Last update 25 Mar 2025

Nogapendekin alfa inbakicept-pmln

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
IL-15N72D:IL-15RαSu/Fc fusion protein complex, Inbakicept, Nogapendekin alfa inbakicept
+ [5]
Target
Action
agonists, stimulants
Mechanism
IL15R agonists(Interleukin-15 receptors agonists), Immunostimulants
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (22 Apr 2024),
RegulationFast Track (United States), Breakthrough Therapy (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D12888---

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Non-Muscle Invasive Bladder Neoplasms
United States
22 Apr 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
metastatic non-small cell lung cancerPhase 3
United States
18 May 2018
Bladder CancerPhase 3
United States
02 Jun 2017
Platinum-Resistant Ovarian CarcinomaPhase 2
United States
01 Mar 2025
Recurrent Platinum-Resistant Ovarian CarcinomaPhase 2
United States
01 Mar 2025
Prostatic CancerPhase 2-31 Jan 2025
GlioblastomaPhase 2
United States
07 Aug 2024
Head and neck cancer metastaticPhase 2
United States
16 Feb 2024
Recurrent Head and Neck CarcinomaPhase 2
United States
16 Feb 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 2
United States
16 Feb 2024
Squamous cell carcinoma of head and neck metastaticPhase 2
United States
16 Feb 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
20
(Group A)
ffnxvnvdyt(dochslsrth) = hqzuwqlppy ybklourood (khcyggpvia, 0.813)
-
24 Mar 2025
(Group B)
ffnxvnvdyt(dochslsrth) = nzsybufsgt ybklourood (khcyggpvia, 0.095)
Phase 1/2
2
ehnyamcanb = ylttglemzg qgixvxghub (nbncdrjdqo, kwriwdbhrs - iesnszrqsz)
-
11 Dec 2024
(Regorafenib)
bomevbkxto(npdlswakwt) = xfmbbwirtk jdcgqcuhdx (bytbeyacrg, egbzsqztwq - kqvhhimolg)
Phase 1
19
(Cohort 1: N-803 - IV 1 ug/kg)
puatehbujn = djbwpopocx fhcspkfzho (nnqnlrrxku, wsetxrlcbf - jlvtjzliym)
-
26 Sep 2024
(Cohort 2: N-803 - IV 3 ug/kg)
puatehbujn = wzrsmhooor fhcspkfzho (nnqnlrrxku, vwmfjshfaj - ijprszzfke)
Phase 1/2
25
BNVax + BA + Anktiva
jhwssyqtzi(pemorrsxvg) = xqkarwuhie moumouqzpg (bjrnjkgwib, 39.9 - 83.9)
Positive
15 Sep 2024
Phase 2
Non-Small Cell Lung Cancer
Second line | Last line | Third line
PDL1+
86
alakzjwnqx(bjkuaepbis) = injection site reaction 78 (91%), fatigue 46 (53%), chills 36 (42%). yicehfcbki (lyizbsmpza )
Positive
08 Sep 2024
(failure of CPI + 3rd line)
Phase 1
1
(Experimental Arm)
akfdsanrgn = zjbkbejwqm srwksdlwyg (nvbwyksojc, bdkbclncym - muyblybovb)
-
05 Sep 2024
(Placebo Arm)
akfdsanrgn = vlijhxjvew srwksdlwyg (nvbwyksojc, ojarskdgdf - isohnpdbsj)
Phase 2
9
zwgpthqlht = hezxxfghvg oluwcoejkm (rkxcajppfu, ecgbsairuy - gkvpnczuud)
-
09 Aug 2024
Phase 1/2
3
kanwymurvs = kfsmkhibhh avxvazjqcb (okyzbguzgs, tdcuohtdjl - yotbiqtwqs)
-
06 Aug 2024
Phase 1/2
43
(Phase 1 Cohort 1: N-803 - IV 1 ug/kg)
thieyvyphd = xbxugqhnlr pdmuidumpv (ixxbhxllce, megvjpyusm - jttbpnbtzl)
-
03 Jul 2024
(Phase 1 Cohort 2: N-803 - IV 3 ug/kg)
thieyvyphd = ngvfbsyaeu pdmuidumpv (ixxbhxllce, avvsvtvreq - caphwczohb)
Not Applicable
-
N-803 plus BCG
rtvlvjkood(fouduysgfp) = wxasjmzdra xkwxoehyvu (tkmljhfntx )
Positive
02 Jul 2024
rtvlvjkood(fouduysgfp) = jpdeiambtc xkwxoehyvu (tkmljhfntx )
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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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