CD16b

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

BRISBANE, Calif., Sept. 12, 2022 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company” or “GTB”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE® platform, today announced highlights of an accepted abstract titled, “B7H3-Targeted Tri-specific Killer Engagers deliver IL-15 to NK cells but not T cells, and specifically targets solid tumors as a pan-tumor antigen strategy mediated through NK cells,” for poster presentation both virtually at the European Society for Medical Oncology ("ESMO") Congress 2022 being held at the Paris Expo Porte de Versailles from September 9-13, in Paris, France. GTB-5550 product candidate is in development for the treatment of B7H3 positive solid tumor cancers and multiple myeloma. GTB-5550 TriKE is a tri-specific molecule composed of a dual camelid nanobody that binds the CD16 receptor on NK cells, the single chain variable fragment (scFv) of an anti-B7H3 antibody, and human IL-15. Highlights of the abstract poster and mini-oral session include: GTB-5550 gives a robust and NK cell specific proliferation signal compared to IL-15 alone GTB-5550 specifically targets B7-H3+ cells GTB-5550 effectively induced NK cell degranulation and interferon gamma production in response to various prostate, brain tumor (atypical rhabdoid/teratoid), HNSCC, multiple myeloma, sarcoma, ovarian, and myeloid malignancies GTB-5550 TriKE In vivo activity in xenogeneic models of human tumor is underway and already validating in vitro studies “GT Biopharma’s TriKE platform harnesses the natural killing power of NK cells with protein therapeutics, not NK cell therapy. Our approach induces activation of NK cells via CD16 and IL-15 while targeting well-known tumor antigens, offering a potentially safer alternative to T-cell related immunotherapy without cytokine release syndrome and neurotoxicity and we expect to submit an Investigational New Drug (IND) application in 2023 in solid tumors,” said Michael Breen, Executive Chairman and Interim CEO of GT Biopharma.” About the Study Background IL-15, the homeostatic factor for NK cells is being clinically developed but it has little anti-tumor activity alone. GT Biopharma hypothesized that targeted delivery of IL-15 to NK cells along with Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) would impart NK cells with specificity to tumor antigens. As proof of concept, a clinical trial of GTB-3550 (a CD33- targeted Tri-specific Killer Engager (TriKE) in AML) induced endogenous NK cell expansion and activation in refractory AML patients. GTB-5550 (a B7H3 TriKE) was developed as a novel dual camelid (cam) TriKE containing wild type IL-15 and comprised of two cam engagers: targeting CD16 on NK cells and B7H3 on multiple solid tumors. Method The IL-15 activity of the B7H3 TriKE was measured in proliferation assays. Tumors were incubated with NK cells with or without B7H3 TriKE. In some tumors, CRISPR tech was used to knockout B7H3 to serve as a specificity control as well as B7H3 negative hematologic tumors. NK cell function was measured by flow cytometry and in live tumor imaging assays. Results B7H3 TriKE was titrated onto lymphocytes resulting in a dose- dependent proliferation of NK cells but not T cells. This was in marked contrast to rhIL-15, that stimulated both, suggesting different biologic activity of IL-15 when delivered through the camCD16 engager. camB7H3 was broadly expressed on prostate, head and neck, ovarian and glioblastoma cancers as well as multiple myeloma. We observed a B7H3 TriKE dose-dependent increase in CD107a degranulation and inflammatory cytokines to all B7H3 positive targets that was highly specific, with no response seen with B7H3 negative hematologic targets and control lines created with a CRISPR knockout of B7H3. Compared to rhIL-15, GTB-5550 given at molar equivalent dosing induced B7H3 killing in in a dose-dependent manner above that seen with rhIL-15 induced natural cytotoxicity. In vivo activity in xenogeneic models of human tumor is underway and already validating our in vitro studies. ESMO Congress 2022 presentation details: Poster Presentation Display (#755P) Title: “B7H3-Targeted Tri-specific Killer Engagers Deliver IL-15 to NK Cells But Not T Cells, And Specifically Targets Solid Tumors As a Pan-Tumor Antigen Strategy Mediated Through NK Cells” Session: Investigational Immunotherapy Speaker: Dr. Jeffrey S. Miller Location: 7.3.O - Orléans Auditorium Date and Time: Saturday, September 10, 2022 at 14:45 - 16:15 (CEST) ESMO Congress 2022 has published full abstracts on their website. GT Biopharma will post its poster on the company's website in the "Presentations" section during the conference. For abstract and event details please visit: https://www.esmo.org/meetings/esmo-congress-2022. About GT Biopharma, Inc. GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE® NK cell engager platform. Our TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology. For more information, please visit gtbiopharma.com.