotechnology invention with the potential for international success, it is important to maximize the value that will be returned on the investment. The following are some key areas on which applicants for biotechnology patents should focus in order to maximize the return on their investment. First and foremost, applicants should not disclose the invention publicly until a patent application has been filed in at least one country. A public disclosure includes absolutely any non-confidential disclosure to any person outside of the company or organization in which the invention was made, and it can include disclosure by a person other than the inventor. Thus, public disclosure includes publication in a journal (whether print or web-based), presentation of a poster or abstract at a scientific or trade meeting, discussions with others in the field at a meeting or over the telephone, and discussion or mention in an e-mail. The disclosure, however, must be ‘enabling’. That is, the information disclosed publicly must be of such a quality and quantity that someone with an ordinary level of skill in the field could make and use the invention. Thus, a mere statement that a company has developed an algorithm to identify and distinguish clinical isolates of a particular pathogen would be unlikely to constitute a patent-defeating public disclosure; more details of the steps in the process would be needed for an ordinary person to arrive at the particular algorithm. Confidential disclosures, such as those between employees of the same company, between an inventor and his or her attorney, or between those covered by a legal agreement, such as a nondisclosure agreement, should not defeat the patentability of an invention. As mentioned above, in most countries, public disclosure of the invention before filing a patent application bars the right to obtain a patent on the invention. In addition, disclosure of improvements or new data relating to the invention could rule out a patent on the new subject matter; care must therefore be taken when discussing any aspect of an invention in public. As a general rule, to avoid the loss of rights to a patent, any information that could serve as the basis for a patent should be included in a patent application - and filed in a patent office - before that information is made available to the public.

The reasons why a biotechnology patent application might never become a patent or might have limited commercial value fall into two main categories: inadequate research and preparation of the application before filing, and inadequate data to support a commercially valuable patent.

Med andre ord lite lurt å dele med omverdenen før patent…Skjønner meget godt Einarsson sitt statement omkring vacc og sikre verdier!

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We do not know exactly what PCIB are talking about with FDA and EMA, but 2 facts; we have gotten the accelerated approval pathway and the board clearly thinks that talking this as far as we can on our own will give the best ROI (according to PW statement). My conclusion from that is that FDA/EMA er quite excited about Amphinex in the perihilar indication.

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Selvsagt mulig, enn om trolig noe tidlig, men det hadde vært fint med litt PCIB-buzz blant CCA-pasienter mtp rekruttering.

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Det som er faktum er at om man får et produkt til marked, særlig hvis det er et onkologisk terpeutika, og aller helst i en orphan indication, spesielt med unmet needs (as in “no approved first line”), så kan et selskap bli avsindig mye verdt.

Så sannsynligheten for å lykkes er en nøkkelparameter.

Check, check, check, check, check and check for PCIB.

Summerer man opp alle NDAer i 2018 (og 2017) er det nepper tilfeldig at akkurat BMS nå ser seg nødt til å klinke til.

Legg spesielt merke til siste setning i følgende:

"As individual drugmakers go, there was one clear winner: Pfizer, which didn’t get a drug approved until September but ended up with four approvals—all in oncology—over the course of two months. Its second approval of 2018, PARP inhibitor Talzenna, earned the FDA’s OK for BRCA-mutated, HER2-negative breast cancer, but the Big Pharma is looking to expand its repertoire to other cancers, including ovarian, pancreatic and lung.

Most of the other companies on this year’s list got just one approval apiece, with the exception of Shire and AstraZeneca, which both got two. Bayer, Eli Lilly, Novartis, and Shionogi also got two, but their second approvals were all for partnered drugs. For the second year in a row, Bristol-Myers Squibb was the only top 15 pharma company that went without. "

Har man en vinner er big pharma villig til å betale nær sagt hva som helst.
Sannsynligheten for at vi har en vinner med PCIB er “once in life opportunity”.

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Hva er grunnen til at du er mest usikker på safty @Bra_Britt? Tidligere erfaringer? Hadde vært interessant å høre siden dette ikke har vært diskutert noe særlig her.

Har fått tilgang på full aksjonærbok og ser at Investech Invest kommer inn på 53 plass med 94 000 aksjer.

Så nå er de facto PCIB i en teknisk opptrend?

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Something worth to remember is that investigating abscopal effect is part of the scope for the extension study, this was mentioned before… quote

“4) Det vil bli tatt et større volum med blod (et tillegg på 162 ml over ca. 6 mnd) i den utvidede fase I delen for å se på mulige immune effekter av PCI behandlingen og farmakokinetikken ved andre gangs PCI, samt at det tas blodprøve for analyse av platinum før og etter andre gangs PCI behandling.”

https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/vedtak?sprek_parent_id=596431&p_document_id=715906&dato=07.06.2017

I’m not sure if this will be the icing on the cake or this will become the cake itself but exciting to know more :slight_smile:

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We want cake! Now!

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Så investtech fondet er såpass stort altså?

Ja det fondet skal vel operere etter investtech sin trendorienterte strategi