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SEK435m
Research: Healthcare
Mendus has provided an update on its development plans for its lead cancer vaccine, vididencel, primarily targeting the acute myeloid leukaemia (AML) maintenance setting. Management expects to share updated survival data in Q423 for its ongoing ADVANCE II trial, consistent with prior guidance; vididencel is being investigated as a monotherapy for AML maintenance. Management also intends to maximise the potential of vididencel by preparing for a Phase II combination study with Onureg, the only approved AML maintenance drug to date. We view the company’s previously disclosed strategy of prioritising a combination study as a sensible and logical step forward for vididencel’s clinical development, and continue to believe that combination treatment regimens (as noted in our AML thematic report) will be important for clinical breakthroughs in oncology. Therefore, the anticipated H223 commencement of the planned Phase II trial represents a key near-term milestone for Mendus, in our view.
Written by
Mendus |
Management update on vididencel in AML |
Operational update |
Pharma and biotech |
28 June 2023 |
Share price performance
Business description
Analysts
Mendus is a research client of Edison Investment Research Limited |
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Mendus has provided an update on its development plans for its lead cancer vaccine, vididencel, primarily targeting the acute myeloid leukaemia (AML) maintenance setting. Management expects to share updated survival data in Q423 for its ongoing ADVANCE II trial, consistent with prior guidance; vididencel is being investigated as a monotherapy for AML maintenance. Management also intends to maximise the potential of vididencel by preparing for a Phase II combination study with Onureg, the only approved AML maintenance drug to date. We view the company’s previously disclosed strategy of prioritising a combination study as a sensible and logical step forward for vididencel’s clinical development, and continue to believe that combination treatment regimens (as noted in our AML thematic report) will be important for clinical breakthroughs in oncology. Therefore, the anticipated H223 commencement of the planned Phase II trial represents a key near-term milestone for Mendus, in our view.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
0.0 |
(133.4) |
(0.73) |
0.0 |
N/A |
N/A |
12/22 |
3.4 |
(138.8) |
(0.70) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(133.6) |
(0.67) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(145.3) |
(0.72) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Management’s webcast (on 27 June 2023) provided an overview and update on the clinical development of vididencel. The ongoing ADVANCE II trial (n=20) is investigating the cancer vaccine as a potential monotherapy in AML maintenance, and is currently in the long-term follow-up stage. The target population for this study is patients who have responded to previous therapy and are in complete remission, but still harbouring measurable residual disease. The company reaffirmed that at a median follow-up of 19.4 months, median relapse-free survival had not been reached. 12 out of the 20 patients enrolled were still in complete disease remission, and median overall survival was recorded as 30.9 months. These data remain encouraging, in our view, and suggest a potentially competitive profile versus Onureg (oral azacitidine), the current standard of care. Updated median relapse-free survival data are expected in Q423, and we believe this may represent a significant catalyst for the company.
Mendus is currently planning a Phase II study to assess vididencel in combination with Onureg. Management has communicated that it would include the same patient population as the ADVANCE II trial, patients who have gone into complete disease remission following first-line induction chemotherapy. This study, expected to commence in H223, will initially involve a small number of patients, randomised to receive either vididencel in combination with Onureg, or Onureg alone. Patients will be monitored across a period of 18–24 months, and if the interim data are supportive, this would then be expanded into a pivotal trial lasting 24–36 months further. We note that management may also consider exploring additional haematological malignancies throughout the duration of this combination study. For more information on ongoing clinical activities involving vididencel, and the AML maintenance treatment landscape, we direct readers to our Outlook note.
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Research: Healthcare
Sequana Medical has reported additional data on safety, quality of life (QoL) and survival from the POSEIDON North American open-label pivotal study assessing the company’s implantable alfapump device in patients with recurrent and refractory ascites (RRA) due to liver cirrhosis. The company previously reported in Q422 that the study met the primary efficacy endpoint, and that the primary safety endpoints were in line with expectations. The additional data, reported at the EASL Congress 2023, show that alfapump was effective in controlling ascites, by virtually eliminating the need for needle paracentesis. Sequana also confirmed that the additional safety data were in line with expectations, while a clinically relevant and statistically significant improvement in patients’ QoL was also shown through validated and pre-specified health survey questionnaires. We believe that the additional data suggest a strong clinical and commercial profile, and support the likelihood of US alfapump approval.