Penpulimab
drugOn this page
Also known as Ak-105Ak105
Summary
Penpulimab (CHEMBL4297571) is a phase-3 clinical-stage antibody targeting PDCD1; indicated across 29 conditions including hodgkins lymphoma and squamous cell lung carcinoma.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Antibody
- Targets: 1 (PDCD1)
- Indications: 29 conditions
- Clinical trials: 55
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4297571 |
| Name | Penpulimab |
| Type | Antibody |
| Max phase | 3 |
Also known as: Ak-105, AK-105, Ak105, AK105, Penpulimab, PENPULIMAB
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| PDCD1 | programmed cell death 1 (CD279) | Binding | 10.23 | 0% | Q15116 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): PDCD1.
Top Reactome pathways
3 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Co-inhibition by PD-1 | 1 | PDCD1 |
| Potential therapeutics for SARS | 1 | PDCD1 |
| PD-L1(CD274) glycosylation and translocation to plasma membrane | 1 | PDCD1 |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| B cell apoptotic process | 1 |
| adaptive immune response | 1 |
| negative regulation of tolerance induction | 1 |
| negative regulation of T cell mediated immune response to tumor cell | 1 |
| negative regulation of B cell apoptotic process | 1 |
| apoptotic process | 1 |
| humoral immune response | 1 |
| negative regulation of inflammatory response | 1 |
| regulation of immune response | 1 |
| negative regulation of immune response | 1 |
| negative regulation of T cell receptor signaling pathway | 1 |
| negative regulation of T cell activation | 1 |
| positive regulation of T cell apoptotic process | 1 |
| regulatory T cell apoptotic process | 1 |
| immune system process | 1 |
Indications & clinical
Indications
29 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| Hodgkins lymphoma | 3 | MONDO:0004952 | EFO:0000183 |
| squamous cell lung carcinoma | 3 | MONDO:0005097 | EFO:0000708 |
| hepatocellular carcinoma | 3 | MONDO:0007256 | EFO:0000182 |
| lung neoplasm | 3 | MONDO:0021117 | MONDO:0008903 |
| head and neck squamous cell carcinoma | 3 | MONDO:0010150 | EFO:0000181 |
| nasopharyngeal carcinoma | 3 | MONDO:0015459 | MONDO:0015459 |
| nasopharyngeal neoplasm | 2 | MONDO:0005375 | EFO:0004252 |
| non-small cell lung carcinoma | 2 | MONDO:0005233 | EFO:0003060 |
| gastric carcinoma | 2 | MONDO:0004950 | EFO:0000178 |
| diffuse large B-cell lymphoma | 2 | MONDO:0018905 | EFO:0000403 |
| glioblastoma | 2 | MONDO:0018177 | EFO:0000519 |
| small cell lung carcinoma | 2 | MONDO:0008433 | EFO:0000702 |
| essential tremor | 2 | MONDO:0003233 | EFO:0003108 |
| pancreatic neoplasm | 2 | MONDO:0021040 | EFO:0003860 |
| breast neoplasm | 2 | MONDO:0021100 | EFO:0003869 |
| esophageal squamous cell carcinoma | 2 | MONDO:0005580 | EFO:0005922 |
| neoplasm | 2 | MONDO:0005070 | EFO:0000616 |
| malignant pancreatic neoplasm | 2 | MONDO:0009831 | EFO:1000359 |
| rectal cancer | 2 | MONDO:0006519 | EFO:1000657 |
| gastric neoplasm | 2 | MONDO:0021085 | MONDO:0001056 |
| adrenal gland pheochromocytoma | 2 | MONDO:0004974 | EFO:0000239 |
| paraganglioma | 2 | MONDO:0000448 | EFO:1000453 |
| colorectal neoplasm | 2 | MONDO:0005335 | MONDO:0005575 |
| lymphoma | 1 | MONDO:0005062 | EFO:0000574 |
5 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 55.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 32 |
| PHASE3 | 7 |
| PHASE1/PHASE2 | 7 |
| PHASE1 | 5 |
| Not specified | 2 |
| PHASE2/PHASE3 | 1 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT04344158 | PHASE3 | ACTIVE_NOT_RECRUITING | A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC) |
| NCT04974398 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma |
| NCT06048315 | PHASE3 | NOT_YET_RECRUITING | A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations and Failed EGFR TKIs With the Combination of Enrotinib and Paclitaxel Monoclonal Antibody |
| NCT03866980 | PHASE3 | TERMINATED | A Study of Anti-PD-1 AK105 in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer |
| NCT03866993 | PHASE3 | COMPLETED | A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer |
| NCT04385550 | PHASE3 | UNKNOWN | A Study of Anlotinib Hydrochloride Capsule Combined With AK105 Injection in Subject With Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma |
| NCT05244642 | PHASE3 | UNKNOWN | A Phase III Study to Evaluate the Efficacy and Safety of Penpulimab in the Relapsed and Refractory Classical Hodgkin’s Lymphoma |
| NCT05344924 | PHASE2/PHASE3 | UNKNOWN | TACE Combined With Penpulimab and Anlotinib for Advanced HCC |
| NCT04846634 | PHASE2 | NOT_YET_RECRUITING | Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043) |
| NCT05193617 | PHASE2 | ACTIVE_NOT_RECRUITING | Penpulimab Combined With GP ± Anlotinib as Neoadjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma |
| NCT05214222 | PHASE2 | RECRUITING | Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma |
| NCT05229003 | PHASE2 | RECRUITING | Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC |
| NCT05347641 | PHASE2 | NOT_YET_RECRUITING | Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma |
| NCT05494060 | PHASE2 | RECRUITING | XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma |
| NCT05576480 | PHASE2 | RECRUITING | SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer |
| NCT06051851 | PHASE2 | RECRUITING | Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer |
| NCT06081673 | PHASE2 | RECRUITING | Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC |
| NCT06516978 | PHASE2 | NOT_YET_RECRUITING | A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL |
| NCT06821503 | PHASE1/PHASE2 | RECRUITING | Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C |
| NCT06825494 | PHASE1/PHASE2 | RECRUITING | Clinical Studies for the Treatment of Advanced Solid Tumors |
| NCT06943820 | PHASE1/PHASE2 | RECRUITING | AK129 Combination Therapy for Advanced Solid Tumors |
| NCT07075419 | PHASE1/PHASE2 | NOT_YET_RECRUITING | JDB153 Combined With Penpulimab for Hepatocellular Carcinoma After Standard Treatment Failure |
| NCT07086326 | PHASE2 | NOT_YET_RECRUITING | A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC |
| NCT07612098 | PHASE2 | NOT_YET_RECRUITING | Preoperative Radiotherapy and Anlotinib With or Without Penpulimab for Soft Tissue Sarcoma |
| NCT03722147 | PHASE1/PHASE2 | COMPLETED | A Study of Anti-PD-1 AK105 in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma |
| NCT03866967 | PHASE2 | COMPLETED | A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma |
| NCT04172506 | PHASE1/PHASE2 | COMPLETED | A Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors |
| NCT04172571 | PHASE2 | COMPLETED | A Study of the Combination of Anti-PD-1 AK105 and Anlotinib in First-line Hepatocellular Carcinoma (HCC) |
| NCT04203719 | PHASE2 | UNKNOWN | A Study of Anlotinib and AK105 Injection in Subjects With Advanced Head, Neck and Chest Cancer |
| NCT04207463 | PHASE2 | UNKNOWN | A Study of Anlotinib and AK105 Injection in Subjects With Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors |
| NCT04291248 | PHASE2 | UNKNOWN | A Study of Anlotinib Combined With AK105 Injection in Subjects With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Advanced Solid Tumor |
| NCT04736810 | PHASE2 | COMPLETED | A Study of Penpulimab Combination Therapy in Patients With Advanced Nasopharyngeal Carcinoma |
| NCT04952493 | PHASE2 | UNKNOWN | Anlotinib or Penpulimab in Combination With RAI for DTC |
| NCT04970914 | PHASE2 | UNKNOWN | Anlotinib Plus Penpulimab (AK105) for Chemo-refractory Metastatic Colorectal Cancer:ALTER-C003 |
| NCT05028504 | PHASE2 | UNKNOWN | A Phase II Study of Anlotinib Combined With Penpulimab in Subjects With Gynecological Cancer |
| NCT05033587 | PHASE2 | UNKNOWN | Study of AK105 With Anlotinib and Radiotherapy Adjuvant Therapy in MGMT Unmethylated Newly Diagnosed Glioblastoma. |
| NCT05068206 | PHASE2 | UNKNOWN | A Clinical Study to Compare the Efficacy and Safety of AK105 Plus Anlotinib and Capecitabine/Oxaliplatin (CapeOx) , Anlotinib Plus CapeOx, Bevacizumab Plus CapeOx |
| NCT05137171 | PHASE2 | UNKNOWN | AK105 Combined With Anlotinib in Patients With Cervical Cancer |
| NCT05186558 | PHASE2 | UNKNOWN | Penpulimab Plus R2-GemOx Regimen in Relapsed or Refractory DLBCL |
| NCT05244993 | PHASE2 | UNKNOWN | AK105 Plus Anlotinib Hydrochloride Combined With Albumin Paclitaxel as a First-line Therapy in Patients With Advanced Triple-negative Breast Cancer |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.
4 molecules share ≥1 primary target. Top 4 by shared-target count:
| Molecule | Source | Status | Shared targets |
|---|---|---|---|
| PYRVINIUM | ChEMBL | Phase 4 (approved) | PDCD1 |
| RIFABUTIN | ChEMBL | Phase 4 (approved) | PDCD1 |
| Gefitinib | PubChem | Approved | PDCD1 |
| Pomalidomide | PubChem | Approved | PDCD1 |