BT-063 / ADMA Biologics - LARVOL DELTA

Production of an interleukin-10 blocking antibody by genetically engineered macrophages increases cancer cell death in human gastrointestinal tumor slice cultures. (PubMed, Cancer Gene Ther) - "LV transduction led to sustained production of BT-063 by αIL-10 GEMs for at least 21 days. Transduction did not alter GEM phenotype as evaluated by flow cytometry, but αIL-10 GEMs produced measurable quantities of BT-063 in the TME that was associated with an ~5-fold higher rate of tumor cell apoptosis than control."

Journal • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • IL10

Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P2a; N=36; Completed; Sponsor: Biotest; Active, not recruiting ➔ Completed; Trial completion date: Jun 2018 ➔ Oct 2017

Trial completion • Trial completion date • Biosimilar • Immunology • Lupus

Interim analysis supports continuation of clinical phase IIa trial in systemic lupus erythematosus (Study No. 990) (Biotest Press Release) - P2, N=NA; NCT02554019; Sponsor: Biotest; "Biotest AG announced today that the Data Safety Monitoring Board (DSMB) has recommended to continue as planned with part 2 of Biotest's phase IIa clinical study of BT-063 for the treatment of systemic lupus erythematosus (SLE). This recommendation is based on an interim analysis after part 1 of study 990...The DSMB did not identify any safety concerns in part 1 and therefore has recommended to continue with part 2 of this clinical study as planned in the study protocol."

DSMB • P2 data • Lupus

Biotest: Kepler Cheuvreux German Corporate Conference (Biotest) - Anticipated first data from P2a study no. 990 trial (NCT02554019) in moderate-to-severe SLE in H2 2016

Anticipated P2a data • Lupus

Xenosiderophore Utilization Promotes Bacteroides thetaiotaomicron Resilience during Colitis. (PubMed, Cell Host Microbe) - "Mutants in the xusABC locus (BT2063-2065) were defective for xenosiderophore-mediated iron uptake in vitro. In the normal mouse gut, the XusABC system was dispensable, while a xusA mutant colonized poorly during colitis. This work identifies xenosiderophore utilization as a critical mechanism for B. thetaiotaomicron to sustain colonization during inflammation and suggests a mechanism of how interphylum iron metabolism contributes to gut microbiota resilience."

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