Biosion Usa, Inc.

- 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, DE, USA and NANJING, China I January 8, 2024 I 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

NEWARK, Del. and NANJING, China, July 5, 2023 /PRNewswire/ -- Biosion, Inc. ("Biosion"), a global, clinical-stage biotechnology company, today announced the appointment of Furqan Ahmed, PharmD., as the Vice President and Head of Business Development. In this position, Furqan will be responsible for all aspects of the company's global business development efforts to maximize the value of Biosion's platforms and innovative pipeline. "Furqan brings a track record of successfully executed transactions along with a unique combination of scientific depth and business acumen to Biosion," said Hugh Davis, Ph.D., Chief Business and Development Officer and President, Biosion USA, Inc. "Furqan is joining us at a critical point, as we enter a growth trajectory building on our successful collaborations to date and expansive pipeline. We will look increasingly towards establishing external innovative collaborations to leverage our platforms and advance our programs as well as attracting investment from global firms. I'm confident that Furqan will be a key driver in leading these efforts." "I look forward to working with the Biosion team to contribute in its development to the next stage and beyond." stated Dr. Ahmed. "Biosion is a very exciting and uniquely positioned company with validated platforms, streamlined development capabilities, and a deep pipeline in immunology and oncology programs with the added ability to create and develop multiple therapeutics including mAbs, bispecifics, and antibody drug conjugates (ADCs) that have the potential to address the unmet medical needs of patients worldwide." Throughout his 15-year career Furqan has held positions of increasing responsibility across medical affairs, business and competitive intelligence, corporate strategy, alliance management, and most recently business and corporate development in small and large cap global biopharma companies. Furqan was most recently the Vice President of Business Development at Immunome, Inc., where he led the company's business development efforts culminating in a transformative collaboration with AbbVie. Prior to Immunome he spent time at Eisai Inc. where he was a member of the corporate strategy and business development team and led multiple successful transactions across the entire business. Furqan also helped lead business development initiatives at Antares Pharma. He started his career at Merck & Co. and worked in a variety of areas including medical affairs, business intelligence, corporate development, alliance management, and business development. Furqan received his PharmD from Rutgers University. 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, BSI-045B (anti-TSLP mAb), is currently in phase-II for severe asthma and atopic dermatitis, with another 4 partnered assets in phase-I/II. Biosion and partners have plans to progress the immune-oncology and antibody drug conjugate-based portfolio into clinical trials for oncology indications over the next year. Biosion has operations in the US, Australia, and China. For more information, please visit: . Biosion Contact: Ewen Bazirake [email protected] SOURCE Biosion, Inc.

NEWARK, Del. and NANJING, China, May 8, 2023 /PRNewswire/ -- Biosion USA, Inc. (Biosion), a global R&D biotechnology company, today announced the upcoming presentation of discovery and development data for BSI-038, an anti-CD40 agonistic antibody at the PEGS Boston conference to be held from May 15 to 19, 2023. BSI-038 is an anti-CD40 agonistic monoclonal antibody, discovered through Biosion's H³ antibody discovery platform. BSI-038 exhibits enhanced binding affinity and bioactivity when compared to Selicrelumab analog. It exhibited potent and dose-dependent anti-tumor activity in animal models. It was well tolerated in pre-clinical studies with the highest non-severely toxic dose (HNSTD) established at 150 mg/kg in non-human primates. Biosion has a licensing agreement with Chia Tai Tianqing Pharmaceutical Group (CTTQ) in which CTTQ has an exclusive license to develop and commercialize BSI-038 (also referred to as TQB2916 by CTTQ) in Greater China. CTTQ is currently conducting a Phase 1 clinical study of BSI-038 in advanced tumors in China. Learn more about clinical trials of CD40，please visit About PEGS Boston Conference & Expo PEGS Boston is the world's largest gathering of protein engineering and biotherapeutics experts. PEGS is the leading biologics event with comprehensive programming covering all aspects of biologic drug development with in-depth presentations on protein and antibody engineering, immunotherapy, oncology, expression, analytics, immunogenicity, and more. Please visit for more information. About Biosion Biosion is a 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® high-throughput endocytosis platform, and Flexibody bispecific platform. Biosion's lead asset, BSI-045B (anti-TSLP mAb), is currently in phase-II for severe asthma and atopic dermatitis, with 4 other assets in the clinic with our partners. Biosion has operations in the US, Australia and China. For more information, please visit .