Ultimovacs (ULTI) Fundamentale forhold

[OYV]

@Martins

Ved 69 events må de da ha hatt minimum 20% bedre OS i UV1 armen for å kunne kalle det klinisk signifikant

Men har de ikke bare sagt at de ser en lovende trend på OS? Eller noe i den duren?

[abacus]

@OYV

Men har de ikke bare sagt at de ser en lovende trend på OS? Eller noe i den duren?

Jo, det er riktig at lederen for NIPU-studien, i tilknytning til børsmeldingen den 7. juni, uttalte dette.

Men her må man ikke glømme at børsmeldingen gjaldt resultatet mht det definerte primærendepunktet, mPFS.

Når Helland nå skal presentere NIPU-studien ved ESMO om vel to uker, vil oppmerksomheten i hovedsak være retta mot hva oppdaterte overlevelsesdata viser. Disse vil være flere måneder mer modne.

Skulle trenden i de tidlige overlevelsesdata nå både bekreftes og forsterkes, så står vi i den situasjonen at BICRs konklusjon kan bli “overkjørt” av gullstandardsdata; altså “overall survival”.

[nhy1024]

7. juni hadde det vel totalt i de to armene vært 69 PFS events, ikke 69 OS events som du antyder her…?

[Pk2k]

ESMO presentasjonen hadde vel neppe blitt godkjent om OS ikke er forbedret siden forrige readout?

[Boms]

Det har vel ikke vært noen «read out» av annet enn den binære vurderingen av PFS nådd eller ikke nådd? Det fantes selvsagt mer data også for OS, men det tidspunktet var jo styrt av PFS og antall events som var oppnådd på det tidspunktet.

[Krampa]

Fra studien står det å lese…Progresjonsfri overlevelse (PFS) i henhold til Modified Response Evaluation Criteria in Solid Tumors (RECIST) som bestemt ved blindet uavhengig sentral gjennomgang (BICR) vurdert ved radiologiske vurderinger

Ferdig snakka. PFS er en gjennomgang av …radiologiske vurderinger

[Krampa]

Dette innlegget ble rapportert og er midlertidig skjult.

[abacus]

@Krampa

Fra studien står det å lese…Progresjonsfri overlevelse (PFS) i henhold til Modified Response Evaluation Criteria in Solid Tumors (RECIST) som bestemt ved blindet uavhengig sentral gjennomgang (BICR) vurdert ved radiologiske vurderinger

Ferdig snakka. PFS er en gjennomgang av …radiologiske vurderinger

Hundre prosent korrekt. Men hva mener du med “Ferdig snakka”?

Det vi kan være trygge på, er at Åslaug Helland ikke har sendt abstraktet sitt til ESMO - og fått antatt det for publisering og muntlig presentasjon - som en invitasjon til “omkamp” om konklusjonen til BICR.

Poenget er at “Overall survival” troner høyt over samtlige surrogatendepunkter, herunder også PFS.

https://www.fda.gov/drugs/news-events-human-drugs/role-disclosures-helping-understand-oncology-clinical-trial-endpoints

Med andre od; om oppdaterte overlevelsesdata allerede nå skulle gi et signifikant resultat, havner BICRs kjennelse langt bak i bakspeilet. Både hos FDA, Bristol Myers Squibb og øvrige farmagiganter (og CPI-eiere) som måtte følge interessert med.

Red.
Om OS-data ennå ikke har nådd signifikant nivå, så kan de ha gjort det ved neste korsveg. For eksempel etter at samtlige pasienter har gjennomgått ett års oppfølging. Da er vi litt utpå nyåret.

[theroger]

Ultimovacs Receives FDA Orphan Drug Designation for the UV1 Cancer Vaccine for Treatment of Mesothelioma

• The orphan drug designation was granted based on data from the randomized
  Phase II clinical trial NIPU
  • The results from the NIPU study will be presented at the ESMO Congress being
    held October 20-24, 2023 in Madrid
  • UV1 also received FDA orphan drug designation for treatment of patients with
    malignant melanoma in December 2021

Oslo, October 09, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, today
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. The designation was granted based on
the initial data from the Phase II clinical trial, NIPU.

Mesothelioma is a rare and aggressive form of cancer with a high mortality rate
and few therapeutic options. Patients with mesothelioma commonly have a history
of occupationally or environmentally exposure to asbestos, and it typically
takes decades for this specific form of cancer to develop.

The impact of UV1 vaccination in patients with malignant pleural mesothelioma is
being assessed in the randomized Phase II clinical trial, NIPU. In the study,
UV1 was combined with checkpoint inhibitors ipilimumab and nivolumab and
compared to ipilimumab and nivolumab alone as a second-line treatment after
first-line treatment with platinum-based chemotherapy. The randomized, open-
label, multicenter trial with 118 patients was conducted in Australia, Denmark,
Norway, Spain, and Sweden. The first patient in the trial was enrolled in June
2020, and the last patient was enrolled in January 2023. The NIPU study is
sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and
Ultimovacs.

The results from the study will be shared at the ESMO Congress in Madrid, held
October 20-24, in an oral presentation by the Principal Investigator, Åslaug
Helland, MD, Ph.D., Professor at Oslo University Hospital. The presentation
title is “LBA99 - First survival data from the NIPU trial; A randomized, open-
label, phase II study evaluating nivolumab and ipilimumab combined with UV1
vaccination as second-line treatment in patients with malignant mesothelioma”.

“Gaining FDA orphan drug designation for UV1 in mesothelioma highlights UV1’s
potential and the significant need for new treatment options for this patient
population,” said Carlos de Sousa, CEO of Ultimovacs. “We look forward to the
presentation of the NIPU results at the ESMO Congress later this month and to
continue our dialogue with the FDA as we seek to bring UV1 to cancer patients as
quickly as possible.”

The FDA’s Office of Orphan Products Developments grants orphan status to support
the development of medicines for rare disorders that affect fewer than 200,000
people in the U.S. Orphan drug designation provides certain benefits, including
potentially up to seven years of market exclusivity upon regulatory approval,
exemption of FDA application fees, and tax credits for qualified clinical
trials.

UV1 is a therapeutic cancer vaccine that generates an immune response against
the human telomerase (hTERT) enzyme. The enzyme is essential for the ability of
cancer cells to proliferate. Telomerase is present in 85-90% of all cancers
across all stages of the disease.

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical
development program across various cancer indications with different biologies
and disease stages, combined with different checkpoint inhibitors. The topline
data from NIPU are the first results among the currently five randomized trials
in the UV1 Phase II clinical program. In addition to malignant pleural
mesothelioma, Phase II studies are ongoing in patients with malignant melanoma,
head and neck cancer, ovarian cancer, and non-small cell lung cancer. The
topline data from the malignant melanoma and head and neck cancer trials are
also expected within a year. UV1 is a patented, proprietary technology owned by
Ultimovacs.

https://newsweb.oslobors.no/message/600985

[TekBot]

Ultimovacs Receives FDA Orphan Drug Designation for the UV1 Cancer Vaccine for Treatment of Mesothelioma

• The orphan drug designation was granted based on data from the randomized
  Phase II clinical trial NIPU
  • The results from the NIPU study will be presented at the ESMO Congress being
    …

Vis børsmeldingen

held October 20-24, 2023 in Madrid

• UV1 also received FDA orphan drug designation for treatment of patients with
  malignant melanoma in December 2021

Oslo, October 09, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, today
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. The designation was granted based on
the initial data from the Phase II clinical trial, NIPU.

Mesothelioma is a rare and aggressive form of cancer with a high mortality rate
and few therapeutic options. Patients with mesothelioma commonly have a history
of occupationally or environmentally exposure to asbestos, and it typically
takes decades for this specific form of cancer to develop.

The impact of UV1 vaccination in patients with malignant pleural mesothelioma is
being assessed in the randomized Phase II clinical trial, NIPU. In the study,
UV1 was combined with checkpoint inhibitors ipilimumab and nivolumab and
compared to ipilimumab and nivolumab alone as a second-line treatment after
first-line treatment with platinum-based chemotherapy. The randomized, open-
label, multicenter trial with 118 patients was conducted in Australia, Denmark,
Norway, Spain, and Sweden. The first patient in the trial was enrolled in June
2020, and the last patient was enrolled in January 2023. The NIPU study is
sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and
Ultimovacs.

The results from the study will be shared at the ESMO Congress in Madrid, held
October 20-24, in an oral presentation by the Principal Investigator, Åslaug
Helland, MD, Ph.D., Professor at Oslo University Hospital. The presentation
title is “LBA99 - First survival data from the NIPU trial; A randomized, open-
label, phase II study evaluating nivolumab and ipilimumab combined with UV1
vaccination as second-line treatment in patients with malignant mesothelioma”.

“Gaining FDA orphan drug designation for UV1 in mesothelioma highlights UV1’s
potential and the significant need for new treatment options for this patient
population,” said Carlos de Sousa, CEO of Ultimovacs. “We look forward to the
presentation of the NIPU results at the ESMO Congress later this month and to
continue our dialogue with the FDA as we seek to bring UV1 to cancer patients as
quickly as possible.”

The FDA’s Office of Orphan Products Developments grants orphan status to support
the development of medicines for rare disorders that affect fewer than 200,000
people in the U.S. Orphan drug designation provides certain benefits, including
potentially up to seven years of market exclusivity upon regulatory approval,
exemption of FDA application fees, and tax credits for qualified clinical
trials.

UV1 is a therapeutic cancer vaccine that generates an immune response against
the human telomerase (hTERT) enzyme. The enzyme is essential for the ability of
cancer cells to proliferate. Telomerase is present in 85-90% of all cancers
across all stages of the disease.

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical
development program across various cancer indications with different biologies
and disease stages, combined with different checkpoint inhibitors. The topline
data from NIPU are the first results among the currently five randomized trials
in the UV1 Phase II clinical program. In addition to malignant pleural
mesothelioma, Phase II studies are ongoing in patients with malignant melanoma,
head and neck cancer, ovarian cancer, and non-small cell lung cancer. The
topline data from the malignant melanoma and head and neck cancer trials are
also expected within a year. UV1 is a patented, proprietary technology owned by
Ultimovacs.

                                ==ENDS==

About NIPU
NIPU (Nivolumab and Ipilimumab Plus/minus UV1 vaccination) is a randomized,
multi-center phase II trial in which Ultimovacs’ universal cancer vaccine, UV1,
is evaluated in combination with Bristol-Myers Squibb’s checkpoint inhibitors,
nivolumab, and ipilimumab, as second-line treatment of malignant pleural
mesothelioma. The trial sponsor is Oslo University Hospital, supported in the
preparation and execution of the trial by Ultimovacs and Bristol-Myers Squibb.
The 118 patients are randomized 1:1 into two treatment arms. All participants
receive treatment with nivolumab (240 mg every two weeks) and ipilimumab (1
mg/kg every six weeks) until disease progression, unacceptable toxicity or for a
maximum of 2 years. Patients randomized to the experimental arm received eight
intradermal injections of UV1 vaccine during the first three months of
treatment. The objective of the study is to achieve a clinically meaningful
benefit in patients with malignant pleural mesothelioma (MPM) after progression
on first-line standard platinum doublet chemotherapy. Subsequent events emerging
in patients in both arms of the NIPU study will continue to be monitored beyond
the read-out of the primary endpoint. The ipilimumab and nivolumab combination
has been approved as first-line treatment for patients with malignant pleural
mesothelioma in Europe and the U.S.

About Mesothelioma

Mesothelioma is a rare and aggressive type of cancer that occurs in the thin
layer of tissue surrounding the lungs and inside the chest. Mesothelioma
accounted for 30 870 new cancer cases and 26 278 cancer deaths worldwide in
2020, according to the International Agency for Research on Cancer (Globocan
2020). Pleural mesothelioma is a disease with a high unmet medical need,
especially in industrialized countries. The median overall survival is
approximately one year. Occupational asbestos exposure is the No. 1 cause of
the disease, and several occupations, like firefighters, military veterans,
construction, and industry workers, are at risk. This cancer usually takes
several decades to develop after a person’s first exposure to asbestos. Most
patients are diagnosed after age 70 because of the long latency period. Even
though the use of asbestos, to a large extent, is banned in many countries
today, new incidences of mesothelioma will continue to be a medical and public
health challenge because of the long latency period typical of the illness. Few
treatment options are available after first-line chemotherapy for patients with
inoperable disease. The combination of ipilimumab and nivolumab has recently
shown increased survival compared to standard chemotherapy, but most patients do
not respond, and improvements are called for. Telomerase is expressed in
mesothelioma cells and is, therefore, a relevant target for therapeutic
vaccination.

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. 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; results will be presented at the ESMO Congress in
  October 2023. 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, 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 recruited 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 recruited 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 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.

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: carlos.desousa@ultimovacs.com (mailto:carlos.desousa@ultimovacs.com)
Phone: +47 908 92507

Anne Worsøe, Head of IR
Email: anne.worsoe@ultimovacs.com (mailto:anne.worsoe@ultimovacs.com)
Phone: +47 90686815

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 Investor
Relations at Ultimovacs ASA, on October 9, 2023 at 07:00 CET.

Kilde

[TekBot]

Ultimovacs Receives FDA Orphan Drug Designation for the UV1 Cancer Vaccine for Treatment of Mesothelioma

• The orphan drug designation was granted based on data from the randomized
  Phase II clinical trial NIPU
  • The results from the NIPU study will be presented at the ESMO Congress being
    …

Vis børsmeldingen

held October 20-24, 2023 in Madrid

• UV1 also received FDA orphan drug designation for treatment of patients with
  malignant melanoma in December 2021

Oslo, October 09, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, today
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. The designation was granted based on
the initial data from the Phase II clinical trial, NIPU.

Mesothelioma is a rare and aggressive form of cancer with a high mortality rate
and few therapeutic options. Patients with mesothelioma commonly have a history
of occupationally or environmentally exposure to asbestos, and it typically
takes decades for this specific form of cancer to develop.

The impact of UV1 vaccination in patients with malignant pleural mesothelioma is
being assessed in the randomized Phase II clinical trial, NIPU. In the study,
UV1 was combined with checkpoint inhibitors ipilimumab and nivolumab and
compared to ipilimumab and nivolumab alone as a second-line treatment after
first-line treatment with platinum-based chemotherapy. The randomized, open-
label, multicenter trial with 118 patients was conducted in Australia, Denmark,
Norway, Spain, and Sweden. The first patient in the trial was enrolled in June
2020, and the last patient was enrolled in January 2023. The NIPU study is
sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and
Ultimovacs.

The results from the study will be shared at the ESMO Congress in Madrid, held
October 20-24, in an oral presentation by the Principal Investigator, Åslaug
Helland, MD, Ph.D., Professor at Oslo University Hospital. The presentation
title is “LBA99 - First survival data from the NIPU trial; A randomized, open-
label, phase II study evaluating nivolumab and ipilimumab combined with UV1
vaccination as second-line treatment in patients with malignant mesothelioma”.

“Gaining FDA orphan drug designation for UV1 in mesothelioma highlights UV1’s
potential and the significant need for new treatment options for this patient
population,” said Carlos de Sousa, CEO of Ultimovacs. “We look forward to the
presentation of the NIPU results at the ESMO Congress later this month and to
continue our dialogue with the FDA as we seek to bring UV1 to cancer patients as
quickly as possible.”

The FDA’s Office of Orphan Products Developments grants orphan status to support
the development of medicines for rare disorders that affect fewer than 200,000
people in the U.S. Orphan drug designation provides certain benefits, including
potentially up to seven years of market exclusivity upon regulatory approval,
exemption of FDA application fees, and tax credits for qualified clinical
trials.

UV1 is a therapeutic cancer vaccine that generates an immune response against
the human telomerase (hTERT) enzyme. The enzyme is essential for the ability of
cancer cells to proliferate. Telomerase is present in 85-90% of all cancers
across all stages of the disease.

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical
development program across various cancer indications with different biologies
and disease stages, combined with different checkpoint inhibitors. The topline
data from NIPU are the first results among the currently five randomized trials
in the UV1 Phase II clinical program. In addition to malignant pleural
mesothelioma, Phase II studies are ongoing in patients with malignant melanoma,
head and neck cancer, ovarian cancer, and non-small cell lung cancer. The
topline data from the malignant melanoma and head and neck cancer trials are
also expected within a year. UV1 is a patented, proprietary technology owned by
Ultimovacs.

                                ==ENDS==

About NIPU
NIPU (Nivolumab and Ipilimumab Plus/minus UV1 vaccination) is a randomized,
multi-center phase II trial in which Ultimovacs’ universal cancer vaccine, UV1,
is evaluated in combination with Bristol-Myers Squibb’s checkpoint inhibitors,
nivolumab, and ipilimumab, as second-line treatment of malignant pleural
mesothelioma. The trial sponsor is Oslo University Hospital, supported in the
preparation and execution of the trial by Ultimovacs and Bristol-Myers Squibb.
The 118 patients are randomized 1:1 into two treatment arms. All participants
receive treatment with nivolumab (240 mg every two weeks) and ipilimumab (1
mg/kg every six weeks) until disease progression, unacceptable toxicity or for a
maximum of 2 years. Patients randomized to the experimental arm received eight
intradermal injections of UV1 vaccine during the first three months of
treatment. The objective of the study is to achieve a clinically meaningful
benefit in patients with malignant pleural mesothelioma (MPM) after progression
on first-line standard platinum doublet chemotherapy. Subsequent events emerging
in patients in both arms of the NIPU study will continue to be monitored beyond
the read-out of the primary endpoint. The ipilimumab and nivolumab combination
has been approved as first-line treatment for patients with malignant pleural
mesothelioma in Europe and the U.S.

About Mesothelioma

Mesothelioma is a rare and aggressive type of cancer that occurs in the thin
layer of tissue surrounding the lungs and inside the chest. Mesothelioma
accounted for 30 870 new cancer cases and 26 278 cancer deaths worldwide in
2020, according to the International Agency for Research on Cancer (Globocan
2020). Pleural mesothelioma is a disease with a high unmet medical need,
especially in industrialized countries. The median overall survival is
approximately one year. Occupational asbestos exposure is the No. 1 cause of
the disease, and several occupations, like firefighters, military veterans,
construction, and industry workers, are at risk. This cancer usually takes
several decades to develop after a person’s first exposure to asbestos. Most
patients are diagnosed after age 70 because of the long latency period. Even
though the use of asbestos, to a large extent, is banned in many countries
today, new incidences of mesothelioma will continue to be a medical and public
health challenge because of the long latency period typical of the illness. Few
treatment options are available after first-line chemotherapy for patients with
inoperable disease. The combination of ipilimumab and nivolumab has recently
shown increased survival compared to standard chemotherapy, but most patients do
not respond, and improvements are called for. Telomerase is expressed in
mesothelioma cells and is, therefore, a relevant target for therapeutic
vaccination.

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. 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; results will be presented at the ESMO Congress in
  October 2023. 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, 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 recruited 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 recruited 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 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.

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: carlos.desousa@ultimovacs.com (mailto:carlos.desousa@ultimovacs.com)
Phone: +47 908 92507

Anne Worsøe, Head of IR
Email: anne.worsoe@ultimovacs.com (mailto:anne.worsoe@ultimovacs.com)
Phone: +47 90686815

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 Investor
Relations at Ultimovacs ASA, on October 9, 2023 at 07:00 CET.

Kilde

[TekBot]

Ultimovacs Provides 4-Year Update from Phase I Study in Malignant Melanoma: Demonstrating Sustained Long-Term Overall Survival in Patients Treated with UV1 Cancer Vaccine

• No confirmed patient deaths occurred in cohort 1 between the 3-year and 4-
  year follow-up.

…

Vis børsmeldingen

Oslo, October 12, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, today
announced encouraging overall survival (OS) data from cohort 1 in the UV1-103
Phase I clinical trial in malignant melanoma. Among the patients in cohort 1 who
were alive at the 3-year follow-up, no further deaths have been reported,
reaffirming an encouraging trend of durable overall survival benefit from UV1
vaccination.

The UV1-103 study evaluates Ultimovacs’ universal cancer vaccine, UV1, in
combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line
treatment in patients with advanced non-resectable or metastatic malignant
melanoma. The study enrolled 30 patients in the U.S. in two cohorts that
differed only in the concentration of GM-CSF used as vaccine adjuvant.

Three patients in cohort 1 chose not to be followed up after 2 years. Measured
in absolute numbers, the overall survival in cohort 1 after 3-year follow-up was
71% (12 out of 17 patients). Out of the 17 patients included in the 4-year
follow-up, one patient could not be reached temporarily, and the status is
pending. Employing a conservative approach, 11 out of 16 patients were confirmed
alive after 4 years, indicating an overall survival of 69% based on absolute
numbers. Overall survival from the trial based on Kaplan-Meier estimates is
described below. The 4-year survival across both cohorts is expected to be
announced in Q2 2024.

Ultimovacs has previously reported data showing a complete response rate in the
UV1-103 study of 33% (complete disappearance of tumors) and an objective
response rate of 57% (complete or partial disappearance of tumors). Biomarker
analyses reported in October 2022 showed robust clinical responses in patients
treated with the combination of UV1 and pembrolizumab, regardless of patients’
PD-L1 status. The safety profile of UV1 in combination with pembrolizumab is
comparable to that of pembrolizumab alone.

“We are very encouraged to report a durable and long-term overall survival rate
at the 4-year follow-up in the UV1-103 study. The data further strengthen the
previously reported results from the study, including good safety for UV1 and
the high number of complete responses in patients with metastatic malignant
melanoma where surgery is not an option,” said Jens Bjørheim, Chief Medical
Officer at Ultimovacs. “The UV1-103 study treats the same patient population as
our Phase II study INITIUM. As we await data from the first three randomized UV1
Phase II trials in the near-term, we are increasingly optimistic about UV1’s
potential to benefit cancer patients.”

Ultimovacs is investigating UV1 in malignant melanoma in its randomized Phase II
INITIUM trial of UV1 in combination with ipilimumab and nivolumab. The trial
completed enrollment of 156 patients with advanced non-resectable or metastatic
malignant melanoma in July 2022. The top-line results will be disclosed after
cancer progression has been verified in 70 patients, which has not yet occurred
due to patients taking longer than estimated to experience cancer progression.
The outcome of the study is now expected to be announced in the first half of
2024.

                                ==ENDS==

About the UV1-103 phase I trial in Malignant Melanoma

This US-based Phase I clinical trial evaluates the Company’s lead candidate,
UV1, combined with the anti-PD-1 checkpoint inhibitor, pembrolizumab, as a
first-line treatment in patients with unresectable metastatic malignant
melanoma. The trial evaluates safety, tolerability, and initial signs of
clinical response. Thirty patients in the U.S. were treated in the study in two
cohorts that differed only in the concentration of granulocyte-macrophage
colony-stimulating factor (GM-CSF) used as vaccine adjuvant. The 20 patients in
the first cohort received a 37.5 mcg GM-CSF adjuvant dose per UV1 vaccination.
The 10 patients in the second cohort received the standard 75 mcg GM-CSF
adjuvant dose per UV1 vaccination. The study has completed the enrollment of 30
patients, as announced on August 18, 2020. All included patients received the
drugs as first-line treatment for advanced and metastatic malignant melanoma.

Compiled clinical results for the 30 patients enrolled are:

• Objective response rate (ORR): 57%. Complete response rate (CR): 33%
• Median progression-free survival (mPFS): 18.9 months (as measured by
  iRECIST)
• Out of the 9 deaths, 4 happened during the first year, 4 during the second
  year, and one during the third year across both cohorts.

Patients will continue to be followed up for long-term survival. Three patients
in cohort 1 chose not to be followed up further after 24 months. The trial had
previously reached its primary endpoint of safety and tolerability, and no
unexpected safety issues related to UV1 have been observed in this trial.

Overall survival in UV1-103 based on absolute numbers (conservative approach,
only including confirmed surviving patients):

1-year: Cohort 1: 85.0% (n= 17/20) I Cohort 2: 90% (n= 9/10) I Both
cohorts: 86.7% (n= 26/30)
2-year: Cohort 1: 80.0% (n= 16/20) I Cohort 2: 60% (n= 6/10) I Both
cohorts: 73.3% (n= 22/30)
3-year: Cohort 1: 70.6% (n= 12/17) I Cohort 2: 60% (n= 6/10) I Both
cohorts: 66.7% (n= 18/27)
4-year: Cohort 1: 68.8% (n= 11/16) I Cohort 2: N.A. I Both cohorts: N.A.

The Kaplan-Meier survival curve is defined as the probability of surviving in a
given length of time while considering time in many small intervals. Overall
survival in UV1-103 based on Kaplan-Meier estimates:

1-year: Cohort 1: 85.0% I Cohort 2: 90% I Both cohorts: 86.7%
2-year: Cohort 1: 80.0% I Cohort 2: 60% I Both cohorts: 73.3%
3-year: Cohort 1: 73.8% I Cohort 2: 60% I Both cohorts: 69.5%
4-year: Cohort 1: 73.8% I Cohort 2: N.A. I Both cohorts: N.A.

As a historical reference (not a head-to-head comparison since dosing and the
patient population differ), the registration study Keynote-006 for pembrolizumab
reported a 48-month overall survival rate of 45.7%.

In December 2021, the U.S. Food and Drug Administration (FDA) granted a dual
Fast Track designation 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.

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.

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 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 with eight
intradermal injections and the immune-modulator GM-CSF.

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

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

Anne Worsøe, Head of Investor Relations
Email: anne.worsoe@ultimovacs.com (mailto:anne.worsoe@ultimovacs.com)
Phone: +47 90686815

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 October 12, 2023 at 07:00 am CET.

Kilde

[Boms]

Fantastiske nyheter, først og fremst for pasientene, men også for selskapet selvfølgelig!

[h3nk1]

Nydelig hale, lav N eller ei (upresist illustrert på ustø morgenhånd og mobil):

[Helt1]

Fundamental analyse: Kjøp

[Tychobrae1]

Gir dette HR på ca 0.63 mot Pembro. Eller regner jeg helt feil.
Hilsen legmann

[polygon]

Du regner nok ikke feil. Men HR er ikke et rent forholdstall.

---

Denne gangen har jo selskapet laget en tabell som ligner på min i meldingen, men jeg oppdaterer den likevel, for den har KN-006 tallene i en kolonne. Og fra den kan man se at differansen bare blir større og større!

OS	KEYNOTE-006	kohort 1 (n=20)	kohort 2 (n=10)	kohort 1+2 (n=30)
12mnd	68 %	85% (17)	90% (9)	87% (26)
18mnd	63 %	80% (16)	?
24mnd	58 %	80% (16)	60% (6)	73% (22)
36mnd	51 %	71% (12/17)	60% (6/10)	67% (18/27)
48mnd	46 %	71% (12/17)
60mnd	43 %

[anon50125742]

Står det ikke 11/16 (69%) på 48 mnd?

Ikke at det forandrer så mye, altså

[polygon]

Ja, min tabell er “the non-conservative approach”

[Otard]

Vedkommende som de midlertidig ikke fikk tak i er vel ikke midlertidig død?