Vi som følger selskapet tett setter veldig stor pris på din, og nåværende ledelse sin innsats. Måten dere har håndtert skapelsesreisen til Ultimovacs tror jeg blir et eksempel til etterfølgelse.
Med ønsker om en god jul og godt nytt år 
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Kan ikke så voldsomt mye om selskapet, men jeg liker veldig godt hvordan selskapet ledes og utfører sin kommunikasjon. Forfriskende å lese et sett børsmeldinger og allerede “føle” at her slipper jeg å starte bakerst i notene til kvartalsrapporten for å lese mellom linjene, hva som ikke sies.
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We are not changing our guidance. We expect to disclose full details and have a press release on the new study in december.
Han siere videre at studien blir på størrelse med INITIUM, og i en “very important” indikasjon.
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“Very important” ???
Ja, han sa dette på spørsmål fra DNB-analytikeren:
About the size of INITIUM and in a very important indication.
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Typisk er dette “high, unmet medical need”
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Sett fra en klinikers ståsted, så vil det være tilfellet. Men de Sousa snakker fra selskapets perspektiv, og da mener jeg det heller betyr en stor indikasjon. Det var også med referanse, og i sammenligning med INITIUM som også er i en stor indikasjon at han sa dette.
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Mente han ikke antall pasienter når han refererte til INITIUM?
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Så er det noen med taletid på konferansen som kan være partner med Ultimo? Type signerer etter presentasjonene i dag? (veldig veldig spekulativt)
@Fornybar addit: tenkte på at de Sousa var i et auditorium, bare for proff til å ta det i sokkelsten eller et sammentreff?
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Hadde det ikke vært for at det er en virtuell konferanse… 
Heldigvis finnes det andre måter å signere noe på enn fysisk oppmøte.
@Sjakk vet du… Siden det er Radium i morgen, kanskje de skal møte noen.
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Leier folketrygdefondet ut også til Short her i Ultimo , som i Nano ? Husker også at Sissener var med i emisjonen til Nano ( tror det var den på 45 kr) han var kjapt ute når det gikk nedover der. Så jeg tar det med en liten klype salt , at alle her er her for hele løpet. Men ikke for det, det ser jo greit ut.
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Det har gått ut noen veldig pene og runde antall aksjer ut fra Trygda i Ultimo også ja, som det er nærliggende å tolke som utlån. Om noen faktisk har solgt disse aksjene, så har de i så fall brent seg på det.
Sissener har vært med siden IPO for ett og et halvt år siden, og tok en del gevinst det påfølgende året. De var med på siste emisjon også for et halvt år siden, men har ikke “dumpet” etter dette på tross av sterk kursøkning.
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Oslo, 22 December 2020: Ultimovacs ASA (“Ultimovacs”, ticker ULTI), today announced the initiation of FOCUS, a Phase II randomized clinical trial that will evaluate the Company’s proprietary universal cancer vaccine, UV1, in 75 patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab. The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle, Germany, who is a renowned oncology clinician and researcher specializing in the analysis of immuno-oncology treatments and their interaction with tumor tissues. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020.
“We continue to strategically expand our clinical development program for our proprietary cancer vaccine, not only by testing UV1 in additional cancer indications with critical need, such as head and neck cancer, but also by collaborating with clinicians like Professor Binder who can provide us with unique insights,” stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. “Professor Binder and her team are well-recognized experts who will increase our understanding of UV1’s mechanism of action and contribute data on anti-tumor activity induced by UV1 vaccination.”
The FOCUS ( F irst-line metastatic O r recurrent HNSCC/ C heckpoint inhibitor U V1 S tudy) Phase II trial is an investigator-sponsored, randomized Phase II clinical trial that will recruit patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma across 10 clinical sites in Germany. The trial will evaluate the addition of UV1 to a standard of care treatment with PD-1 checkpoint inhibitor pembrolizumab as compared to pembrolizumab monotherapy. A total of 75 patients indicated for treatment with pembrolizumab will be enrolled in the FOCUS study, randomized 2-to-1 so that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone. The primary endpoint of the study is the progression-free survival rate at 6 months, and planned readout of topline results is expected in 2023. The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council and will not require Ultimovacs to secure additional financing at this stage.
“This clinical trial is the extension of an earlier collaboration with Ultimovacs that introduced me to the therapeutic potential of the UV1 approach,” commented Professor Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle. “I am excited to apply my own insights as well as my team’s expertise to this trial with the goal of potentially providing head and neck cancer patients with better treatment options.”
“We have continued to build momentum in our broad clinical development program with the start of the FOCUS study, representing the important opportunity to test UV1 in combination with pembrolizumab in a randomized setting for the first time,” said Carlos de Sousa, Chief Executive Officer at Ultimovacs. “We welcome the funding provided by the Norwegian Research Council, which supports our ability as a small biotechnology company to conduct four Phase II trials in parallel and evaluate UV1 in different indications with more than 450 patients and as part of various treatment combinations.”
Dr. de Sousa added: “Although we have signed our agreement with the lead investigator for our previously announced third Phase II clinical trial, we will need to wait for the investigator and the pharmaceutical partner to finalize the signature process for their agreement before we can provide full details, which we expect to do before year end.”
About UV1
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.
About UV1 Clinical Programs
As a universal cancer vaccine, UV1’s unique mechanism of action has the potential to be applicable across most cancer types. The clinical development of the UV1 vaccine includes four randomized, multinational, Phase II combination trials recruiting more than 450 patients in total. The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1 in combination with checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118 patients with advanced malignant pleural mesothelioma, a rare lung cancer. The study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for this study. Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and INITIUM studies in 2022. A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM and NIPU. In this new collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group, which will sponsor the trial. The fourth trial, FOCUS, is an investigator-sponsored, randomized clinical trial, enrolling 75 patients with metastatic head and neck cancer receiving pembrolizumab as standard of care, to evaluate the impact of adding UV1 to this regimen.
About Ultimovacs
Ultimovacs’ UV1 universal cancer vaccine candidate leverages the high prevalence of the human telomerase (hTERT) to be effective across the dynamic stages of the tumor’s growth and its microenvironment. By directing the immune system to hTERT antigens that are present in over 80% of all cancers, UV1 drives CD4 helper T cells to the tumor with the goal of activating an immune system cascade to increase anti-tumor responses. Ultimovacs’ strategy is to clinically demonstrate UV1’s impact in a range of cancers and in several immunotherapy combinations while expanding our pipeline of cancer vaccine therapies, convinced that a universal approach may be the key to achieving better outcomes for patients.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632
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Burde ikke bli noen sell the news grunnet denne linjen.
Må tillegge at dette da altså ikke er den ventede studien uten en fjærde! Utrulig!
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Ultimovacs introduserer en ny måte å investere på i bioteksektoren på Oslo Børs.
“Buy the news”
For å poengtere det: Dette er altså randomisert fase 2-studie nr FIRE - ikke nr tre, som er den vi har ventet på den siste uken.
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Det er så fantastisk å være investert i et selskap som overrasker positivt gang på gang! Da har vi altså BP nummer to som samarbeidspartner i et randomisert studie. Med stor sannsynlighet blir det nå tre!
Jeg skrev om disse 16. millionene for en stund tilbake, og at de ikke hadde annonsert det. Var jo ikke så rart det da 
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Slaget mellom Merck og Bristol Meyers Squbb om hvem som tar størst markedsandel med sine respektive PD-1 hemmere, er sannsynligvis det største slaget som har stått i legemiddelindustrien noen gang. UV1 og Ultimovacs kan sitte med nøkkelen til å avgjøre dette slaget. Og startskuddet går med FOCUS!
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