duvortuxizumab (MGD011) / MacroGenics - LARVOL DELTA

Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Duvortuxizumab (JNJ-64052781) Plus Ibrutinib in Lymphoma (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Janssen Research & Development, LLC | Phase classification: P1b ➔ P1

Phase classification • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Quantitative prediction of human pharmacokinetics for duvortuxizumab from cynomolgus monkey data: a translational pharmacokinetic modeling approach (AACR 2017) - P1; "In conclusion, the developed translational PK model successfully predicted duvortuxizumab PK in humans and has been used to aid dose escalation of duvortuxizumab in the ongoing FIH study. This work showcases the potential of translational PK modeling in supporting the selection of a FIH dose escalation strategy utilizing preclinical PK information."

Biosimilar • Oncology

A Dose Escalation Study of JNJ-64052781 in Participants With Relapsed or Refractory B-cell Malignancies (clinicaltrials.gov) - P2; N=140; Recruiting; Sponsor: Janssen Research & Development, LLC; Phase classification: P1 ➔ P2

Phase classification • Acute Lymphocytic Leukemia • Biosimilar • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology

Eight posters based on MacroGenics-developed molecules featured at AACR Annual Meeting 2017 (GlobeNewswire) - "...the posters featured at AACR relating to a MacroGenics-developed molecule are ...'Potent Antitumor Activity of Duvortuxizumab, a CD19 x CD3 DART Molecule, in Lymphoma Models' [and] 'Quantitative Prediction of Human Pharmacokinetics for Duvortuxizumab from Cynomolgus Monkey Data: a Translational Pharmacokinetic Modeling Approach'."

Conference • Preclinical • Oncology

Duvortuxizumab: Anticipated patent expiry in 2035 (Macrogenics) - Annual Report 2016

Anticipated patent expiry • Oncology

Duvortuxizumab: Regulatory filing in US for B-cell malignancies between 2022-2027 (Johnson and Johnson Ltd) - Pharmaceutical Business Review

BLA • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CD3xCD19 Dart Treatment Is Efficient in Venetoclax Resistant CLL and Reverses T Cell Dysfunction (ASH 2019) - "Methods - Co-culture of CLL derived or aged-matched healthy donor (HD) CD4+ and/or CD8+ T cells with (CD40 activated) primary CLL or CD19+ cell lines JeKo-1 or Ramos in presence of CD3xCD19 (JNJ-64052781), CD3xFITC, anti-CD3/28 antibodies was performed. Furthermore, it shows that venetoclax resistant CLL can still be efficiently targeted by T cells, in a non-apoptotic fashion. These results imply that T cell mediated therapy could be used alongside venetoclax."

IO Biomarker • BCL2L1 • CD40LG • CD8 • PARP