Ultimovacs (ULTI) Fundamentale forhold

[RULE]

jeg er ikke ekspert på området, men kan man sige noget om at når ORR er 2x så høj så vil KM plot også konvergere imod en effekt der er bedre end kontrolarmen…? Og dermed hvis der var nok patienter vil kurverne være fint separeret…?

[WernerVonHaussenberg]

ORR vil vises i OS. Og OS er det vi ser på i KM-plottet som er diskutert over.

I posten over (for en dag siden) skriver ketilaaj at han anser det:

@ketilaaj

som lite sannsynlig at kurvene kommer til å krysse i et større fase 3 studie.

I en fase III studie snakker vi trolig om minst 5-600 pasienter.

I NIPU (som er fase II-studie) er det 118 pasienter. Ca. 70 av disse er døde. Resten er sensurerte (betyr at de allerede er estimert inn i plottet der man tror de får OS-event). Kanskje vil de gjenlevende pasientene gjøre at armene skiller seg, kanskje ikke. Vi får neppe svaret på det før jul, og mest sannsynlig ikke før ASCO-konferansen i juni 2024.

Dette innlegget og spørsmålet + de to over det igjen hører hjemme i småprat. La oss prøve å holde fundamental ryddig.

[TekBot]

Ultimovacs Announces Protocol Amendment in UV1 Phase II Study INITIUM in Malignant Melanoma, Enabling Data Readout in First Half of 2024

• Patients in the INITIUM study are taking longer than expected to experience
  cancer progression. Reaching the number of progressing patients required for
  readout may take several months or even years, which has justified an
  …

Vis børsmeldingen

amendment of the study protocol.

• The amended protocol in INITIUM enables the data analysis to start mid-
  January 2024 after the last enrolled patient has been followed up for 18
  months. The topline results from the randomized Phase II study are expected
  to be announced approximately two to three months later.

• INITIUM completed enrollment of 156 patients in July 2022. The results from
  the randomized trial will provide comparative data on efficacy and safety
  for UV1 treatment in malignant melanoma added to standard-of-care
  immunotherapy, ipilimumab and nivolumab.

Oslo, October 31, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, today
announced that the analysis of the INITIUM data will be initiated in mid-January
2024, following an amendment of the clinical trial protocol. The INITIUM
protocol has been amended to allow data readout based on a minimum of 18-month
follow-up of all evaluable patients, at which time the patients have a mean
follow-up time of 24 months. The amendment will maintain the integrity of the
study statistics.

The protocol amendment was submitted to the regulatory authorities in the
countries where the INITIUM trial is conducted: The U.S. Food and Drug
Administration (FDA) and regulatory bodies in Belgium, Norway, and the U.K. The
FDA has not issued any objections to the amendment and the Regulatory
Authorities in two European countries have approved the amendment with one
pending.

The INITIUM study (NCT04382664
(CTG Labs - NCBI)) evaluates
Ultimovacs’ universal cancer vaccine, UV1, as first-line treatment in
unresectable or metastatic malignant melanoma in combination with PD-1
checkpoint inhibitor nivolumab and CTLA-4 checkpoint inhibitor ipilimumab. The
first patient was enrolled in June 2020, and the trial completed enrollment of
156 patients in July 2022. Per the original trial protocol, data analysis would
be conducted after cancer progression or death has been verified in 70 patients.

Based on published historical references, progression was estimated to occur in
70 patients by the first half of 2023. With the current development in patient
progression, reaching these 70 events could take many months or even years,
justifying the decision to implement the protocol amendment. Based on the recent
acceptance from the regulators, the data can now be analyzed in early 2024,
enabling Ultimovacs to maintain its guidance on reporting the outcome of the
study two to three months later in the first half of 2024.

“We are pleased for the patients in the INITIUM study that it takes longer than
anticipated to experience progression of the disease. With positive survival
results from the first randomized Phase II study in malignant mesothelioma, a
very hard-to-treat cancer, we are increasingly optimistic about UV1’s potential
to benefit cancer patients. As we seek to bring UV1 to the patients as quickly
as possible, it is important to advance the INITIUM trial towards a data
readout,” said Carlos de Sousa, CEO of Ultimovacs. “We appreciate the support
from regulatory authorities, and we now look forward to sharing the results in
the first half of 2024.”

The primary endpoint of the Phase II study INITIUM is progression-free survival
(PFS) as per RECIST 1.1. Secondary endpoints include overall survival (OS),
objective response rate (ORR), duration of response (DOR), and safety of UV1
vaccination in combination with nivolumab and ipilimumab.

Ultimovacs has received a dual Fast Track designation from the FDA, granted in
October 2021 (https://ultimovacs.com/investors/news/ultimovacs-receives-dual-
fda-fast-track-designation-for-uv1-in-advanced-malignant-melanoma), for UV1 in
combination with checkpoint inhibitors in the treatment of unresectable or
metastatic melanoma - either as add-on therapy to pembrolizumab or as add-on
therapy to ipilimumab. In December 2021
(https://ultimovacs.com/investors/news/ultimovacs-granted-orphan-drug-
designation-by-fda-for-uv1-cancer-vaccine-in-metastatic-melanoma), UV1 was
granted Orphan Drug designation from the FDA for treatment of stage IIB-IV
melanoma.

UV1 is a therapeutic cancer vaccine used to generate an immune response against
the enzyme human telomerase (hTERT). The enzyme is essential for the ability of
cancer cells to proliferate. Telomerase is present in 85-90% of all cancers,
across the stages of the disease. The vaccine is manufactured as an off-the-
shelf product with a long shelf life. UV1 is easy to use and does not require
sophisticated hospital infrastructure, enabling patient access to therapy also
in community centers, and rural and underserved communities.

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical
development program across various cancer indications with different biology and
disease stages, combined with different checkpoint inhibitors. The topline data
from INITIUM will be the second readout among the five randomized trials in the
UV1 Phase II clinical program. In October 2023, the UV1 Phase II trial NIPU in
malignant mesothelioma reported a clinically meaningful overall survival benefit
in the patients receiving UV1 vaccination, with no added toxicities. Per
protocol, the overall survival results were statistically significant. In
addition to the studies in malignant melanoma and malignant mesothelioma, Phase
II studies are ongoing in patients with head and neck cancer (FOCUS), ovarian
cancer (DOVACC), and non-small cell lung cancer (LUNGVAC). The data from the
FOCUS trial is expected in the second half of 2024.

                                ==ENDS==

About INITIUM
INITIUM is an Ultimovacs-sponsored randomized, comparative, multicenter Phase II
trial in which the universal cancer vaccine UV1 will be evaluated in combination
with the checkpoint inhibitors ipilimumab and nivolumab for first-line treatment
of patients with unresectable or metastatic malignant melanoma. The first
patient received treatment in the INITIUM trial in June 2020, and the last
patient was enrolled in July 2022. The study was conducted at 39 hospitals
across the U.S., U.K., Belgium, and Norway. The initial study design called for
enrollment of 154 patients. Two additional patients were enrolled bringing the
total number of patients in the study to 156.

About Ultimovacs

Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic
cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine
candidate UV1 is directed against human telomerase (hTERT), an antigen present
in 85-90% of cancers in all stages of tumor growth. A broad clinical program,
with Phase II trials in five cancer indications enrolling more than 670
patients, aims to demonstrate UV1’s impact in combination with other
immunotherapies in multiple cancer types expressing telomerase and where
patients have unmet medical needs. UV1 is universal, off-the-shelf, and easy to
use, and is a patented technology owned by Ultimovacs.

In addition, Ultimovacs’ adjuvant platform, based on the proprietary Tetanus-
Epitope-Targeting (TET) technology, combines tumor-specific antigens and
adjuvant in the same molecule and is in Phase I clinical development.
The Company is listed on the Euronext Oslo Stock Exchange (ULTI.OL).

About the UV1 Phase II program

The immunotherapeutic cancer vaccine UV1 is investigated in combination with
checkpoint inhibitors in patients with various cancer indications with diverse
tumor biology. The diversity of the UV1 Phase II program places Ultimovacs in a
favorable position to capture the cancer vaccine’s potential broad applicability
when combined with checkpoint inhibitors:

• INITIUM: Evaluating UV1 in combination with ipilimumab and nivolumab as
  first-line treatment for patients with malignant melanoma. Enrollment of
  156 patients completed in July 2022. As of the Q2 2023 report, 70 events
  were not reached. Expected readout H1 2024. Sponsored by Ultimovacs.
• NIPU: Evaluating UV1 in combination with ipilimumab and nivolumab as second-
  line treatment for patients with malignant pleural mesothelioma. Enrollment
  of 118 patients completed in January 2023. Data presented at the ESMO
  Congress in October 2023, showed that UV1 as an add-on to ipilimumab and
  nivolumab, demonstrated a statistically significant and clinically
  meaningful improvement in overall survival versus ipilimumab and nivolumab
  alone. 31% of the patients receiving the UV1 vaccine experienced an
  objective response, compared to 16% in the control arm. The investigator-
  initiated study is led by Oslo University Hospital and supported by Bristol-
  Myers Squibb and Ultimovacs.
• FOCUS: Evaluating UV1 in combination with pembrolizumab as first-line
  treatment for patients with head and neck cancer. Enrollment of 75 patients
  completed in August 2023, expected readout H2 2024. The investigator-
  initiated study is led by Halle University in Germany, supported by
  Ultimovacs.
• DOVACC: Evaluating UV1 in combination with olaparib and durvalumab as
  maintenance therapy in non-BRCA mutated patients with advanced ovarian
  cancer. >20% of 184 patients enrolled as of Q2 2023 reporting, expected
  readout H2 2024. The investigator-initiated study is led by NSGO-CTU and
  supported by ENGOT, AstraZeneca, and Ultimovacs.
• LUNGVAC: Evaluating UV1 combined with cemiplimab as first-line treatment of
  non-small cell lung cancer patients. <10% of 138 patients enrolled as of Q2
  2023 reporting, expected readout H2 2025. The investigator-initiated study
  is led by Vestre Viken (Drammen Hospital) and supported by Ultimovacs.

About UV1

UV1 is a universal cancer vaccine designed to induce a specific T-cell response
against telomerase. UV1 consists of long, synthetic peptides representing a
sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to
induce CD4+ T-cells. These CD4+ T-cells have the potential to provide
inflammatory signals, and T-cell support is believed to be critical for
triggering a strong anti-tumor immune response. Following intradermal injection,
antigen-presenting cells (APCs) in the skin are exposed to the vaccine peptides.
These APCs will process the peptides and present vaccine epitopes on Human
Leukocyte Antigen (HLA) molecules to naïve T-cells in the lymph nodes. Activated
vaccine-specific T-cells will then enter the circulation and search for cells
displaying their cognate antigen in the context of HLA molecules.
The UV1 peptides contain several epitopes, shown to be non-restrictive in terms
of (HLA) alleles for presentation. It is, therefore not required to perform HLA
pre-screening of patients, which potentially enables broad population
utilization of the vaccine. UV1 is administered over three months as eight
intradermal injections together with the immune-modulator GM-CSF.

For further information, please contact:

Carlos de Sousa, CEO
Email: [email protected] (mailto:[email protected])
Phone: +47 908 92507

Anne Worsøe, Head of Investor Relations
Email: [email protected] (mailto:[email protected])
Phone: +47 90686815

This information is considered 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 Anne Worsøe, Head of Investor Relations at
Ultimovacs ASA, on October 31, 2023 at 07:00 CET.

Kilde

[Martins]

INITIUM P2 Trial opening: 15. january ± 5 days
INITIUM P2 Trial readout analysis results: 10. march-20. april
Primary endpoint: PFS, Secondary endpoints: OS, ORR, DOR, safety

NIPU P2 Update OS, ORR, PFS, DOR, safety: ASCO 2024 (31.5-4.6 2024)
FOCUS P2 Trial readout analysis expected: H2 2024 (1.7-31.12.2024)
DOVACC P2 Trial readout analysis results expected: H2 2024 (1.7-31.12 2024)
LUNGVAC P2 Trial readout analysis results expected: H2 2025 ( 1.7-31.12 2025)

TET P1: TBA

Q3 rapport: 8. november 2023

Generalforsamling: ca. 20. april 2024

Unknowns:

Emi: estimert april-mai 2024
Søknader til FDA/Europeiske myndigheter basert på NIPU data: Svar 31.okt-feb. 2024 en gang
Avtaler basert på NIPU data: Svar 31.okt-juni 2024 en gang
Søknader andre indikasjoner for UV1: TBA
BMS takeover: TBA

[Smacks]

NIPU update: ASCO 24?

[polygon]

En PFS-event er progresjon i sykdom eller død. Man kan ikke lese direkte ut av et KM-plot for PFS hva som er hva. Død vil i de aller fleste tilfeller være som følge av forutgående progresjon i sykdommen, men pga. raskt sykdomsforløp, ventetid og logistikk så vil man i en del tilfeller ikke ha bilder fra et tidspunkt der progresjon kunne ha blitt påvist. Og radiologene vil i en del tilfeller ikke konkludere med progresjon selv om man har bilder fra et “riktig” tidspunkt. Av disse grunnene vil en del dødsfall ikke ha definert progresjon i forkant. Eller sagt på en annen måte: I en del tilfeller vil en OS-event definere en PFS-event.

Fra NIPU har vi nå to PFS-plot og et OS-plot. Jeg har lagt de tre KM-plottene over hverandre, skalert slik at x-aksene blir like, zoomet inn og så tegnet en haug med vertikale streker. Da har jeg funnet ut følgende:

• I UV1 armen har 4 OS-eventer definert PFS-eventer både lokalt og sentralt
• i SoC armen har 7 OS-eventer definert PFS-eventer både lokalt og sentralt

Hele tanken bak PFS som et surrogatendepunkt for OS er at progresjon skal avdekkes og komme som et datapunkt før OS. Det er derfor et mål at man skal klare å avdekke progresjon i sykdommen før evt. død i den enkelte pasient. I alle de pasientene som ikke både lokal og sentral bedømming har latt en OS-event definere en PFS-event for, så vil man nødvendigvis hatt bilder og vurdere ut i fra. Da har man hatt muligheten til å avdekke en PFS-event før en OS-event. Dersom radiologene da har vært kompetente, så vil det alt annet likt være færre heller en flere PFS-eventer som er definert av en OS-eventer fra disse. Og hvordan ser forskjellen på lokal og sentral bedømming av PFS ut i dette henseende?

• I UV1 armen har 6 OS-eventer definert PFS-eventer lokalt
• I SoC armen har 9 OS-eventer definert PFS-eventer lokalt
• I UV1 armen har 10 OS-eventer definert PFS-eventer sentralt
• I SoC armen har 15 OS-eventer definert PFS-eventer sentralt

Jeg mener man av dette alene kan konkludere med at lokale radiologer gjorde en kvalitativt bedre vurdering av bildene. Lokal vurdering konkluderte som kjent med en høyst signifikant forskjell mellom armene til fordel for eksperimentell arm.

En feilkilde til metoden er at man kan ha hatt en definert PFS-event helt samtidig med en OS-event fra en pasient som tidligere har hatt en PFS-event. Men at disse inntreffer eksakt samtidig er ikke særlig sannsynsynlig, og nuller uansett ikke denne store forskjellen mellom lokal og sentral.

[Fartin]

Jøss. Her levere du på ett nivå som kanskje Helland burde få vite om. Men de er kanskje på saken.

[abacus]

@polygon

Jeg mener man av dette alene kan konkludere med at lokale radiologer gjorde en kvalitativt bedre vurdering av bildene

QED

Et glimrende stykke arbeid, @polygon

[Syklisten]

Nesten stum av beundring. Vi middelhavsfarere bør bøye oss i støvhatten for et slikt imponerende detektiv arbeid.

[Snoeffelen]

Wow ! , det er virkelige ikke trivielt at du har laget et solid rasjonale for, og sannsynliggjort at, det for PFS i NIPU er avlesning gjort av Local Assessment, og ikke BICR vi bør forholde oss til.

[polygon]

@Fartin

som kanskje Helland burde få vite om

Disse tingene hadde man sett umiddelbart i swimmer-plot. Det tipper jeg Helland og hennes folk allerede har laget for seg selv.

[Rolsu]

Du får sende inn og spørre om det.

[RULE]

Tusind tak for belysning og deling af helt overlegen viden og observation. Glup.
Har et par opfølgende Qs:
(1a) hvorfor har man i begge tilfælde (lokal og sentralt) misset at identificere flest PFS-eventer i kontrol armen…?
(1b) det burde vel ideelt set være ens / tilfældigt…?
(1c) det kan vel tyde på at progression er mindre aggressiv i UV1 og man har haft en bedre chance for at identificere PFS-eventer…?
(2) det må også betyde at PFS sammenligning har et negativ bias imod UV1 både lokal og sentral…?

[nordpolen]

La oss si at LA ble gjort 2-3 uker (eller kanskje mye lengre, gitt den lange vasketiden) tidligere enn CA, og i disse ukene inntraff flere OS-events som da ble rapportert til CA og det medførte at de aldri fikk en PFS-vurdering i CA. Kan det forklare noe av forskjellene?

Hva tenker du, Poly? Er det du sier med andre ord?

[TekBot]

Ultimovacs Announces Completion of Patient Enrollment in Supplementary Study to INITIUM, UV1 Phase II Trial in Malignant Melanoma

• The supplementary study to INITIUM is designed to provide in-depth data on
  the biological activity and mode of action of the vaccine-induced T cells,
  to support the next stages of development
  …

Vis børsmeldingen

• Enrollment of 21 patients with unresectable or metastatic malignant melanoma
  completed

• All patients received UV1 vaccination as an add-on to the checkpoint
  inhibitors ipilimumab and nivolumab

Oslo, November 2, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, today
announced the completed recruitment of 21 patients in the exploratory single-arm
study complementing the INITIUM trial. INITIUM (NCT04382664
(CTG Labs - NCBI)) is
Ultimovacs’ randomized Phase II trial investigating its universal cancer vaccine
UV1 in combination with the checkpoint inhibitors ipilimumab and nivolumab in
the treatment of patients with unresectable or metastatic malignant melanoma.

The supplementary study was designed to elucidate and describe the mechanisms
leading to improved clinical effects in patients treated with UV1 vaccination.
The study will provide in-depth data on the biological activity and mode of
action of the T cells induced by the UV1 vaccination on top of ipilimumab and
nivolumab.

The results from the research will help identify patients with vaccine-specific
immune responses and evaluate the vaccine’s impact on broadening the overall
immune response. The data will also help assess the vaccine’s effectiveness in
enhancing responsiveness to checkpoint inhibitors in otherwise resistant
patients. Analyses from the supplementary study will be performed in parallel
with the analyses from the randomized INITIUM study. The results from the
supplementary study will not be included in the topline results from the INITIUM
study.

“The insights from this supplementary study will enhance our comprehension of
vaccine-specific induced immune responses in patients with malignant melanoma.
As we prepare for the next stage of UV1 clinical development, these
supplementary data will support us in designing late-stage clinical trial
programs,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs.

                                ==ENDS==

About INITIUM

INITIUM is an Ultimovacs-sponsored randomized, comparative, multicenter Phase II
trial in which the universal cancer vaccine UV1 will be evaluated in combination
with the checkpoint inhibitors ipilimumab and nivolumab for first-line treatment
of patients with unresectable or metastatic malignant melanoma. The first
patient received treatment in the INITIUM trial in June 2020, and the last
patient was enrolled in July 2022. The study is being conducted at 39 hospitals
across the U.S., U.K., Belgium, and Norway. The initial study design called for
enrollment of 154 patients. Two additional patients were enrolled bringing the
total number of patients in the study to 156.

The patients in the INITIUM study are taking longer than anticipated to
experience cancer progression. The current slow pace of event development has
justified an amendment of the study protocol approved by the regulatory
authorities. Analysis of the INITIUM data will be initiated in mid-January 2024
to enable readout based on a minimum of 18-month follow-up of all evaluable
patients and a mean follow-up time of 24 months. The protocol amendment will
have minor consequences for the study’s statistical integrity.

About Ultimovacs

Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic
cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine
candidate UV1 is directed against human telomerase (hTERT), an antigen present
in 85-90% of cancers in all stages of tumor growth. A broad clinical program,
with Phase II trials in five cancer indications enrolling more than 670
patients, aims to demonstrate UV1’s impact in combination with other
immunotherapies in multiple cancer types expressing telomerase and where
patients have unmet medical needs. UV1 is universal, off-the-shelf and easy to
use, and is a patented technology owned by Ultimovacs.
In addition, Ultimovacs’ adjuvant platform, based on the proprietary Tetanus-
Epitope-Targeting (TET) technology, combines tumor-specific antigens and
adjuvant in the same molecule and is in Phase I clinical development.
The Company is listed on the Euronext Oslo Stock Exchange (ULTI.OL).

About the UV1 Phase II program

The immunotherapeutic cancer vaccine UV1 is investigated in combination with
checkpoint inhibitors in patients with various cancer indications with diverse
tumor biology. The diversity of the UV1 Phase II program places Ultimovacs in a
favorable position to capture the cancer vaccine’s potential broad applicability
when combined with checkpoint inhibitors:

• INITIUM: Evaluating UV1 in combination with ipilimumab and nivolumab as
  first-line treatment for patients with unresectable or metastatic malignant
  melanoma. Enrollment of 156 patients completed in July 2022. Expected
  readout H1 2024. Sponsored by Ultimovacs.
• NIPU: Evaluating UV1 in combination with ipilimumab and nivolumab as second-
  line treatment for patients with malignant pleural mesothelioma. Enrollment
  of 118 patients completed in January 2023. Data presented at the ESMO
  Congress in October 2023, showed that UV1 as an add-on to ipilimumab and
  nivolumab, demonstrated a statistically significant and clinically
  meaningful improvement in overall survival versus ipilimumab and nivolumab
  alone. 31% of the patients receiving the UV1 vaccine experienced an
  objective response, compared to 16% in the control arm. The investigator-
  initiated study is led by Oslo University Hospital and supported by Bristol-
  Myers Squibb and Ultimovacs.
• FOCUS: Evaluating UV1 in combination with pembrolizumab as first-line
  treatment for patients with head and neck cancer. Enrollment of 75 patients
  completed in August 2023, expected readout H2 2024. The investigator-
  initiated study is led by Halle University in Germany, supported by
  Ultimovacs.
• DOVACC: Evaluating UV1 in combination with olaparib and durvalumab as
  maintenance therapy in non-BRCA mutated patients with advanced ovarian
  cancer. >20% of 184 patients enrolled as of Q2 2023 reporting, expected
  readout H2 2024. The investigator-initiated study is led by NSGO-CTU and
  supported by ENGOT, AstraZeneca, and Ultimovacs.
• LUNGVAC: Evaluating UV1 combined with cemiplimab as first-line treatment of
  non-small cell lung cancer patients. <10% of 138 patients enrolled as of Q2
  2023 reporting, expected readout H2 2025. The investigator-initiated study
  is led by Vestre Viken (Drammen Hospital) and supported by Ultimovacs.

About UV1

UV1 is a universal cancer vaccine designed to induce a specific T-cell response
against telomerase. UV1 consists of long, synthetic peptides representing a
sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to
induce CD4+ T-cells. These CD4+ T-cells have the potential to provide
inflammatory signals, and T-cell support is believed to be critical for
triggering a strong anti-tumor immune response. Following intradermal injection,
antigen-presenting cells (APCs) in the skin are exposed to the vaccine peptides.
These APCs will process the peptides and present vaccine epitopes on Human
Leukocyte Antigen (HLA) molecules to naïve T-cells in the lymph nodes. Activated
vaccine-specific T-cells will then enter the circulation and search for cells
displaying their cognate antigen in the context of HLA molecules.

The UV1 peptides contain several epitopes, shown to be non-restrictive in terms
of (HLA) alleles for presentation. It is, therefore not required to perform HLA
pre-screening of patients, which potentially enables broad population
utilization of the vaccine. UV1 is administered over three months as eight
intradermal injections together with the immune-modulator GM-CSF.

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

Carlos de Sousa, CEO
Email: [email protected] (mailto:[email protected])
Phone: +47 908 92 507

Anne Worsøe, Head of IR
Email: [email protected] (mailto:[email protected])
Phone: +47 906 86 815

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 Anne Worsøe, Head of IR at Ultimovacs ASA, on
November 2, 2023, at 07:00 CET.

Kilde

[TekBot]

Ultimovacs ASA: Invitation to third quarter 2023 results webcast presentation

Oslo, November 2, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, invites
to a webcast presentation of its third quarter 2023 results on Wednesday,
…

Vis børsmeldingen

November 8, 2023.

The presentation can be followed as a live webcast accessed through a link on
www.ultimovacs.com at 14:00 CET on Wednesday, November 8, 2023, and is scheduled
to conclude at 14:55 CET. The webcast presentation will be available on the
Ultimovacs website, and it will be possible to post questions during the
presentation through the webcast.

The report and presentation will be available on the company website from 08:00
CET the same day.

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

Carlos de Sousa, CEO
Email: [email protected]
Phone: +47 908 92507

Hans Vassgård Eid, CFO
Email: [email protected]
Phone: +47 482 48632

Anne Worsøe, Head of Investor Relations
Email: [email protected]
Phone: +47 906 86815

Kilde

[Boms]

Initium studien ble oppdatert i Clinical Trails databasen i går. Ingen overraskelser, men greit og notere seg de nye tidslinjene.

https://www.clinicaltrials.gov/study/NCT04382664

[Krampa]

Overall Status : Studien er aktiv men det er ingen rekrutering lenger.

[Boms]

Ja, dette har vært kjent lenge. Regner med at du forstår hva det innebærer. Se f eks børsmelding 31.10 om status for studien.

[TekBot]

Ultimovacs ASA Reports Third Quarter 2023 Financial Results and Provides General Business Update

Oslo, November 8, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, announces
its third quarter 2023 results today.
…

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“The recent months have allowed us to further advance the clinical development
of our universal therapeutic cancer vaccine, UV1. The first data from a
randomized Phase II study reported that UV1 showed a clinically meaningful
survival benefit in cancer patients suffering from malignant mesothelioma, a
very hard-to-treat form of cancer,” said Carlos de Sousa, Chief Executive
Officer of Ultimovacs. “The oral data presentation at the renowned ESMO congress
coupled with the enduring long-term survival rates from the 4-year follow-up of
the UV1-103 trial are a testament to UV1’s potential. Our goal is to make a
positive impact on the lives of cancer patients, and the data we have accrued to
date confirm our belief that UV1 can make a difference for cancer patients.”

Third Quarter 2023 Highlights

Ultimovacs’ universal cancer vaccine UV1 demonstrated clinically meaningful
prolonged survival over standard of care immunotherapy in NIPU, the first
randomized Phase II clinical trial - a remarkable milestone for the Company.

Phase II study NIPU in malignant mesothelioma

• NIPU trial principal investigator, Professor Åslaug Helland, MD, PhD,
  reported the results from the study in second-line treatment of patients
  with malignant mesothelioma as an oral presentation at the ESMO Congress
  2023 in Madrid in October. The data presented showed that UV1, as an add-on
  to the checkpoint inhibitors ipilimumab and nivolumab, demonstrated a
  clinically meaningful overall survival benefit after a relevant observation
  period, with no added toxicities compared to ipilimumab and nivolumab alone.
  The study also reported that 31% of the patients treated experienced an
  objective response, as compared to 16% in the control arm. An analysis of
  the Hazard Ratio in Overall Survival showed that UV1 cancer vaccination
  combined with ipilimumab and nivolumab reduced the risk of death by 27% and
  met the protocol’s predefined threshold for statistical significance.
• On October 9, 2023, Ultimovacs announced that the U.S. Food and Drug
  Administration (FDA) has granted Orphan Drug Designation (ODD) to the
  Company’s therapeutic cancer vaccine UV1 for the treatment of patients with
  mesothelioma.

Phase II study INITIUM in unresectable or metastatic malignant melanoma

• On October 31, 2023, Ultimovacs announced that the protocol for the UV1
  Phase II INITIUM study in malignant melanoma has been amended based on
  acceptance by the relevant regulatory authorities. This confirms the topline
  readout from the study in the first half of 2024, as previously
  communicated. By mid-January 2024, the last enrolled patient will have
  completed follow-up for 18 months, and all patients will have achieved a
  mean follow-up time of approximately 24 months. The topline readout is
  expected to be announced two to three months later. The original trial
  protocol set a final data analysis after cancer progression had been
  verified in 70 patients. The amendment was implemented based on the
  observation that it takes longer than anticipated for patients in the study
  to experience progression of the disease. The protocol amendment will
  maintain the integrity of the study statistics without materially affecting
  the scientific value of the clinical trial.
• On November 2, 2023, the Company announced the completed enrollment of 21
  patients in the INITIUM supplementary single-arm study in malignant
  melanoma. The objective of the study is to elucidate and describe that an
  immune response specific to the UV1 vaccine transfers into anti-tumor
  activity and clinical benefit for the patients.

Phase II study FOCUS in head and neck cancer

• On August 3, 2023, the Company announced that the Phase II FOCUS study had
  completed enrollment of 75 patients with head and neck cancer (also reported
  in the Q2-2023 report). The study will provide randomized data on the
  benefit of UV1 vaccination as an add-on to standard pembrolizumab treatment.
  The topline readout, including Progression Free Survival (PFS) and Overall
  Survival (OS), will be disclosed after 12 months minimum follow-up, expected
  during H2 2024.

Phase I study UV1-103 in malignant melanoma

• On October 12, 2023, Ultimovacs reported sustained long-term overall
  survival in patients treated with UV1 cancer vaccine in the UV1-103 Phase I
  study in malignant melanoma. No confirmed patient deaths occurred in cohort
  1 between the 3-year and 4-year follow-up period.

Intellectual Property

• Ultimovacs received a Decision to Grant from the Japanese patent office
  (PN822210JP) in July 2023. The patent is the Japanese counterpart of the
  European and US patents previously granted. These patents protect UV1 cancer
  vaccine-checkpoint inhibitor combinations until at least 2037, and cover UV1
  combined with CTLA-4, PD-1 or PD-L1 checkpoint inhibitors.

Clinical trial enrollment updates

UV1 Phase II program

• INITIUM (malignant melanoma): The enrollment of 156 patients was completed
  in July 2022. Readout is expected in the first half of 2024.

• NIPU (metastatic pleural mesothelioma): The enrollment of 118 patients was
  completed in January 2023. The positive overall results from the study were
  reported in October 2023.

• FOCUS (head and neck cancer): The enrollment of 75 patients was completed in
  August 2023. The readout is expected in the second half of 2024.

• DOVACC (ovarian cancer): 46 out of 184 patients have been enrolled to date,
  up from 37 as of the previous quarterly report.

• LUNGVAC (non-small cell lung cancer): 13 out of 138 patients have been
  enrolled to date, up from 11 as of the previous quarterly report.

• An update on the expected timeline for readout from the Phase II studies
  DOVACC and LUNGVAC will be provided with the Q4 2023 report.

• INITIUM Supplementary Study: Enrollment in the single-arm supplementary
  study, which will not be included in the INITIUM topline readout, was
  completed in October 2023 with a total of 21 patients.

TENDU Phase I trial (prostate cancer) based on the TET technology platform:

• The enrollment of 12 patients was completed in mid-December 2022. The
  results from the study will be reported in Q4 2023.

Financial update

• Ultimovacs expects that the current cash resources will support operations
  to H2 2024, based on current programs and plans, through the topline
  readouts in INITIUM and FOCUS.
• Total operating expenses amounted to MNOK 54.7 in Q3 2023 and MNOK 156.1
  YTD. Total loss was MNOK 55.8 for the period and MNOK 133.3 YTD.
• Net negative cash flow from operations was MNOK 40.7 in Q3 2023, and net
  decrease in cash and cash equivalents, not including currency effects, was
  MNOK 37.6 during Q3 2023. Cash and cash equivalents amounted to MNOK 300.3
  as of September 30, 2023.

The quarterly report and presentation will be published at 07:00 CET on November
8, 2023, and will be publicly available on the Ultimovacs website. The
presentation by the Company’s management can be followed as a live webcast at
14:00 CET today, November 8, 2023. Questions can be submitted throughout the
event. The webcast is scheduled to conclude at 14:55 CET.
Link to webcast here
(https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20231108_5).

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

Carlos de Sousa, CEO
Email: [email protected]
Phone: +47 908 92507

Hans Vassgård Eid, CFO
Email: [email protected]
Phone: +47 482 48632

Anne Worsøe, Head of IR
Email: [email protected]
Phone: +47 906 86815

About Ultimovacs
Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic
cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine
candidate UV1 is directed against human telomerase (hTERT) an antigen that is
present in 85-90% of cancers in all stages of tumor growth. A broad clinical
program, with Phase II trials in five cancer indications enrolling more than
670 patients, aims to demonstrate UV1’s impact in combination with other
immunotherapies in multiple cancer types expressing telomerase and where
patients have unmet medical needs. UV1 is universal, off-the-shelf, and easy to
use, and is a patented technology owned by Ultimovacs.

In addition, Ultimovacs’ adjuvant platform, based on the proprietary Tetanus-
Epitope-Targeting (TET) technology, combines tumor-specific peptides and
adjuvant in the same molecule and is in Phase I clinical development.

This information is subject to the disclosure requirements pursuant to Section
5-12 in the Norwegian Securities Trading Act.

This stock exchange announcement was published by Anne Worsøe, Head of Investor
Relations at Ultimovacs ASA, on November 8, 2023, at 07:00 CET.

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