Biosion Usa, Inc.

- BSI-082 is a fully human anti-SIRPα antagonistic monoclonal antibody with potential broad combo therapies for the treatment of hematologic and solid tumors NEWARK, Del. and NANJING, China, Jan. 24, 2024 /PRNewswire/ -- Biosion USA, Inc. (Biosion), a global clinical-stage R&D biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BSI-082, a novel anti-SIRPα monoclonal antibody (mAb) candidate. "The FDA clearance of our investigational new drug application for BSI-082 marks a pivotal milestone for Biosion and our mission to discover and develop antibody-based therapeutics for the treatment of patients worldwide," said Mingjiu Chen, Ph.D., Founder and Chief Executive Officer of Biosion, Inc.. "BSI-082 was discovered by Biosion's H³ antibody discovery platform that has delivered seven clinical candidates in our global innovative pipeline. This IND approval once again validates the unique advantages and potential of our antibody technology platform." "We are pleased that the FDA has cleared our IND for BSI-082 clinical development. Our novel anti-SIRPa mAb provides many therapeutic opportunities for patients- it has the potential to be combined with a broad array of anti-tumor agents such as mAbs with ADCC/ADCP activity, immune oncology therapies and Antibody Drug Conjugates (ADCs) to enhance both hematologic and solid tumor killing" said Hugh M. Davis, Ph.D., Chief Business & Development Officer, and President of Biosion USA, Inc.. "We are very excited about BSI-082's broad applicability and patient population and are looking forward to showing its potential in upcoming clinical development" continued Dr. Davis. About BSI-082 BSI-082 is a best-in-class highly differentiated fully human anti-SIRPα antagonistic monoclonal antibody. It shows strong binding activity to huSIRPα variants V1/V2/V8, thus can cover over 90% of human populations. BSI-082 specifically binds to SIRPα and SIRPβ but not to SIRPγ, and blocks the interaction of SIRPα to CD47, the "don't eat me" signal expressed on a wide variety of tumors. Blocking SIRPα enables tumor associated macrophages and dendritic cells to resume their phagocytoxic activity against tumor cells while avoiding the broad toxicity issue that many CD47-targeting therapies encountered. BSI-082 demonstrated potent in vivo anti-tumor efficacy when combined with mAbs against tumor-associated antigens in multiple animal models. 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 (BSI-045B/TQC2731), an anti-TSLP mAb, is currently in phase II for severe asthma, atopic dermatitis and chronic rhinosinusitis with nasal polyps (CRS w/NP), with another 6 partnered assets in phase I/II. Biosion has operations in the US, Australia, and China. For more information, please visit . SOURCE Biosion, 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, N.J. and NANJING, China, July 31, 2023 /PRNewswire/ -- Biosion USA, Inc. (Biosion), a global clinical-stage R&D biotechnology company, today announced the phase 2 study initiation for the evaluation of BSI-045B, an anti-TLSP mAb, in the treatment of atopic dermatitis (AD) . "We are pleased to have initiated this important Phase 2 trial, which brings us closer to delivering a new treatment option for patients with atopic dermatitis," said Hugh M. Davis, Ph.D. Chief Business and Development Officer & President, Biosion USA. "This marks another important clinical milestone for Biosion in our effort to develop more high value treatment options for patients." The phase I study of BSI-045B demonstrated its potential to be a first-in-class treatment for AD due to its single dose activity in a cohort of AD patients, excellent PK and favorable safety profile. The phase II study is designed to assess the efficacy of BSI-045B as monotherapy as well as in combination therapy with Dupixent® to further increase therapeutic effectiveness for patients who are suffering from AD. For additional information on this trial (NCT05114889), please visit About BSI-045B BSI-045B is a high-affinity, humanized monoclonal antibody, targeting thymic stromal lymphopoietin (TSLP), a cytokine that is implicated in the pathogenesis of atopic dermatitis, asthma and other eosinophilic and Th2 immune-related diseases. Biosion's collaboration partner - CTTQ, a China-based pharmaceutical company with rights to BSI-045B (TQC2731) for China development and commercialization, is currently conducting a Phase II clinical trial of BSI-045B in China for the treatment of severe uncontrolled asthma. About Biosion Biosion is a global, clinical-stage biotechnology company committed to developing 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 phase-I for atopic dermatitis. 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.To learn more about Biosion, please go to . SOURCE Biosion, Inc.