Zelluna (ZLNA)

Fartin · august 21, 2020, 7:11am

Skammelig av Hegnar. For noen svin som sitter der å vinkler ting slik at de skal få mest klikk.

Fornybar · august 21, 2020, 7:30am

Hahaha! Nå lo jeg godt

Synes de leverer helt etter guiding og forventninger. Ny randomisert fase 2-studie meldt innen noen uker, og TET forventet startet opp i prostata i løpet av året. Melding med top line melanomadata i fra den første kohorten også i løpet av 2H.

Jeg tror høsten kan bli fin!

En kurs midt på 50-tallet er fremdeles lavt i mine øyne, gitt to (snart tre) randomiserte studier med registreringsmuligheter som faktisk innrullerer pasienter. Tidligere har aksjen konsolidert i noen dager etter kraftige kurshopp, men hva som skjer denne gang er vanskelig å spå. Her kan det komme helt nye partnerstudier eller andre godmeldinger helt ut av det blå, i tillegg til de meldingene vi forventer.

For min del forsvarer det en posisjon.

polygon · august 23, 2020, 9:10am

Det var vel i grunnen ikke så mye jeg fikk ut av svarene på mine spørsmål, annet enn at TET kan brukes til mye, og at de har mye viktig IP å beskytte rundt dette. Men det var vel i alle fall ikke utelukket at de fortsatte med Mangsbo sine peptider?

Men alt i alt: Ingen store nyheter, men solid inntrykk, og en solid fremdrift som er 100% i henhold til guiding. Og som @Fornybar poengterer - en fin strøm av nyheter fremover. Sannsynligvis aller først det hemmelige studiet, som CMO sa “will be signed in Q3 … now”.

Longtrader · august 21, 2020, 10:01am

21.8.2020, 10:27 · TDN Finans Delayed

ULTIMO: OPPRETTHOLDER PLANLAGT AVLESING AV DATA I INITIUM- OG NIPU-STUDIEN TIL 2H 2022 FORELØPIG

Oslo (TDN Direkt): For å kontrollere spredningen av koronaviruset besluttet en rekke sykehus i mange land å midlertidig stanse kliniske studier i mars.

Nå har aktiviteten knyttet til kliniske studier gradvis blitt gjenopptatt i de fleste land.

-Vi samarbeider aktivt med våre partnere i de kliniske studiene for å sikre at aktivering av sykehus og pasientrekruttering går i henholdt til plan, men den langsiktige effekten av koronapandemien på bioteknologiindustrien og evnen til å utføre kliniske studier er fremdeles usikker, sier administrerende direktør Carlos de Sousa i Ultimovacs under dagens kvartalspresentasjon.

I midten av juni meldte Ultimovacs om første doserte pasient i både INITIUM- og NIPU-studien og i dagens kvartalsrapport rapporterer selskapet at det ved utgangen av kvartalet var rekruttert tre pasienter til INITIUM-studien og henholdsvis fire pasienter til NIPU-studien. Det skal totalt rekrutteres 154 pasienter i INITIUM studien og 118 pasienter i NIPU-studien.

Ultimovacs opprettholder den tidligere annonserte guidingen om planlagt avlesing av data i både INITIUM- og NIPU-studien i andre halvår 2022, men tidslinjen kan endres ettersom effektene av koronakrisen fremdeles er usikre.

-Som mange andre bioteknologiselskaper så har våre kliniske studier også blitt påvirket av koronaviruspandemien. Nå har aktiviteten knyttet til de kliniske studiene blitt gjenopptatt og vi åpner opp flere og flere sykehus. Vi vil se en økning i rekrutteringstakten, men det er fortsatt usikkerhet om effektene av koronapandemien. Til tross for dette opprettholder vi på nåværende tidspunkt våre mål om avlesing av data i både INITIUM- og NIPU-studien i andre halvår 2022, sier de Sousa.

susanne.solberg.nilssen@tdn.no Infront TDN Direkt, +47 21 95 60 70

alfred_e_neuman · august 25, 2020, 9:19pm

UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma

https://clinicaltrials.gov/ct2/show/NCT04382664
Last Update Posted: August 24, 2020
Changes: Contacts/Locations and Study Status

«Record Verification» er endret fra «June 2020» til «August 2020».

Én i USA har blitt endret til at de rekrutterer:

United States, California

Saint John’s Health Center - John Wayne Cancer Institute (JWCI)
[recruiting]
Santa Monica, California, United States, 90404

Mens de har lagt til Belgia:

Belgium

Leuven University Hospital
[Not yet recruiting]
Leuven, Belgium, 3000

Tekspert · september 1, 2020, 10:35am

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

@polygon (181 likes)

@Fornybar (116 likes)

@Longtrader (34 likes)

Resten av topp 10:

@Snoeffelen (28 likes)
@Neladner (24 likes)
@alfred_e_neuman (12 likes)
@Morgo26 (10 likes)
@Krieghoff (9 likes)
@Timm (8 likes)
@Legoland (6 likes)

Gratulerer!

theroger · september 9, 2020, 8:45am

Usikker på om dette er delt før, fant ikke noe etter ett kjapt søk.

Ser Gustav Gaudernack skal delta på World Vaccine Congress 19-21. oktober

https://www.terrapinn.com/conference/world-vaccine-congress-europe/

Fornybar · september 9, 2020, 8:54am

Viktigheten av å ha Gustav Gaudernack og den kompetansen og nettverket i Ultimovacs kan ikke overdrives. I dette selskapet har vi nøkkelpersonell som personlig kjenner alle av betydning ingen bransjen, og som er på fornavn med nobelprisvinnere.

Denne synes jeg er ganske god for å foklare casen på en veldig lettfattelig måte.
https://soundcloud.com/user-972208711/episode-67?ref=clipboard

“Det vil være en sensasjon”

TekBot · september 30, 2020, 3:17pm

Ultimovacs Announces Positive Topline Results from Phase I Combination Trial Evaluating Universal Cancer Vaccine, UV1, in Malignant Melanoma Patients

–Results confirm achievement of primary endpoints of safety and tolerability–

–Initial signs of clinical response observed based on Overall Survival and median Progression-Free Survival outcomes reported to date–
…

Vis børsmeldingen

Oslo, 30 September 2020: Ultimovacs ASA (“Ultimovacs”, ticker ULTIMO), today announced positive topline results from the first cohort of 20 patients in its ongoing US-based Phase I clinical trial evaluating the Company’s lead candidate, UV1, in combination with PD-1 checkpoint inhibitor, pembrolizumab, as a first line treatment in patients with metastatic malignant melanoma. The results confirm achievement of the primary endpoints of safety and tolerability and indicate initial signs of clinical response.

As per the cut-off date of September 30, 2020, every patient in the first cohort reached at least 12-months of follow-up post treatment with UV1 and pembrolizumab. At the one-year landmark, the overall survival (OS) rate was 85%. Median Progression-Free Survival (mPFS) was not reached at 12 months, indicating that more than half of the participating patients did not demonstrate disease progression. None of the patients experienced unexpected safety issues related to UV1 and the vaccine was well-tolerated. The safety events observed are in line with the established data on UV1 and pembrolizumab.

“The safety profile observed to date in this first cohort of the PD-L1 combination study is consistent with the promising safety profiles seen in our earlier Phase I trials. For the further development of our vaccine, it is important to demonstrate that UV1 can be combined with different classes of immunotherapies without compromising on safety,” commented Jens Bjørheim, Chief Medical Officer at Ultimovacs. “From our perspective, an appropriate historical comparison for our trial is the cohort in the KEYNOTE006 trial in which patients with advanced melanoma without prior treatment history were treated with pembrolizumab only. Results from that study demonstrated a 68% OS and a mPFS of 11.6 months. Comparing this to our data presented today, we are encouraged by the results and look forward to additional data readouts over the next years that will demonstrate if the initial signs of efficacy in this cohort persist and mature into long-term added clinical benefit for the patients.”

The Phase I trial in malignant melanoma is evaluating the safety, tolerability and initial signs of clinical response in patients treated with UV1 in combination with pembrolizumab. Pembrolizumab improves the ability of immune cells to kill tumor cells and is a current standard-of-care therapy for malignant melanoma. The 20 patients in the first cohort had no prior treatment history and received a 37.5 µg GM-CSF adjuvant dose per UV1 vaccination, combined to strengthen the ability of UV1 to stimulate the immune system. The study has completed full enrollment of 30 patients, as announced on August 18, 2020. The 10 patients in the second cohort have received the standard 75 µg GM-CSF adjuvant dose per UV1 vaccination. One-year of follow-up data on these patients will be available in the second half of 2021.

“In all four Phase I studies, UV1 has demonstrated a consistent and positive safety and tolerability profile. The topline results announced today complement our extensive and growing clinical data package, confirming that this strong safety profile holds when combining UV1 with a PD-1 checkpoint inhibitor,” stated Carlos de Sousa, Chief Executive Officer at Ultimovacs. “As an update on other clinical development progress, we had announced in May this year a collaboration with a leading Big Pharma company and a European oncology clinical trial group to evaluate UV1 in an additional Phase II study, which we had planned to confirm with all details in the third quarter. Ultimovacs, the sponsor and the Big Pharma partner have been making improvements to the trial protocol and due to the challenges of operating in the current pandemic environment, the agreement is still in the process of finalization. We look forward to announcing the collaboration and trial timelines during the fourth quarter.”

More complete data on the patients in the first cohort will be presented at an upcoming oncology conference in the first half of 2021.

About UV1 and the UV1 Phase II Clinical Trials
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 immuno-oncology drugs which require 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.

UV1 is being tested in different randomized Phase II trials:

• The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II trial for patients with metastatic malignant melanoma. Patients will be treated with UV1 in combination with ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor). The trial will be conducted in the U.S. and Europe, including Norway. The first patient was dosed on June 15, 2020. A total of 154 patients will be enrolled in the study, 77 patients will receive nivolumab and ipilimumab and the second half of the patients will receive nivolumab, ipilimumab and UV1. The primary endpoint for the study is progression-free survival and the planned readout of the primary endpoint is in the second half of 2022.
• The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, is investigated in combination with the checkpoint inhibitors, ipilimumab and nivolumab, as second-line treatment in mesothelioma. Oslo University Hospital is the sponsor of the NIPU study. Bristol-Myers Squibb and Ultimovacs have entered into agreements with OUS to support the preparations and execution of the trial. The first patient was dosed on June 15, 2020. A total of 118 patients will be included in the NIPU study. Half of the patients will be treated with the combination of UV1, ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor), whereas the other half will receive nivolumab and ipilimumab only. The study is planned to be conducted at six national hospital centers specialized in treating mesothelioma in four countries (Norway, Sweden, Denmark and Australia). Planned readout of the primary endpoint progression-free survival is the second half of 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 (malignant melanoma, 154 patients) and NIPU (mesothelioma, 118 patients). In the 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.

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, Chief Executive Officer
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Hans Vassgård Eid, Chief Financial Officer
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632

Kilde

Fornybar · september 30, 2020, 3:41pm

@polygon @Longtrader Ding ding! Told you

Fy faen. Snakk om å slå ballen rett ut av parken

polygon · september 30, 2020, 3:43pm

Ja, dette er knallbra! Og virkelig ikke den meldingen jeg forventet allerede i dag!

InVivo · september 30, 2020, 3:46pm

8/10 poeng her!

Eller var det 9/10 vi ble enig om @Fornybar?

Men kult å se at mPFS ikke ble nådd og at OS kom inn mye høyere en benchmark

Realize_1 · september 30, 2020, 3:46pm

Denne var litt synd, er veldig nysgjerrig hvilken type de går for.

InVivo · september 30, 2020, 3:49pm

Kan jo potensielt sett komme i morgen da!

Uansett kontret de fint med dagens godbit

polygon · september 30, 2020, 3:50pm

Litt synd det ja, men helt forståelig. Det viktige er at de oppdaterer markedet innen datoen (noe jo ikke alle selskaper har hatt for vane å gjøre).

Bonusfrelst · september 30, 2020, 3:52pm

Noen som har gjort noen estimater for mulig inntektspotensiale ved godkjenning i dette markedet?

InVivo · september 30, 2020, 3:54pm

Du blir vel ikke sur hvis jeg inviterer på kjøttkaker men serverer deg biff?

Forsinkelsen kom jo i en meget hyggelig innpakning

Fornybar · september 30, 2020, 4:01pm

Jeg kommer tilbake til det senere i dag, men vi snakker blockbustersalg. Dette er en medisin som skapt for odf label salg.

Realize_1 · september 30, 2020, 4:05pm

Blir spennende om det flere får øynene opp for Ultimo.
Hva var siste telling på Shareville? 380?

InVivo · september 30, 2020, 4:10pm

Hvis den blir det nye Nano, så bikker kursen fort 100.

Der er vel ca 2000 Sharevillere.

Mange biotrøtte som er lei av emier og forsinkelser som er klar for å hoppe på noe nytt vil jeg tro.

Ultimo har en del kvaliteter som skiller den fra resten av gjengen