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Inmagene of Shanghai Partners Affibody's Novel Immunotherapy Candidate
Inmagene Biopharma of Shanghai acquired greater China rights to a bispecific molecule aimed at Interleukin-17A (IL-17) for multiple autoimmune diseases from Sweden's Affibody AB. ABY-035 is currently undergoing a German Phase II trial in patients with psoriasis, where it has shown clear clinical benefits and a good safety profile. Inmagene will be responsible for commercialization in Greater China and South Korea along with development activities in Asia Pacific region, excluding Japan.
Affibody will retain global commercial rights outside of Greater China and South Korea. The partners will collaborate on global registrational trials to support Biologics License Applications (BLAs) in multiple indications worldwide.
With subsidiaries in Shanghai, Hangzhou and Beijing, Inmagene wants to be a leading company in developing immunology therapies for China. The Affibody IL-17 candidate is the company's only disclosed candidate, although its website shows four other unspecified projects in development.
Inmagene's Chairman and CEO is Jonathan Wang, PhD, who is also Venture Partner at OrbiMed, a prominent China investor in life science companies. Dr. Wang is experienced in drug development and in developing pharmaceutical companies.
Inmagene says its pipeline is comprised of clinical stage drug candidates with first- or best-in-class potential licensed from global partners. Inmagene has also established the ability to conduct innovative research and pre-clinical development, pushing drug candidates from discovery to clinical stages.
According to Affibody, ABY-035 was produced by its proprietary protein therapeutics platform (Affibody® technology), which confers greater potency in a small molecular format, and the Albumod™ technology which provides a long half-life. The company expects the result will be a best-in-class efficacy in a convenient, less frequent and at-home subcutaneous administration.
“Based on ABY-035’s strong clinical data and significant advantages over antibody-based IL-17 therapies, we believe it has the best-in-class potential,” said Inmagene’s Dr. Wang. “ABY-035 may provide affordable solutions to Chinese patients with high unmet medical needs and become a key pillar for Inmagene to establish a leadership position in China’s immunology related therapeutic areas.”
With experience in bringing multiple relevant biologics targeting IL-17, IL-1, IL6, T cell and B cell to China as well as US and European markets, the Inmagene clinical development team will work closely with Affibody to conduct global trials in multiple regions to shorten the development timelines. Inmagene will lead global development strategy and implementation in two indications.
“This creative alliance between Affibody and Inmagene is poised to deliver on ABY-035’s best-in-class potential by accelerating the time to commercialization across multiple indications and accessing a significant market opportunity in Greater China” said David Bejker, CEO of Affibody.
“With the extensive track record of the Inmagene team, we will be able to leverage access to the Chinese market, providing additional opportunities for development and commercialization. The team’s vision of creating the leading Chinese immunology company is one we are excited to be a part of.”
ABY-035 is a novel bispecific agent, potently targeting subunits of IL-17A as well as albumin, which has been specifically designed to utilize the strengths of Affibody’s technology platform to create a very small protein drug (18 kDa, an eighth of the size of an antibody) with very high apparent affinity to IL-17A (KD ~300fM) and antibody-like half-life due to the strong (KD ~50pM) binding affinity to serum albumin.
Accumulated patient data from ~150 psoriasis patients, some of whom have been dosed for more than two years, support the partners' goal of best-in-class potential.
ABY-035 is currently being evaluated in an open-label extension of a double-blinded, placebo controlled, 52 week, Phase II proof-of-concept study. AFFIRM-35 has enrolled 108 moderate-to-severe psoriasis patients in centers throughout Germany to evaluate the efficacy, safety and tolerability of ABY-035. The primary efficacy measure is PASI 90 at twelve weeks. Secondary endpoints include absolute and relative PASI-measures at weeks 12, 24, and 52; DLQI; itch and pain VAS; safety and tolerability, and pharmacokinetics.