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Research: Healthcare
Ultimovacs has announced that UV1 in combination with ipilimumab and nivolumab has shown clinically meaningful benefit in overall survival (reducing death risk by 27%), meeting a protocol-predefined threshold for statistical significance. Although overall survival (OS) is the secondary endpoint in the NIPU Phase II trial, OS is regarded as the gold standard in cancer treatment and is a critical consideration in malignant mesothelioma, an aggressive type of cancer with a high mortality rate and few therapeutic options in first-line treatment and no established standard of care in second-line treatment. This announcement follows the US FDA granting orphan drug designation (ODD) to UV1 for the treatment of mesothelioma and is a positive contrast from the June 2023 announcement (where a central independent review concluded the NIPU study did not meet the primary endpoint of progression-free survival). While we await the full study dataset to be presented by the lead investigator at ESMO 2023 (Saturday), these preliminary results are a positive indication of the vaccine’s efficacy. Shares reacted positively to the news and increased over 20% in early trading.
Written by
Ultimovacs |
Overall survival is the name of the NIPU PII game |
Clinical update |
Pharma and biotech |
18 October 2023 |
Share price performance
Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
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Ultimovacs has announced that UV1 in combination with ipilimumab and nivolumab has shown clinically meaningful benefit in overall survival (reducing death risk by 27%), meeting a protocol-predefined threshold for statistical significance. Although overall survival (OS) is the secondary endpoint in the NIPU Phase II trial, OS is regarded as the gold standard in cancer treatment and is a critical consideration in malignant mesothelioma, an aggressive type of cancer with a high mortality rate and few therapeutic options in first-line treatment and no established standard of care in second-line treatment. This announcement follows the US FDA granting orphan drug designation (ODD) to UV1 for the treatment of mesothelioma and is a positive contrast from the June 2023 announcement (where a central independent review concluded the NIPU study did not meet the primary endpoint of progression-free survival). While we await the full study dataset to be presented by the lead investigator at ESMO 2023 (Saturday), these preliminary results are a positive indication of the vaccine’s efficacy. Shares reacted positively to the news and increased over 20% in early trading.
Year end |
Revenue (NOKm) |
PBT* (NOKm) |
EPS** |
DPS |
P/E |
Yield |
12/21 |
0.0 |
(164.7) |
(5.09) |
0.0 |
N/A |
N/A |
12/22 |
0.0 |
(167.8) |
(4.89) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(214.8) |
(6.24) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(227.9) |
(8.08) |
0.0 |
N/A |
N/A |
Note: *PBT is reported. **EPS is fully diluted.
The latest results from the NIPU trial show that UV1 in combination with ipilimumab and nivolumab from Bristol-Myers Squibb resulted in improved OS compared to ipilimumab and nivolumab alone, a key secondary endpoint, and reduced the risk of death by 27%. The median OS of 15.4 months was observed (95% CI, 11.1–22.6) for UV1 plus ipilimumab and nivolumab (UV1 treatment arm) as compared to OS of 11.1 months (95% CI, 8.8–18.1) in the control arm (ipilimumab and nivolumab), with a median observation time of 17.3 months. In a blinded independent central review, the data indicated an improved objective response rate – 31% of patients experienced an objective response in the UV1 arm versus 16% in the control arm (odds ratio 2.44 (80% CI, 1.35–4.49)). UV1 presented a good safety profile as it was consistent with the profile for the control arm.
We note that OS is regarded as the gold standard in cancer treatment and management believes that the new data support further development of UV1 in mesothelioma. Given the few treatment options available for malignant mesothelioma and high unmet need, we believe it represents an important therapeutic opportunity for UV1.
In early October, the FDA granted ODD to UV1 for the treatment of mesothelioma. In our view, the next near-term catalyst for the company will be the readout from the INITIUM study (metastatic malignant melanoma), expected in H124. Further, we anticipate the FOCUS (head & neck) read out in H224 and DOVACC (ovarian cancer) and LUNGVAC (non-small cell lung cancer) updates with the 4Q24 earnings release.
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Research: Healthcare
At the AACR-NCI-EORTC conference in Boston, OSE presented the initial positive data supporting the potential efficacy of its anti-PD1 monoclonal antibody, OSE-279, in patients with advanced solid tumours, with no therapeutic option available. The interim data from the Phase I/II dose escalation study indicated that OSE-279 monotherapy exhibited manageable safety and showed preliminary signs of efficacy. Both the pharmacokinetic and pharmacodynamic profiles aligned with the company’s expectations. As a reminder, OSE-279 serves as the key anti-PD1 component in the company’s bifunctional checkpoint inhibitor (BiCKI) platform, designed to address primary (lack of response to treatment) and secondary resistance (resistance after an initial response) mechanisms. The data shared are promising with potential for OSE-279 as a monotherapy, but given the small cohort (13), we await further data from the Phase II component of the current study. Incremental positive results could provide validation for OSE-279 and the BiCKI platform approach.