Michael Pourdehnad
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View article: Golcadomide (GOLCA), a potential, first-in-class, oral CELMoD™ agent, ± rituximab (R) in patients with Relapsed/Refractory follicular lymphoma (R/R FL): Phase 1/2 study extended follow-up Results
Golcadomide (GOLCA), a potential, first-in-class, oral CELMoD™ agent, ± rituximab (R) in patients with Relapsed/Refractory follicular lymphoma (R/R FL): Phase 1/2 study extended follow-up Results Open
Introduction While outcomes in patients with R/R FL have improved with T-cell–redirecting treatments (e.g. CAR T-cell therapy, bispecific antibodies), there remains an unmet need for safe, efficacious, and more convenient chemotherapy-free…
View article: Longer Follow-up of Golcadomide (GOLCA), a Cereblon E3 Ligase Modulator (CELMoD™) Agent ± Rituximab (RTX), in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Longer Follow-up of Golcadomide (GOLCA), a Cereblon E3 Ligase Modulator (CELMoD™) Agent ± Rituximab (RTX), in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Open
Introduction GOLCA is a potential first-in-class CELMoD agent for the treatment of lymphoma. GOLCA targets the proteins Ikaros and Aiolos (Ik/Ai) to produce dual immunomodulatory and anti-tumor activity, with preferential distribution to l…
View article: Model based assessment of food and acid reducing agent effects on oral absorption of mezigdomide (CC‐92480), a novel cereblon E3 ligase modulator
Model based assessment of food and acid reducing agent effects on oral absorption of mezigdomide (CC‐92480), a novel cereblon E3 ligase modulator Open
Mezigdomide is a novel cereblon E3 ligase modulator (CELMoD) agent with enhanced autonomous cell‐killing activity in multiple myeloma (MM) cells, and promising immunomodulatory and antitumor activity in patients with MM. We developed a pop…
View article: OPEN‐LABEL PHASE 1/2 STUDY OF CC‐99282, A CEREBLON E3 LIGASE MODULATOR (CELMOD) AGENT ± RITUXIMAB, IN PATIENTS WITH RELAPSED/REFRACTORY (<i>R</i>/<i>R</i>) NON‐HODGKIN LYMPHOMA (NHL)
OPEN‐LABEL PHASE 1/2 STUDY OF CC‐99282, A CEREBLON E3 LIGASE MODULATOR (CELMOD) AGENT ± RITUXIMAB, IN PATIENTS WITH RELAPSED/REFRACTORY (<i>R</i>/<i>R</i>) NON‐HODGKIN LYMPHOMA (NHL) Open
Introduction: CC-99282 is a novel, oral, small molecule CELMoD® agent that co-opts cereblon to induce targeted degradation of Ikaros/Aiolos, transcription factors critical for B-cell malignancy development. Compared with immunomodulatory d…
View article: Data from A First-in-Human Study of Novel Cereblon Modulator Avadomide (CC-122) in Advanced Malignancies
Data from A First-in-Human Study of Novel Cereblon Modulator Avadomide (CC-122) in Advanced Malignancies Open
Purpose:Avadomide is a novel, small-molecule therapeutic agent that modulates cereblon E3 ligase activity and exhibits potent antitumor and immunomodulatory activities. This first-in-human phase I study (NCT01421524) evaluated the safety a…
View article: Supplementary Data from A First-in-Human Study of Novel Cereblon Modulator Avadomide (CC-122) in Advanced Malignancies
Supplementary Data from A First-in-Human Study of Novel Cereblon Modulator Avadomide (CC-122) in Advanced Malignancies Open
Supplementary Table S1. Summary of avadomide plasma pharmacokinetic parameters by day and dose level Supplementary Figure S1. Representative flow cytometry analysis of Aiolos degradation in peripheral B cells (A) and T cells (B). Supplemen…
View article: Data from A First-in-Human Study of Novel Cereblon Modulator Avadomide (CC-122) in Advanced Malignancies
Data from A First-in-Human Study of Novel Cereblon Modulator Avadomide (CC-122) in Advanced Malignancies Open
Purpose:Avadomide is a novel, small-molecule therapeutic agent that modulates cereblon E3 ligase activity and exhibits potent antitumor and immunomodulatory activities. This first-in-human phase I study (NCT01421524) evaluated the safety a…
View article: Supplementary Data from A First-in-Human Study of Novel Cereblon Modulator Avadomide (CC-122) in Advanced Malignancies
Supplementary Data from A First-in-Human Study of Novel Cereblon Modulator Avadomide (CC-122) in Advanced Malignancies Open
Supplementary Table S1. Summary of avadomide plasma pharmacokinetic parameters by day and dose level Supplementary Figure S1. Representative flow cytometry analysis of Aiolos degradation in peripheral B cells (A) and T cells (B). Supplemen…
View article: Phase Ib study of avadomide (CC‐122) in combination with rituximab in patients with relapsed/refractory diffuse large B‐cell lymphoma and follicular lymphoma
Phase Ib study of avadomide (CC‐122) in combination with rituximab in patients with relapsed/refractory diffuse large B‐cell lymphoma and follicular lymphoma Open
The multicenter, phase Ib CC‐122‐DLBCL‐001 dose‐expansion study (NCT02031419) explored the cereblon E3 ligase modulator (CELMoD) agent avadomide (CC‐122) plus rituximab in patients with relapsed/refractory (R/R) diffuse large B‐cell lympho…
View article: Phase Ib study of combinations of avadomide (CC‐122), CC‐223, CC‐292, and rituximab in patients with relapsed/refractory diffuse large B‐cell lymphoma
Phase Ib study of combinations of avadomide (CC‐122), CC‐223, CC‐292, and rituximab in patients with relapsed/refractory diffuse large B‐cell lymphoma Open
There is a need for additional treatment options for patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL) who do not benefit from available therapies. We examined combinations of the cereblon E3 ligase modulator (CELM…
View article: Quantitative Systems Pharmacology Modeling of Avadomide-Induced Neutropenia Enables Virtual Clinical Dose and Schedule Finding Studies
Quantitative Systems Pharmacology Modeling of Avadomide-Induced Neutropenia Enables Virtual Clinical Dose and Schedule Finding Studies Open
Avadomide is a cereblon E3 ligase modulator and a potent antitumor and immunomodulatory agent. Avadomide trials are challenged by neutropenia as a major adverse event and a dose-limiting toxicity. Intermittent dosing schedules supported by…
View article: A PHASE 1, MULTICENTER, OPEN‐LABEL STUDY OF CC‐99282 ALONE AND IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH RELAPSED OR REFRACTORY NON‐HODGKIN LYMPHOMAS
A PHASE 1, MULTICENTER, OPEN‐LABEL STUDY OF CC‐99282 ALONE AND IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH RELAPSED OR REFRACTORY NON‐HODGKIN LYMPHOMAS Open
Background: CC-99282 is a novel, oral cereblon (CRBN) E3 ligase modulator (CELMoD) agent that co-opts CRBN to induce potent and targeted degradation of Ikaros and Aiolos, transcription factors that are known to be important for the normal …
View article: Quantitative systems pharmacology modeling of avadomide-induced neutropenia enables virtual clinical dose and schedule finding studies
Quantitative systems pharmacology modeling of avadomide-induced neutropenia enables virtual clinical dose and schedule finding studies Open
Avadomide is a cereblon E3 ligase modulator and a potent antitumor and immunomodulatory agent. Avadomide trials are challenged by neutropenia as a major adverse event and a dose-limiting toxicity. Intermittent dosing schedules supported by…
View article: Population Pharmacokinetics of CC-122
Population Pharmacokinetics of CC-122 Open
In conclusion, the two-compartment model built can be used to adequately describe the time course of the population pharmacokinetics of CC-122 and should serve as the basis for dose adjustment decision-making of CC-122.
View article: CC-90009: A Cereblon E3 Ligase Modulating Drug That Promotes Selective Degradation of GSPT1 for the Treatment of Acute Myeloid Leukemia
CC-90009: A Cereblon E3 Ligase Modulating Drug That Promotes Selective Degradation of GSPT1 for the Treatment of Acute Myeloid Leukemia Open
Acute myeloid leukemia (AML) is marked by significant unmet clinical need due to both poor survival and high relapse rates where long-term disease control for most patients with relapsed or refractory AML remain dismal. Inspired to bring n…
View article: CC-90009, a novel cereblon E3 ligase modulator, targets acute myeloid leukemia blasts and leukemia stem cells
CC-90009, a novel cereblon E3 ligase modulator, targets acute myeloid leukemia blasts and leukemia stem cells Open
A number of clinically validated drugs have been developed by repurposing the CUL4-DDB1-CRBN-RBX1 (CRL4CRBN) E3 ubiquitin ligase complex with molecular glue degraders to eliminate disease-driving proteins. Here, we present the identificati…
View article: Phase I, multicenter, dose‐escalation study of avadomide in adult Japanese patients with advanced malignancies
Phase I, multicenter, dose‐escalation study of avadomide in adult Japanese patients with advanced malignancies Open
Non‐Hodgkin lymphoma (NHL) treated with chemoimmunotherapy has limited efficacy in some patients, resulting in relapsed or refractory disease. Avadomide (CC‐122) is a novel cereblon‐binding agent that exhibits antilymphoma and immune‐modul…
View article: Avadomide monotherapy in relapsed/refractory DLBCL: safety, efficacy, and a predictive gene classifier
Avadomide monotherapy in relapsed/refractory DLBCL: safety, efficacy, and a predictive gene classifier Open
Treatment options for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) are limited, with no standard of care; prognosis is poor, with 4- to 6-month median survival. Avadomide (CC-122) is a cereblon-modulating agent with immu…
View article: Leveraging Gene Expression Subgroups to Classify DLBCL Patients and Enrich for Clinical Benefit to a Novel Agent
Leveraging Gene Expression Subgroups to Classify DLBCL Patients and Enrich for Clinical Benefit to a Novel Agent Open
Diffuse large B-cell lymphoma is a heterogeneous disease, commonly described by cell-of-origin (COO) molecular subtypes. We sought to identify novel patient subgroups through an unsupervised analysis of a large public dataset of gene expre…
View article: PHASE IB STUDY OF CC‐122 IN COMBINATION WITH OBINUTUZUMAB (GA101): RELAPSED OR REFRACTORY (R/R) PATIENTS WITH B‐CELL NON‐HODGKIN LYMPHOMAS (NHL)
PHASE IB STUDY OF CC‐122 IN COMBINATION WITH OBINUTUZUMAB (GA101): RELAPSED OR REFRACTORY (R/R) PATIENTS WITH B‐CELL NON‐HODGKIN LYMPHOMAS (NHL) Open
Introduction: CC-122 is a cereblon modulating agent with promising clinical activity in FL and DLBCL. Preclinically, CC-122 with obinutuzumab has improved activity vs either single agent. Methods: This phase Ib study (EUDRACT 2014-003333-2…
View article: ATIM-28. A PHASE 1A/1B, MULTI-CENTER, OPEN-LABEL DOSE FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY AND EFFICACY OF THE PLEIOTROPIC PATHWAY MODIFIER CC-122 ADMINISTERED ORALLY TO PATIENTS WITH GLIOBLASTOMA MULTIFORME (GBM) AND OTHER BRAIN TUMORS
ATIM-28. A PHASE 1A/1B, MULTI-CENTER, OPEN-LABEL DOSE FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY AND EFFICACY OF THE PLEIOTROPIC PATHWAY MODIFIER CC-122 ADMINISTERED ORALLY TO PATIENTS WITH GLIOBLASTOMA MULTIFORME (GBM) AND OTHER BRAIN TUMORS Open
CC-122 is a novel cereblon binding agent with multiple biological activities including potent immunomodulatory and anti-angiogenic effects. Following establishment of oral CC-122 3mg daily (QD) as the maximum tolerated dose (Blood 122:2905…
View article: CC-122, a pleiotropic pathway modifier, mimics an interferon response and has antitumor activity in DLBCL
CC-122, a pleiotropic pathway modifier, mimics an interferon response and has antitumor activity in DLBCL Open
Key Points CC-122 is a novel agent for DLBCL with antitumor and immunomodulatory activity. CC-122 binds CRBN and degrades Aiolos and Ikaros resulting in a mimicry of IFN signaling and apoptosis in DLBCL.