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Biosion’s Partner Aclaris Therapeutics Announces FDA Clearance of IND Application for ATI-052, a Novel Bispecific Anti-TSLP/IL-4R Investigational Antibody
Release time:
2025-04-27 20:10:00
Newark, DE, U.S. and Nanjing, China, Apr. 27, 2025 —— Biosion, a global clinical-stage biotechnology company, announced that its partner, Aclaris Therapeutics, Inc. (NASDAQ: ACRS), has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1a/1b clinical trial of ATI-052 (BSI-502), a potential best-in-class bispecificanti-TSLP/IL-4R monoclonal antibody.
" We are very pleased to see Aclaris Therapeutics, receive FDA clearance for ATI-052 (BSI-502) . " said Kedan Lin, Ph.D., Chief Development Officer and President of Biosion US. " ATI-052 has strong therapeutic potential in immune inflammatory diseases. It is a solid validation of the unique advantages of Biosion's Flexibody® bispecific platform for the novel bispecific antibody therapies development. We are excited about this innovative treatment and making a meaningful difference for patients worldwide. "
" Therapeutic innovation is at the core of the important work we do at Aclaris, and bispecific antibodies represent a groundbreaking innovation in immunotherapy that we believe will evolve the therapeutic armamentarium in a variety of settings, " said Dr. Hugh Davis, Aclaris' President and Chief Operating Officer. " Key to our license agreement with Biosion, Inc. were the rights to ATI-052, a potential best-in-class investigational bispecific antibody that exhibits a high binding affinity to, and dual blockade of, both the TSLP ligand and the IL-4 receptor, and as such inhibits a key central proinflammatory pathway. Developing bispecific antibodies for immuno-inflammatory disorders is of significant interest to Aclaris, and the clearance of the ATI-052 IND by the FDA is an important milestone in that regard. "
The randomized, blinded, placebo-controlled, Phase 1a/1b clinical trial will evaluate single and multiple ascending doses of ATI-052 followed by a proof-of-concept portion in an undisclosed indication. The Company expects to initiate the trial in the second quarter of 2025. Bispecific antibodies are engineered to have two distinct binding domains that can bind to two targets simultaneously. This dual binding and pathway inhibition potentially enhances efficacy over traditional monoclonal antibodies, with broad applications for the potential treatment of many immunemodulated diseases.
About ATI-052 (BSI-502)
ATI-052（BSI-502） is an investigational, potential best-in-class anti-TSLP/IL-4R bispecific monoclonal antibody being developed to treat certain immunoinflammatory diseases. ATI-052 targets thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor (IL-4R) that blocks both the upstream TSLP receptor signal transduction and downstream IL-4R activation which inhibits both IL-4 and IL-13 signaling, thereby inhibiting this central proinflammatory pathway and potentially offering enhanced efficacy through dual pathway inhibition. ATI-052 utilizes the same TSLP antigen-binding fragment (Fab) region as Bosakitug (ATI-045/BSI-045B), Aclaris’ investigational anti-TSLP monoclonal antibody, but is engineered to bind more tightly to the neonatal Fc receptor (FcRn), potentially extending its half-life. ATI-052 has the potential to treat a variety of atopic, immunologic and respiratory diseases. Aclaris has the exclusive worldwide rights to ATI-052, excluding Greater China.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on X (formerly Twitter) at @AclarisTx and on LinkedIn.
About Biosion
Biosion is a global clinical-stage biotechnology company focused on developing innovative antibody-based therapies to improve outcomes for patients with immune and oncologic diseases. Leveraging its proprietary technologies such as the H³ antibody discovery platform, SynTracer® HT endocytosis platform, and Flexibody® bispecific platform, Biosion creates highly differentiated medicines to address significant unmet medical needs worldwide. With its “discover-development-partnership” model, the company has forged 10 global collaborations, advancing eight clinical-stage assets, including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Biosion operates across the US, China, and Australia. Learn more at www.Biosion.com.
COPYRIGHT © 2023.
BIOSION ALL RIGHTS RESERVED.
BIOSION ALL RIGHTS RESERVED.
Biosion USA, Inc. 1 Innovation Way, Suite 300, Newark, Delaware 19711, USA
Copyright © 2022. Biosion All rights reserved. 苏ICP备2022027163号
Biosion USA, Inc. 1 Innovation Way, Suite 300, Newark, Delaware 19711, USA
BD@Biosion.com
1-302-257-5085
Biosion’s Partner Aclaris Therapeutics Announces FDA Clearance of IND Application for ATI-052, a Novel Bispecific Anti-TSLP/IL-4R Investigational Antibody
Release time:
2025-04-27 20:10:00
Newark, DE, U.S. and Nanjing, China, Apr. 27, 2025 —— Biosion, a global clinical-stage biotechnology company, announced that its partner, Aclaris Therapeutics, Inc. (NASDAQ: ACRS), has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1a/1b clinical trial of ATI-052 (BSI-502), a potential best-in-class bispecificanti-TSLP/IL-4R monoclonal antibody.
" We are very pleased to see Aclaris Therapeutics, receive FDA clearance for ATI-052 (BSI-502) . " said Kedan Lin, Ph.D., Chief Development Officer and President of Biosion US. " ATI-052 has strong therapeutic potential in immune inflammatory diseases. It is a solid validation of the unique advantages of Biosion's Flexibody® bispecific platform for the novel bispecific antibody therapies development. We are excited about this innovative treatment and making a meaningful difference for patients worldwide. "
" Therapeutic innovation is at the core of the important work we do at Aclaris, and bispecific antibodies represent a groundbreaking innovation in immunotherapy that we believe will evolve the therapeutic armamentarium in a variety of settings, " said Dr. Hugh Davis, Aclaris' President and Chief Operating Officer. " Key to our license agreement with Biosion, Inc. were the rights to ATI-052, a potential best-in-class investigational bispecific antibody that exhibits a high binding affinity to, and dual blockade of, both the TSLP ligand and the IL-4 receptor, and as such inhibits a key central proinflammatory pathway. Developing bispecific antibodies for immuno-inflammatory disorders is of significant interest to Aclaris, and the clearance of the ATI-052 IND by the FDA is an important milestone in that regard. "
The randomized, blinded, placebo-controlled, Phase 1a/1b clinical trial will evaluate single and multiple ascending doses of ATI-052 followed by a proof-of-concept portion in an undisclosed indication. The Company expects to initiate the trial in the second quarter of 2025. Bispecific antibodies are engineered to have two distinct binding domains that can bind to two targets simultaneously. This dual binding and pathway inhibition potentially enhances efficacy over traditional monoclonal antibodies, with broad applications for the potential treatment of many immunemodulated diseases.
About ATI-052 (BSI-502)
ATI-052（BSI-502） is an investigational, potential best-in-class anti-TSLP/IL-4R bispecific monoclonal antibody being developed to treat certain immunoinflammatory diseases. ATI-052 targets thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor (IL-4R) that blocks both the upstream TSLP receptor signal transduction and downstream IL-4R activation which inhibits both IL-4 and IL-13 signaling, thereby inhibiting this central proinflammatory pathway and potentially offering enhanced efficacy through dual pathway inhibition. ATI-052 utilizes the same TSLP antigen-binding fragment (Fab) region as Bosakitug (ATI-045/BSI-045B), Aclaris’ investigational anti-TSLP monoclonal antibody, but is engineered to bind more tightly to the neonatal Fc receptor (FcRn), potentially extending its half-life. ATI-052 has the potential to treat a variety of atopic, immunologic and respiratory diseases. Aclaris has the exclusive worldwide rights to ATI-052, excluding Greater China.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on X (formerly Twitter) at @AclarisTx and on LinkedIn.
About Biosion
Biosion is a global clinical-stage biotechnology company focused on developing innovative antibody-based therapies to improve outcomes for patients with immune and oncologic diseases. Leveraging its proprietary technologies such as the H³ antibody discovery platform, SynTracer® HT endocytosis platform, and Flexibody® bispecific platform, Biosion creates highly differentiated medicines to address significant unmet medical needs worldwide. With its “discover-development-partnership” model, the company has forged 10 global collaborations, advancing eight clinical-stage assets, including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Biosion operates across the US, China, and Australia. Learn more at www.Biosion.com.
COPYRIGHT © 2023.
BIOSION ALL RIGHTS RESERVED.
BIOSION ALL RIGHTS RESERVED.
Biosion USA, Inc. 1 Innovation Way, Suite 300, Newark, Delaware 19711, USA
Copyright © 2022. Biosion All rights reserved. 苏ICP备2022027163号
Biosion USA, Inc. 1 Innovation Way, Suite 300, Newark, Delaware 19711, USA
BD@Biosion.com
1-302-257-5085