Oncology Focused Pipeline​

The core value of OBI lies in its passion to develop and deliver a portfolio of unique antibody-drug conjugates (ADC) drugs for patients, in addition to its promising Globo H cancer therapeutic vaccine. This evolving portfolio includes a spectrum of cancer targets, such as TROP2, Nectin-4, HER2, and other potential targets.​​

This table provides an overview of our pipeline. ​

Molecule Name

Target

Potential Indications

Status

Modality

Molecule Name

Adagloxad simolenin

Target:

Globo H

Potential Indications:

Breast (TNBC)

Status:

Phase 3

Modality:

Vaccine

Adagloxad simolenin is a novel active immunotherapy for cancer targeting the tumor surface glycan antigen Globo H. Globo H is linked to the carrier protein keyhole limpet hemocyanin (KLH). Upon administration into the body, it stimulates the production of antibodies against Globo H by the immune cells, aiming to treat cancer. Read more on Globo H

Molecule Name

OBI-833

Target:

Globo H

Potential Indications:

Lung (NSCLC)

Status:

Phase 2

Modality:

Vaccine

OBI-833 is a novel active immunotherapy for cancer, targeting the tumor surface glycan antigen Globo H. Globo H is linked to the carrier protein diphtheria toxin CRM197. Upon administration into the body, it stimulates the production of antibodies against Globo H by the immune cells, aiming to treat cancer.

Molecule Name

OBI-3424

Target:

AKR1C3

Potential Indications:

Liver (HCC) and T-ALL

Status:

Phase 2

Modality:

Prodrug

OBI-3424 is a first-in-class novel prodrug that can selectively act on a variety of cancers with overexpression of Aldo-keto reductase family 1 member C3 (AKR1C3). OBI-3424 has been granted Orphan Drug Designation (ODD) for the treatment of hepatocellular carcinoma (HCC) and acute lymphocytic leukemia (ALL). Clinical trials of HCC and ALL are in collaboration with Ascentawits* and SWOG Cancer Research Network**, respectively.

Molecule Name

OBI-992

Target:

TROP2

Potential Indications:

Solid Tumors

Status:

Phase 1

Modality:

ADC

OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor via a hydrophilic, enzyme-cleavable linker. OBI-992 remains stable in circulation but delivers the cytotoxic payload to TROP2-expressing tumor cells, leading to tumor cell death while avoiding off-target toxicities. TROP2 is highly expressed in a variety of solid tumors with no or low expression in normal tissues, rendering it an ideal target for cancer therapy.​

OBI-992 demonstrates unique target-binding characteristics, superior antitumor efficacy, improved pharmacokinetics, and a favorable safety profile in preclinical in vitro and in vivo models. These results were published in three posters at AACR 2024. The outstanding preclinical results support further clinical development of OBI-992. ​

U.S. FDA cleared an IND application for a Phase 1/2 Study of OBI-992 in Jan 2024. The Phase 1/2 study has been initiated in Q2 2024 to evaluate OBI-992’s safety, PK, and preliminary efficacy. ​

The TROP-2 targeting antibody was in-licensed from Biosion, Inc. in Dec 2021. OBI owns ex-China rights of OBI-992.

Molecule Name

OBI-902

Target:

TROP2

Potential Indications:

Solid Tumors

Status:

Preclinical

Modality:

ADC

OBI-902 is the next generation TROP2-directed ADC. OBI-902 is created by OBI’s proprietary platform GlycOBI™ and enzymatic technology EndoSymeOBI™. OBI-902 is currently at preclinical stage. Preliminary data of OBI-902 indicate that GlycOBI™ is an efficient platform to generate homogeneous ADCs with good stability and antitumor activity.

Molecule Name

OBI-904

Target:

Nectin-4

Potential Indications:

Solid Tumors

Status:

Preclinical

Modality:

ADC

OBI-904 is an antibody-drug conjugate (ADC) comprising a monoclonal antibody specific to Nectin-4 (Nectin cell adhesion molecule 4), linked to a potent topoisomerase I inhibitor payload through OBI’s proprietary GlycOBI platform. It is an OBI self-developed novel and potential first-in-class ADC designed to anti-cancer therapy against Nectin4-expressing multiple cancer types.

Molecule Name

BsADC

Target:

TROP2, HER2

Potential Indications:

Solid tumors

Status:

Discovery

Modality:

BsADC

Bispecific ADCs have emerged as promising modalities for cancer therapeutics. By targeting dual antigens, BsADC can potentially overcome resistance mechanisms that arise from the downregulation or mutation of a single target antigen. The broader targeting approach not only enhances specificity but is also expected to improve efficacy while reducing toxicity, thereby expanding the patient population that could benefit from these treatments. OBI’s bispecific ADC, utilizing a proprietary GlycOBI platform, represents an advanced development in this field. By linking a potent topoisomerase I inhibitor payload to a bispecific Ab targeting TROP2 and HER2 antigens, to enhance the therapeutic potential of ADC and offers advantages in terms of stability, pharmacokinetics, and payload delivery, contributing to the overall efficacy and safety of the therapeutic.