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Last close As at 09/06/2023
EUR2.29
▲ 0.22 (10.63%)
Market capitalisation
EUR132m
Research: Healthcare
Oryzon Genomics has announced it has enrolled the first patient in its Phase Ib FRIDA study investigating iadademstat in combination with Astellas’ FDA-approved FLT3 inhibitor gilteritinib to treat FLT3+ relapsed/refractory (r/r) acute myeloid leukaemia (AML) patients. The FRIDA study is central to Oryzon’s overall strategy as management believes the second-line AML setting may represent a potentially quicker route to market for iadademstat, targeting an AML patient population with limited and sub-optimal treatment options. FRIDA will recruit up to 45 patients across 10–15 trial sites in the United States and, in our view, its initiation marks a significant clinical milestone for the company.
Oryzon Genomics |
Clinical milestone reached with FRIDA initiation |
Clinical update |
Pharma and biotech |
16 March 2023 |
Share price performance Business description
Analysts
Oryzon Genomics is a research client of Edison Investment Research Limited |
Oryzon Genomics has announced it has enrolled the first patient in its Phase Ib FRIDA study investigating iadademstat in combination with Astellas’ FDA-approved FLT3 inhibitor gilteritinib to treat FLT3+ relapsed/refractory (r/r) acute myeloid leukaemia (AML) patients. The FRIDA study is central to Oryzon’s overall strategy as management believes the second-line AML setting may represent a potentially quicker route to market for iadademstat, targeting an AML patient population with limited and sub-optimal treatment options. FRIDA will recruit up to 45 patients across 10–15 trial sites in the United States and, in our view, its initiation marks a significant clinical milestone for the company.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
10.6 |
(7.2) |
(0.09) |
0.0 |
N/A |
N/A |
12/22 |
15.7 |
(6.6) |
(0.07) |
0.0 |
N/A |
N/A |
12/23e |
17.3 |
(4.2) |
(0.03) |
0.0 |
N/A |
N/A |
12/24e |
19.0 |
(10.0) |
(0.14) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, other income and exceptional items.
The FRIDA trial is an open-label, multi-centre study with the primary objective of assessing the safety and tolerability of the iadademstat and gilteritinib combination in r/r FLT3+ patients, and to determine the Recommended Phase 2 Dose (RP2D) for the drug combination. Key secondary outcomes from the study include early efficacy assessments to measure rates of complete remission and complete remission with partial haematological recovery (CR/CRh), duration of treatment response and levels of measurable residual disease (MRD). Approximately 50% of patients relapse after first-line AML treatment and 30% possess an FLT3 mutation, with gilteritinib monotherapy currently the standard of care. The median overall survival for gilteritinib treatment is 9.3 months in r/r FLT3+ patients and, in our view, combinational treatments such as iadademstat may provide scope for synergistic efficacy enhancements.
Iadademstat has already demonstrated an encouraging safety and efficacy profile in first-line AML patients, with positive data reported from the recently completed Phase II ALICE study. In our view, a potentially promising result from this trial was the observation that those evaluable AML patients (n = 3) possessing an FLT3 mutation (FLT3+) all responded to iadademstat treatment. However, we acknowledge that the current data only represent a small number of patients so there may be limitations in extrapolating from this finding.
While FRIDA represents one of Oryzon’s key strategic priorities, iadademstat is also being investigated in a Phase II study in collaboration with the Fox Chase Cancer Center for the treatment of high-grade neuroendocrine carcinomas and planning for a Phase Ib/II trial (STELLAR) in metastatic small-cell lung cancer is underway.
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Research: Real Estate
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