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▲ −0.01 (−0.41%)
Market capitalisation
EUR248m
Research: Healthcare
Oryzon Genomics announced that it has received FDA investigational new drug (IND) approval for the initiation of a collaborative Phase II trial investigating the use of the company’s LSD1 inhibitor, iadademstat, in the treatment of relapsed and refractory (r/r) neuroendocrine carcinomas (NECs). The trial will be conducted in collaboration with the Fox Chase Cancer Center, with Oryzon providing funding, iadademstat and technical advice. r/r NECs (of which it is estimated that 22–27% are small cell lung cancers, SCLCs) are highly aggressive tumours for which there are limited treatment options, meaning prognosis is often poor. In the new trial, iadademstat will be investigated in combination with other therapeutics that have shown activity in NECs. In our view, the IND approval represents an important event for Oryzon as the company continues to maximise the utility of iadademstat. We value Oryzon at €861m or €16.2 per share.
Written by
Oryzon Genomics |
IND granted for collaborative Phase II trial |
Clinical update |
Pharma and biotech |
9 November 2022 |
Share price performance
Business description
Analysts
Oryzon Genomics is a research client of Edison Investment Research Limited |
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Oryzon Genomics announced that it has received FDA investigational new drug (IND) approval for the initiation of a collaborative Phase II trial investigating the use of the company’s LSD1 inhibitor, iadademstat, in the treatment of relapsed and refractory (r/r) neuroendocrine carcinomas (NECs). The trial will be conducted in collaboration with the Fox Chase Cancer Center, with Oryzon providing funding, iadademstat and technical advice. r/r NECs (of which it is estimated that 22–27% are small cell lung cancers, SCLCs) are highly aggressive tumours for which there are limited treatment options, meaning prognosis is often poor. In the new trial, iadademstat will be investigated in combination with other therapeutics that have shown activity in NECs. In our view, the IND approval represents an important event for Oryzon as the company continues to maximise the utility of iadademstat. We value Oryzon at €861m or €16.2 per share.
Year end |
Revenue |
PBT* (€m) |
EPS* |
DPS |
P/E |
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 |
12/22e |
14.4 |
(5.2) |
(0.06) |
0.0 |
N/A |
N/A |
12/23e |
15.9 |
(6.1) |
(0.07) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
NECs are a rare form of cancers (US incidence is estimated at 1–5 cases per 100,000 people) which can form in various areas of the body, including gastrointestinal tract (c 43% of cases), the lungs (c 30% of cases) and pancreas (c 7% of cases), meaning that symptoms can be varied, often leading to late diagnosis. Hence, when diagnosed, NECs are likely to be late-stage, aggressive tumours and patients commonly relapse from or develop resistance to initial chemotherapy treatment. The aggressive nature and tumour heterogeneity of r/r NECs leaves a significant unmet medical need for new efficacious therapeutics, presenting a distinct opportunity for Oryzon and iadademstat in this indication, in our view.
As a reminder, iadademstat is an oral small molecule inhibitor of lysine-specific demethylase 1 (LSD1), a gene expression regulator, which is overexpressed in a variety of cancers. Importantly for Oryzon, LSD1 dysregulation has been observed in NECs (including SCLCs), making it a potentially attractive target in this indication, in our view. Oryzon’s strategy involves maximising the clinical potential of iadademstat and the company is conducting trials with the drug in 1L acute myeloid leukaemia (AML, Phase IIa, ALICE), FLT3 mutant r/r AML (Phase Ib, FRIDA), and is preparing to initiate a new study in SCLCs in combination with immune checkpoint inhibitors (Phase Ib/II, STELLAR). The new IND approval, in our view, represents encouraging support for iadademstat’s use in oncology, especially in SCLCs. We value Oryzon at €861m or €16.2 per share.
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Research: TMT
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