Desentum aims to initiate clinical trials with its birch pollen allergy vaccine this fall
Preparations are currently being finalized for the first clinical study with DM-101 hypoallergen, Desentum’s lead product candidate for the treatment of birch pollen allergy.
DM-101 (rBet v 1 dm) is a genetically engineered birch pollen allergen that is designed to improve immunotherapeutic treatment of birch pollen allergy by making it significantly faster and easier than currently available immunotherapies using allergen extracts.
The clinical study is designed to help determine safe dosing and to gain information about immunological response generated by DM-101. Desentum has manufactured a GMP batch of DM-101 that fulfills all the regulatory requirements and is ready for use in the clinical study. The company has also performed safety and toxicology tests on DM-101. Based on the preliminary report, no safety concerns were raised in the tests. In the summer 2019, Desentum submitted the clinical study plan to regulatory authorities and ethics committee to apply for Clinical Trial Authorization and ethical permission. There were no major issues that would prevent the approval of the study, so Desentum has a permission to initiate the study once the final toxicology report is available. The final preparations for the clinical study are ongoing, and Desentum aims to carry out the study before birch pollen season next spring.