Biosion Announces Exclusive, Global License Agreement with Aclaris Therapeutics on two potential First-in-Class and Best-in-Class Immunology Assets

Rhea-AI Summary

Biosion has entered into an exclusive license agreement with Aclaris Therapeutics (NASDAQ: ACRS) for worldwide rights (excluding Greater China) to two immunology assets: BSI-045B and BSI-502. The deal includes an upfront payment of over $40 million, 19.9% of Aclaris common stock, and potential milestone payments exceeding $900M with tiered royalties.

BSI-045B, a clinical-stage anti-TSLP antibody, has shown promising results in a Phase 2a trial for atopic dermatitis with 22 patients. BSI-502 is a pre-clinical stage bispecific antibody targeting both TSLP and IL4R. The agreement grants Aclaris development and commercialization rights worldwide, except for Greater China.

Positive

• Substantial upfront payment of over $40 million plus 19.9% equity stake in Aclaris
• Potential milestone payments exceeding $900M with additional royalties
• Positive Phase 2a trial results for BSI-045B in atopic dermatitis
• Multiple ongoing Phase 2 studies for BSI-045B in additional indications

Negative

• None.

Insights

Financial Analyst

This licensing deal represents a significant financial milestone for both companies. The $40 million upfront payment plus 19.9% equity stake in Aclaris, combined with potential milestone payments exceeding $900 million, demonstrates substantial value recognition for Biosion's assets. The structure combines immediate cash benefits with long-term value potential through equity ownership and milestone-based compensation.

For Aclaris, this strategic acquisition expands their immunology portfolio with two promising assets - BSI-045B (Phase 2a completed) and BSI-502 (preclinical). The deal's financial structure, spreading payments across development stages, helps manage near-term cash outlays while maintaining significant upside potential through commercialization. The tiered royalty structure aligns interests for successful commercialization.

The Phase 2a results for BSI-045B in atopic dermatitis and ongoing Phase 2 studies in asthma and chronic rhinosinusitis suggest multiple potential revenue streams, reducing commercial risk through indication diversification.

Medical Research Analyst

The acquisition of BSI-045B and BSI-502 represents significant therapeutic potential in immunology. BSI-045B's novel anti-TSLP mechanism, combined with encouraging Phase 2a results in atopic dermatitis, positions it well in the competitive landscape. The potential first-in-class status could provide significant market advantage.

The dual-targeting approach of BSI-502 (TSLP and IL4R) is particularly noteworthy, as combination therapy approaches often show superior efficacy in immunological conditions. The ongoing Phase 2 studies across multiple indications (asthma and chronic rhinosinusitis with nasal polyps) suggest broad therapeutic potential, which could significantly expand the market opportunity.

• Biosion receives over $40 million cash payment as upfront license fee and reimbursement for certain development costs & drug product materials, and 19.9% shares of common stock of Aclaris Therapeutics; additional regulatory and sales milestone payments exceed $900M with tiered single digit sales royalty
• Aclaris Therapeutics will be responsible for development and commercialization of BSI-045B, a novel anti-TSLP monoclonal antibody, and BSI-502, a novel bispecific antibody that is directed against both TSLP and IL4R  worldwide (excluding Greater China)

NEWARK, Del. and NANJING, China, Nov. 18, 2024 /PRNewswire/ -- Biosion, Inc. (Biosion), a global R&D stage biotechnology company, today announced that it has entered into an exclusive license agreement with Aclaris Therapeutics (NASDAQ: ACRS) for worldwide rights (excluding Greater China) to BSI-045B, a potential First-in-class, clinical-stage, novel anti-TSLP monoclonal antibody, and BSI-502, a potential best-in-class, pre-clinical stage, novel bispecific antibody that is directed against both TSLP and IL4R.

Under the terms of the agreement, Biosion shall receive over $40 million cash payment as upfront license fee and reimbursement for certain development costs & drug product materials. Biosion shall also receive 19.9% shares of common stock of Aclaris Therapeutics. Additional regulatory and sales milestone payments exceed $900M with tiered low-to-mid single digit royalty based upon a percentage of annual net sales.

"This transaction once again validates our proprietary antibody discovery platforms, BSI-045B and BSI-502 demonstrate the power of our discovery capabilities in generating potential first-in-class and best-in-class therapeutics." said Mingjiu Chen, Ph.D., Founder and CEO of Biosion. "Together with our global partners through the complementary expertise and resources, we hope to bring more transformative medicines to patients worldwide."

"This transaction marks Biosion's ninth and tenth global partnered programs under our 'discover-development-partnership' model," said Anthony Yeh, Ph.D., Chief Strategy Officer of Biosion. "This partnership accelerates the worldwide clinical development of two key assets while securing the financial resources necessary to advance our other innovative programs to IND filings."

In a completed Phase 2a, single-arm, proof-of-concept trial in the United States in 22 patients with moderate to severe atopic dermatitis, BSI-045B was observed to have a pharmacodynamic, safety and efficacy profile that could position it as a potential best-in-class therapy. BSI-045B is also being advanced in multiple Phase 2 studies in China by Biosion's regional partner, Chia Tai Tianqing Pharmaceutical Group, Co., Ltd. (CTTQ), targeting both severe asthma and chronic rhinosinusitis with nasal polyps, accelerating the potential to show proof-of-concept across additional indications.

"This strategic transaction brings together Biosion's innovative programs with our development capabilities in immunology, and we are excited to enhance our portfolio with these compelling assets," said Dr. Neal Walker, Interim CEO and Chair of the Board of Directors of Aclaris. "We look forward to further developing these assets in our quest to deliver exceptional therapies for patients worldwide."

About BSI-045B

BSI-045B is a humanized anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody that specifically binds to human TSLP, blocking its interaction with the receptor complex and disrupting signal transduction. This mechanism prevents immune cells targeted by TSLP from releasing proinflammatory cytokines. BSI-045B is currently in clinical development, and its safety and efficacy have not been evaluated by regulatory authorities.

About BSI-502

BSI-502 is a humanized anti-TSLP and anti-interleukin 4 receptor (IL4R) bispecific antibody that blocks both the upstream TSLP receptor signal transduction and downstream IL4R activation thereby inhibiting this central proinflammatory pathway. BSI-502 is currently in pre-clinical development, and its safety and efficacy have not been evaluated by regulatory authorities.

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 seven 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. 

 

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SOURCE Biosion, Inc.

FAQ

What are the financial terms of Biosion's license agreement with Aclaris (ACRS)?

The agreement includes over $40 million in upfront payments, 19.9% of Aclaris common stock, potential milestone payments exceeding $900M, and tiered low-to-mid single digit royalties based on annual net sales.

What are the two immunology assets licensed to Aclaris (ACRS)?

The assets are BSI-045B, a clinical-stage anti-TSLP monoclonal antibody, and BSI-502, a pre-clinical stage bispecific antibody targeting both TSLP and IL4R.

What were the results of BSI-045B's Phase 2a trial?

In a Phase 2a trial with 22 patients with moderate to severe atopic dermatitis, BSI-045B demonstrated a pharmacodynamic, safety and efficacy profile that could position it as a potential best-in-class therapy.