APX005M

Phase 2Small molecule

BBioNTech US Inc.

APX005M is one of 53 small molecule programs targeting Renal Cell Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Renal Cell CarcinomaActive, not recruiting

Advanced SarcomaActive, not recruiting

Renal Cell CarcinomaPhase 1

Active, not recruiting

Advanced SarcomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

77 competitors in Renal Cell Carcinoma

#DrugCompanyPhaseTrials

Opdivo

Bristol-Myers Squibb

Approved

41 2

Keytruda

Merck & Co.

Phase 3

24 3

Yervoy

Bristol-Myers Squibb

Phase 3

20 4

Lenvima

Eisai

Phase 3

17 5

Istodax

Cellcept

Inlyta

PPrism Pharmaceuticals

Phase 3

24 8

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Zantac 150

Welireg

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Advanced Sarcoma

NCT03719430

Clinical

Trials by Indication[1]

Metastatic Melanoma1 trial

APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT02706353·34 enrolled

Advanced Sarcoma1 trial

APX005M and Doxorubicin in Advanced Sarcoma

Active, not recruiting·—·Phase 2·NCT03719430·27 enrolled

Pancreatic1 trial

Switch Maintenance in Pancreatic

Suspended·—·Phase 1/2·NCT05419479·46 enrolled

Pancreatic Adenocarcinoma1 trial

Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Completed·PParker Institute for Cancer Immunotherapy·Phase 1/2·NCT03214250·129 enrolled

Non-Small Cell Lung Cancer1 trial

APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma

Completed·YYale University·Phase 1·NCT03502330·42 enrolled

6 more indications

Nivolumab1 trial

CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

Completed·AApexigen America, Inc.·Phase 1/2·NCT03123783·140 enrolled

Monoclonal1 trial

Study of the CD40 Agonistic Monoclonal Antibody APX005M

Completed·AApexigen America, Inc.·Phase 1·NCT02482168·43 enrolled

Melanoma1 trial

A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma

Terminated·BBioNTech US Inc.·Phase 1·NCT03597282·22 enrolled

Renal Cell Carcinoma1 trial

A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC)

Active, not recruiting·YYale University·Phase 1·NCT04495257·26 enrolled

Gastroesophageal Junction Cancer1 trial

APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers

Completed·AApexigen America, Inc.·Phase 2·NCT03165994·34 enrolled

Ovarian Cancer1 trial

APX005M in Patients With Recurrent Ovarian Cancer

Withdrawn·NNordic Society of Gynaecological Oncology - Clinical Trials Unit·Phase 2·NCT05201001

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for APX005M. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — APX005M compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for APX005M. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — BioNTech US Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: BBioNTech US Inc.

APX005M

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Metastatic Melanoma1 trial

Advanced Sarcoma1 trial

Pancreatic1 trial

Pancreatic Adenocarcinoma1 trial

Non-Small Cell Lung Cancer1 trial

Nivolumab1 trial

Monoclonal1 trial

Melanoma1 trial

Renal Cell Carcinoma1 trial

Gastroesophageal Junction Cancer1 trial

Ovarian Cancer1 trial

References

Drug Info

Quick Facts

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