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

Scientists have developed a new method to engineer more powerful immune cells that can potentially be used for 'off-the-shelf' cell therapy to treat challenging cancers. UCLA scientists have developed a new method to engineer more powerful immune cells that can potentially be used for "off-the-shelf" cell therapy to treat challenging cancers. "Off-the-shelf" cell therapy, also known as allogenic therapy, uses immune cells derived from healthy donors instead of patients. The approach can bring cell therapies, like chimeric antigen receptor (CAR) T cell therapy, to more patients in a timelier manner, which is one of the major barriers in getting these life-saving treatments to patients. "Time is often of the essence when it comes to treating people with advanced cancers," said Lili Yang, associate professor of microbiology, immunology and molecular genetics and member of the UCLA Health Jonsson Comprehensive Cancer Center. "Currently, these types of therapies need to be tailored to the individual patient. We have to extract white blood cells from a patient, genetically engineer the cells and then re-infuse them back into the patient. This process can take weeks to months and can cost hundreds of thousands of dollars to treat each patient." This new approach, described in Nature Communications, is a crucial step toward developing more effective cell therapies that have a lower cost and wait that can be mass-produced and shipped to hospitals around the world, making CAR-T cell therapy more affordable and accessible to a broader range of patients. For the study, Yang and her team focused on gamma delta T cells, an immune cell known for its ability to target a wide array of cancers -- including solid tumors -- without causing graft-versus-host disease, a common complication in allogeneic cell therapies. While gamma delta T cell-based treatments have been studied before, they have had limited clinical success due to donor variability, short-lived persistence and cancer cells' ability to escape or avoid the body's immune response. However, Yang and her team found that donor gamma delta T cells with high expressions of a CD16 surface marker had a greater ability to kill cancer cells. "These CD16-high gamma delta T cells exhibit unique characteristics that increases their ability to recognize a tumor," said Yang, who is also a member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA and the study's senior author. "They demonstrate heightened levels of effector molecules and are equipped with the ability to engage in antibody-dependent cellular cytotoxicity against cancer cells. We found by using CD16 as a biomarker for donor selection we can improve their anti-cancer properties." Yang and her team also overcame some of the issues seen in previous studies with gamma delta T cell treatments by engineering the cells so they were equipped with CAR and IL-15, two essential components that help enhance gamma delta T cells' cancer-fighting capabilities. The team of scientists were then able to efficiently produce the more potent engineered cells in large quantities, which they then tested on two different preclinical ovarian cancer models. They found the cells were capable of attacking tumors and remained in the models for a long period of time, enabling them to continue their anti-tumor effects. Additionally, there were no signs of complications such as graft-versus-host disease. "The results of this research shed light on the promising feasibility, therapeutic potential, and remarkable safety pro these engineered CD16-high gamma delta T cells," Yang said. "We hope this can be a viable therapeutic option for cancer treatment in the future." The study's first authors are Derek Lee and Wenbin Guo from UCLA, and Zachary Dunn from USC. Other authors include Carl Rosenthal, Natalie Penn, Yanqi Yu, Kuangyi Zhou, Feiyang Ma, Miao Li, Tsuan-Ching Song, Xinjian Cen, Yan-Ruide Li, Jin Zhou, and Matteo Pellegrini, all from UCLA, and Pin Wang from USC. This work was supported in part by a UCAL Faculty Startup Fund, a UCLA Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research Innovation Award and an Ablon Scholars Award.

This marks the first IND clearance for an allogeneic, off-the-shelf NK or CAR-T cell therapy candidate in autoimmune disease Artiva also announced the formation of an advisory board to provide expertise in advancing innovative cell therapies for lupus and other autoimmune diseases SAN DIEGO--(BUSINESS WIRE)-- Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for AlloNK® (also known as AB-101), in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis (LN). AlloNK is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved NK cell therapy candidate designed to enhance antibody-dependent cellular cytotoxicity (ADCC). This IND clearance marks the first for an allogeneic, off-the-shelf NK or CAR-T cell therapy in autoimmune disease. AlloNK is currently being investigated in two cancer clinical trials in combination with antibody or NK-engager biologics. Artiva presented data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating the therapeutic potential and favorable safety pro AlloNK in combination with rituximab in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). “Seminal clinical data has been generated using autologous CAR-T cells suggesting that a deeper B cell depletion can induce complete and long-lasting responses in patients with lupus nephritis. However, the use of autologous CAR-T cells requires apheresis, likely hospitalization, and the potential for serious side effects,” said Fred Aslan, M.D., Chief Executive Officer of Artiva. “AlloNK given in combination with rituximab, an anti-CD20 antibody that targets B-cells, is already driving complete responses in late line B-NHL patients in an ongoing Phase 1 study by enhancing the activity of rituximab. Our hypothesis is that AlloNK plus rituximab also has the potential to drive deep B-cell depletion in LN patients with an off-the-shelf therapy that could be administered and managed in an outpatient setting.” As Artiva broadens the applications of AlloNK into autoimmune disease, the company has assembled an advisory board of experts in SLE and LN: Kenneth Kalunian, M.D., is a clinician and Professor of Medicine at UC San Diego, where he directs the Lupus Research and Clinical Center of Excellence. Dr. Kalunian participates in multiple lupus clinical networks, including as a founding member of both the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) and the Lupus Clinical Investigators Network (LuCIN). Jill Buyon, M.D., is a clinician and Professor of Rheumatology and Director of the Division of Rheumatology at New York University (NYU) School of Medicine, and Director of the NYU Lupus Center. Dr. Buyon has published more than 200 papers in peer-reviewed science journals and has been an active member of the Accelerating Medicines Partnership. Maureen McMahon, M.D., is a clinician and Professor of Medicine / Rheumatology at UCLA and site director of the UCLA Lupus Clinical Trials Network. Her research and clinical work have focused on identifying new treatments for SLE. Brad Rovin, M.D., is a Professor of Medicine and Pathology and Director of the Division of Nephrology at The Ohio State University, Wexner Medical Center. Dr. Rovin studies the immunopathogenesis of glomerular and autoimmune diseases and is heavily involved in clinical trial development and design for investigator-initiated and industry-sponsored trials. “Although rituximab has been used off-label in the treatment of SLE, rituximab alone has been shown to give incomplete B-cell depletion. The addition of allogeneic NK cells as an ADCC-enhancing therapy could significantly enhance rituximab’s ability to drive deeper levels of B-cell depletion,” said Dr. Kalunian. “Furthermore, SLE patients may have lower levels of NK cells than healthy subjects, and these cells may be functionally impaired. An effective off-the-shelf cell therapy that can be administered and managed in the community setting could be well received by lupus patients and physicians.” About Systemic Lupus Erythematosus Systemic lupus erythematosus (SLE) is a chronic, potentially severe, autoimmune disease characterized by abnormal B-cell function and autoantibody production resulting in a range of clinical manifestations including end organ damage and an increased risk of death. SLE affects an estimated 160,000-320,000 patients in the U.S. Lupus nephritis (LN) is the most common end-organ manifestation of SLE, affecting approximately 40% of SLE patients, and more than 40% of patients with the most severe LN will develop end-stage renal disease requiring dialysis and transplant within 15 years. About AlloNK® AlloNK® (also known as AB-101) is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers in the out-patient setting. Artiva is investigating AlloNK® in a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AlloNK alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL). Artiva is also investigating the safety and clinical activity of AlloNK in combination with rituximab in patients with lupus nephritis. In addition, Artiva is collaborating with Affimed N.V. in a Phase 2, open-label, multi-center, multi-cohort study (NCT05883449, LuminICE-203) testing a combination therapy, comprised of AlloNK and the innate cell engager AFM13, for the treatment of patients with relapsed/refractory CD30-positive lymphomas. Artiva selects cord blood units with the high affinity variant of the CD16 receptor and a KIR-B haplotype for enhanced product activity. Using the company’s cell therapy manufacturing platform, Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 and other activating NK receptors, without the need for engineering. AlloNK is being administered in the outpatient setting over multiple doses and multiple cycles. About Artiva Biotherapeutics Artiva’s mission is to deliver highly effective, off-the-shelf, allogeneic NK cell-based therapies that are safe and accessible to patients. Artiva has taken a Manufacturing-First approach to create a highly scaled process where one umbilical cord blood unit yields thousands of one-billion cell doses of AlloNK. Artiva’s pipeline includes AlloNK®, an ADCC enhancer NK-cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva’s pipeline also includes AB-201, an anti-HER2 CAR-NK cell therapy candidate for the treatment of HER2-overexpressing tumors, such as breast, gastric, and bladder cancers, and for which an IND has been allowed by FDA, and a pipeline of CAR-NK candidates targeting both solid and hematopoietic cancers. Artiva has entered into therapeutic NK cell collaborations with Merck Sharp & Dohme and with Affimed N.V. Artiva’s cell therapy manufacturing platform incorporates cell expansion, activation, and engineering technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea. Artiva is headquartered in San Diego. For more information, visit .