Last close As at 05/08/2026
—
— 0.00 (0.00%)
Market capitalisation
—
Research: Healthcare
Ultimovacs has announced that its exploratory Phase I TENDU study, built on the company’s vaccine technology platform, Tetanus-Epitope Targeting (TET), has met both its primary and secondary endpoints. The study, which evaluated 12 patients with relapsed prostate cancer across three dose levels, showed a good safety profile across all dose cohorts, with no dose-limiting toxicities observed. The study also met its secondary endpoint of activating an immune response against prostate specific peptides. We see this as an encouraging development, providing early validation of the company’s TET platform, which combines antigens and the vaccine adjuvant into the same molecule with the aim of enhancing T cell response against cancer-specific peptides. We remind readers that the company’s primary asset is its universal cancer vaccine UV1, currently being assessed in five Phase II and two Phase I studies. Topline data from the Phase II INITIUM study (investigating UV1 in combination with ipilimumab and nivolumab in malignant melanoma) are expected in March/April 2024 and represent a key near-term catalyst, in our opinion.
Written by
Ultimovacs |
TENDU results support TET platform expansion |
Clinical update |
Pharma and biotech |
19 December 2023 |
Share price performance
Business description
Analysts
Ultimovacs is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||||||||||||||
Ultimovacs has announced that its exploratory Phase I TENDU study, built on the company’s vaccine technology platform, Tetanus-Epitope Targeting (TET), has met both its primary and secondary endpoints. The study, which evaluated 12 patients with relapsed prostate cancer across three dose levels, showed a good safety profile across all dose cohorts, with no dose-limiting toxicities observed. The study also met its secondary endpoint of activating an immune response against prostate specific peptides. We see this as an encouraging development, providing early validation of the company’s TET platform, which combines antigens and the vaccine adjuvant into the same molecule with the aim of enhancing Tcell response against cancer-specific peptides. We remind readers that the company’s primary asset is its universal cancer vaccine UV1, currently being assessed in five Phase II and two Phase I studies. Topline data from the Phase II INITIUM study (investigating UV1 in combination with ipilimumab and nivolumab in malignant melanoma) are expected in March/April 2024 and represent a key near-term catalyst, in our opinion.
Year |
Revenue (NOKm) |
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 |
(191.5) |
(5.57) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(235.9) |
(6.86) |
0.0 |
N/A |
N/A |
Note: *PBT is reported. **EPS is fully diluted.
The Phase I exploratory TENDU study was an open-label dose escalation study to investigate the safety, tolerability, immune response and preliminary clinical efficacy of Ultimovacs’ TET platform-derived vaccine, in prostate cancer patients with disease progression after primary radical prostatectomy. The study enrolled 12 patients across three different dose cohorts (40 ug and 400 μg doses were each administered to three patients, and six patients received a higher 960 μg dose). The vaccine was administered four times over a six-week period, with a follow-up period of six months following the last dose. The treatment was observed to be safe and well tolerated. No dose-limiting toxicities were noted, indicating potential for higher dose levels to be used in future studies. On the secondary endpoint, while the company has not provided specific details (to be presented in a peer-reviewed publication), it indicated that vaccine specific T-cell responses were observed, reflecting immune activation.
The TET platform is a unique vaccine technology being developed by Ultimovacs, which aims to strengthen T-cell response against tumour cells by combining cancer-specific antigens and the vaccine adjuvant into the same molecule. Management asserts that this allows for targeted delivery of antigens and adjuvant signals to dendritic cells and can be customised according to the cancer type. We see the results from the TENDU study as providing initial validation of the platform, with the potential to generate additional vaccine candidates for the company.
The company’s primary asset is its universal cancer vaccine, UV1, which is being investigated across several cancer indications, with several Phase II read-outs expected in FY24, including the INITIUM trial in H124 and the FOCUS and DOVACC trials in H224, which we see as key inflection points for the company.
|
|
Research: Healthcare
IRLAB has submitted a request for an end-of-Phase II meeting (EoP2) with the FDA for its lead asset, mesdopetam, to chart the Phase III roadmap for the drug. According to FDA guidelines, the agency intends to respond to such requests within 14 days and schedule a meeting within 70 calendar days from the receipt of the request. We see the EoP2 meeting as an important inflection point for IRLAB to continue clinical development of mesdopetam after securing full ownership rights from Ipsen in August 2023. Management met a key efficacy secondary endpoint and the drug has shown dose-dependent anti-dyskinetic and anti-Parkinsonian effects, which support continued development, in our view. Our valuation currently assumes a 40% probability of success for mesdopetam in levodopa-induced dyskinesias (PD-LIDs) and we plan to revisit our assumptions following the results from the FDA meeting.