Ultimovacs (ULTI) småprat 1

[Syvcys]

Et annet tema, hvor blir det av første pasienten i LUNGVAC. Jens Bjørheim har vel annonsert minst et par ganger at første innrullering skjer i Q2!

[h3nk1]

Q2 avsluttes om noen få dager, så det er kanskje ikke så lenge til, da. Som de altså har guidet for FPD. Det samme gjelder enrollment complete for INITUM. Any day.

[Birgitte]

Det vel ikke sikkert slikt blir oppdatert før på Q2 presentasjonen i august.

Å børsmeldte innrullering av en pasient høres litt panisk ut?

[Bruskus]

Å melde FPD er standard for de fleste biotechs som prøver å være så åpne som mulig.
Dro bare også fram FPD meldingen til INITIUM så du kan se innholdet:

Ultimovacs ASA Announces First Patient Dosed in the Phase II INITIUM Trial in...

[Birgitte]

Ser den

[Neutral]

Siden de meldte fpd H1 11.mai, så vil jeg tro den er like rundt hjørnet. Så er det jo også slik at det kan oppstå hickups ifb med innrullering, men langt unna er den nok ikke

[TekBot]

Ultimovacs Completes Patient Recruitment in INITIUM Phase II Trial of UV1 in Malignant Melanoma

• Full recruitment of 154 patients with malignant melanoma in U.S. and Europe
  in 24 months
  • Study provides randomized data on impact of UV1 on standard-of-care
    …

Vis børsmeldingen

immunotherapy

• Topline progression-free survival data expected H1 2023

Oslo, 30 June 2022: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical stage
leader in immune stimulatory vaccines for cancer, announces the completed
recruitment of 154 patients in the INITIUM trial. INITIUM is Ultimovacs’ Phase
II clinical trial of its universal cancer vaccine UV1 in combination with the
checkpoint inhibitors ipilimumab and nivolumab in metastatic malignant melanoma.
Consistent with INITIUM’s event-driven design, topline progression-free survival
results will be disclosed after progression of cancer or death has been observed
in a total of 70 patients.

“It is a remarkable achievement that Ultimovacs and its clinical partners have
completed recruitment to INITIUM largely on schedule despite challenges caused
by the pandemic,” said Carlos de Sousa, Chief Executive Officer of Ultimovacs.
“INITIUM has been designed as a robust comparative study to demonstrate that UV1
substantially enhances outcomes for patients over and above those that can be
achieved with checkpoint inhibitors alone. The results will provide a rational
basis for the design and implementation of future pivotal clinical studies,
together with the positive data that we have seen from our Phase I studies in
malignant melanoma.”

INITIUM is an Ultimovacs-sponsored randomized Phase II trial for first-line
treatment of patients with advanced or metastatic malignant melanoma. Half of
the 154 patients recruited to the trial have been dosed with UV1 plus the PD-1
checkpoint inhibitor nivolumab and the CTLA-4 checkpoint inhibitor ipilimumab,
while the other half received nivolumab and ipilimumab. All five of Ultimovacs’
current Phase II trials have a similar comparative design, in each case to
demonstrate in a statistically robust manner the effectiveness of UV1 as an add-
on to standard-of-care treatment in a particular cancer type.

“We are grateful for the continuing work of our international group of
collaborators supporting the execution of the INITIUM trial, and for their
dedication in improving the treatment of cancer patients,” said Jens Bjørheim,
Chief Medical Officer of Ultimovacs. “The topline progression-free survival data
in INITIUM will be an important primary readout. Following this readout, we will
continue to monitor other efficacy endpoints such as tumor response, duration of
response and overall survival.”

In June 2022, Ultimovacs reported positive data from a Phase I trial in
malignant melanoma with a treatment that combines UV1 with the PD-1 checkpoint
inhibitor, pembrolizumab. Across 30 patients, the 24-month overall survival rate
was 73% with an objective response rate of 57% (partial or complete
disappearance of tumors) including a complete response rate of 33%.
==ENDS==

About UV1 in malignant melanoma
Ultimovacs has a long-standing commitment to the development of UV1-based
treatments for melanoma. Malignant melanoma is a form of skin cancer where there
is a large and unmet medical need for improved treatments. More than 130,000 new
cases of melanoma are diagnosed worldwide every year and an estimated 50,000
people die from metastatic melanoma every year.

INITIUM is Ultimovacs’ most advanced clinical study in malignant melanoma, an
Ultimovacs-sponsored randomized, comparative Phase II study involving 154
patients treated with UV1 plus ipilimumab and nivolumab. In addition, Ultimovacs
has completed two Phase I studies: UV1 in combination with ipilimumab involving
12 patients in Norway, and UV1 in combination with pembrolizumab involving 30
patients in the U.S. Based partially on data from those early trials, UV1 has
Fast Track designation from the U.S. FDA for UV1 as add-on therapy to
pembrolizumab or as add-on therapy to ipilimumab in the treatment of
unresectable or metastatic melanoma. UV1 has Orphan Drug designation from the
U.S. FDA in the treatment of malignant melanoma.

About Ultimovacs
Ultimovacs is an immunotherapy company developing immune-stimulatory vaccines to
treat 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 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 92 507

Anne Worsøe, Head of IR & Communication
Email: anne.worsoe@ultimovacs.com
Phone: +47 906 86 815

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

This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 in the Norwegian Securities Trading Act.

This stock exchange announcement was published by Joachim Midttun, Finance
Manager at Ultimovacs ASA, on 30 June 2022 at 08:00 CET.

Kilde

[Jubel]

Ultimovacs ser ut til å være «vår» stjerne innen norsk biotek. Må det fortsette

[h3nk1]

@h3nk1

Any day.

Snakk om shady selskap, rekrutterer ferdig hovedstudien for å ta vekk fokus på at FPD i sitt femte r2p kan ryke med én dag på guidingen.

[Johan07]

mange har noe lære av dette selskapet.

[vegar_beider]

@h3nk1

…rekrutterer ferdig hovedstudien for å ta vekk fokus på at FPD i sitt femte r2p kan ryke med én dag på guidingen.

Så det du sier er at FPD i Lungvac kommer i morgen?

[nordpolen]

«Trakta er full», sier Sausen, samtidig som Ultimo-ansatte er observert lettere stresset i det hardt belastede nikotinmiljøet i hovedstaden…

[h3nk1]

Jazzing til side, det de har fått til gjennom pandemien med INITIUM er ekstremt imponerende.

Det forteller videre to viktige ting:

• Selskapet har et kompetent og dedikert team
• Klinikerne elsker UV1

[Rassen]

Vil ikke si det tok helt av i dag. Går nok i minus i løpet av dagen.

[Martins]

Makro er blodrødt:

Noen ganger er å stå i 0 langt over snittet, selv om det er kjedelig. Ikke at makro nødvendigvis styrer Ulti-kursen, siden de er fundet, men risikovilligheten hos investorer ser dårlig ut nå og da blir naturligvis biotech noe av det første folk kvitter seg med.

[h3nk1]

Det er rebalansering hos 1-2 fond som legger lokk på kursen. Umulig å vite når disse er ferdige. Kunne vært forrige uke, eller neste. Når disse har gjort sitt er det om ikke annet slutt på tilgjengelig volum på disse kursene.

[Hallakis]

Uffda. Er vel bare å selge dritten. Ingenting å se her

[TekBot]

Ultimovacs ASA: Mandatory notification of trade by primary insider

Oslo, 30 June 2022, a closely related party of Carlos de Sousa, Chief Executive
Officer and primary insider in Ultimovacs ASA, has today bought 2,000 shares in
the company at an average price of NOK 69.50 per share. Following this
…

Vis børsmeldingen

transaction, Carlos de Sousa and closely related parties hold 18,056 shares and
416,035 share options in Ultimovacs ASA.

This information is subject to the disclosure requirements pursuant to the
Market Abuse Regulation article 19 and section 5-12 of the Norwegian Securities
Trading Act.

Kilde

[Fintech]

Deilig med et selskap som leverer til de grader - på tiden, som lovet med litt aksjonær- og kurs-pleie på toppen.

[h3nk1]

Hva blir dette, sjette eller syvende innsidekjøpet fra CEO/nærståebde på 12-18 måneder? Uansett, takk til Carlos som en av de ekstremt få i sektoren som kommuniserer til markedet på denne måten - igjen og igjen. En del av et helhetlig bilde som innbyr til (fortjent) tillitt.