FDA Clears IND of BSI-082 for Hematologic and Solid Tumors

• BSI-082 is a fully human anti-SIRPα antagonistic monoclonal antibody (mAb).

• When given with other mAbs, preclinical studies of BSI-082 have shown potent in vivo antitumor efficacy.

• This approval confirms the advantages and potential of the antibody technology platform from Biosion, Inc.

The FDA has granted clearance to an investigational new drug (IND) application for the novel anti-SIRPα mAb candidate BSI-082 for the treatment of hematologic and solid tumors.¹

BSI-082 is a best-in-class, highly differentiated, fully human anti-SIRPα antagonistic mAb which shows potential in combination with other therapies. The agent shows strong binding activity to huSIRPα variants V1/V2/V8 and is able to cover over 90% of human populations.

BSI-082 works by binding specifically to SIRPα and SIRPβ. The agent does not bind to SIRPγ. Once bound, it works by blocking the interaction of SIRPα to CD47, which enables tumor-associated macrophages and dendritic cells to resume their phagocytic activity against tumor cells while avoiding the broad toxicity issue that many CD47-targeting therapies encountered.

Tumor Cell:© nevio - stock.adobe.com

"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, PhD, founder and chief executive officer of Biosion, Inc., in a press release. "BSI-082 was discovered by Biosion's H³ antibody discovery platform that has delivered 7 clinical candidates in our global innovative pipeline. This IND approval once again validates the unique advantages and potential of our antibody technology platform."

In preclinical studies, BSI-082 demonstrated potent in vivo antitumor efficacy when given in combination with mAbs against tumor-associated antigens.

According to a poster presented at the 2022 American Association for Cancer Research Annual Meeting, BSI-082 was found to exhibit best-in-class biophysical properties.² In addition, the agent showed SIRPα specificity, broad SIRPα variant binding, and superior functional characteristics.

These findings support the commencement of IND-enabling studies as well as further manufacturing.

"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 [antibody-dependent cellular cytotoxicity]/[antibody-dependent cellular phagocytosis] activity, immune oncology therapies, and antibody drug conjugates to enhance both hematologic and solid tumor killing," said Hugh M. Davis, PhD, chief business and development officer and president of Biosion USA, Inc., in a press release.¹ "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."

REFERENCES:

1. Biosion announces FDA clearance of IND application for BSI-082, a novel anti-SIRPα monoclonal antibody. News release. January 24, 2024. Accessed January 24, 2024. http://tinyurl.com/yckb62be

2. Peng Z, Liu J, Dai W, et al. BSI-082, a fully human anti-SIRPα antibody with both high specificity and broad coverage of SIRPα variant populations. Cancer Res. 2022;82(12):5312. doi:10.1158/1538-7445.AM2022-5312