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MESSAGE _ENGLISH VERSION_ |
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Current Report No. 23/2026
Date of preparation: 2026-08-11
Abbreviated name of the issuer: MABION S.A.
Subject: Achievement of the first milestone on the path to the
introduction of MabionCD20 as an orphan drug for the treatment of immune
thrombocytopenia _ITP_ - confirmation of the notice scheduling a meeting
with the U.S. Food and Drug Administration _FDA
Legal basis: Article 17_1_ of the MAR Regulationconfidential information
Report content:
The Management Board of Mabion S.A. _"the Company"_ announces that on
August 11, 2026, it received confirmation from Oddifact SAS _"the
Partner"_ that documentation regarding the planned development of
MabionCD20 for the treatment of immune thrombocytopenia _ITP_ had been
successfully submitted to the U.S. Food and Drug Administration _"FDA,"
"the Agency"_ of documentation regarding the planned development of
MabionCD20 for the treatment of immune thrombocytopenia _ITP_, including
a request for a Type B Pre-IND consultation meeting.
The submission of the documentation to the FDA is a significant
milestone in the reactivation of the MabionCD20 project and in the
implementation of the Company's strategy for 2025-2030, which, in
addition to the further development of its CDMO operations, also
involves the development of innovative biologics projects with higher
added value, including projects based on the Company's existing assets
and intellectual property and carried out in collaboration with
strategic partners.
Reaching this stage fulfills Mabion's ambition to address unmet medical
needs, particularly in the area of rare diseases, and to develop
innovative therapies with global potential. By leveraging the Company's
experience in the development and characterization of the MabionCD20
molecule, as well as its scientific expertise, the project may serve as
the foundation for the further development of its own innovative
therapy. Subject to the successful completion of subsequent development
stages and the obtaining of the required regulatory approvals, this
project offers the prospect of bringing a medicinal product to the
global market within the next 4-5 years.
The achievement of this milestone is the result of intensive work
carried out by the Company in cooperation with the Partner, in
accordance with the letter of intent and the agreement, which the
Company disclosed in Current Reports No. 9/2026 dated May 7, 2026, and
No. 13/2026 dated June 16, 2026.
In the course of this work, the parties selected the orphan disease area
with the greatest potential for MabionCD20 at this timeITP. In the
Company's assessment, the potential annual market value of treatment
with the CD20 monoclonal antibody for this indication in the United
States can be estimated at approximately $100 million per year.
With this in mind, the parties developed a clinical trial program and
prepared the materials necessary to submit to the Agency in order to
secure a Type B Pre-IND consultation meeting. The purpose of the meeting
is to obtain feedback from the FDA regarding the planned preclinical
program, work in the areas of CMC _Chemistry, Manufacturing, and
Control_, and clinical development; to confirm the adequacy of the study
scope required for progression to the clinical phase; to develop a
coherent strategy for submitting a complete application to initiate
Phase I clinical trials; and to identify potential regulatory risks.
At the same time, the Company emphasizes that the implementation of
subsequent stages of MabionCD20's developmentincluding obtaining FDA
approval for the meeting, the course of the consultation, further
preclinical and clinical development, and the eventual marketing
authorization of the productwill depend on the results of further
development work, the decisions and positions of the relevant regulatory
authorities, as well as the availability of partners for the subsequent
stages of the project.
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RB: Osiągnięcie pierwszego kamienia milowego na drodze do wprowadzenia MabionCD20 jako
leku sierocego stosowanego w leczeniu immunologicznej trombocytopenii (ITP) - potwierdzenie
zgłoszenia o wyznaczenie terminu spotkania z amerykańską Agencją ds. Żywności i Leków
(FDA)
