Hvis teknologien er saa god som vi tror, faar vi ikke beholde PCIB paa vaare hender de neste ti aarene. For naar man ser hva BP har kastet sin appetitt over opp igjennom historien, vil vaar leveringsteknologi staa hoeyt paa samme liste. Vi kan motta bud, allerede etter Burgerens fimaVacc presentasjon.
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Jeg tenker noe av det samme som dere. Jeg tror ikke vi eier PCIB-aksjer på denne tiden neste år.
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Så lenge kursen da er over target så er det helt greit.
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Hvis det går så fort som noen her inne antyder, at selskapet blir solgt innen 2020 er omme, så må det være fordi teknologien er overlegen og resultatene oppsiktsvekkende.
I så fall, blir jeg forferdelig skuffet dersom dagens aksjonærer presterer å gi bort selskapet for noe annet enn firesifret kurs.
MINST!!!
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Eg er helt enig!
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Grunwitz et al. studied immunity provoked by E7 RNA-LPX, a liposome-encapsulated mRNA encoding human papillomavirus 16 E7 oncoprotein fused to the MHC class I signal sequence and transmembrane and cytoplasmic domains. Given intravenously to mice, E7 RNA-LPX expanded antigen-specific effector and memory T cell populations. In submucosal (orthotopic) and subcutaneous syngeneic mouse E7+tumor models, E7 RNA-LPX induced intratumoral and systemic proinflammatory innate and adaptive immune responses, regression of and protection from rechallenge with E7+ tumors, and conversion of one model to anti-PD-L1 sensitivity.
Litt for teknisk for meg. Dette er det jeg plukker opp: Produserer T-celler som kjenner igjen HPV E7-protein; Bruker MHC class 1; transmembrane.
Høres ut som de klarer det samme som fimaVacc? Trenger de fortsatt hjelp med leveringen av mRNA?
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Ser siRNA og photochemical internalization er nevnt men jeg får ingenting ut av dette. Noen andre?
Publisert 3. September i år.
https://pubs.rsc.org/en/Content/ArticleLanding/2019/CC/C9CC05703J#!divRelatedContent&articles
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BioNTech goes public. Her skal vi følge nøye med. Forut for IPOen kommer det vel et fyldig prospekt.
Denne funker trolig bedre:
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… og der var det:
https://www.sec.gov/Archives/edgar/data/1776985/000119312519241112/d635330df1.htm#toc635330_5
Godt over 300 sider, så her trengs god tid og skarpt blikk. Men jeg er ganske sikker på at her finnes interessant informasjon sett med “PCIB- øyne”.
F.eks. på side 98:
"ing no change in the assumed initial public offering price and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.
We currently intend to use the net proceeds from this offering as follows:
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approximately $ million to complete our ongoing and currently planned clinical trials for our FixVac product candidates BNT111, BNT113 and BNT114, as well as to fund our portion of the research and development expenses for each of the following: RO7198457 (BNT122), which is being developed in collaboration with Genentech, SAR441000 (BNT131), which is being developed in collaboration with Sanofi, and GEN1046 (BNT311) and GEN1042 (BNT312), which are being developed in collaboration with Genmab;
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approximately $ to advance additional product candidates through Phase 1 clinical trials, including product candidates from our CAR T, RiboMabs, RiboCytokines and TCR platforms in oncology, and our infectious disease immunotherapy and rare disease protein replacement therapy platforms outside oncology;
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approximately $ to advance additional preclinical product candidates, develop additional product candidates leveraging our current therapeutic platforms and fund the further development of our core technologies; and
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approximately $ million to fund the further expansion of our manufacturing and laboratory capacity and the continued development of our infrastructure."
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Flotte greier abacus, her skal det scannes i gjennom:+1:
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BioNTech er ikke noe hvilket som helst selskap for oss PCIB-aksjonærer. En preklinisk samarbeidspartner helt i fronten av nye terapier basert både på peptider og nukleinsyrer.
Godt at proffene tar ansvar og dissekerer dokumentet 
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Ser ut som om selskapet verdsatt til ca 32 mrd, og har ca 1 100 ansatt, et tall som skal økes. bare sånn at man har en ide om selskapets størrelse.
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s. 65 “There are many issued and pending patent filings that claim aspects of technologies that we may need for our mRNA product candidates or other product candidates, including patent filings that relate to relevant delivery technologies.”
Vi får jo håpe og tro at dette baserer seg på PCIBs patenter igjen.
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Når man leser følgende fra prospektet så skjønner man hvor utrolig heldig man er med at Amphinex kan sluttsteriliseres (autoklaveres), og har sikkert mange års holdbarhet i romtemperatur. Dokumentasjons- og bevisbyrden er bare en brøkdel av hva den er for biologiske legemidler, og mange færre steder å snuble. CMC-cost for PCIB var i følge 2Q19-rapporten på 2,7 millNOK for 1H19 og 3,8millNOK for 2018.
Much of our pipeline is in preclinical development and these programs could be delayed or not advance into the clinic. Before we can initiate clinical trials for product candidates, we must complete extensive preclinical studies, including IND-enabling Good Laboratory Practice toxicology testing, that support our planned Investigational New Drug applications, or INDs, in the United States or similar applications in other jurisdictions. We must also complete extensive work on CMC activities (including collecting yield, purity and stability data) to be included in the IND filing. CMC activities for a new category of medicines such as mRNA therapies require extensive manufacturing processes and analytical development, which are uncertain and lengthy. For instance, batch failures have occurred as we scale up our manufacturing and may occur in the future. In addition, we have in the past and may in the future have difficulty identifying appropriate buffers and storage conditions to enable sufficient shelf life of batches of our preclinical or clinical product candidates. If we are required to produce new batches of our product candidates due to insufficient shelf life, it may delay the commencement or completion of preclinical or clinical trials of such product candidates. For example, we cannot be certain of the timely completion or outcome of our preclinical testing and studies and cannot predict if the FDA or other regulatory authorities will accept the results of our preclinical testing or our proposed clinical programs or if the outcome of our preclinical testing, studies and CMC activities will ultimately support the further development of our programs. As a result, we cannot be sure that we will be able to submit INDs or similar applications for our preclinical programs on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin.
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Mer om samme tema (sensitivt produkt som trenger masse utvikling og dokementasjon), og hvis man leser det under kan det sikkert være interessant å igjen høre på podcast der Vaccibody er på besøk og Agnete Fredriksen forteller om deres produksjon. De har jo heller ikke batch-produksjon, men produserer for hver pasient. Så hver frigivelse er 1 pasient. Vaccibody har forøvrig klart seg fint med disse utfordringene så langt og fru Fredriksen sa at de så langt ikke har misset en batch. Det er også andreutfordringer med nye retningslnjer som trolig ikke er testet så mye ut da FDA er vant med batch dokumentasjon, og ikke per pasient.
Kanskje litt avsporinger dette, men det viser at PCIB har 1 mindre bekymring enn mange andre, særlig de som skal levere en BLA istedet for en NDA, og ikke minst mye mindre kostnader på CMC, og selvsagt totale kostnader med derav bedre ROI.
We are utilizing a number of raw materials and excipients that are either new to the pharmaceutical industry or are being employed in a novel manner. Some of these raw materials and excipients have not been scaled to a level to support commercial supply and could experience unexpected manufacturing or testing failures, or supply shortages. Such issues with raw materials and excipients could cause delays or interruptions to clinical and
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commercial supply of our product candidates. Further, now and in the future one or more of our programs may have a single source of supply for raw materials and excipients.
We have established a number of analytical assays, and may have to establish several more, to assess the quality of our mRNA product candidates. We may identify gaps in our analytical testing strategy that might prevent release of product or could require product withdrawal or recall. For example, we may discover new impurities that have an impact on product safety, efficacy or stability. This may lead to an inability to release mRNA product candidates until the manufacturing or testing process is rectified.
Our product and product intermediates are extremely temperature sensitive, and we may learn that any or all of our products are less stable than desired. We may also find that transportation conditions negatively impact product quality. This may require changes to the formulation or manufacturing process for one or more of our product candidates and result in delays or interruptions to clinical or commercial supply. In addition, the cost associated with such transportation services and the limited pool of vendors may also add additional risks of supply disruptions.
Certain of our product candidates are uniquely manufactured for each patient and we may encounter difficulties in production, particularly with respect to scaling our manufacturing capabilities. If we or any of the third-party manufacturers with whom we contract encounter these types of difficulties, our ability to provide our product candidates for clinical trials or our products for patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure.
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Ser på side 217 i BioNTech-prospektet at de bruker og forstår terminologien slik jeg har forstått mtp Accelerated Approval Pathway.
PCIB er altså på Accelerated Approval Pathway.
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Sorry Snoeffelen, men vennligst forklar hva 217 sier … ingen pcib, amphinex, fimporfin, Tpsc2a eller andre PCIB termonoloiger er i den rapporten, hvordan kobbles det ifølge deg og @abacus dette til PCIB?
Tror med meg fleste vanlig aksjonær forstår ikke det hele.
Takk.
@anon44025098, jeg kan bare svare for meg sjøl. Jeg har bare påpekt at hva som skjer hos en av våre samarbeidspartnere innenfor fimaNAc generelt bør interessere oss PCIB-aksjonærer.
For øvrig synes jeg at - av det som så langt er gravd fram, så er det særlig det som @polygon har gjengitt, er svært interessant.
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