US-based drugmaker Aclaris Therapeutics has signed a licence agreement with Biosion to obtain rights to Biosion’s drug candidates BSI-045B and BSI-502 worldwide, except in Greater China.
Under the terms of the agreement, Biosion will receive more than $40m in upfront payment, license fee and compensation for certain development costs and drug product materials.
The Chinese biotech will also receive over $900m in regulatory and sales milestone payments, along with tiered royalties based on annual net sales of the drugs.
In addition, Biosion will receive 19.9% shares of Aclaris Therapeutics’ common stock.
As part of the transaction, Aclaris has appointed Hugh Davis as president and chief operating officer, Steven Knapp as executive vice president and regulatory and quality head.
Aclaris interim CEO and board of directors chairman Neal Walker said: “Despite recent advances with anti-TSLP and anti-IL4R therapies, there remains a substantial unmet need for more effective and convenient treatment options.
“BSI-045B’s compelling Phase 2a proof-of-concept data in atopic dermatitis, together with BSI-502’s dual-targeting approach, complement our existing ITK inhibitor portfolio, resulting in a pipeline of differentiated assets that target multiple high-value indications.
“In addition, the proceeds from the private placement financing announced this morning bolsters our balance sheet and provides us with enhanced financial flexibility to support our strategic growth while maintaining our cash runway into 2028.”
Biosion is a China-based biotechnology research company that has developed a portfolio of advanced biologics through its in-house developed technologies.
Its BSI-045B is a humanised monoclonal antibody that specifically binds to thymic stromal lymphopoietin (TSLP), to prevent immune cells from triggering an immune response.
The drug is being studied in multiple Phase 2 clinical trials in China by Biosion’s regional partner, Chia Tai Tianqing Pharmaceutical Group (CTTQ).
The Phase 2 studies target severe asthma and chronic rhinosinusitis with nasal polyps.
In a completed Phase 2a trial in the US, in 22 patients with moderate to severe atopic dermatitis, BSI-045B showed a promising pharmacodynamic, safety and efficacy profile.
BSI-502 is a novel bispecific antibody, directed against both TSLP and IL4R (interleukin-4 receptor), to block the central proinflammatory pathway, and is currently in pre-clinical development.
Leerink Partners and Cantor served as financial advisors, Cooley as corporate counsel and DLA Piper (US) as IP counsel to Aclaris, while Morgan, Lewis & Bockius served as counsel to Biosion, on the transaction.
Biosion founder and CEO Mingjiu Chen said: “Our proprietary antibody discovery platforms have enabled us to rapidly identify and optimise novel antibodies with exceptional potency and selectivity.
“BSI-045B and BSI-502 demonstrate the power of our discovery capabilities in generating potential first and best-in-class therapeutics.”
Biosion chief strategy officer Anthony Yeh said: “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.”
