Ultimovacs (ULTI) Fundamentale forhold

[polygon]

Det der er vel labelen i de indikasjonene GM-CSF er godkjent, men ja, det er daglig i 14 dager av gangen i NCI-studiene også.

[Laaarsas]

Var bara som referens för halveringstiden

[h3nk1]

Health Economic Consequences Associated With COVID-19–Related Delay in...

Question: What were the consequences associated with delays in melanoma screenings during pandemic-related lockdowns, in terms of years of life lost and economic costs?

Findings: This economic evaluation using population data from 31 European countries estimated that delayed melanoma diagnoses due to pandemic lockdowns were associated with 111 464 years of life lost, incurring additional costs of US$7.65 billion, signifying a significant burden on European health care.

Meaning These findings highlight the need for sustained prevention strategies and the substantial public health and economic implications of delayed melanoma diagnosis during pandemics.

Fersk artikkel plukket opp av @theroger. Føyer seg inn i bildet som er at forsinket screening/diagnose tilsynelatende har vært et internasjonalt, omfattende problem i INITIUM sin indikasjon og rekrutterende populasjon under pandemien.

[Pk2k]

https://ascopubs.org/doi/10.1200/CCI.20.00068

Purpose

While there are studies under way to characterize the direct effects of the COVID-19 pandemic on the care of patients with cancer, there have been few quantitative reports of the impact that efforts to control the pandemic have had on the normal course of cancer diagnosis and treatment encounters.

Methods

We used the TriNetX platform to analyze 20 health care institutions that have relevant, up-to-date encounter data. Using this COVID and Cancer Research Network (CCRN), we compared cancer cohorts identified by querying encounter data pre-COVID (January 2019-April 2019) and current (January 2020-April 2020). Cohorts were generated for all patients with neoplasms (malignant, benign, in situ, and of unspecified behavior), with new incidence neoplasms (first encounter), with exclusively malignant neoplasms, and with new incidence malignant neoplasms. Data from a UK institution were similarly analyzed. Additional analyses were performed on patients with selected cancers, as well as on those having had cancer screening.

Results

Clear trends were identified that suggest a significant decline in all current cohorts explored, with April 2020 displaying the largest decrease in the number of patients with cancer having encounters. Of the cancer types analyzed, lung, colorectal, and hematologic cancer cohorts exhibited smaller decreases in size in April 2020 versus 2019 (−39.1%, −39.9%, −39.1%, respectively) compared with cohort size decreases for breast cancer, prostate cancer, and melanoma (−47.7%, −49.1%, −51.8%, respectively). In addition, cancer screenings declined drastically, with breast cancer screenings dropping by −89.2% and colorectal cancer screenings by −84.5%.

Conclusion

Trends seen in the CCRN clearly suggest a significant decrease in all cancer-related patient encounters as a result of the pandemic. The steep decreases in cancer screening and patients with a new incidence of cancer suggest the possibility of a future increase in patients with later-stage cancer being seen initially as well as an increased demand for cancer screening procedures as delayed tests are rescheduled.

[Oblix]

Litt usikker om jeg forstår effekten av dette riktig, men indikerer dette at populasjonen i INITIUM da antakeligvis har vært på et senere stadie utviklingsmessig i kreftløpet enn normalt da de ble rekrutert, og at forsinkelsen av avlesning derfor trolig er enda mer imponerende? En slags “double whammy”?

[h3nk1]

Korrekt, en slik pandemieffekt har blitt diskutert og spekulert rundt flere ganger her inne all den tid veldig mye “friskere” pasienter (til tross for like inklusjonskriterier som historiske kontroller) er en av de få tingene som kan forklare at man ikke har oppnådd 70 event.

[Funcomi10kr]

Viktig artikkel som underbygger at vi faktisk kan stå foran helt eksepsjonelle resultater i INITIUM

[solskimm]

Vart du skræmt når du så TekBot-logoen nå kl. 1630?
sorry, skal slette innlegget om noen minutter - ville bare holde litt hlvtte

[Fornybar]

Hahahahaha

[pdx]

Skal vi gi @solskimm en liten forum og chatpause til april?

• Ja
• Nei

[h3nk1]

[aol]

https://www.ejcancer.com/article/S0959-8049(24)00129-1/fulltext

[TekBot]

Ultimovacs announces publication of results from NIPU Phase II trial with UV1 vaccination in mesothelioma in European Journal of Cancer

NON-REGULATORY PRESS RELEASE

• The NIPU trial is investigating the effect of adding UV1 vaccine to
  …

Vis børsmeldingen

immunotherapy as second-line treatment of pleural mesothelioma. The results
were initially presented at the ESMO Conference in October 2023

• The publication outlines the full trial results, including observations on
  UV1’s positive impact on objective response rate, overall survival, and
  additional data on increased efficacy in defined histological subtypes

Oslo, March 2, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage
biotechnology company developing immunotherapeutic cancer vaccines, today
announced that the results from the randomized controlled Phase II clinical
trial, NIPU, are published in the European Journal of Cancer
(https://www.ejcancer.com/article/S0959-8049(24)00129-1/fulltext). The trial
investigates the effect of adding Ultimovacs’ cancer vaccine UV1 to second-line
treatment with ipilimumab and nivolumab for patients with pleural mesothelioma
(NCT04300244).

NIPU is an investigator-initiated, open-label, multi-center Phase II trial
sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and
Ultimovacs. Six university hospitals in Australia, Denmark, Norway, Spain, and
Sweden participated in the trial. 118 patients were randomized between June
2020 and January 2023.

The study did not meet its primary endpoint of improved progression-free
survival (PFS) based on blinded independent central review (BICR). Analyses on
the secondary endpoints, objective response rate (ORR) by BICR and overall
survival (OS), showed a significant benefit of adding the UV1 vaccine to
ipilimumab and nivolumab. Local assessment demonstrated an improved PFS among
patients in the vaccine arm for all histological subtypes combined, and new
subgroup analysis demonstrates further improvement for the epithelioid subtype.
The epithelioid subtype represents approximately 70% of all patients with
mesothelioma.

The safety profile of the combination of UV1 plus ipilimumab and nivolumab
observed in the trial was consistent with that of ipilimumab and nivolumab
alone, confirming the good safety profile for the UV1 vaccine.

                                ==ENDS==

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. UV1 is a patented technology owned by Ultimovacs.

In addition, Ultimovacs holds all rights to the proprietary TET technology
platform for any possible future formulations for the treatment of solid tumor
indications. The Company is listed on the Euronext Oslo Stock Exchange (OSE:
ULTI).

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 2 weeks) and ipilimumab (1 mg/kg
every 6 weeks) until disease progression, unacceptable toxicity or for a maximum
of 2 years. Patients randomized to the experimental arm received 8 intradermal
injections of UV1 vaccine during the first three months of treatment. The
objective of the study is to achieve a clinically meaningful progression-free
survival (PFS) 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 recently been approved as first-line
treatment for patients with malignant pleural mesothelioma in Europe and the
U.S.

About Mesothelioma
Malignant pleural mesothelioma is a rare and aggressive type of cancer that
occurs in the thin layer of tissue that surrounds the lungs and inside of the
chest. Mesothelioma accounted for 30 870 new cancer cases and 26 278 cancer
deaths worldwide in 2020, according to 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 1 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. For
patients with inoperable disease, few treatment options are available after
first-line chemotherapy. 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 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 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 stock exchange announcement was published by Anne Worsøe, Head at Investor
Relations at Ultimovacs ASA, on March 2, 2024 at 18:40 CET.

Kilde

[pdx]

Dette er ikke tråden for småprat

[sjerkyll]

Ultimovacs – executive interview

[Gautosaur]

Dette innlegget ble rapportert og er midlertidig skjult.

[TekBot]

Ultimovacs Announces Topline Results from INITIUM Study Evaluating UV1 Vaccination Added to Ipilimumab and Nivolumab in Patients with Unresectable or Metastatic Malignant Melanoma

• With the 18-month minimum follow-up of the patients in the INITIUM trial,
  the trial did not meet the primary endpoint of prolonging progression-free
  survival (PFS). Median PFS was not reached in either arm. Evaluation of
  …

Vis børsmeldingen

secondary endpoints did not show a difference in overall survival and
objective response rate between the treatment and control arms

• UV1 maintained its positive safety profile with similar safety and
  tolerability as observed in the control arm
• Ultimovacs remains confident in the potential of the UV1 vaccine and its
  promise in specific therapeutic combinations and indications
• Upcoming data from the FOCUS Phase II trial and overall survival updates
  from the NIPU Phase II trial will be the next important data points for the
  further assessment of UV1
• Cash preservation initiatives will be implemented to ensure that the
  available financial resources will sustain the company into 2025, enabling
  the achievement of upcoming key inflection points.

Oslo, March 7 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage
biotechnology leader in novel immunotherapeutic cancer vaccines, today announced
topline results from the Phase II clinical trial, INITIUM (NCT04382664
(ClinicalTrials.gov)),
evaluating the company’s therapeutic cancer vaccine candidate UV1 as first-line
treatment in unresectable or metastatic malignant melanoma.

The study’s primary endpoint was to investigate progression-free survival (PFS)
in the experimental arm (UV1 plus treatment with checkpoint inhibitors (CPIs)
ipilimumab and nivolumab) as compared to the control arm (ipilimumab and
nivolumab alone). Secondary endpoints included overall survival (OS), objective
response rate (ORR) as well as duration of response (DOR) and safety. Topline
data demonstrated that the combined treatment of UV1 with ipilimumab and
nivolumab showed similar clinical benefits as treatment with ipilimumab and
nivolumab alone, meaning the primary and secondary endpoints of the study were
not met.

With the 18-month minimum follow-up of the patients in the trial, the median PFS
was not reached in either arm, and the Hazard Ratio (HR) between the arms for
PFS was 0.95. Evaluation of secondary endpoints did not show a difference in
overall survival and objective response rate between the arms. UV1 maintained a
positive safety and tolerability profile.

Ultimovacs will further analyze the full data set while continuing to advance
its ongoing Phase II trials for UV1.

“Ultimovacs had set a very high bar for UV1 by comparing it to the ipilimumab
and nivolumab combination, currently considered the most effective treatment for
this patient population. Nevertheless, we are disappointed that UV1 did not add
further clinical benefit for these late-stage melanoma patients in the INITIUM
trial. Looking forward, our first objective is to complete the analysis of the
full data set in depth to gain further insights on UV1’s effects,” said Jens
Bjørheim, Chief Medical Officer, Ultimovacs. “We wish to thank the patients for
their trust and the investigators for their collaboration with us.”

“We have seen signals in previous trials that UV1 has the ability to show
positive effects in cancer patients. We remain committed to UV1, and we look
forward to thoroughly examining the INITIUM data, receiving the FOCUS data, and
updated NIPU survival data over the next several months. Our objective is to
define the best path forward for our development strategy for UV1,” said Carlos
de Sousa, Chief Executive Officer, Ultimovacs.

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical
development program across various cancer indications with different biology and
disease stages, in combination with different checkpoint inhibitors. The topline
data from INITIUM is 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 on top of ipilimumab and nivolumab
compared to ipilimumab and nivolumab alone, 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 third quarter of 2024.

The Company will host a webcast presentation and discussion of the results from
the INITIUM study on Thursday, March 7 2024 at 08:00 (CET). Link to the webcast
here: https://channel.royalcast.com/landingpage/hegnarmedia/20240307_2/
(https://urldefense.proofpoint.com/v2/url?u=https-
3A__channel.royalcast.com_landingpage_hegnarmedia_20240307-5F2_&d=DwMFaQ&c=euGZs
tcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=NB00oGVLQOaeHXBZQC-EDIkuh0a-
ih3j5C_LRXMn-
jk&m=g2RDit1mycZXDKmcS2hPnxo3DTr9B04o9vArcvxUdoKLH0LO5aoKQq7mZCM0j5Uf&s=QgboDLMj
nLK5H7x3W9rUovtlYV4rylHnoRn7KUQJykQ&e=)

                                ==ENDS==

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 which 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 holds all rights of the proprietary TET technology
platform for any possible future use of formulations in various solid tumor
indications. The Company is listed on Euronext Oslo Stock Exchange (ULTI.OL).

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.

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. 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 add-on to ipilimumab and
  nivolumab, demonstrated a statistically significant and clinically
  meaningful improvement of overall survival versus ipilimumab and nivolumab
  alone. 31% of the patients receiving 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 Q3 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. 75 of 184 patients enrolled as of Q4 2023 reporting, expected
  readout H1 2025. 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. 23 of 138 patients enrolled as of Q4
  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: 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
March 7, 2024 at 07:00 CET

Kilde

[h3nk1]

Sjokkerende. Trist. Vondt.

[polygon]

Herregud dette var trist!

Her er det flere ÅR til mPFS oppnås i noen av armene! Her må pasientene ha vært friskere enn historiske kontroller og nyere real world studier i en grad som er way beyond tilfeldigheter. Her MÅ det ha skjedd en endring i generell klinisk praksis eller legene hatt en bias i hvem de inkluderte.

[WernerVonHaussenberg]

Nei, nei, nei. Hva faen har skjedd her?