OBI-902 / OBI Pharma - LARVOL DELTA

OBI-902 Has Been Granted by US FDA for Orphan Drug Designation for the Treatment of Cholangiocarcinoma (ACCESS Newswire)

Orphan drug • Cholangiocarcinoma

A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=111 | Recruiting | Sponsor: OBI Pharma, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Cholangiocarcinoma • Solid Tumor

OBI Pharma Announces Phase 1/2 Study Initiation for OBI-902, a TROP2 Targeted Antibody-Drug Conjugate Therapy (ADC) in Advanced Solid Tumors (GlobeNewswire) - "OBI plans to enroll patients with advanced solid tumors with the objective of verifying the safety, pharmacokinetics, and preliminary efficacy profile of OBI-902 in these patient populations."

Trial status • Solid Tumor

A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=111 | Not yet recruiting | Sponsor: OBI Pharma, Inc

New P1/2 trial • Cholangiocarcinoma • Solid Tumor

OBI Pharma Announces U.S. FDA Clearance of IND Application for a Phase 1/2 Study of OBI-902, a Trop-2 Targeting ADC (GlobeNewswire) - "OBI Pharma...announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-902, to conduct a Phase 1/2 study. OBI plans to enroll patients with advanced solid tumors. This IND clearance represents a significant milestone for OBI-902, bringing forward a potentially best-in-class Trop-2 -targeted cancer therapy for patients with high unmet medical needs....'We are very excited to begin dosing patients in our Phase 1/2 clinical study of OBI-902 later this year'."

IND • New P1/2 trial • Solid Tumor

OBI Pharma Announces Poster Presentations at the AACR 2025 Annual Meeting for OBI-992 and OBI-902 Antibody-Drug Conjugates (ADCs), GlycOBI and ThiOBI ADC enabling technologies, the OBI-3424 prodrug, and Globo H (GH) science (GlobeNewswire) - "OBI Pharma, Inc...today announced nonclinical data for OBI-902, a potential best-in-class anti-TROP2 ADC developed using the next generation proprietary GlycOBI technologies. OBI-902 demonstrated superior antitumor activity and favorable PK/PD properties compared to benchmark TROP2 ADCs across various animal models. OBI-992...demonstrated a differentiated resistance profile compared to benchmark ADCs. Additionally, characterization and non-clinical in vivo data will be presented for the glycan-specific GlycOBI and cysteine-based ThiOBI proprietary ADC platforms, highlighting enhanced antitumor activity and stability in animal model studies. ThiOBI is a new next-generation platform and adds to OBI’s armamentarium of ADC enabling technologies. Additionally, the non-clinical and antitumor activity of OBI-3424, a novel AKR1C3 targeted prodrug, will be presented."

Preclinical • Solid Tumor

Harnessing the GlycOBI® enabling technologies: next-generation site-specific glycan ADCs with versatile DAR to enhance therapeutic index (AACR 2025) - "In preclinical models, OBI-902 (TROP2 GlycOBI® DAR4 ADC) and OBI-904 (Nectin-4 GlycOBI® DAR8 ADC), both using Exatecan, a potent topoisomerase 1 inhibitor as the payload, have demonstrated promising antitumor activities. The integration of glycan engineering, EndoSymeOBI®, and a novel linker design establishes the GlycOBI® suite of technologies as a robust and adaptable solution to address the current ADC limitations. These advancements underscore its transformative potential in driving the next generation of therapeutics."

Oncology • NECTIN4

OBI-902, a novel TROP2 targeted antibody-drug conjugate via GlycOBI® platform, has favorable pharmacokinetics and sustained antitumor activities in challenging solid tumors (AACR 2025) - "The antitumor activity studies of OBI-902 were conducted in NSCLC, PC, GC, and challenging CRC xenograft mouse models with Dato-DXd, SG, or MK-2870 as benchmarks. Similarly, in the large-tumor PC xenograft model, OBI-902 prolonged survival beyond day 50, while all mice in the benchmark groups were sacrificed by day 28. OBI-902 can efficiently deliver payload to the site of action (tumor) to achieve desirable drug exposure and sustainable antitumor activities in various challenging solid tumors, pointing to its potential to be the best-in-class TROP2 ADC."

PK/PD data • Colorectal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • TACSTD2 • TOP1