On May 15, 2020 Affibody AB ("Affibody") and Inmagene Biopharmaceuticals ("Inmagene") reported a strategic partnership to develop and commercialize ABY-035, a bispecific molecule targeting Interleukin-17A (IL-17), for multiple auto-immune diseases (Press release, Affibody, MAY 15, 2020, View Source [SID1234575707]). Inmagene will be responsible for commercialization in mainland China, Hong Kong, Taiwan, and Macau (Greater China), and South Korea, as well as development activities in the Asia Pacific region, excluding Japan. Affibody will retain global commercial rights outside of Greater China and South Korea. The partners will work together to enroll patients into global registrational trials to support Biologics License Applications (BLAs) in multiple indications worldwide.

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Under the terms of the agreement, Affibody will receive a $10 million upfront payment and is eligible to receive up to $215.5 million in additional regulatory and sales milestones, plus royalties on sales in Inmagene’s commercialization territory. Additionally, Inmagene will share the global development costs of select clinical trials and be eligible to receive payments and royalties from Affibody relating to certain global development and commercialization milestones. Affibody will be responsible for the manufacturing and supply of ABY-035 for development and commercialization worldwide and is not precluded from additional collaboration and licensing agreements in territories not covered by this agreement.

Currently in Phase 2 development, ABY-035 is an innovative fusion protein targeting IL-17. ABY-035 combines Affibody’s 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. Together, these features provide the potential for best-in-class efficacy in a convenient, less frequent and at-home subcutaneous administration. In the ongoing Phase 2 Psoriasis Trial, ABY-035 has demonstrated a strong safety profile and clear clinical benefits.

"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 Jonathan Wang, Ph.D., Inmagene’s Chairman and CEO. "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 rich experience in bringing multiple relevant biologics targeting IL-17, IL-1, IL6, T cell and B cell to China as well as the US and Europe 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 take the lead of the 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."

About ABY-035

ABY-035 is a novel bispecific agent, potently targeting both 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 which have been dosed for more than two years, support a safe and efficacious product profile with best-in-class potential.

ABY-035 is currently being evaluated in an open-label extension of the double-blinded, placebo controlled, 52 week, Phase 2 proof-of-concept study (AFFIRM-35, NCT03591887) which 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.

In a Phase 1/2 study, ABY-035 demonstrated favorable safety and tolerability across multiple doses and dosing regimens with rapid and sustained efficacy in patients. The primary objective of this study was to evaluate mechanism of action, safety, tolerability and pharmacokinetics of ABY-035.