PD-1 inhibitors

Phase 2Small molecule

BBioNTech US Inc.

PD-1 inhibitors is one of 158 small molecule programs targeting Nasopharyngeal Carcinoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

157

Competitors

Pipeline

Status by Indication[3][1]

Indication

Nasopharyngeal CarcinomaRecruiting

Non-Small Cell Lung CancerActive, not recruiting

Biliary Tract Cancer (BTC)Recruiting

Metastatic Colorectal CancerNot yet recruiting

Breast CancerRecruiting

Low Dose RadiotherapyRecruiting

Recurrent or Metastatic NPCRecruiting

Nasopharyngeal CarcinomaPhase 2

Recruiting

Non-Small Cell Lung CancerPreclinical

Active, not recruiting

Biliary Tract Cancer (BTC)Phase 2

Recruiting

Metastatic Colorectal CancerPhase 2

Not yet recruiting

Breast CancerPhase 2

Recruiting

Low Dose RadiotherapyPhase 1

Recruiting

Recurrent or Metastatic NPCPhase 2

Recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

PD-1 inhibitors

BBioNTech US Inc.

Phase 2

1 2

Adenocard

Astellas

Preclinical

2 3

Spravato

WWim Janssens

Preclinical

2 4

Nubain

AAultman Health Foundation

Preclinical

1 5

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 6

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 7

Beta Blocker

WWeill Medical College of Cornell University

Preclinical

1 8

Ablavar

LLantheus Medical Imaging

Preclinical

2 9

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 10

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Low Dose Radiotherapy

NCT05615142

Q2 2027

Not yet recruiting

Advanced NSCLC

NCT06496009

Phase 2Not yet recruiting

Metastatic Colorectal Cancer

NCT06835179

Q3 2027

Phase 2Recruiting

Recurrent or Metastatic NPC

NCT06472713

Q4 2027

Active, not recruiting

Non-Small Cell Lung Cancer

NCT07359040

Active, not recruiting

Non-Small Cell Lung Cancer

NCT07256002

Clinical

Trials by Indication[1]

Hepatocellular Carcinoma5 trials

TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma

Recruiting·SSun Yat-sen University·N/A·NCT06740370·32 enrolled

TACE-HAIC Combined With TKIs and Immunotherapy Versus TACE Alone for Hepatocellular Carcinoma With PVTT

Completed·YYunfei Yuan··NCT05535998·743 enrolled

PD-1 Inhibitor Combined With 125I Seed Implantation for Hepatocellular Carcinoma's Extrahepatic Metastasis: Efficacy and Safety

Completed·JJiangxi Provincial Cancer Hospital·N/A·NCT06991907·80 enrolled

Show 2 more trials

Adjuvant Anti-PD-1 Therapy in Resected Hepatocellular Carcinoma

Not yet recruiting·TTongji Hospital··NCT07379489·300 enrolled

Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation: a Prospective Cohort Study

Completed·CChen Xiaoping·Preclinical·NCT06248554·251 enrolled

PD-1 Inhibitors3 trials

High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for MSS CRLM

Unknown status·JJiangsu Cancer Institute & Hospital·Phase 1·NCT06045286·30 enrolled

HAIC Combine With Lenvatinib and PD-1 Inhibitors for Advanced HCC With PVTT

Completed·PPeking University·Phase 2·NCT05166239·66 enrolled

Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC

Completed·HHunan Cancer Hospital··NCT06031376·106 enrolled

PD-1antibody2 trials

The Immune Assessment of PD-1 Antibody Therapy in Tumor

Recruiting·QQuanli Gao··NCT06693440·3,000 enrolled

PD-1 Antibody Combined With mXELIRI Versus mXELIRI in the Second-line Setting for ESCC

Unknown status·SSun Yat-sen University·Phase 3·NCT05737563·380 enrolled

Melanoma2 trials

Gastrointestinal Microbiome and Response to Immunotherapy in Metastatic Malignant Melanoma

Active, not recruiting·IInstitute of Oncology Ljubljana·N/A·NCT07428252·150 enrolled

A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma

Terminated·BBioNTech US Inc.·Phase 1·NCT04625205·22 enrolled

Non-Small Cell Lung Cancer2 trials

Survival Analysis and Prognostic Biomarker Exploration of Postoperative Adjuvant Therapy Patterns in Patients With Non-small Cell Lung Cancer After Neoadjuvant Immunotherapy

Active, not recruiting·—··NCT07256002·10,000 enrolled

Mechanism of Enhanced Efficacy of Ivonescimab in Neoadjuvant Therapy for Non-Small Cell Lung Cancer

Active, not recruiting·PPeking University People's Hospital··NCT07359040·80 enrolled

12 more indications

Nasopharyngeal Carcinoma2 trials

Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial

Recruiting·MMing-Yuan Chen·Phase 2·NCT07070479·208 enrolled

PD-1 Inhibitors Plus Chemoradiotherapy for Metastatic Nasopharyngeal Carcinoma: an Open-label Single-arm, Phase II Trial

Unknown status·SSichuan Cancer Hospital and Research Institute·Phase 2·NCT05520814·50 enrolled

Metastatic Colorectal Cancer1 trial

SBRT Combined With CAPEOX, Bevacizumab, and PD-1 Inhibitor for the Treatment of RAS-Mutant, MSS-Type, Unresectable Metastatic Colorectal Cancer.

Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06835179·28 enrolled

Recurrent or Metastatic NPC1 trial

Clinical Study of Mitoxantrone Hydrochloride Liposome Combined with PD-1 Blockade in Recurrent or Metastatic NPC

Recruiting·MMing-Yuan Chen·Phase 2·NCT06472713·32 enrolled

Advanced Biliary Tract Carcinoma1 trial

Lenvatinib Combined With PD-1 Inhibitors as First-line Treatment for Unresectable/Advanced Biliary Tract Carcinoma

Unknown status·TThe First Hospital of Jilin University·Phase 2·NCT05509478·46 enrolled

Advanced1 trial

HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion

Not yet recruiting·PPeking University··NCT07466225·150 enrolled

Low Dose Radiotherapy1 trial

Safety and Tolerability of Low Dose Radiotherapy Concurrent SBRT and PD-1 Inhibitors in Advanced NSCLC.

Recruiting·SSichuan University·Phase 1·NCT05615142·9 enrolled

Intrahepatic Cholangiocarcinoma1 trial

Pemigatinib Combined With PD-1 Inhibitor in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT05913661·30 enrolled

Neoadjuvant Immunotherapy1 trial

Proposal of a Novel Model for Identifying Complete Response in dMMR Colon Cancer Following Neoadjuvant Immunotherapy

Completed·SSun Yat-sen University··NCT06980350·156 enrolled

Postoperative Adjuvant Therapy1 trial

Postoperative Adjuvant Therapy of HCC Based on PD-1

Completed·CChen Xiaoping··NCT05307926·573 enrolled

Advanced NSCLC1 trial

The Clinical Characteristics and Efficacy of Immunotherapy in First-line PD-L1-negative Advanced NSCLC Patients

Not yet recruiting·SShanghai Pulmonary Hospital, Shanghai, China··NCT06496009·845 enrolled

Breast Cancer1 trial

Posaconazole Plus PD-1 Inhibitors and Chemotherapy vs PD-1 Inhibitors and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer

Recruiting·SShandong Cancer Hospital and Institute·Phase 2·NCT06802757·72 enrolled

Biliary Tract Cancer (BTC)1 trial

An Open-Label, Phase II Clinical Study Evaluating the Efficacy and Safety of Pemigatinib in Combination With a PD-1 Inhibitor, With or Without Chemotherapy, in Patients With Unresectable or Metastatic Cholangiocarcinoma Harboring FGFR2 Fusions or Rearrangements

Recruiting·HHaitao Zhao, MD·Phase 2·NCT07786766·154 enrolled

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for PD-1 inhibitors. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — PD-1 inhibitors compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for PD-1 inhibitors. 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.

PD-1 inhibitors

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Hepatocellular Carcinoma5 trials

PD-1 Inhibitors3 trials

PD-1antibody2 trials

Melanoma2 trials

Non-Small Cell Lung Cancer2 trials

Nasopharyngeal Carcinoma2 trials

Metastatic Colorectal Cancer1 trial

Recurrent or Metastatic NPC1 trial

Advanced Biliary Tract Carcinoma1 trial

Advanced1 trial

Low Dose Radiotherapy1 trial

Intrahepatic Cholangiocarcinoma1 trial

Neoadjuvant Immunotherapy1 trial

Postoperative Adjuvant Therapy1 trial

Advanced NSCLC1 trial

Breast Cancer1 trial

Biliary Tract Cancer (BTC)1 trial

References

Drug Info

Quick Facts

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