Pipeline
A robust pipeline to treat the most resistant cancers
Diverse tumors demand a diverse arsenal of therapeutic approaches.
From monoclonal and bispecific antibodies, to antibody drug conjugates, to CAR T-cell therapies, discover what we have in development.
CTLA-4
Preclinical
IND-enabling
Phase 1
Phase 2
Phase 3
Next Milestone
Worldwide Rights
gotistobart
(ONC-392)
2L IO-resistant NSCLC
Preclinical
IND-enabling
Phase 1
Phase 2
Phase 3
Enrollment
completion 1H 2025
gotistobart
(ONC-392)*
Advanced solid tumors
Preclinical
IND-enabling
Phase 1
Phase 2
Phase 3
Enrollment
completion 1H 2024
AI-061, PD-1
coformulation
Solid tumors
Preclinical
IND-enabling
Phase 1
Phase 2
Phase 3
Ph 1 completion 1H 2024
*In partnership with
SIGLEC
Preclinical
IND-enabling
Phase 1
Phase 2
Phase 3
Next Milestone
Worldwide Rights
AI-071
Immune-related adverse events
Preclinical
IND-enabling
Phase 1
Phase 2
Phase 3
Ph 2 initiation
2H 2024
ONC-841
Solid tumors
Preclinical
IND-enabling
Phase 1
Phase 2
Phase 3
Ph 1 initiation
2H 2024
CD24
Preclinical
IND-enabling
Phase 1
Phase 2
Phase 3
Next Milestone
Worldwide Rights
ONC-782
Solid and hematologic
malignancies
Preclinical
IND-enabling
Phase 1
Phase 2
Phase 3
IND enabling
studies Q1 2024
ONC-783
Hematologic malignancies
Preclinical
IND-enabling
Phase 1
Phase 2
Phase 3
IND enabling
studies Q1 2024
ONC-784
Oncology
Preclinical
IND-enabling
Phase 1
Phase 2
Phase 3
IND enabling
studies Q1 2024
Clinical trials recruiting now
We are currently recruiting patients for 4 clinical trials in a range of indications.
If you or someone you care about is battling cancer, we welcome you to learn more and get in touch.
PRESERVE-009
An open-label phase 1 study on the safety, pharmacokinetics, and efficacy of AI-061 in advanced solid tumors
Indications: melanoma, non–small cell lung cancer, head and neck squamous cell carcinoma, high-grade serous adenocarcinoma of the ovary, primary peritoneal carcinoma, fallopian tube cancer, endometrial cancer, cervical cancer, renal cell carcinoma, bladder cancer, esophageal cancer, gastric cancer, anal cancer, hepatocellular carcinoma, bile duct cancer
PRESERVE-004
A Phase 2 study that compares two doses of gotistobart in combination with a fixed dose of pembrolizumab
Indications: Platinum-resistant ovarian cancer
PRESERVE-001
A Phase 1 open-label study of gotistobart as a monotherapy and in combination with Pembrolizumab
Indications: Non Small Cell Lung Cancer, Metastatic Melanoma, Metastatic Head and Neck Carcinoma, Metastatic Renal Cell Carcinoma, Metastatic Colorectal Cancer, Sarcomas, Metastatic Prostate Cance, Ovarian Cance, Small Cell Lung Cancer, Metastatic Breast Cancer, Pancreatic Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Junction adenocarcinoma, Cervical Cancer, AAdenoid Cystic Carcinoma, Salivary Gland Cancer, Urothelial Carcinoma
PRESERVE-006
A Phase 2 study examining the safety and efficacy of gotistobart in combination with lutetium Lu 177 vipivotide tetraxetan
Indications: Metastatic Castration-resistant Prostate Cancer
PRESERVE-003
A Phase 3 study of gotistobart versus docetaxel
Indications: Non-Small Cell Lung Cancers that Progressed on PD-1/PD-l1 Inhibitors
ONC-841-002
Safety, Pharmacokinetics (PK) and Efficacy of ONC-841 in Advanced Solid Tumors NCT06352359
Indications: Advanced or metastatic cancers
Clinical trials recruiting soon
For further inquiries about our clinical trials, don’t hesitate to reach out.