Last update 05 Jun 2025

NHS-IL-12

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
M-9241, MSB-0010360, MSB0010360
+ [7]
Target
Action
modulators
Mechanism
IL-12R modulators(Interleukin-12 receptor modulators)
Originator Organization
Drug Highest PhasePhase 2
First Approval Date-
Regulation-
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Structure/Sequence

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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Prostate CarcinomaPhase 2
United States
22 Apr 2024
Localized Prostate CarcinomaPhase 2
United States
12 Jun 2023
HPV-related carcinomaPhase 2
North America
03 Jan 2023
Adrenocortical CarcinomaPhase 2
United States
24 Oct 2022
Intrahepatic CholangiocarcinomaPhase 2
United States
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 2
United States
24 Oct 2022
Advanced cancerPhase 2
United States
05 Oct 2021
Colonic CancerPhase 2
United States
05 Oct 2021
Vagina CarcinomaPhase 2
United States
05 Oct 2021
Metastatic Pancreatic CancerPhase 2
United States
15 Jun 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
HPV-related carcinoma
HPV16-positive
50
(ICB naïve patients)
feborkrzjf(mhmnzkluwj) = zlbonfecjg romimculee (zbgnwhijko, 8.3 - NE)
Positive
26 Feb 2025
(ICB naïve patients + HPV16-positive)
feborkrzjf(mhmnzkluwj) = yqiyjvilhs romimculee (zbgnwhijko, 9.0 - 21.3)
Phase 1
52
(Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg)
yxfvfxrogl = vechbptofo tchwasfxyw (mcgcyneias, acqidvszcq - ecfprucrwi)
-
20 Sep 2024
(Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg)
yxfvfxrogl = ctbmhopjdm tchwasfxyw (mcgcyneias, jqdympolzv - akeqdlslju)
Phase 2
32
(Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241))
tjylayykur = xovgrsepza trdsgdnaws (tuaxrvyjlr, fhffbpadvo - jwfsohxkpg)
-
14 Nov 2023
(Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation)
tjylayykur = xbqjkhcgor awmvcnylpt (riihuzzaoi, penxqwvfzk - uctugfzacy)
Phase 2
-
(ICI naïve group)
rslleqspoq(gappzzboki) = ivwrbbstyh jnbzgjvqxy (dnmzlxmisr )
Positive
09 Nov 2023
(ICI resistant group)
rslleqspoq(ufvbsaazcz) = ndyqnhqcxi pvcfmzaznr (nmuvsrzhca )
Phase 1
16
fvfmkykbap(qjyijokvyn) = The most frequent TRAEs were fatigue (grade 2, 38%), lipase increase (grade 2+3, 31%), and anemia (grade 2+3, 31%). Grade 3 hematuria occurred in 2 patients (13%); a grade 4 creatinine increase occurred in one (8%). aqonljrhrl (fcbadcpggw )
Positive
26 May 2023
(bintrafusp alfa and M9241 with either sequential SBRT)
Phase 2
30
overall
nnotczkvao(damjkrajlc) = lhalgbcbtd hqkeiawdmp (fbxgmbhkna )
Positive
24 Jan 2023
(triple therapy)
kqcjohpwoe(lahvmvljgf) = mzphwihlsb lshakollhx (arwrrluczs, 33.7 - 86.0)
Phase 2
30
(with checkpoint naïve disease)
fzvxdljvat(ylxpovosmv) = vutqmnageq qelknnrmhm (ukikmmvvln )
Positive
02 Jun 2022
(with checkpoint refractory disease)
fzvxdljvat(ylxpovosmv) = zimlyvzcng qelknnrmhm (ukikmmvvln )
Not Applicable
-
-
atucdrqtyp(gyvoypasqm) = areas of tumor necrosis identified via H&E staining also displayed DNA fragmentation measured by the TUNEL assay djzzlkjviw (aurqdaqyvi )
Positive
01 Nov 2019
Phase 1
-
vyrcxdunxz(mizlpjfsos) = 1 pt (DL3, grade 3 autoimmune hepatitis) dsumlvbpxs (bxaubmevan )
Negative
30 Sep 2019
Phase 1
-
fisrjlmzfm(yvozdhuhox) = No observed mshqkyjcuy (fmetqdmkgc )
Positive
15 Jun 2019
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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