THERAPY DOSSIER · th-2cb8ccaa3bc0

CBLB502, a pharmacologically optimised flagellin derivative

Biologic · Toll-like receptor 5 agonist (AGONIST, direct_interaction=true, disease_efficacy=true). Binds to and activates TLR5, stimulating TNF production and activating NF-kB. USAN 2012, stem -imod (toll-like receptor agonists).

Not approved Suggest a correction

Evidence & regulatory context

Mechanism: Toll-like receptor 5 agonist (AGONIST, direct_interaction=true, disease_efficacy=true). Binds to and activates TLR5, stimulating TNF production and activating NF-kB. USAN 2012, stem -imod (toll-like receptor agonists).
Target: CHEMBL2176839 (Toll-like receptor 5)
Injury models: Radiation
Reported indication: Not recorded
First approval: Not recorded
Development stage: In trials, not approved
ChEMBL record: CHEMBL2108683 ↗
ChEMBL max phase: 2 / 4 (development scale, not regulatory approval)
Synonyms: CBLB-502; CBLB502; Entolimod
Note: Not recorded

Clinical trials 5

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT02715882 ↗PHASE2unknown

Randomised single-blind placebo-controlled study of CBLB502 safety and tolerability as neo-adjuvant treatment in colorectal cancer

Colorectal Cancer

Enrolment: 40 · Results not recorded

NCT04176133 ↗PHASE2completed

Randomised placebo-controlled dose-escalation study of entolimod on immunosenescence in healthy geriatric subjects receiving influenza vaccination

Healthy

Enrolment: 61 · Results not recorded

NCT01527136 ↗PHASE1completed

Phase 1 safety and pharmacokinetic study of CBLB502 (entolimod) in patients with advanced cancers

Unspecified Adult Solid Tumor, Protocol Specific

Enrolment: 25 · Results not recorded

NCT01728480 ↗PHASE1withdrawn

Phase I study of CBLB502 in poor-prognosis advanced squamous cell carcinoma of the head and neck receiving chemoradiotherapy

Mucositis · Head and neck squamous cell carcinoma (multiple stages)

Enrolment: 0 · Results not recorded

NCT03063736 ↗EARLY_PHASE1completed

Entolimod as an adjuvant for vaccine augmentation

Substance Use Disorders

Enrolment: 40 · Results not recorded

Preclinical evidence 2

1 studies reported at therapy level; 2 evidence entries itemised.

PMID 22000579 ↗2011Reported benefit

Toll-like receptor 5 agonist protects mice from dermatitis and oral mucositis caused by local radiation: implications for head-and-neck cancer radiotherapy.

MouseRadiationFemaleSubcutaneous injection30 min before irradiation

Model: Local single-dose (10, 15, 20 or 25 Gy) or fractionated (10 plus 15 Gy, or 3 times 10 Gy) irradiation of the head and neck area

CBLB502 reduced dermatitis and mucositis severity, accelerated tissue recovery and limited weight loss after single doses of 15 and 20 Gy but not 25 Gy, and after cumulative fractionated doses of 25 and 30 Gy, without protecting the syngeneic tumour and while inhibiting growth of TLR5-expressing tu…

Extraction: extract · Supplied extraction confidence: 0.7. Machine-extracted fields require source verification.

PMID 18403709 ↗2008

An agonist of toll-like receptor 5 has radioprotective activity in mouse and primate models

MouseRadiation

Extraction: mesh. Machine-extracted fields require source verification.

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