ACELYRIN acquires ValenzaBio, strengthens immunology position

ACELYRIN, Inc., a Los Angeles area-based, late-stage clinical biopharma, with additional operations in the San Francisco Bay area, has announced it is acquiring privately held ValenzaBio – which develops therapies for autoimmune and inflammatory diseases – in an all-stock transaction.

The acquisition adds multiple clinical and pre-clinical immunology assets to the company’s own immunology pipeline – led by izokibep, a small therapeutic protein inhibitor of interleukin-17A (IL-17A), designed to overcome the limitations of monoclonal antibodies – and includes a potentially differentiated therapeutic for the treatment of thyroid eye disease (TED). As Dr Shao-Lee Lin, founder and CEO of ACELYRIN, commented: “The acquisition of ValenzaBio adds additional programmes to our portfolio, such as lonigutamab.”

Lonigutamab (VB-421) is a subcutaneously delivered anti-IGF-1R that is currently being evaluated in a phase 1 study for thyroid eye disease. It is estimated to be a market opportunity worth over $4 billion. Additionally, there is VB-517, a pre-IND anti-c-KIT being studied as a treatment option in chronic urticaria. The estimated market opportunity value for that is in excess of $2.5 billion.

Dr John Doux, a board-certified dermatologist, analyst at Palo Alto Investors, and chairman of the ValenzaBio board of directors, said: “I have long-standing respect for Shao-Lee and her colleagues at ACELYRIN, and firmly believe that they are best suited to further advance these immunology assets and transform how these diseases are treated.”

Doux continued: “I have confidence that this acquisition by ACELYRIN offers the greatest opportunity to drive value creation for the shareholders of ValenzaBio, and the patients we all strive to serve.”

In conjunction with the acquisition of ValenzaBio, Dr Doux will join the ACELYRIN board of directors.

Meanwhile, ACELYRIN is due to accelerate its development of izokibep in patients with moderate-to-severe Hidradenitis Suppurativa (HS), following a 30-patient open-label Part A of a phase 2b/3 trial, the top-line 12-week data from which found that izokibep achieves higher orders of Hidradenitis Suppurativa Clinical Responses (HiSCR).

Izokibep has been administered to over 300 patients, some for up to three years. The safety results from Part A of the phase 2b/3 trial were consistent with previous trials, as well as with the IL-17Ai class as a whole, with no increased risk of infection, including candida.

HS is an autoimmune disease characterised by inflammation of the exocrine glands, which leads to skin abscesses, pain, scarring, malodour, and has a devastating impact on patients’ quality of life. A double-blind, placebo-controlled Part B of the phase 2b/3 trial is ongoing, based on the Part A results.

Dr Lin said: “The previously shared phase 2 psoriatic arthritis data supports our hypothesis that the characteristics of izokibep can lead to differentiated patient outcomes relative to current treatment options, and the results reported separately […] for Hidradenitis Suppurativa now offer data in a second indication that further support that hypothesis.”