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Research: Healthcare
Ultimovacs has announced that the Phase II LUNGVAC study (NCT05344209) will be switching the immune checkpoint inhibitor (ICI) to be used in combination with its lead cancer vaccine candidate, UV1. The trial is currently dosing UV1 and ICI pembrolizumab (Keytruda) in patients with advanced or metastatic non-small cell lung cancer (NSCLC). However, as of 1 January 2023, patients enrolled in the study will receive cemiplimab (Libtayo). The decision was taken after the Norwegian health authorities agreed to provide reimbursement for Libtayo in NSCLC. Multiple ICI/UV1 combination treatment modalities, including Libtayo, had already been integrated into the LUNGVAC trial protocol, so we do not see the change in drug as having any impact on patient enrolment. We value the company at NOK7.9bn or NOK231 per share.
Written by
Ultimovacs |
Slight adjustment but trial continues as planned |
Clinical update |
Pharma and biotech |
21 December 2022 |
Share price performance
Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
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Ultimovacs has announced that the Phase II LUNGVAC study (NCT05344209) will be switching the immune checkpoint inhibitor (ICI) to be used in combination with its lead cancer vaccine candidate, UV1. The trial is currently dosing UV1 and ICI pembrolizumab (Keytruda) in patients with advanced or metastatic non-small cell lung cancer (NSCLC). However, as of 1 January 2023, patients enrolled in the study will receive cemiplimab (Libtayo). The decision was taken after the Norwegian health authorities agreed to provide reimbursement for Libtayo in NSCLC. Multiple ICI/UV1 combination treatment modalities, including Libtayo, had already been integrated into the LUNGVAC trial protocol, so we do not see the change in drug as having any impact on patient enrolment. We value the company at NOK7.9bn or NOK231 per 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 |
(159.2) |
(4.65) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(196.0) |
(5.73) |
0.0 |
N/A |
N/A |
Note: *PBT is reported, EPS is fully diluted.
As a reminder, the LUNGVAC study is a multicentre, randomised, open-label trial assessing the safety and efficacy of UV1 in two sub-populations of NSCLC patients with adenocarcinoma (c 40% of cases) or squamous tumours (c 30% of cases). The primary endpoint for the study will be progression-free survival with key secondary endpoints including overall survival, response rate, duration of response and safety. The trial dosed its first patient in October 2022 and is expected to recruit up to 138 participants. Management intends to update the market regarding top-line readouts as part of its Q422 presentation. Patients recruited to the study before 1 January 2023 will continue to be treated with Keytruda, while patients recruited thereafter will be treated with Libtayo.
Libtayo is a programmed death-ligand 1 (PD-L1) ICI developed and marketed by Regeneron. The drug has received approval for the treatment of advanced NSCLC in the first-line setting as both a monotherapy and, more recently, as a combination treatment with chemotherapy. Flexibility had been integrated into the LUNGVAC trial design, allowing patients to be treated with multiple ICIs that include Keytruda, Libtayo and Roche’s Tecentriq. The accepted protocol gives Ultimovacs the freedom to change patient ICI treatment regimens without facing the prospect of having to obtain additional regulatory approval, which means the overall study timelines will not be negatively affected, in our view.
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Research: Healthcare
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