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Cobomarsen

Phase 2

Cutaneous T-cell Lymphoma (CTCL) | RNA therapy | Oncology |CASI Pharmaceuticals, Inc.|Trials Updated: Nov 23, 2020

Cobomarsen development status

Highest phase Phase 2 (NCT03837457)
Phase scored for CASIPhase 1
Registered trials 3 across 1 sponsor since Oct 2001

Cobomarsen target and mechanism

Target class-Sen (Aso)
ModalityRNA therapy

Also known as MRG-106

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Cobomarsen clinical trials

Cobomarsen · 1 trial · 5 indications

Phase 1 1
NCT02580552Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLLCutaneous T-cell Lymphoma (CTCL)
COMPLETED66 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLL
Cutaneous T-cell Lymphoma (CTCL)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of cobomarsen based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events
From start of treatment to end of study participation

Secondary Endpoints

Area under the plasma concentration vs. time curve (AUC) of cobomarsen following single and repeat doses administered intratumorally, subcutaneously or intravenously
Up to 56 days
Peak plasma concentration (Cmax) of cobomarsen following single and repeat doses administered intratumorally, subcutaneously or intravenously
Up to 56 days
Trough plasma concentration (Ctrough) of cobomarsen following each 4-week cycle of dosing
Monthly from Week 5 up to end of study participation
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A, MFEXPERIMENTALIntratumoral Injection of cobomarsen
Part B, MFEXPERIMENTALSubcutaneous, intravenous or a combination of systemic and intratumoral administration of cobomarsen with or without stable background therapy
Part C, MFEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy
Part D, CLLEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy
Part E, DLBCL, activated B-cell (ABC) subtypeEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy
Part F, ATLLEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy

Interventions

NameTypeDescription
CobomarsenDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Parts A-C only: Patients must have biopsy proven MF, clinical stage I, II, or III (excluding visceral or nodal involvement), and must be refractory to or intolerant of established therapies for their condition * Part D only: Patients diagnosed with CLL who are intolerant to, o...

Countries:United States
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Competitive Landscape -Cutaneous T-Cell Lymphoma 7 trials (matched to "Cutaneous T-cell Lymphoma (CTCL)")

Top 1 of 2 competitors

CompanyTickerTrialsLead PhaseDrugs
Incyte CorporationINCY2PHASE2Ruxolitinib
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Frequently asked questions about Cobomarsen

What is Cobomarsen used for?

Cobomarsen is being developed for the treatment of cutaneous T-cell lymphoma (CTCL), including mycosis fungoides. It has also been studied in chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and adult T-cell leukemia/lymphoma. It is an investigational RNA therapy and is not approved for commercial use.

How does Cobomarsen work?

Cobomarsen is an antisense oligonucleotide, an RNA therapy designed to target RNA rather than protein. Antisense oligonucleotides bind complementary RNA sequences to modulate gene expression. The specific molecular target of cobomarsen is not stated here, so its precise mechanism of action cannot be described beyond its antisense oligonucleotide class.

Who is developing Cobomarsen?

Cobomarsen is being developed by CASI Pharmaceuticals, Inc., which trades under the ticker CASI. The company holds the development program for this investigational antisense oligonucleotide therapy in oncology indications including cutaneous T-cell lymphoma.

What phase is Cobomarsen in?

Cobomarsen is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 program has completed, with one completed trial and no active trials currently listed.

What clinical trials is Cobomarsen in?

Cobomarsen has been evaluated in one clinical trial, NCT02580552, titled a study of safety, tolerability and pharmacokinetics of MRG-106 in patients with mycosis fungoides, CLL, DLBCL or ATLL. That Phase 1 trial is completed, enrolled 66 patients, and was conducted in the United States.

Is Cobomarsen the same as MRG-106?

Yes, Cobomarsen is also known as MRG-106. The Phase 1 trial NCT02580552 was conducted under the MRG-106 name in patients with mycosis fungoides, chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and adult T-cell leukemia/lymphoma. Both names refer to the same investigational antisense oligonucleotide developed by CASI Pharmaceuticals.