Currency in EUR
Last close As at 02/06/2023
EUR2.06
▲ 0.01 (0.49%)
Market capitalisation
EUR119m
Research: Healthcare
Oryzon presented a 42-month update of its ongoing Phase IIa ALICE trial for the treatment of acute myeloid leukaemia (AML) in newly diagnosed elderly/unfit patients. The latest positive efficacy and safety data in the single-arm, open-label study follows what has been a consistent trend of encouraging data readouts from this fully enrolled study. The study is currently evaluating the objective response (OR) in patients treated with LSD1 inhibitor iadademstat in combination with standard of care chemotherapy azacitidine in a front-line setting. Of the 27 evaluable patients, 22 (81%) achieved an OR significantly higher than that of azacitidine monotherapy, which achieves OR rates of c 30%. We will revisit our estimates and valuation based on the recent updates reported by Oryzon on iadademstat.
Oryzon Genomics |
Continued positive responses in ALICE trial |
Clinical study update |
Pharma and biotech |
10 June 2022 |
Share price performance Business description
Analysts
Oryzon Genomics is a research client of Edison Investment Research Limited |
Oryzon presented a 42-month update of its ongoing Phase IIa ALICE trial for the treatment of acute myeloid leukaemia (AML) in newly diagnosed elderly/unfit patients. The latest positive efficacy and safety data in the single-arm, open-label study follows what has been a consistent trend of encouraging data readouts from this fully enrolled study. The study is currently evaluating the objective response (OR) in patients treated with LSD1 inhibitor iadademstat in combination with standard of care chemotherapy azacitidine in a front-line setting. Of the 27 evaluable patients, 22 (81%) achieved an OR significantly higher than that of azacitidine monotherapy, which achieves OR rates of c 30%. We will revisit our estimates and valuation based on the recent updates reported by Oryzon on iadademstat.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
DPS |
Yield |
12/20 |
9.5 |
(4.8) |
(0.07) |
0.0 |
N/A |
N/A |
12/21 |
10.6 |
(7.2) |
(0.09) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles and exceptional items.
ALICE 42-month consistent efficacy
The latest data reported by Oryzon is yet another significant milestone in the fully enrolled ALICE study, which has displayed positive results throughout. While dose-finding data and safety/tolerability evaluation are the primary endpoints, efficacy was evaluated using the secondary endpoints: objective response rates (ORR), time to response and duration of response. Of the 27 evaluable patients, 22 (81%) achieved an OR, comprising 14 complete responses (CR) or complete responses with incomplete haematologic recovery (CRi), and eight partial responses (PR). The time to response was rapid: 20 of 22 patients (91%) responded after two 28-day cycles of treatment; and durable, as nine of the 14 CR/CRi patients (64%) responded for more than six months. Of further note, 12 CR/CRi patients (86%) achieved transfusion independence for red blood cells and platelets – a result that we believe should elicit a positive impact on overall patient compliance going forward.
Comparable performance and promise for FRIDA
The OR rates observed from ALICE have remained consistently higher than historical response rates with classic chemotherapy (25–32%). The rates also align well with the combination chemotherapy developed by AbbVie/Genentech, which utilises the BCL2 inhibitor venetoclax in combination with azacitidine or decitabine for front-line AML treatment, which achieved an OR rate of 68%. The latest results from the ALICE study also provide encouraging signs for Oryzon’s Phase Ib FRIDA trial investigating iadademstat in combination with gilteritinib for treating patients with FLT3-mutated AML in a second-line setting. The latest ALICE data reported that three out of three evaluable patients possessing the FLT3 mutation responded to treatment, thus providing promise for this further sub-population of AML patients.
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Research: Industrials
Following the disposal of Ergotron, Melrose has now completed four transactions since 2005 with an average IRR of 28%. Focus now turns to the fifth deal, GKN Aerospace. Recovery in the aerospace market and management confidence to lift margin expectations from 12% to 14%+, along with greater disclosure on the engine contracts, suggest GKN is recovering strongly, albeit value realisation is likely a few years out. In the shorter term, the fully restructured GKN Powder Metallurgy and GKN Automotive operations are likely to be exited, which should provide further support to our 246p/share valuation. Investor attention may also start turning towards the next acquisition and sixth deal.
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