OBI Pharma Announces Phase 1/2 Study Initiation for OBI-992, a TROP2-Targeted Antibody-Drug Conjugat

Clinical trial to evaluate the safety and efficacy of OBI-992 in advanced solid tumors.

TAIPEI, Taiwan, June 12, 2024 (GLOBE NEWSWIRE) - OBI Pharma, a clinical-stage oncology company (4174.TWO), today announced the initiation of a Phase 1/2 clinical trial of OBI-992, an antibody-drug conjugate (ADC) targeting TROP2 (Trophoblast cell-surface antigen 2), an antigen overexpressed in multiple tumor types.

OBI plans to enroll patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), gastric cancer (GC), and other potential cancers. The objective of the trial is to verify the safety, pharmacokinetics, and preliminary efficacy profile of OBI-992 in these patient populations.

OBI Pharma's Chief Medical Officer, M. Wayne Saville, M.D., noted, “Based on our preclinical data, OBI-992 has several important advantages over other TROP2 ADCs in development; including high serum stability, excellent bystander effect, potential ability to overcome drug resistance, and outstanding activity in animal and organoid models of cancer 1, 2, 3. We look forward to investigating this potential best-in-class TROP2 ADC in the clinic. Leia Tsimberidou MD, of MD Anderson Cancer Center in Houston, TX. USA is the lead investigator for the study.”

Heidi Wang, Ph.D., OBI Pharma’s Chief Executive Officer, added, “We are excited to initiate this first in human study of OBI-992. This is an important company milestone and highlights our commitment to building and strengthening the novel OBI Pharma oncology pipeline. We thank the patients and the investigators for their efforts and dedication.”

About OBI-992

OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload (exatecan) proven to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, gastric, and other cancers, rendering it an ideal target for cancer therapy.

OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. In preclinical animal models, OBI-992 demonstrated remarkable antitumor activity, improved pharmacokinetic characteristics, and a favorable safety profile relative to comparator ADCs.

The TROP2 targeting antibody was in-licensed from Biosion, Inc. www.Biosion.com, in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992.

About OBI Pharma

OBI Pharma, Inc., is a clinical stage oncology company that is headquartered in Taiwan and established in 2002. Its mission is to develop novel cancer therapeutic agents for patients with high unmet medical needs.

The company’s novel first-in-class immuno-oncology portfolio targeting Globo H includes: two Globo H active immunotherapy vaccines, adagloxad simolenin (formerly OBI-822) and OBI-833. Using the company’s unique ADC platforms, including GlycOBI™, OBI created its novel ADC pipeline which includes OBI-992, OBI-902 and OBI-904, targeting TROP2 and Nectin-4, respectively. OBI’s pipeline also includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme. Additional information can be found at www.obipharma.com.

GlycOBI™ is a trademark of OBI Pharma, Inc.

1, 2, 3: AACR Annual Meeting 2024 Abstracts online. OBI Pharma, Inc. Taipei, Taiwan.
https://www.obipharma.com/zh-hant/news-zh-hant/poster-presentations-at-the-aacr-2024-annual-meeting-for-obi-992-and-glycobi-adc-platform/

Forward-Looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma’s reports and presentations, including OBI Pharma’s filings with the Taiwan Securities and Futures Bureau.

COMPANY CONTACT:
Kevin Poulos
Chief Business Officer
OBI Pharma, Inc.
1.619.537.7698 Ext. 102
kpoulos@obipharmausa.com

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