Selicrelumab

NEWARK, Del. and NANJING, China, March 21, 2024 /PRNewswire/ -- Biosion, a global, clinical-stage biotechnology company, today announced upcoming presentations of pre-clinical data for its oncology pipeline assets, including BSI-111, an anti-CD16a monoclonal antibody, BSI-730, a HER2/PD-L1 bispecific antibody and BSI-093, an anti-BTN3A monoclonal antibody at the American Association for Cancer Research (AACR) Annual Meeting to be held from April 5 to 10, 2024. "We are thrilled to present three posters at the AACR annual meeting. BSI-093, BSI-111 and BSI-730 demonstrate favorable biophysical and functional characteristics, supporting the initiation of development activities including manufacturing and IND-enabling studies" said Mingjiu Chen, Ph.D., Founder and Chief Executive Officer of Biosion, Inc. "We look forward to sharing the key data of these important therapeutic assets with the oncology research community at AACR." 01. BSI-111, a highly selective anti-CD16a monoclonal antibody with potent agonist activity for building a NK cell engager platform BSI-111 is a fully human monoclonal antibody discovered through Biosion's proprietary H³ Antibody Discovery Platform. BSI-111 binds specifically to CD16a without recognizing CD16b and binds the two allelic variants of CD16A - 158F and 158V with similar high affinity. BSI-111 demonstrates superior biophysical properties and functional characteristics, supporting the development of anti-CD16a-based NK cell engagers for the potential benefit of cancer patients. Time：April 8, 2024, 9:00 AM - 12:30 PM Location: Poster Section 2 Poster Board Number: 26 Published Abstract Number: 1343 02. BSI-730, a bispecific antibody targeting HER2 and PD-L1 for the development of a first-in-class bispecific ADC BSI-730 is a novel bispecific antibody for the development of a first-in-class bispecific ADC，identified through Biosion's proprietary SynTracer® High Throughput Endocytosis Platform. BSI-730 showed comparable binding affinity to HER2 as compared to trastuzumab, as well as comparable bioactivity to the parental anti-PD-L1 antibody regarding PD-L1 binding and PD-1/PD-L1 blocking. Time：April 8, 2024, 1:30 PM - 5:00 PM Location: Poster Section 21 Poster Board Number: 16 Published Abstract Number: 3135 03. BSI-093, a best-in-class anti-BTN3A monoclonal antibody for the treatment of cancer through the activation of Vγ9Vδ2 T cells BSI-093 is a highly differentiated, humanized anti-BTN3A agonistic monoclonal antibody with strong Vγ9Vδ2 T cell activation activity. The BTN3A family including BTN3A1, BTN3A2 and BTN3A3 are members of the Ig superfamily receptors, and is essential for the activation of Vγ9Vδ2 T cell-mediated anti-tumor immune responses. BTN3A's expression is significantly higher in tumor samples of cholangiocarcinoma, esophageal carcinoma, head and neck squamous cell carcinoma, compared to their counterpart normal tissue controls. Time：April 9, 2024, 1:30 PM - 5:00 PM Location: Poster Section 3 Poster Board Number: 7 Published Abstract Number: 5298 Additionally, Biosion's partner, CTTQ Pharma, OBI Pharma and Pyxis Oncology, will also be presenting posters at the AACR meeting. Partner：CTTQ A first-in-human phase 1 study of TQB2916, a novel CD40 agonist antibody for advanced malignancies TQB2916（BSI-038） is an anti-CD40 humanized agonist monoclonal antibody with 7-fold higher binding affinity and 4-fold higher cellular bioactivity compared to selicrelumab. By binding to CD40 receptor, it triggers the cellular proliferation and activation of antigen-presenting cells. In 2019, Biosion licensed Greater China rights of BSI-038 to CTTQ and retains all rights for development and commercialization in the rest of the world. Time：April 9, 2024, 9:00 AM - 12:30 PM Location: Poster Section 48 Poster Board Number: 20 Published Abstract Number: CT192 Partner：OBI Pharma 1. OBI-992, a novel TROP2 targeting antibody-drug conjugate, displayed excellent antitumor efficacy in various animal models Time：April 8, 2024, 9:00 AM - 12:30 PM Location: Poster Section 23 Poster Board Number:4 Published Abstract Number:1893 2. In vitro characterization of a novel TROP2-targeting antibody-drug conjugate OBI-992 Time：April 8, 2024, 1:30 PM - 5:00 PM Location: Poster Section 21 Poster Board Number: 11 Published Abstract Number:3130 3. OBI-992, a novel TROP2 targeting antibody drug conjugate demonstrates superior in vivo PK/PD properties and a favorable safety pro > Time：April 10, 2024, 9:00 AM - 12:30 PM Location: Poster Section 24 Poster Board Number: 20 Published Abstract Number: 7179 OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumor cells. 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 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. OBI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety pro animal models. OBI-992 received US IND clearance in December 2023 and Phase 1/2 efficacy and safety human studies are planned to commence early Q2,2024. The TROP2 targeting antibody was in-licensed from Biosion, Inc. , in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992. Partner：Pyxis Oncology Gene expression correlation of immune checkpoint molecules Siglec-15 and PD-L1 varies widely by cancer indication TIME：April 8, 2024, 9:00 AM - 12:30 PM Location: Poster Section 3 Poster Board Number: 24 Published Abstract Number: 1373 PYX-106 (BSI-060T) is a humanized anti-Siglec-15 monoclonal antibody being developed for solid tumors, including for patients that are not candidates for anti-PD-(L)1 treatment approaches. In this research, analysis of Siglec-15 mRNA expression was performed across single cells, cell lines, and bulk tumor samples to evaluate Siglec-15 target expression across a range of cancer types, including non-small cell lung cancer (NSCLC), cholangiocarcinoma, breast, thyroid, head and neck, colon, rectal, bladder, kidney, and endometrial cancers. These results demonstrate that Siglec-15 and PD-L1 are rarely found co-expressed on the same cell, provide detailed data on Siglec-15 and PD-L1 expression patterns by cancer type, and are expected to help inform potential future PYX-106 (BSI-060T) therapeutic strategies. In Mar 2022, Biosion licensed ex-Greater China rights of BSI-060T to Pyxis Oncology and retains all rights for development and commercialization in Greater China. Pyxis Oncology is conducting a Phase 1 clinical study of PYX-106 (BSI-060T) in solid tumors in the US and Europe. About Biosion 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 (CRSwNP), with another 6 partnered assets in phase I/II. Biosion has operations in the US, China and Australia. For more information, please visit . Contact: Mason Xu mason.xu@biosion.com

中国南京和美国纽瓦克 2023年5月8日 /美通社/ -- 博奥信（以下简称：“公司”），一家处于临床阶段的全球化创新生物技术公司，今天宣布将在5月15-19号在美国波士顿举办的PEGS（蛋白质工程高峰会议）上展示其抗CD40激动型抗体药物BSI-038的发现与开发数据。 BSI-038是一种抗CD40激动型单克隆抗体，由博奥信内部专有的H 3 （高通量，高含量，高效率）抗体发现平台发现获得。BSI-038在与Selicrelumab类似物的对比试验中展示出更高的亲和力和生物活性，并在动物模型中表现出优秀的剂量依赖性抗肿瘤活性。同时BSI-038在临床前研究中也展示出良好的耐受性，非人类灵长类动物的最高非严重毒性剂量（HNSTD）达到150 mg/kg。 BSI-038（正大天晴项目编号：TQB2916）由博奥信与正大天晴合作开发，正大天晴拥有大中华区范围内的开发和商业化权利，目前正在国内进行针对晚期肿瘤的临床I期试验。更多临床试验信息请访问: http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml?keywords=CTR20213326 关于 PEGS PEGS波士顿是世界上最大的蛋白质工程和生物疗法专家会议。会议涵盖了生物药物开发的各个方面，并将就蛋白质和抗体工程、免疫疗法、肿瘤学、表达、分析、免疫原性等领域最新成果进行深度探讨。更多信息请访问 www.PEGSUMMIT.com。 关于博奥信 博奥信是一家处于临床阶段的全球化创新生物技术公司，致力于应用专有的抗体技术平台开发创新疗法，使患者在免疫及肿瘤疾病的治疗中获益。成立于2017年，博奥信通过内部专有的H 3（高通量，高含量，高效率）抗体发现平台、SynTracer ®高通量抗体内吞筛选平台、Flexibody ® 双功能抗体技术平台及全球合作建立了一系列创新药物管线。自研产品BSI-045B（抗TSLP单抗）正在中美开展针对严重哮喘与特应性皮炎的临床II期试验，另有4项自研合作产品在中美开展临床I期或II期试验。博奥信在中国，美国与澳大利亚均设有分支机构。更多公司及管线信息，请访问 www.biosion.com。 Mason Xu, mason.xu@biosion.com