Tror det stemmer. De kan ikke ta betalt gjennom kurtasje lengre. 1000 kr i kurtasje ved kjøp av Vaccibody var ikke nok til å få analysetilgang hos Arctic.
Bavarian Nordic, PCIB sin partner. Spennende!
01/11-2018 14:33:38: (BAVA.CPH) Bavarian Nordic Announces Initiation of Phase 2 Trial of BN-Brachyury for the Treatment of Chordoma
First dose has been administered in the multiple-center study
BN-Brachyury for the treatment of chordoma received FDA Orphan Drug Designation in May 2018
COPENHAGEN, Denmark, November 1, 2018 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced that the first patient has been dosed in a Phase 2 study evaluating its novel, targeted cancer immunotherapy, BN-Brachyury, and radiation in patients with advanced
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative and safe therapies against cancer and infectious diseases. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates intended to improve the health and quality of life for children and adults. We supply our MVA-BN® non-replicating smallpox vaccine to the U.S. Strategic National Stockpile and other government stockpiles. The vaccine is approved in the European Union and in Canada (under the trade names IMVANEX® and IMVAMUNE® respectively). In addition to our long-standing collaboration with the U.S. government on the development of medical countermeasures, our infectious disease pipeline comprises a proprietary RSV program as well as vaccine candidates for Ebola, HPV, HBV and HIV, which are developed through a strategic partnership with Janssen. Additionally, in collaboration with the National Cancer Institute, we have developed a portfolio of active cancer immunotherapies, designed to alter the disease course by eliciting a robust and broad anti-cancer immune response while maintaining a favorable risk-benefit profile. Through multiple industry collaborations, we seek to explore the potential synergies of combining our immunotherapies with other immune-modulating agents, e.g. checkpoint inhibitors. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.
Styreleder viser takter. Fort å glemme når kursen har blitt gruset samtidig som risiko er redusert.
19/09-2018 16:55:20: (PCIB) PCI Biotech: Mandatory notification regarding exercise and trade of subscription rights
The Chairman Hans Peter Bøhn has today, 19 September 2018, subscribed for 40,106 new shares in PCI Biotech Holding ASA (the “Company”) at a subscription price of NOK 30 per share by exercising all his 40,106 subscription rights allocated in the Company’s ongoing rights issue. After the transaction, Hans Peter Bøhn will have a total shareholding in the Company of 123,662 shares.
*Proposed fully underwritten rights issue of NOK 360 million
*Encouraging data from the Phase I study at the dose level selected for the fimaChem pivotal study
*Initial data suggests that two fimaChem treatments are well tolerated and preparation for pivotal study progressing towards initiation early 2019
*Phase I fimaVacc interim data suggests enhancement of several parameters of importance for vaccination . near-term focus is on analysis and characterisation of the clinical immune responses
*Extension of the top-10 pharma fimaNAc collaboration and new research collaborations established with the immunotherapy focused companies IMV in Canada and Bavarian Nordic in Denmark
Er PCIB stakeholder her???!!!
Biontech samarbeid med PCIB:
- Collaboration initiated 3Q 2016
- German biotech company developing individualised cancer immunotherapies
- Clinical programmes in melanoma, head & neck, breast, ovarian and pancreatic cancer
BioNTech Signs Collaboration Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza
16th August 2018/in Press Releases /
Mainz, Germany, and NEW YORK, August 16, 2018 – BioNTech AG, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease, today announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. (NYSE: PFE) to develop mRNA-based vaccines for prevention of influenza (flu).
Under the terms of the agreement, BioNTech and Pfizer will jointly conduct research and development activities to help advance mRNA-based flu vaccines. Pfizer will assume sole responsibility for further clinical development and commercialization of mRNA-based flu vaccines, following BioNTech’s completion of a first in human clinical study.
BioNTech will receive $120 million in upfront, equity and near-term research payments and up to an additional $305 million in potential development, regulatory and commercial milestone payments. In addition, BioNTech will receive up to double-digit tiered royalty payments associated with worldwide sales if the program reaches commercialization.
BioNTech is an industry leader in mRNA vaccine approaches with validated science, innovative manufacturing expertise and a broad understanding of the clinical applications of this technology.
“Today’s agreement with Pfizer is one of a number of steps that we are taking to rapidly build a sustainable R&D presence in infectious disease, combining our deep understanding of the immune system to treat disease with the cutting-edge technologies and significant infrastructure that we have built-up over many years to develop immunotherapy treatments,” said Prof. Dr. Ugur Sahin, Co-Founder and CEO of BioNTech. “A significant presence in infectious disease supports our goal of building a global immunotherapy company that provides more effective and precise immune-mediated approaches for the prevention and treatment of serious illnesses, such as the prevention of flu and the treatment of cancer.”
Kathrin Jansen, Senior Vice President and Head of Pfizer’s Vaccine Research and Development Unit said, “Innovative vaccine approaches are urgently needed to provide improved protection against seasonal flu, and to respond rapidly and in quantity to pandemic influenza threats. mRNA vaccines offer a novel approach to code for any protein or multiple proteins, and the potential to manufacture higher potency flu vaccines more rapidly and at a lower cost than contemporary flu vaccines. BioNTech is one of the industry leaders in mRNA technology and we are looking forward to working closely with them to help bring cutting-edge mRNA influenza vaccines to the market to improve people’s lives.”
Er PCIB stakeholder her???!
ETheRNA samarbeid med PCIB:
-Collaboration initiated 4Q 2016
- Belgian biotech with proprietary TriMix platform programming dendritic cells
- Clinical programmes in melanoma and triple negative breast cancer
eTheRNA opens state-of-the-art manufacturing facility in Belgium to support the development of its TriMix-based mRNA cancer immunotherapies
Niel (Belgium), 8 October 2018 - eTheRNA immunotherapies, a clinical-stage company developing novel cancer immunotherapies based on its proprietary mRNA-based TriMix platform, announces the opening of a state-of-the-art mRNA manufacturing facility enabling the production of mRNA immunotherapies.
Designed to Current Good Manufacturing Practices (cGMP) specifications and certified by the Belgian Federal Agency for Medicines and Healthcare Products, the new EUR 5 million facility, adjacent to its headquarters in Niel, gives eTheRNA the capacity to manufacture mRNA-based TriMix immunotherapies for Phase 1 and 2 clinical development programs as well as for preclinical studies. Initially, eTheRNA intends to use the facility exclusively to supply material for its own existing and planned clinical studies. Depending on future demand, the Company has the option to expand capacity allowing it to manufacture mRNA products for strategic partnerships with third parties.
eTheRNA’s mRNA immunotherapy pipeline is based on its TriMix platform, which comprises three mRNAs encoding proteins that work synergistically to deliver optimal activation of dendritic immune cells. These cells behave as immune response mediators and so mobilize the immune system to attack cancer cells through inducing a directed cytotoxic T-cell response.
A Phase 1b study (E011-MEL) evaluating ECI-006, a TriMix-based immunotherapy boosted with mRNAs encoding five melanoma tumor-specific antigens, is on-going in melanoma patients. Completion of enrolment for a low dose cohort of the study and initial safety data were announced in March, with ten patients recruited. No adverse safety signals were observed in this cohort, which has completed the dosing phase. The treatment via intranodal administration was well tolerated. The study is progressing in a high-dose cohort with results, including immunological responses and the full safety dataset, from both cohorts anticipated in the first half of 2019. Further clinical studies for TriMix immunotherapies are expected to commence in 2018 and 2019 using material produced at the new manufacturing facility.
Dr. Russell G. Greig, Chairman of eTheRNA, said: “This manufacturing facility is core to our long-term strategy and brings us closer to the industrialisation of our TriMix immunotherapies. It will enable us to leverage the potential of the TriMix platform, control our supply chain and provide the necessary scale and flexibility to support development of our mRNA-based immunotherapy portfolio. We also believe this facility to be an opportunity to develop new global R&D collaborations based on our manufacturing capabilities.”
The facility was officially inaugurated in a ceremony today by Philippe Muyters, Flemish minister for Work, Economy, Innovation and Sports, and Tom De Vries, Mayor of Niel.
Philippe Muyters, Flemish minister for Work, Economy, Innovation and Sports, said: “I am very happy that I had the honour to officially open this unique mRNA production facility. This event provides further confirmation of the important role that Flanders plays in the field of research and development of innovative therapies. Innovation is in our DNA, as already evidenced by the successes of several other companies in the biotechnology and related sectors, headquartered in Flanders.
Innovation is also in our mRNA, thus enabling Flanders to provide a significant contribution to the development of novel immunotherapies against various diseases including cancer.”
About eTheRNA Immunotherapies
eTheRNA immunotherapies is a clinical-stage company working to deliver innovative cancer immunotherapies from its proprietary mRNA-based TriMix platform. eTheRNA’s goal is to commercialise these immunotherapies to deliver long lasting clinical remission to cancer patients.
eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is backed by leading international life sciences investors.
The TriMix platform, on which eTheRNA’s immunotherapies are based, comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that work synergistically to deliver optimal activation of dendritic cells. These cells behave as immune response mediators and so mobilize the immune system to attack cancer cells through inducing a T-cell response.
Clinical proof of concept for TriMix-based immunotherapies has been established through an extensive dataset demonstrating clear clinical benefits in advanced melanoma patients.
The Phase 1b study, E011-MEL, recruited its first patient in June 2017 and is assessing two different doses of ECI-006.
Further clinical studies for TriMix immunotherapies are planned to initiate in 2018/19, focused on melanoma and breast cancer indications. These and further studies are designed to determine the optimal route of administration and confirm the potential of TriMix-based treatments as a cornerstone for cancer immunotherapy, both alone and in combination with checkpoint inhibitors.
Further information is available at http://www.etherna.be/.
PCIB er i samarbeid
- Collaboration initiated 1Q 2016
- Norwegian immunotherapy company
- Therapeutic cancer vaccine against human telomerase
Fra release 30 AUG 18
Ultimovacs going forward
Ultimovacs will continue the clinical testing of its cancer vaccine UV1 towards a possible approval of the product. Additionally, Ultimovacs will pursue the development of a new first-in-class cancer vaccine solution utilizing the acquired TET-platformTM. Ultimovacs has started preparations for a potential listing of the Company on the Oslo Stock Exchange. The main purpose of the IPO is to ensure financing of the core development projects for the next five 5 years with intent to file for Marketing Authorisation of UV1.
Eksempler på partnere/samarbeid med PCIB teknologi. Er imponerende hva PCIB og Oslo Cancer Cluster har fått til. Bøyer meg i støvet.
Se Targovax, Nano og Algeta. Uten tvil KAN dette bli Norges nye store næring.
Er pcib allergisk mot å børsmelde slikt?
Er det noen som kan bekrefte om Pcib har vært i forhandlinger med Big Pharma som ett alternativ til emisjon?
Eller er det bare rykter jeg har hørt.
Er dette noe vi kan spørre RS eller PW om på mail kanskje.
Hadde vært kjekt å få en bekreftelse att det er interesse fra BP.
I disse kjedelige dager som Pcib aksjonær.
it looks like they will present the work in this paper which kristian Berg was also a co-author:
Ikke bruk RS/PW sin tid på dette, for dette vil de ikke svare på.
PW ville ikke si noe om dette i podcasten til Radforsk. Dette er vel naturlig da info ang dette kan påvirke evt forhandlinger som pågår/ evt fremtidige forhandlinger.
Tatt ut axa i dag, økt i pcib😉
Vi får nok ingen info her før en avtale foreligger. Vi kan jo bare synse, men jeg ser det som ekstremt sannsynlig at det har vært diskusjoner med en mulig partner allerede.
Skal jeg tippe vil jeg tro at de ikke kom frem til en avtale begge parter kunne akseptere på nåværende tidspunkt. Det har vært mye diskusjoner om hva som ville vært best.
En partneravtale nå ville nok utvilsomt vært best for aksjekursen på kort sikt, men PCIB kjører nå hele pivotalstudien alene og kommer de i mål så vil vel en parneravtale bli vesentlig bedre med godkjenning i bakhånd.
Det er min mening i hvert fall
Sendte forøvrig en mail til Ronny med spørsmål om hvilke oppdateringer vi kan forvente underveis i pivotalstudien. Antall åpne sites, pasientrekruttering osv. Han sa at vi får informasjon om dette på Q3- rapporten, så det blir jo noe å glede seg til i hvert fall
Der er kun to ting som gjelder i disse dager.
Tegner topp 10 BP klinisk fimaNac avtale med upfront payment.
Presenterer PCIB gode fimaVacc resultater.
Uten minst en av disse paa plass, kan det bli soergelige PCIB kurser en god stund fremover. Og det motsatte, hvis en eller begge innfrir. Skulle begge innfri? Vel, da vil PCIB bli verdensberoemte over natten, med hva det maatte bety for aksje kursen.
Uansett, faar vi snart vite hva Per Waldays “several strong respons” (fimanac) var ett signal om suksess??, og om “strongs respons”, rapporten fra fimaVacc betyr det samme??. I desember faar vi svar paa hva Per Walday Staar for.
Walday har gjort det helt klart at en uansett vil trenge en partner for brei distribusjon av PCIBs behandlingsløsning for gallegangskreft. Da snakker vi i første omgang om USA-markedet og EEA (EU+). Det kan bety én eller to partnere. Så har Walday også uttalt at det kan være aktuelt at selskapet sjøl betjener det skandinaviske/ nordiske markedet (nærmest som referansemarked).
Men så er det jo slik at PCIB kan få midlertidig markedsføringstillatelse på grunnlag av foreløpige resultater undervegs i den pivotale fasen. Det er jo det vi inderlig håper på. I så fall bør PCIB allerede da ha en partner på plass. Og hva om IDMC intervenerer i studien enda tidligere - det håper vi jo også sterkt.
Med andre ord tror jeg PCIB har sterke motiver for å sikre seg en partner lenge før hele studien er gjennomført og endelig markedsadgang er i boks.
Så har vi det asiatiske markedet …
Godt poeng. Så nå får vi en avtale der Pcib betaler Pf2 og har risikoen for godkjenning som vi skal ha bra betalt for og vi kan få en partneravtale allerede I 2019.
Eg mener de bør ikke stresse med partner no, desto bedre og lenger dei er kommet i utvikling , jo mer får vi aksjonærer beholde.