Brief: Medigene Achieves Positive Preliminary Results In Phase I Of Phase I/II Trial Of TCR-T Therapy MDG1011 In Blood Cancers

Medigene AG

21/12/2021 14:18

Dec 21 (Reuters) - MEDIGENE AG  MDG1k.DE :
    * MEDIGENE ACHIEVES POSITIVE PRELIMINARY RESULTS IN PHASE I
OF
PHASE I/II TRIAL OF TCR-T THERAPY MDG1011 IN BLOOD CANCERS
    * CLINICAL OUTCOME DATA FROM ONGOING PATIENT FOLLOW-UP AND
DATA
REGARDING BIOLOGIC ACTIVITY OF DRUG PRODUCT FROM
IMMUNE-MONITORING ANALYSES ARE EXPECTED TO BECOME AVAILABLE IN
Q1 2022
    * PRIMARY OBJECTIVE OF 3+3 STUDY DESIGN IS TO EVALUATE
SAFETY AND
TOLERABILITY OF MDG1011 AND FEASIBILITY OF MANUFACTURING MDG1011
USING AUTOLOGOUS CD8+ T CELLS FROM PATIENTS
    * DATA CUT-OFF POINT FOR REPORTED RESULTS HEREIN IS 3 MONTHS
POST
TREATMENT
    * FOUR PATIENTS SUCCUMBED TO DISEASE BEFORE TREATMENT COULD
BE
ADMINISTERED, IN LINE WITH SEVERITY OF UNDERLYING CONDITION OF
STUDY PATIENTS
    * THUS, 9 PATIENTS WERE TREATED WITH A SINGLE INTRAVENOUS
ADMINISTRATION OF MDG1011
    * ALL PATIENTS EXPERIENCED ADVERSE EVENTS, WITH A
PREPONDERANCE OF
TREATMENT EMERGENT ADVERSE EVENTS (TEAES) EXPECTED FOR
UNDERLYING MALIGNANT CONDITION
    * GRADE 1-2 TRANSIENT CYTOKINE RELEASE SYNDROME (CRS)
CONSIDERED
ATTRIBUTABLE TO MDG1011 WAS EXPERIENCED BY 2 PATIENTS, GIVING
DIRECT EVIDENCE FOR BIOLOGICAL ACTIVITY OF INFUSED T CELLS
    * NEITHER IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY
SYNDROME
(ICANS) NOR DOSE-LIMITING TOXICITIES WERE REPORTED

Source text for Eikon:  ID:nPexxn0vja 
Further company coverage:  MDG1k.DE 

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