THERAPY DOSSIER · th-a2f8162590e6

Designer TLR9 agonist (synthetic oligonucleotide)

Drug

Evidence & regulatory context

Mechanism: Not recorded
Target: Not recorded
Injury models: Radiation
Reported indication: Not recorded
First approval: Not recorded
Development stage: Not recorded
ChEMBL record: Not recorded
ChEMBL max phase: Not recorded
Synonyms: Not recorded
Note: Not recorded

Clinical trials 10

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

NCT04985968 ↗PHASE3terminated

Cobitolimod as induction and maintenance therapy in moderate to severe left-sided ulcerative colitis

Ulcerative Colitis

Enrolment: 171 · Results not recorded

NCT03445533 ↗PHASE3terminated

IMO-2125 (tilsotolimod) with ipilimumab versus ipilimumab in anti-PD-1 refractory melanoma (ILLUMINATE-301)

Metastatic Melanoma

Enrolment: 481 · Results not recorded

NCT02898662 ↗PHASE2completed

Phase 2 trial of inhaled TLR9 agonist AZD1419 in eosinophilic moderate to severe asthma

Asthma

Enrolment: 81 · Results not recorded

NCT03618641 ↗PHASE2completed

Neoadjuvant TLR9 agonist CMP-001 with nivolumab in stage IIIB/C/D melanoma

Melanoma · Lymph Node Cancer

Enrolment: 34 · Results not recorded

NCT02087644 ↗PHASE2withdrawn

CYT003-QbG10, a TLR9 agonist, in mild to moderate allergic asthma

Asthma

Enrolment: 0 · Results not recorded

NCT03837756 ↗PHASE2completed

TLR9 agonist lefitolimod with broadly neutralising antibodies for HIV reservoir reduction

HIV-1-infection

Enrolment: 47 · Results not recorded

NCT02554812 ↗PHASE1/PHASE2terminated

Avelumab with other cancer immunotherapies including CMP-001 in advanced malignancies

Advanced Cancer

Enrolment: 409 · Results not recorded

NCT06710223 ↗PHASE1active not recruiting

Cryoablation and pressure-enabled hepatic arterial infusion of TLR9 agonist SD-101 with durvalumab and tremelimumab in advanced HCC

Hepatocellular Carcinoma

Enrolment: 16 · Results not recorded

NCT03831295 ↗PHASE1completed

Intratumoral SD-101, an immunostimulatory CpG oligonucleotide, with BMS-986178 OX40 agonist in advanced solid malignancies

Advanced Malignant Solid Neoplasm · Metastatic Malignant Solid Neoplasm

Enrolment: 12 · Results not recorded

NCT03373214 ↗PHASE1completed

Na-GST-1/Alhydrogel with or without a CpG ODN adjuvant in Gabonese adults

Hookworm Infection · Hookworm Disease

Enrolment: 24 · Results not recorded

Preclinical evidence 1

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

PMID 22238604 ↗2012Reported benefit

TLR9 agonist protects mice from radiation-induced gastrointestinal syndrome.

MouseRadiationC57BL/6 for radioprotection and survival; BALB/c for macrophage transplantation and CT26 tumour studiesmalen = n=15 per cohort for survival studies; n=3 per group for his…subcutaneous for the TLR9 agonist; intravenous for the macrophage transplantationTLR9 agonist 1.0 mg/kg; MyD88 homodimerisation inhibitory p…1 h before or 1 h after whole body irradiation; 1 h before whole abdominal irra…

Model: radiation-induced gastrointestinal syndrome from single fraction whole body caesium-137 irradiation at 8.4, 9.4 or 10.4 Gy (236 cGy/min), or 14 Gy whole abdominal irradiation at 72 cGy/min with shielding

TLR9 agonist given 1 h before irradiation improved survival at 8.4, 9.4 and 10.4 Gy, reduced crypt apoptosis, increased crypt proliferation and restored xylose absorption; given 1 h after irradiation it mitigated injury only at 8.4 Gy, and protection was abolished by MyD88 inhibition.

Extraction: extract · Supplied extraction confidence: 0.85. Machine-extracted fields require source verification.

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