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Research: Healthcare
Ultimovacs has shared an encouraging update from its Phase I trial (UV1-103) assessing UV1 in combination with pembrolizumab for the treatment of malignant melanoma. The latest data show that 11 out of 16 patients who agreed to long-term monitoring from cohort 1 were confirmed alive at the four-year follow-up point, corresponding to an overall survival (OS) rate of 69%. This demonstrates a durable benefit of Ultimovac’s lead cancer vaccine, in our view, indicating no confirmed patient deaths since the three-year follow-up point for this cohort. Four-year survival data in both cohorts are anticipated in Q224. We note that the UV1-103 study is treating the same patient population as the Phase II INITIUM trial, for which top-line results are expected in H124. We believe that the readouts for UV1 as a potential treatment for malignant melanoma in this period could represent a major catalyst for investor attention.
Written by
Ultimovacs |
Two for two in melanoma Phase I trial |
Clinical update |
Pharma and biotech |
12 October 2023 |
Share price performance
Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
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Ultimovacs has shared an encouraging update from its Phase I trial (UV1-103) assessing UV1 in combination with pembrolizumab for the treatment of malignant melanoma. The latest data show that 11 out of 16 patients who agreed to long-term monitoring from cohort 1 were confirmed alive at the four-year follow-up point, corresponding to an overall survival (OS) rate of 69%. This demonstrates a durable benefit of Ultimovac’s lead cancer vaccine, in our view, indicating no confirmed patient deaths since the three-year follow-up point for this cohort. Four-year survival data in both cohorts are anticipated in Q224. We note that the UV1-103 study is treating the same patient population as the Phase II INITIUM trial, for which top-line results are expected in H124. We believe that the readouts for UV1 as a potential treatment for malignant melanoma in this period could represent a major catalyst for investor attention.
Year end |
Revenue |
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.
Ultimovacs has announced an update from the UV1-103 study. This Phase I trial is investigating UV1 in combination with pembrolizumab as a potential first-line therapy in patients with advanced non-resectable or metastatic malignant melanoma. Patient enrolment was completed in August 2020 (n=30), with two cohorts differing only in the dose of vaccine adjuvant GM-CSF (cohort 1: 37.5 µg, n=20; cohort 2: 70 µg, n=10). For cohort 1, 17 out of 20 patients agreed to long-term monitoring, and at the three-year follow-up, the OS rate was 71% (12/17 patients). The latest update corresponds to the four-year follow-up for this cohort, and while the status of one patient is still pending, the OS rate was reported as 69% (11/16 patients). With no confirmed deaths between the three- and four-year follow-up, we believe this shows a durable survival benefit of UV1, providing encouragement for future readouts in this indication. Further, while we caution direct read across between clinical trials, we note that pembrolizumab demonstrated an OS rate of 46% at the four-year follow-up in the registrational KEYNOTE-006 study. The safety profile of UV1 with pembrolizumab is also reported as comparable to pembrolizumab alone.
As a reminder, in June 2023, Ultimovacs shared three-year data from both cohorts of the UV1-103 study, where the OS rate was 67% (18/27 patients who agreed to long-term monitoring). In this prior update, it was also noted that compiled data to date had shown a 33% complete response rate (complete tumour disappearance) and a 57% objective response rate (complete or partial tumour disappearance). Four-year data from both cohorts is expected in Q224, potentially representing a significant catalyst for the company, provided the data continue to be positive.
We also wish to highlight that, in December 2021, the US FDA granted orphan drug designation (ODD) to UV1 (as a sole agent or part of a combination) for the treatment of stage IIB–IV melanoma. A key benefit of ODD includes a potential seven years of market exclusivity, subject to regulatory approval.
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Research: Metals & Mining
Pan American Silver (PAAS) has announced that it will begin restarting operations at the La Colorada mine on 16 October. Operating activities at the project have temporarily been suspended since 5 October due to security concerns at the mine site following the concentrate robbery. The company does not expect any impact on the FY23 production and cost guidance from the suspension of production. We maintain our estimates and valuation.