aibioAclaris Therapeutics licenses two Biosion antibodies, ends strategic review
Tickers ACRS
Aclaris also pointed to a private placement financing announced the same morning and said it maintains its cash runway into 2028. The release gives no license payment terms.
Key facts
- Company
- Aclaris Therapeutics, Inc. (NASDAQ: ACRS)
- News type
- Financings
- Primary source
- Aclaris Therapeutics, Inc. 8-K (2024-11-18)
Aclaris Therapeutics, Inc. (Nasdaq: ACRS) said on November 18, 2024 that it has entered into an exclusive license agreement with Biosion, Inc. for worldwide rights, excluding Greater China, to two antibody drug candidates. The company, a clinical-stage biopharmaceutical business focused on immuno-inflammatory diseases, said the deal marks the completion of its strategic review process. The details come from an exhibit to its current report.
What Aclaris licensed
The first candidate, BSI-045B, is a humanized anti-TSLP monoclonal antibody in clinical development. TSLP is thymic stromal lymphopoietin, and the antibody is designed to block its interaction with the receptor complex and so stop immune cells from releasing proinflammatory cytokines. The second, BSI-502, is a humanized bispecific antibody aimed at both TSLP and the interleukin 4 receptor, or IL4R, and is in pre-clinical development. Aclaris itself notes that regulators have not evaluated the safety or efficacy of either one.
The only human data cited are from a completed Phase 2a, single-arm, proof-of-concept trial in the United States in 22 patients with moderate to severe atopic dermatitis. Aclaris says BSI-045B was observed to have a pharmacodynamic, safety and efficacy profile that could position it as a potential best-in-class therapy. That is a company characterization of a small study with no control group, and the release gives no efficacy numbers. Biosion's regional partner, Chia Tai Tianqing Pharmaceutical Group, Co., Ltd., is advancing BSI-045B in multiple Phase 2 studies in China, in severe asthma and in chronic rhinosinusitis with nasal polyps. Those studies fall outside the territory Aclaris licensed.
Terms, financing and advisors
The release does not disclose an upfront payment, milestones or royalties. It does say that proceeds from a private placement financing announced the same morning bolster the balance sheet and support the company's cash runway into 2028. Interim CEO and Board Chair Dr. Neal Walker called the transaction "transformative" and said it accelerates the company's evolution into a leading immunology company with both small and large molecule drugs. The release does not give the size or terms of the placement.
Leerink Partners and Cantor acted as financial advisors to Aclaris on the license transaction. Cooley LLP acted as corporate counsel and DLA Piper LLP (US) as IP counsel to Aclaris, and Morgan, Lewis & Bockius acted as counsel to Biosion. The release names no placement agents for the private placement.
New leadership
Aclaris also added two executives. Hugh Davis, Ph.D., joins as President and Chief Operating Officer, bringing more than 35 years of experience in biologics development, clinical pharmacology and business development from roles at Biosion, Frontage, GSK, and Johnson & Johnson. Steven Knapp, PharmD, joins as Executive Vice President, Head of Regulatory & Quality, with more than 35 years of regulatory and quality experience from positions at Biosion, Antares, Valeant, and BMS. Dr. Davis and Mr. Knapp both previously held roles at Biosion, the licensor, a connection the release does not discuss further.
James Loerop, Chief Business Officer of Aclaris, said the deal brings Biosion's and Aclaris' programs together with Aclaris' development capabilities in immunology and creates a diversified pipeline across immunologic and respiratory indications. Mingjiu Chen, Ph.D., Biosion's founder and CEO, said BSI-045B and BSI-502 show the power of its antibody discovery platforms.
What the deal means for the company
Aclaris described its existing pipeline as including an ITK inhibitor portfolio, and it now adds biologics to what it calls a multi-stage portfolio of drug candidates powered by protein kinase regulation. The company says the new assets complement that work and target multiple high value indications. It also acknowledges, in its cautionary note, risks that include the uncertainty inherent in clinical trials, its reliance on third parties it does not fully control, and its ability to enter into strategic partnerships on commercially reasonable terms.
The company held a conference call at 8:30 AM ET on the day of the announcement to discuss the transaction and give a corporate update. Investors have so far been given the strategic rationale, the data from 22 patients and the advisers involved, but not the financial terms of the license.