Biosion's Partner OBI Pharma Announces FDA Clearance of IND Application for a Phase 1/2 Study of OBI-992 (TROP2 ADC)

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Jan 08, 2024, 06:35 ET

- First clinical trial to evaluate the safety and efficacy of OBI-992 (a.k.a BSI-992), a novel antibody drug conjugate (ADC) targeting TROP2
- Dosing of first patient in the Phase 1/2 clinical trial expected in early 2024

NEWARK, Del. and NANJING, China, Jan. 8, 2024 /PRNewswire/ -- The Partner of Biosion Inc. (Biosion) , OBI Pharma (4174.TWO), announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-992, to conduct a Phase 1/2 study of its novel antibody drug conjugate (ADC) cancer therapy targeting TROP2. The targeting antibody was discovered through Biosion's SynTracer^® High Throughput Endocytosis Platform and was licensed to OBI Pharma in Dec 2021. OBI Pharma owns ex-China commercial rights for OBI-992 (BSI-992), and Biosion owns China rights.

"We are very pleased to see OBI Pharma receive FDA clearance for OBI-992 (BSI-992)," said Hugh M. Davis, Ph.D., Chief Business & Development Officer, and President of Biosion USA, Inc. "OBI-992 demonstrated superiority over other TROP2 ADCs in pre-clinical studies. It is a solid validation of the unique advantages of Biosion's SynTracer^® platform to identify fit-for-purpose antibodies for the development of novel ADC therapies. We are excited about this innovative treatment and making a meaningful difference for patients worldwide."

OBI Pharma plans to enroll patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC), although several other cancers are also potential targets. OBI Pharma's Chief Medical Officer, Wayne Saville, M.D. noted, "The clinical trial intends to evaluate the safety, pharmacokinetics, and preliminary efficacy of OBI-992, a novel anti-TROP2 ADC with best-in-class potential. We look forward to dosing the first patient in our Phase 1/2 clinical study of OBI-992, which is expected to begin in early 2024."

Heidi Wang, Ph.D., OBI Pharma's Chief Executive Officer, added, "OBI-992 is a novel anti-TROP2 ADC designed and engineered by OBI Pharma. It demonstrates outstanding preclinical efficacy, favorable safety, and high stability in numerous in-vivo studies compared to other TROP2 ADCs. We are excited to commence the first-in-human clinical trial of OBI-992. OBI Pharma strives to advance our promising therapeutics to the clinic for cancer patients."

About OBI-992 (BSI-992)

OBI-992 (BSI-992) is a TROP2-targeted antibody-drug-conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill solid tumors. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, and gastric cancer, rendering it an ideal target for cancer therapy. OBI-992 (BSI-992) uses a differentiated hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. OBI-992 (BSI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety profile in animal models. The anti-TROP-2 targeting antibody was discovered and developed by Biosion, OBI Pharma owns ex-China commercial rights for OBI-992 (BSI-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 pipelines, OBI-992, OBI-902, OBI-904, and OBI-905, targeting TROP2, Nectin-4, and HER2, 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.

About Biosion, Inc.

Biosion is a global, clinical-stage biotechnology company committed to developing breakthrough antibody-based therapies to improve patient outcomes for the treatment of immune and oncologic diseases. Established in 2017, Biosion has built a pipeline of innovative biologics through its internally derived proprietary technologies including the H³ antibody discovery platform, SynTracer^® HT endocytosis platform, and Flexibody^® bispecific platform. Biosion's lead asset, Bosakitug (anti-TSLP mAb), is currently in phase II for severe asthma and atopic dermatitis, with another 5 partnered assets in phase I/II. Biosion has operations in the US, Australia, and China. For more information, please visit www.Biosion.com.

SOURCE Biosion, Inc.