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Helmed by Orbimed's Wang, Inmagene debues with phase II autoimmune program

 

BioCentury

2020年05月18日

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HELMED BY ORBIMED'S WANG, INMAGENE DEBUTS WITH PHASE II AUTOIMMUNE PROGRAM

lnmagene emerged from stealth with a clinical psoriasis program from Swedish biotech Affibody.

lnmagene emerged from stealth last week with plans to  expand the biologics markets in China. starting with a Phase II psoriasis program it in-licensed  from Swedish  biotech Affibody. The candidate, IMG-020, is expected to be cheaper to manufacture and more convenient to administer than marketed antibodies against the same target. 

According to lnmagene, biologics account for only 1796 of pharmaceutical sales for autoimmune diseases in China compared with 8096 in the U.S.

Chairman and CEO Jonathan Wang told BioCentury that biologics for autoimmune diseases have yet to establish themselves in China "because they are more expensive and many are unavailable in China." Wang is also a venture partner at OrbiMed, where he co-founded OrbiMed Asia.

lnmagene's management team includes CMO Wei Zhu, who was previously global immunology therapeutic area head at UCB S.A. (Euronext:UCB), and CBO Jimmy Wei, who has served as a managing partner at Pivotal bioVenture and iBridge Capital as well as a partner at Kleiner Perkins, where he was involved with the formation of companies Including Zai Lab Ltd. (NASDAQ:ZLAB) and I-Mab Biopharma (NASDAQ:IMAB).

On Friday, the company gained commercialization rights to protein-based IL-17A inhibitor IMG-020 (ABY-035) from Affibody AB in mainland China, Taiwan, Hong Kong, Macau and South Korea in exchange for a $10 million upfront payment and up to $215.5 million in milestones plus royalties. Outside of China, lnmagene will share development costs in return for undisclosed development milestone and royalty payments.

The candidate is in Phase II testing for plaque psoriasis and the partners plan to begin a global Phase 11/111 trial by year-end.

IMG-020 is capable of simultaneously binding both subunits of the IL-17A homodimer and consists of a non­ immunoglobulin scaffold linked to an albumin-binding domain to extend serum stability and tissue distribution. According to Affibody, both IL-17a and albumin are enriched in psoriatic skin.

Last year, Affibody reported interim results from the Phase II AFFIRM-35 study showing Ha high number" of  plaque psoriasis patients treated with IMG-020 exhibited 9096 improvement in psoriasis area and severity scores. Completion of the study is expected in by the end of June. 

The compound has been tested in over 150 patients and chronic use for up to two years has shown "a good safety profile," said Wang.

Several antibodies against IL-17A or its receptor IL17R have already reached the market for autoimmune conditions. Taltz ixekizumab from Eli Lilly and Co. (NYSE:LLY) and Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN), which target IL-17A, are each delivered via two subcutaneous injections, while Siliq brodalumab from Amgen Inc. (NASDAQ:AMGN), which targets the receptor, is delivered via a single injection.

Wang said IMG-020 is designed to be administered as a single injection, noting that its small size provides an opportunity to administer a higher dose per injection volume.

The molecule is about one eighth the size of an antibody, which also allows for better penetration. Wang said some sites of autoimmune disease, such as joints, are hard to penetrate with large molecules.

Furthermore, IMG-020 is produced in E. coli and is cheaper to manufacture than antibodies produced in mammalian cell lines. "The manufacturing cost per dose is only about one-twentieth of our competitors' costs," said Wang. "Some of the cost savings are expected to translate into more competitive pricing."

"The majority of the population here are still very price sensitive," he said, adding that patients in China have faced higher out-of-pocket costs than those in the U.S.

lnmagene plans to develop IMG-020 for five additional undisclosed autoimmune disorders.

The company is planning additional in-licensing deals from global partners to expand its pipeline with both biologics and small molecules. It will not conduct in-house discovery in the near term.

The company is in late-stage negotiations to gain two more clinical products, one finishing Phase II testing and one that has completed Phase I, said Wang.

Wang did not disclose specific targets the company is pursuing, but said lnmagene would remain generally focused on immunology, including autoimmune, asthma, allergy, transplant-related and immuno-oncology indications.

The company raised $20  million in a series A round in February and is negotiating to  raise over  $10 million more by 4Q20, said Wang. He said lnmagene is planning an IPO in Hong Kong or on NASDAQ in three to four years. Wang serves as a member the Hong Kong stock exchange's biotech advisory panel. The Hong Kong Exchanges and Clearing Ltd. (HKEX) launched Chapter 18A two years ago (see nHKEX's Biotech Chapter Shows All the Signs of a Sustainable Market").