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Research: Healthcare
Ultimovacs has announced positive three-year data from the UV1-103 Phase I trial (n=30) assessing UV1 in combination with pembrolizumab for the treatment of malignant melanoma. Of the participants that agreed to long-term monitoring, an overall survival (OS) rate of 67% (18/27) was reported at three years. While we caution against direct read across, and acknowledge there are differences in study designs, we highlight that pembrolizumab showed an OS rate of 51% at three years in the registrational KEYNOTE-006 study. We also note that UV1-103 treats the same patient population as Ultimovacs’ INITIUM Phase II trial, and top-line results are expected in H223, representing a significant upcoming catalyst.
Written by
Ultimovacs |
Positive Phase I update in malignant melanoma |
Clinical update |
Pharma and biotech |
20 June 2023 |
Share price performance
Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
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Ultimovacs has announced positive three-year data from the UV1-103 Phase I trial (n=30) assessing UV1 in combination with pembrolizumab for the treatment of malignant melanoma. Of the participants that agreed to long-term monitoring, an overall survival (OS) rate of 67% (18/27) was reported at three years. While we caution against direct read across, and acknowledge there are differences in study designs, we highlight that pembrolizumab showed an OS rate of 51% at three years in the registrational KEYNOTE-006 study. We also note that UV1-103 treats the same patient population as Ultimovacs’ INITIUM Phase II trial, and top-line results are expected in H223, representing a significant upcoming catalyst.
Year end |
Revenue |
PBT* |
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 |
(210.8) |
(6.13) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(277.9) |
(8.08) |
0.0 |
N/A |
N/A |
Note: *PBT is reported. **EPS is fully diluted.
Ultimovacs has shared a three-year update from the UV1-103 Phase I trial. This study is evaluating UV1, in combination with pembrolizumab, as a first-line therapy for advanced non-resectable or metastatic malignant melanoma, aiming to assess safety, tolerability and initial signs of efficacy. 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). Of the patients who agreed to long-term monitoring, 67% (18/27) were still alive at three years. OS in cohort 1 was 71% (12/17), and OS in cohort 2 was 60% (6/10). To date, the compiled data show a 33% complete response rate (complete tumour disappearance) and a 57% objective response rate (complete or partial tumour disappearance). Further, the safety profile of UV1 with pembrolizumab was comparable to pembrolizumab alone. Collectively, these results are encouraging for Ultimovacs, in our view, and contribute to a growing data package for the cancer vaccine.
As discussed in our prior note, the UV1-103 study is treating the same patient population as Ultimovacs’ ongoing INITIUM Phase II trial, a strategic priority for the company. INITIUM is evaluating UV1 in combination with ipilimumab and nivolumab. Patient enrolment (n=156) was completed in July 2022, and while top-line results were initially expected in H123, the readout is now expected in H223. This is due to patients taking longer than anticipated to experience disease progression, which may be considered an encouraging sign for the outcome of the trial, although this is not assured (i.e. in the event that the control arm is performing better than anticipated). The top-line INITIUM results represent a major catalyst for the company, as they will provide information on whether the slower pace of disease progression is due to UV1 treatment. Ultimovacs also recently shared results from the NIPU Phase II trial (mesothelioma), and while the study did not meet the primary endpoint of progression-free survival, a positive trend was observed in OS for the UV1 arm. Other ongoing Phase II trials include: FOCUS (head and neck cancer), DOVACC (ovarian cancer) and LUNGVAC (non-small cell lung cancer). Top-line results from these trials are expected in H124, H224 and H225, respectively.
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Research: Consumer
Portobello’s management has a very clear strategy to expand its retail presence across Italy over the long term from its current low penetration of 35 stores. It believes the company’s relatively unique business model, the use of its own and third-party media in exchange for inventory, enables it to source products more competitively than its peers. Recent M&A should enable Portobello to shift from a historical land-based focus to an omni-channel presence and enhance its product offer so that it appeals to a greater number of retail and B2B customers. The shares continue to trade at a significant discount to its (imperfect) quoted peer group, and our revised discounted cash flow (DCF) based valuation of €91/share.