M7824

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Kaposi SarcomaCancer of ProstateThymic Epithelial Tumor

9 competitors in Kaposi Sarcoma

#DrugCompanyPhaseTrials

1

Ninlaro

Takeda

Phase 2

12

Pomalyst

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 2

23

Inderal

WWyeth-Lederle Vaccines

Phase 2

14

Inderal

Mylan Pharmaceuticals Inc

Phase 2

15

Liposomal Doxorubicin

Eli Lilly

Phase 1

16

Verzenio

Eli Lilly

Preclinical

17

M7824

EMD Serono Research & Development Institute, Inc.

Phase 2

18

Sephb4-HSA

VVasgene Therapeutics, Inc

Phase 2

19

CYT107

RRevimmune

Phase 2

110

PDS01ADC

NNational Cancer Institute (NCI)

Preclinical

1

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

Terminated·EMD Serono Research & Development Institute, Inc.·Phase 2·NCT03840902·153 enrolled

M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)

Completed·EMD Serono Research & Development Institute, Inc.·Phase 1/2·NCT03840915·70 enrolled

M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

Completed·EMD Serono Research & Development Institute, Inc.·Phase 3·NCT03631706·304 enrolled

Cervical Cancer2 trials

Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)

Completed·EMD Serono Research & Development Institute, Inc.·Phase 1·NCT04551950·25 enrolled

Phase I/II Trial of Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies

Completed·NNational Cancer Institute (NCI)·Preclinical·NCT04287868·51 enrolled

Stereotactic Body Radiation Therapy (SBRT)1 trial

Immune Checkpoint Inhibitor M7824 and the Immunocytokine M9241 in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Advanced Pancreas Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT04327986·3 enrolled

Small Cell Lung Cancer1 trial

M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03554473·37 enrolled

Gemcitabine1 trial

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

Terminated·EMD Serono Research & Development Institute, Inc.·Phase 2/3·NCT04066491·309 enrolled

14 more indications

Imaging1 trial

Bioimaging Study of 89Zr-M7824 in NSCLC

Terminated·OOlivia Newton-John Cancer Research Institute·Phase 1/2·NCT04297748·5 enrolled

Adenocarcinoma1 trial

M7824 (MSB0011359C) in Combination With Gemcitabine in Adults With Previously Treated Advanced Adenocarcinoma of the Pancreas

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT03451773·7 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT04247282·21 enrolled

Advanced Solid Tumors1 trial

Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT04574583·12 enrolled

Biliary Tract Cancer1 trial

M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

Completed·EMD Serono Research & Development Institute, Inc.·Phase 2·NCT03833661·159 enrolled

Papilloma1 trial

M7824 in People With Recurrent Respiratory Papillomatosis

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03707587·9 enrolled

Malignancies1 trial

M7824 in Subjects With HPV Associated Malignancies

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03427411·57 enrolled

Immunotherapy1 trial

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03493945·59 enrolled

Breast Cancer1 trial

BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT04296942·1 enrolled

Urothelial Cancer1 trial

A Phase I Study of Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04235777·22 enrolled

Cancer Of Prostate1 trial

A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04633252·86 enrolled

Thymic Epithelial Tumor1 trial

A Phase II, Open-Label Trial of Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04417660·9 enrolled

Kaposi Sarcoma1 trial

Phase I/II Study of PDS01ADC Monotherapy and in Combination With M7824 in Advanced Kaposi Sarcoma

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04303117·80 enrolled

HPV Positive Cancer1 trial

Phase I/II Trial of HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PD-L1/TGF-Beta Trap (M7824) in Subjects With HPV Positive Cancers

Completed·NNational Cancer Institute (NCI)·Preclinical·NCT04432597·39 enrolled

Details

Drug Info

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