SIRPγ

- 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.

SHANGHAI, Oct. 24, 2023 /PRNewswire/ -- BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") announced on October 7th that its clinical trial application for BR105 Injection has received approval from the United States Food and Drug Administration (FDA). This marks BioRay's first project to receive FDA IND approval. BR105 Injection is a humanized monoclonal antibody developed in-house, specifically targeting SIRPα. It can recognize common genotypes of SIRPα (V1, V2, V8) and disrupt the interaction between SIRPα and its ligand CD47, thereby abolishing the "don't eat me" signal between macrophage and tumor cell. This activation enables macrophages to perform their tumor-phagocytosing function, achieving anti-tumor immunotherapy. The efficacy of targeting CD47/SIRPα has been validated in various tumor models, and previous clinical studies suggest that targeting the CD47/SIRPα signaling pathway may have a broad spectrum of anti-tumor activity. CD47/SIRPα-targeted therapy has shown positive results in acute myeloid leukemia, lymphoma, head and neck squamous cell carcinoma, gastric cancer, and other malignancies. Compared to CD47, the expression of SIRPα is more specific. By targeting SIRPα instead of CD47, BR105 exhibits enhanced safety profile intrinsically. Additionally, CD47 interacts with other proteins, such as TSP-1, SIRPγ, leading to a more complex signaling network and increased risks in corresponding targeted therapies. Therefore, developing SIRPα antibodies to block the CD47/SIRPα signaling pathway is a more promising strategy in oncology drug development. Currently, no medicine targeting SIRPα has been approved in the global market. Phase I clinical trial of BR105 Injection is currently on-going in China, and preliminary result has confirmed its good clinical safety. "Based on our global strategic layout of innovative drugs, the FDA IND approval of BR105 Injection as our first FDA approved clinical trial project is a significant milestone for BioRay. Currently, fierce competition exists in the global innovative drug discovery and development arena, where innovation is indispensable. BioRay continues to invest heavily in innovation and build a rich pipeline of innovative biopharmaceuticals," said by Dr. Wei Zhu, Chief Medical Officer of BioRay. "We look forward to transforming these pipelines and BR105 into best-in-class therapies in autoimmunology and immuno-oncology, benefiting an increasing number of patients both in China and overseas." SOURCE BioRay Pharmaceutical Co., Ltd

Byondis' Lead IO Therapy Scheduled to Enter Phase I Study This Year NIJMEGEN, Netherlands, April 17, 2023 /PRNewswire/ -- Byondis B.V., an independent, clinical-stage Dutch biopharmaceutical company creating precision medicines, today announced that the Journal for ImmunoTherapy of Cancer (the official journal of the Society for Immunotherapy of Cancer) has published encouraging preclinical data on its investigational monoclonal antibody (mAb) BYON4228. BYON4228 targets and blocks the Cluster of Differentiation 47-Signal Regulatory Protein alpha (CD47-SIRPα) interaction responsible for tumors' ability to escape recognition and destruction by the immune system. The Byondis paper, "BYON4228 is a pan-allelic antagonistic SIRPα antibody that potentiates destruction of antibody-opsonized tumor cells and lacks binding to SIRPγ on T cells," reports the findings of an extensive preclinical characterization of the novel SIRPα-directed antibody, including direct comparisons to previously reported anti-SIRPα antibodies. Side-by-side comparisons show that BYON4228 has a unique and favorable preclinical profile. The therapy is scheduled to enter First-in-Human (Phase I) study later this year. The Phase I clinical study (NCT05737628) is designed to evaluate BYON4228 alone and in combination with rituximab in patients with relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma. Byondis Chief Scientific Officer Wim Dokter, Ph.D. explains: "BYON4228 is a pan-allelic antibody, meaning it recognizes the two major SIRPα variants in humans. In addition, because BYON4228 does not recognize SIRPγ, a related molecule on T cells, it should not compromise T cell activity." "This implies that the therapy could benefit all eligible patients. Used in combination, BYON4228 can potentially increase the efficacy of a wide range of therapeutic mAbs in different blood and solid cancers," Byondis Chief Executive Officer Marco Timmers, Ph.D. added. According to the published data, BYON4228 potentiates macrophage- and neutrophil-mediated killing of both hematologic and solid cancer cells in vitro in the presence of a variety of tumor-targeting antibodies, including trastuzumab, rituximab, daratumumab, panitumumab and cetuximab. In vivo, BYON4228 promotes the anti-tumor activity of such antibodies. Finally, BYON4228 shows a favorable preclinical safety profile. More About BYON4228 BYON4228 is a humanized therapeutic monoclonal antibody designed to stimulate the innate immune system. It binds to SIRPα expressed on innate immune cells, especially monocytes, macrophages and neutrophils. BYON4228 blocks binding of SIRPα to CD47 (a cell surface molecule often over-expressed on cancer cells), preventing signaling through the CD47-SIRPα axis. The CD47-SIRPα axis limits the antibody-mediated destruction of cancer cells by transducing a "don't eat me" signal to the immune system. By inhibiting the CD47-SIRPα axis, BYON4228 prevents the inhibitory "don't eat me" signal to be detected, thereby stimulating the immune cell to do what it is supposed to do: destroy the tumor cell. As a pan-allelic antagonistic SIRPα antibody that lacks binding to SIRPγ on T cells, BYON4228 has the potential to become best in class. It distinguishes itself from previously reported SIRPα antibodies that in all probability are representative of antibodies currently being tested in clinical trials. About Byondis Driven to improve patients' lives, Byondis is a privately held, Dutch clinical-stage biopharmaceutical research and development company creating precision medicines targeting intractable cancers and autoimmune diseases. Byondis' broad development portfolio comprises targeted and immuno-oncology (IO) therapies in preclinical, early- and late-stage clinical phases. These candidates combine Byondis' expertise in linker-drug (LD) technology, antibody-drug conjugation, targeted cytotoxic therapy, and monoclonal antibody (mAb) development. Byondis designs and produces next generation antibody-drug conjugates (ADCs), as well as mAbs and new chemical entities (NCEs) that can stand alone or be incorporated in its ADCs. Byondis has a dedicated team of more than 400 employees, including highly educated scientists and skilled technicians working in state-of-the-art R&D laboratories and Good Manufacturing Practice (GMP) production and conjugation facilities on its campus in Nijmegen, the Netherlands. The company collaborates with other global biotechnology and pharmaceutical companies and many leading academic research institutions. For more information, visit . Logo: SOURCE Byondis B.V.