Ultimovacs (ULTI) Fundamentale forhold

[ketilaaj]

Jeg ble gjort oppmerksom på at KM plottet jeg brukte ikke nødvendigvis er 100% representativ . Poster den igjen på småprat straks med presisering rundt det.

Oppdatering : Her er lenken:

Ultimovacs småprat (ULTI)

Mens vi venter på resultatene fra INITIUM er det også interessant å se hvordan NIPU ligger an. Hensikten med NIPU er å se om UV1 sammen med Nivo+Ipi gir en forbedret Progression Free Survival (PFS) i for individer med påvist Malignt Pleuralt Mesoteliom (MPM - brysthinnekreft) og som har gjennomgått chemoterapi i førsteline. Studiet planlegger å rulle inn 118 individer i to armer der den ene armen får UV1 med nivo+ipi og kontrollarmen får nivo+ipi. Studiet er ikke ferdig rekruttert, men forskutt…

[Savepig]

For ordens skyld

https://newsweb.oslobors.no/search?category=&issuer=12711&fromDate=&toDate=&market=&messageTitle=tendu

Ultimovacs Announces Completed Patient Recruitment in TENDU Phase I Clinical Trial in Prostate Cancer

• First clinical trial based on Ultimovacs’ proprietary TET adjuvant platform
  technologyFirst clinical trial based on Ultimovacs’ proprietary TET adjuvant
  platform technology
  • 12 patients with prostate cancer treated in TENDU study
  • Study provides immune activation and safety data important for future
    clinical development within the TET technology

Oslo, 14 December 2022: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, announced
that last patient enrollment has been completed in the Phase I TENDU trial in
prostate cancer. Patients with relapse after primary radical prostatectomy
received four doses of the TENDU vaccine during a 6-week treatment period. Three
different dose levels have been explored (40, 400, 960 mcg) and half of the
patients were treated at the highest dose level.

“We are pleased to have completed the enrollment of patients in the first
clinical trial based on the TET platform technology”, said Carlos de Sousa,
Chief Executive Officer at Ultimovacs. “The TET platform represents an
innovative approach that can provide the flexibility to incorporate different
antigens in vaccines relevant in different tumor types and stages.”

The TENDU clinical trial is the first trial based on the Ultimovacs’ novel
vaccine-adjuvant platform, TET (Tetanus-Epitope Targeting). The technology
combines the two key components of a vaccine in a single molecule, the cancer-
specific antigens and the immune response strengthening adjuvant. The primary
objective of TENDU is to evaluate safety and tolerability of different doses of
the vaccine in patients with progressive disease after prostatectomy. No safety
concerns have emerged in the on-going study. All patients are followed up for 6
months after the last treatment.

“The evidence to date indicates that the TET vaccine-adjuvant platform has the
potential to be a highly flexible platform, which can be effectively combined
with many therapeutic approaches in oncology,” said Jens Bjørheim, Chief Medical
Officer at Ultimovacs. “The data from the TENDU trial will be valuable in
exploring the opportunities for future development of a clinical program based
on the TET platform technology.”

[polygon]

Ja, kan vi ordne sånn så børsmeldinger kommer i fundamental og ikke småprat? @pdx

[pdx]

Fikset

[anon6994212]

På hugget for tiden

BioStock Life Science Fall Summit 2022 | Interview: Carlos de Sousa

[polygon]

Da er UV2-patentet publisert folkens!

WO2022258794 - A CONJUGATE

“the polypeptide or the combination is for use in the treatment or prophylaxis of cancer”

Det som er ekstra interessant er at det beskrives flere alternative polypeptider basert på hTERT. Om det er for å lage patentet så bredt som mulig for beskyttelsen sin del, eller om det er for at man faktisk kommer til å gjøre endringer fra peptidene fra de som brukes i UV1 er uklart.

WO2022258794-APBDY-20221215-1214.pdf (13,0 MB)

Dette patentet har prioritetsdato 09.06.2021, som betyr at man har beskyttelse helt til 08.06.2042 - og DET er lenge det!

Edit: For de som ikke har det helt klart for seg, så er altså TET+UV1=UV2

[Otard]

Flott Sånt må jo aksjen bare straffes for

[Rassen]

Dette innlegget ble rapportert og er midlertidig skjult.

[Birgitte]

Takk for info. Strålande

[Boms]

Nå er det jo ikke meldt som en nyhet på børsen, så det er nok ikke alle som har fått det med seg. Alternativt så har det vært forventet

Edit: Blir småprat dette, men om det var ment til meg så har jeg kjøpt en liten trading post på 124,- tidligere i uken, i tillegg til en rimelig stor langsiktig posisjon jeg har hatt i to år.

[Rassen]

Fylle på litt da kanskje?

[h3nk1]

https://register.epo.org/application?number=EP22733376

Status: The international publication has been made

Da har den dukket opp hos EPO.

[Fartin]

Blir børsmelding snart da?

[sjog]

Ingen sender børsmelding når patentsøknad er innsendt, ikke når det er publisert heller, men når det er innvilget.

[h3nk1]

Nei, det vi derimot kan si at skjer “snart” er at selskapet deler mer informasjon om planene for det for TET-plattformen. De har vært sparsommelige med informasjonen, fortrinnsvis fordi de venter på at patentene blir publisert/kjent.

[Truls2]

Sikkert noen her inne som vet ca. tidsperspektivet fra innsendt til innvilget?

[Teiner]

Den som Targo nå har fått “intention to grant” på men som ikke er børsmeldt ble sent inn 16.04.2020 - men det har tydelig vært dialog om innsending opptil et år før dette siden det er en registrering april '19 på samme patent → intention to grant 31 måneder etterpå.

[polygon]

Det kan ta alt fra to til åtte år. Men en oppfinnelse er altså beskyttet fra prioritetsdato dersom den er patenterbar - og dermed godkjennes til slutt.

[TekBot]

Cemiplimab to replace pembrolizumab in UV1 Phase II LUNGVAC Trial

Oslo, 20 December 2022: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, announced
today that cemiplimab (Libtayo) will be used as the PD-1 checkpoint inhibitor in
…

Vis børsmeldingen

combination with UV1 in the Phase II randomized LUNGVAC trial rather than
pembrolizumab (Keytruda). The move, which will be implemented January 1, 2023,
follows the decision by the Norwegian Health Authorities of reimbursement of
cemiplimab for monotherapy or first-line treatment of advanced non-small-cell
lung cancer (NSCLC) in Norway.

The protocol for LUNGVAC as submitted and approved was designed to be flexible
and encompassed the use of a range of different PD-1 checkpoint inhibitors. No
regulatory interaction is needed based on change of drug, and enrollment is
ongoing without delay.

LUNGVAC is a multi-center, randomized, open-label trial assessing the safety and
efficacy of UV1 in combination with PD-1 checkpoint inhibitor versus PD-1
checkpoint inhibitor alone. The study will enroll patients with advanced or
metastatic non-small cell lung cancer (NSCLC) at approximately all lung cancer
centers in Norway. 138 patients will be recruited for treatment with cemiplimab
as standard-of care. The patients already enrolled in the study will continue
the treatment with pembrolizumab. The primary endpoint of the phase II
trial will be progression-free survival. The principal investigator for LUNGVAC
is Professor Odd Terje Brustugun, a leading oncologist in the Nordic region with
active involvement in multiple international lung cancer clinical trials.

LUNGVAC is the fifth Phase II clinical trial in which the universal cancer
vaccine, UV1, is being investigated in combination with checkpoint inhibitors.
The timeline for topline readout of LUNGVAC will be reviewed in Ultimovacs’ Q4
2022 reporting.

                                ==ENDS==

About Ultimovacs
Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic
cancer vaccines, treating a broad range of cancers. Ultimovacs’ lead universal
cancer vaccine candidate UV1 targets human telomerase (hTERT), present in
85-90% of cancers in all stages of tumor growth. By directing the immune system
to hTERT antigens, UV1 drives CD4 helper T cells to the tumor and draining lymph
nodes to activate an immune system cascade and increase anti-tumor responses.
With a broad Phase II program in five cancer indications enrolling more than
650 patients, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple
cancer types, in combination with other immunotherapies, for patients with unmet
needs. Ultimovacs’ second technology approach, based on the proprietary Tetanus-
Epitope-Targeting (TET) platform, combines tumor-specific peptides and adjuvant
in the same molecule and entered Phase I studies in 2021.

For further information, please see www.ultimovacs.com or contact:

Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Anne Worsøe, Head of IR & Communication
Email: anne.worsoe@ultimovacs.com
Phone: +47 90686815

Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
Phone: +44 7483 284 853

This stock exchange announcement was published by Joachim Midttun, Finance
Manager at Ultimovacs ASA, on 20 December 2022 at 08:00 CET.

Kilde

[Chrkni]

@TekBot

The protocol for LUNGVAC as submitted and approved was designed to be flexible
and encompassed the use of a range of different PD-1 checkpoint inhibitors. No
regulatory interaction is needed based on change of drug, and enrollment is
ongoing without delay.

Genialt!