Currency in EUR
Last close As at 25/03/2023
EUR5.08
▲ −0.05 (−0.97%)
Market capitalisation
EUR95m
Research: Healthcare
OSE Immunotherapeutics has announced that the first participant in a Phase I study has been dosed with the company’s CD28-targeting antibody fragment, FR104 (VEL-101). The study will assess the safety, tolerability and pharmacology of single ascending doses of FR104 in healthy volunteers and is designed to inform further Phase II trials in the kidney transplant population. The trial is sponsored and conducted by OSE’s partner, Veloxis Pharmaceuticals, which specialises in transplant medicine. Clinical data from the trial, especially information surrounding subcutaneous injection administration, will add to safety data gathered by OSE in the FIRsT Phase I/II trial in kidney transplant patients, which began in April 2021. We see this as an encouraging development for OSE and for the development of FR104. Our valuation remains unchanged at €319m or €17.5 per share.
OSE Immunotherapeutics |
First patient dosed with FR104/VEL-101 |
Clinical trial update |
Healthcare/biotech |
19 May 2022 |
Share price performance Business description
Analysts
OSE Immunotherapeutics is a research client of Edison Investment Research Limited |
OSE Immunotherapeutics has announced that the first participant in a Phase I study has been dosed with the company’s CD28-targeting antibody fragment, FR104 (VEL-101). The study will assess the safety, tolerability and pharmacology of single ascending doses of FR104 in healthy volunteers and is designed to inform further Phase II trials in the kidney transplant population. The trial is sponsored and conducted by OSE’s partner, Veloxis Pharmaceuticals, which specialises in transplant medicine. Clinical data from the trial, especially information surrounding subcutaneous injection administration, will add to safety data gathered by OSE in the FIRsT Phase I/II trial in kidney transplant patients, which began in April 2021. We see this as an encouraging development for OSE and for the development of FR104. Our valuation remains unchanged at €319m or €17.5 per share.
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
DPS |
Yield |
12/20 |
10.4 |
(18.5) |
(1.02) |
0.0 |
N/A |
N/A |
12/21 |
26.3 |
(16.5) |
(0.89) |
0.0 |
N/A |
N/A |
12/22e |
5.0 |
(38.8) |
(1.89) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(44.2) |
(2.42) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
FR104 is currently in two separate Phase I clinical trials. The first, aptly named FIRsT (NCT04837092), is investigating the safety and tolerability of FR104 in 10 kidney transplant patients. The study is being conducted by OSE and is expected to complete in July 2024. Previous first-in-human Phase I trial data have shown FR104 to have a good safety profile and potential efficacy. The second new trial, led by Veloxis Pharmaceuticals, will further assess FR104’s (VEL-101) safety profile and route of administration. Importantly, the study will provide data on whether subcutaneous injection administration is viable for FR104, potentially opening the door to ‘at-home’ dosing in further trials of kidney transplant patients. The randomised, double-blinded, placebo-controlled, dose-escalation study aims to enrol 56 healthy human participants and the primary outcomes will measure the number and severity of adverse events from subcutaneous injection administration of FR104. OSE is also planning Phase II trials for the treatment of autoimmune diseases with FR104.
FR104 is a monoclonal antibody fragment that targets and silences CD28 signalling. Importantly, FR104 does not block CTLA-4, with the net effect being the promotion of regulatory T-cell activity and suppression of effector T-cells, blunting immune responses. For this reason, OSE Therapeutics believes FR104 to be an attractive therapeutic in addressing conditions where the immune system is functioning adversely, such as transplant rejection or autoimmune diseases.
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Research: Consumer
Evolva has signed a distribution agreement to jointly develop the Brazilian market for resveratrol with its new partner, Tovani Benzaquen, a distributor of food and functional ingredients. Management expects revenues to exceed CHF1.5m over the next 2.5 years. The distribution agreement opens the Brazilian market for resveratrol, thus should result in an uplift in revenue expectations for the product. If successful, we believe the distribution agreement could be extended to other markets in Latin America and the model could eventually be rolled out to new markets in Asia, for example. We believe this is a significant step in Evolva’s commercialisation capabilities under new CEO Christian Wichert, as he instils a sense of urgency into the business and transitions the company to a fully product-based commercial model.
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