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Research: Healthcare
Ultimovacs has announced positive two-year overall survival (OS) data from a Phase I study (n=30) of UV1, a potential universal cancer vaccine, in combination with PD-1 immunotherapy (pembrolizumab, Merck) for the treatment of malignant melanoma. In this, the UV1/pembrolizumab combination demonstrated a 73% two-year OS rate, adding to data reported in March 2022 showing a complete response rate of 33% and an objective response rate (ORR) of 57%. Patients will be followed for further long-term survival data and management expect to report three-year OS data for the first cohort (n=20) in Q422. We continue to see the UV1/pembrolizumab combination in malignant melanoma as a potentially significant opportunity for the company. We value Ultimovacs at NOK6.90bn, or NOK202/share.
Written by
Ultimovacs |
Positive Phase I survival data in melanoma |
Clinical trial update |
Pharma and biotech |
21 June 2022 |
Share price performance
Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
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Ultimovacs has announced positive two-year overall survival (OS) data from a Phase I study (n=30) of UV1, a potential universal cancer vaccine, in combination with PD-1 immunotherapy (pembrolizumab, Merck) for the treatment of malignant melanoma. In this, the UV1/pembrolizumab combination demonstrated a 73% two-year OS rate, adding to data reported in March 2022 showing a complete response rate of 33% and an objective response rate (ORR) of 57%. Patients will be followed for further long-term survival data and management expect to report three-year OS data for the first cohort (n=20) in Q422. We continue to see the UV1/pembrolizumab combination in malignant melanoma as a potentially significant opportunity for the company. We value Ultimovacs at NOK6.90bn, or NOK202/share.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
0.0 |
(120.6) |
(3.98) |
0.0 |
N/A |
N/A |
12/21 |
0.0 |
(164.7) |
(5.09) |
0.0 |
N/A |
N/A |
12/22e |
0.0 |
(243.2) |
(7.11) |
0.0 |
N/A |
N/A |
12.23e |
0.0 |
(206.2) |
(6.02) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Melanoma is a common cause of cancer; it is estimated that c 100k new cases will be diagnosed in the United States in 2022. Pembrolizumab (Keytruda, Merck) was approved for the adjuvant treatment of melanoma in 2019 and has estimated global sales in 2028 for this indication of $3.2bn (source: Evaluate Pharma), highlighting the potential opportunity for UV1 in this setting. In naïve advanced malignant melanoma (KEYNOTE-006), pembrolizumab has demonstrated an ORR of 33% (6% CR, 27% PR) and a two-year OS of 55%. In this context, we see the previously reported clinical response data and newly presented survival data as a positive development for UV1 in malignant melanoma.
As a reminder, UV1 is a cancer vaccine that primes the patient’s immune system to recognise human telomerase reverse-transcriptase, a protein that is estimated to be overexpressed in 85–90% of human cancers but not in healthy tissues. Ultimovacs is investigating the combination of UV1 and ipilimumab (anti-CTLA-4 antibody) and nivolumab (anti-PD-1 antibody) in metastatic malignant melanoma in the Phase II INITIUM trial (NCT04382664), for which we expect top-line data in H123. We see the recent OS data as supporting the UV1/immune checkpoint inhibitor combination.
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Research: Healthcare
Midatech’s lead clinical asset, MTX110, has achieved another regulatory milestone following the decision by the European Medicines Agency (EMA) to grant the drug orphan drug designation for the treatment of gliomas. This includes recurrent glioblastoma (rGBM), diffuse intrinsic pontine glioma (DIPG) and medulloblastoma, currently being targeted by MTX110. ODD should grant Midatech 10 years of market exclusivity on approval, in addition to other incentives such as protocol development assistance and reduced fees. As a reminder, MTX110 already has ODD in DIPG and recently received fast track designation for rGBM by the US FDA.