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Currency in SEK
Last close As at 24/03/2023
SEK1.28
▲ −0.01 (−0.78%)
Market capitalisation
SEK258m
Research: Healthcare
Ilixadencel, Immunicum’s cell-based cancer immunotherapy, has been granted orphan drug designation (ODD) by the FDA as a treatment for gastrointestinal stromal tumours (GIST). The treatment is currently in preparations to start a Phase II trial in GIST, which we expect to begin later this year, in combination with tyrosine kinase inhibitors (TKIs). The ODD award adds to the fast-track designation previously awarded to ilixadencel in GIST in December 2020, highlighting the unmet medical need in this indication. GIST are a rare type of gastrointestinal tumour for which TKIs are commonly prescribed. The ODD award represents further external recognition for ilixadencel and Immunicum’s underlying platform, in our view.
Immunicum |
Ilixandencel awarded orphan drug designation |
Q1 results |
Pharma and biotech |
9 June 2022 |
Share price performance
Business description
Analysts
Immunicum is a research client of Edison Investment Research Limited. |
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Ilixadencel, Immunicum’s cell-based cancer immunotherapy, has been granted orphan drug designation (ODD) by the FDA as a treatment for gastrointestinal stromal tumours (GIST). The treatment is currently in preparations to start a Phase II trial in GIST, which we expect to begin later this year, in combination with tyrosine kinase inhibitors (TKIs). The ODD award adds to the fast-track designation previously awarded to ilixadencel in GIST in December 2020, highlighting the unmet medical need in this indication. GIST are a rare type of gastrointestinal tumour for which TKIs are commonly prescribed. The ODD award represents further external recognition for ilixadencel and Immunicum’s underlying platform, in our view.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
0.0 |
(89.2) |
(1.17) |
0.00 |
N/A |
N/A |
12/21 |
0.0 |
(133.4) |
(0.73) |
0.00 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Ilixadencel is an immune primer made up of pro-inflammatory activated allogeneic dendritic cells (DCs) and intended for intratumoural administration. When injected into the tumour, ilixadencel DCs cause local recruitment and activation of the patient’s immature DCs, natural killer cells and T-cells, potentially causing an anti-cancer response. Orphan drug designation is awarded to treatments for rare diseases (less than 200,000 cases in US) and could potentially provide ilixadencel with seven years of market exclusivity, if approved.
GIST effect approximately 4,000–6,000 people in the US each year. The five-year survival rate for patients with GIST is 83%. However, this can be affected by different factors, including treatment type. Surgery is often the first line of treatment for GIST but, if the disease has metastasised, often it cannot be cured. Targeted TKIs such as imatinib (Gleevec), sunitinib (Sutent) and regorafenib (Stivarga) are often prescribed to patients with GIST (hence the planned combination with ilixadencel in Phase II). However, as with many TKIs, undesirable side effects are common and there remains an unmet medical need in GIST.
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Research: Healthcare
Oryzon Genomics has been awarded a $2m public grant to support its ongoing Phase Ib FRIDA clinical study. This follows recent FDA approval of its investigational new drug (IND) application of this initiation Phase Ib study of iadademstat. FRIDA aims to investigate the safety, tolerability and recommended dose for Phase II of one of Oryzon’s lead assets, the LSD1 inhibitor iadademstat, in combination with FDA-approved FLT3 inhibitor gilteritinib for treating patients with FLT3-mutated acute myeloid leukaemia (AML) in a second-line setting. We anticipate a positive readout from the FRIDA trial would likely provide a positive catalyst for the company’s shares. Iadademstat is also being investigated for its use as a first-line treatment in patients with metastatic small-cell lung cancer (SCLC) for which the FDA has now granted orphan drug designation (ODD). This ODD in SCLC will help expedite development in a further area of high unmet clinical need. Based on the current annual burn rate of around €13–15m (c €15m cash spent in FY21) and the company’s gross cash position of $28m (€26.2m) at end-March 2022, we estimate Oryzon has a cash runway through early FY24. We will revisit our estimates and valuation based on this news.
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