Biosion Announces FDA Clearance of IND Application for BSI-082, a Novel Anti-SIRPα Monoclonal Antibody

- 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 www.Biosion.com.

SOURCE Biosion, Inc.