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.
2 Likes
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.
4 Likes
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
17 Likes
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!
3 Likes
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.
16 Likes
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 
12 Likes
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!
10 Likes
Dette selskapet leverer virkelig varene. Dypt imponert. Jeg er tilsvarende litt satt ut av potensialet videre, og hvor raskt ting kan skje. Kampen om å vinne CPI-krigen er og blir en av de største i biotekverden.
Og midt i denne krigen dukker lille Ultimovacs opp. Produktet UV1 ser ut til å fungere godt, har god safety og er enkel å kombinere i…nesten samtlige indikasjoner.
Til poenget: Selskapet får nå en TREDJE BP-partner med det FJERDE fase2 studiet (mysteriestudien). Ikke at det spiller noen veldig stor rolle, men TENK om denne partneren er AZ. Da har man de tre gigantene spilt opp mot hverandre. Allerede nå må det tas valg, raskt, om hvorvidt risikoen for å ikke sikre seg UV1 er akseptabel.
Det blir mildt sagt spennende å følge med videre.
Edit:
Avtalen jeg forventer at kommer vil bli uten sidestykke for norsk biotek. Og jeg tror det vil skje noe allerede innen vi går inn i 2022.
11 Likes
Det kan være verdt å nevne at også denne studien er forrige CEO sin fortjeneste. Søknaden om de 16. millionene ble sendt inn 14. mai, og da hadde nødvendigvis også dialogen med The Immunological Tumor Group at University Medicine Halle pågått en stund. Så honnør til @Neladner nok en gang!
24 Likes
Takk for hyggelige ord, men det er CMO, Jens Bjørheim som har største æren for dette. Mitt viktigste bidrag var å sette sammen det fantastiske laget Ultimovacs er. FOCUS er en medisinsk sett viktig studie, krefttypen er kanskje den som er aller mest plagsom for pasientene.
57 Likes
Flyttet en del innlegg over i småprattråden, ber om at vi holder denne til de litt mer gjennomarbeidede innleggene. 
4 Likes
Når man sier at telomerase uttrykkes på celleoverflaten av ~90% kreftceller/typer, hva betyr det egentlig i praksis? Vil 10% av tumoren overleve og kan dette ha noe å si for pasienten? Eller menes det at 90/100 pasienter har en type kreftceller hvor 100% av disse kreftcellene uttrykker telomerase. Er dette en viktig distinksjon i det hele tatt?
1 Like
Det betyr at i 90% av alle krettyper, dvs lungekreft, føflekkreft, etc, så uttrykker kreftcellene telomerase på overflaten. Disse er aktuelle for UV1. I noen krefttyper uttrykker ikke kreften telomerase, og da har ikke T-cellene UV1 lærer opp noe target, så det gir ingen mening å vaksinere mot det. Jeg ser for meg at f.eks benmargskreft kan være en av disse, siden benmargscellene ikke viser telomerase på overflaten men er udødelige likevel.
I tillegg er det helt sikkert variabler i ekspresjon på individnivå som kan gi noen bedre respons enn andre.
Jeg tror en god del kreft overlever, men at immunsystemet blir bedre til å holde veksten i sjakk, noe som øker overlevelsen hos pasientene - kanskje ved at metastaser enklere tas ut av immunsystemet. Eksemplifisert med 44% ORR rate i ipililumab + UV1-studien.
7 Likes
Her kan jeg informere fordi det jeg nå skriver gjelder generelt for immunterapi , det er ikke spesifikt for Ultimovacs sin teknologi. For å forstå hvordan utviklingen av immunterapi skjer, er det vitkig å huske noen helt enkle prinsipper:
All immunterapi går ut på å sette immunforsvaret bedre i stand til å kjenne igjen og drepe kreftceller.
Immunterapi er en revolusjon i kreftbehandling fordi vi nå er helt sikre på at immunforsvaret er i stand til å fjerne kreftsvulster helt. Det er ikke så veldig mange år vi har visst dette. Immunsystemet reagerer spontant på nesten all kreft, men det er stor variasjon i hvorkraftig. Det er også variasjon mellom pasienter med samme krefttype, men størst variasjon mellom de ulike typene kreft.
Sjekkpunkthemmere virker best hvor det spontant, før noen form for behandling, er en ganske kraftig reaksjonfra immunsystemet mot krefsvulsten. Grunnen til at sykdommen utvikler seg, selv med en kraftig immunrespons, er at kreftcellene klarer å dempe effekten av angrep fra immunsystemet.
Sjekkpunkthemmere får kreftcellene opp av skyttergravene så immunsystemet vinner slaget.
Immunterapi (f.eks. vaksiner) som stimulerer immunsystemet til et kraftigere angrep virker gjennom å gjøre immunsystemet mer effektivt når det angriper. Vaksinen har fått immunsystemet til å lage immunceller som kan gjøre jobben. (Det er derfor vi kaller det “vaksiner”)
Å gjøre begge deler samtidig gjennom å kombinere sjekkpunkthemmere og vaksine en ganske åpenbar tilnærming fordi en vaksine alene har dårlige vilkår hvis kreftcellene er gode til å beskytte seg og sjekkpunkthemmere virker dårlig hvis det ikke er særlig kraft i den spontane immunresponsen.
Det viktige er at vaksinen er like generell som sjekkpunkthemmere. Angrepspunktene er generelle for kreft som sykdom og ikke spesifikke for hverken enkelte krefttyper eller enkeltpasienter.
66 Likes
Ultimovacs - Announces Phase II DOVACC Collaboration Study in Ovarian Cancer with the Nordic Society of Gynaecological Oncology – Clinical Trial Unit, the European Network of Gynaecological Oncological Trial Groups and AstraZeneca
Oslo, 11 January 2021: Ultimovacs ASA (“Ultimovacs”, ticker ULTI), today announced its participation in the Phase II DOVACC collaboration study with the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU), the European Network of Gynaecological Oncological Trial Groups (ENGOT) and AstraZeneca, to conduct a randomized Phase II clinical trial to evaluate Ultimovacs’ proprietary universal cancer vaccine, UV1, in combination with AstraZeneca’s durvalumab and olaparib in patients with relapsed ovarian cancer.
Carlos de Sousa, Chief Executive Officer at Ultimovacs stated: “Now that the formal collaboration with NSGO-CTU/ENGOT and AstraZeneca is in place and preparations for the study are well underway, I am happy to provide further details on the DOVACC Phase II clinical trial which was first announced in May of 2020. A key benefit of UV1 is its safety profile, which enables a triple combination study with a PD-L1 inhibitor and now for the first time also with a PARP inhibitor, in an indication in desperate need of new treatment options. Ultimovacs has four Phase II trials evaluating UV1, including more than 500 patients in total, supporting its universal potential across many cancer indications and as part of various treatment combinations.”
“The NSGO-CTU is a highly regarded oncology society that has strong connections with similar organizations across Europe through the ENGOT collaboration,” commented Jens Bjørheim, Chief Medical Officer at Ultimovacs. “The collaboration with the NSGO-CTU and ENGOT is exciting for us as they are very experienced with conducting clinical trials in the field of gynaecological oncology. Their expertise and network will support the recruitment of patients at multiple participating study sites across Europe.”
“Our purpose at the NSGO-CTU and ENGOT is to improve treatment options in gynaecological cancer indications by coordinating clinical trial efforts across countries,” added Dr. Mansoor Raza Mirza, Medical Director of the NSGO-CTU and Chair of the ENGOT. “The evaluation of UV1, durvalumab and olaparib in this Phase II triple combination study is an important next step in changing the standard of care for patients with ovarian cancer. We look forward to working with Ultimovacs to reach our mutual goal.”
DOVACC is a multi-center, multinational, randomized Phase II clinical trial sponsored by the NSGO, the leading gynaecological oncology research society in the Nordic and Baltic regions. The trial is designed to evaluate Ultimovacs’ proprietary UV1 cancer vaccine in combination with AstraZeneca’s durvalumab, a PD-L1 checkpoint inhibitor and its PARP inhibitor, olaparib, the maintenance therapy for BRCA-mutated advanced ovarian cancer. The trial will be conducted at more than 30 hospitals in around 10 European countries. The Company expects to treat the first patient in the first half of 2021. Topline data on the primary endpoint is expected in 2023.
The second-line maintenance study will enroll patients with high-grade BRCA negative ovarian cancer after partial or complete response following the second round of chemotherapy. The study includes three arms treating a total of 184 patients. The first arm will enroll 46 patients receiving the PARP inhibitor olaparib. The 46 patients enrolled in the second arm will receive olaparib and the checkpoint inhibitor durvalumab. The third arm will include 92 patients that will receive Ultimovacs’ UV1 vaccine in combination with both AstraZeneca drugs. The primary endpoint is progression-free survival (PFS) in the treatment arm with solely the PARP inhibitor olaparib, versus PFS in the triple combination treatment arm. Under the terms of the collaboration, Ultimovacs will provide its UV1 vaccine and AstraZeneca will provide the PD-L1 and PARP inhibitors for the study.
Innovation Norway has granted Ultimovacs NOK 10 million, approximately EUR 1 million, to support the execution of the Phase II DOVACC study. In addition, the successful private placement in May of this year raised NOK 160 million, approximately EUR 16 million, allowing Ultimovacs to continue to implement the Company’s clinical development plan and fund its operations through the expected readout of the primary endpoint in the DOVACC study in 2023.
Ultimovacs management will host a webcast on Monday, January 11, 2021, at 11:00 a.m. CET to discuss the DOVACC clinical trial in more detail. The webcast will also feature a short video statement from lead investigator Dr. Mirza. The live webcast can be accessed through the investor section of Ultimovacs’ corporate website at www.ultimovacs.com. The webcast replay will be available for at least 72 hours following the call.
11 Likes
Dagens presentasjon:
4 Likes
Dette er studien som DOVACC vil måles mot:
Og så har Merck og European Network for Gynaecological Oncological Trial Groups denne gående med Pembro og Olaparib:
Kanskje er det denne konkurransen AZ vil til livs med hjelp av UV1? For her kjempes CPI-slaget på mange fronter! At Merck må på banen er helt sikkert 
7 Likes
Progression-free survival was significantly longer with olaparib than with placebo (median, 8.4 months vs. 4.8 months from randomization on completion of chemotherapy;…) Så da er målet for trippelkomboen med UV1 å bedre 8,4mnd uten progresjon.
1 Like
Man kan merke seg at Ultimovacs er i den klubben som faktisk bruker twitter forbilledlig
8 Likes