StemCell Therapy

Ablynx said today it will receive a 15 million ($16.9 million) milestone payment from Merck KGaA after the pharma giant approved its preclinical package for ALX-1141, setting the stage for advancing the osteoarthritis candidate into clinical studies.

Merck KGaA will oversee clinical development of ALX-1141, Ablynx said.

ALX-1141 is the first candidate to be developed through a 6-year-old collaboration between the companies. Ablynx and Merck KGaA agreed in 2011 to develop candidates against two Merck-selected osteoarthritis targets, with Merck at the time agreeing to pay Ablynx 20 million ($22.5 million) upfront.

Ablynx is eligible for approximately 120 million ($135 million) in development, regulatory, and commercial milestones, plus tiered royalties into double digits, upon successful development and approval of ALX-1141.

ALX-1141 and the second osteoarthritis candidate are being developed using Ablynxs platform based on single-domain antibody fragments, or Nanobodies, that contain the unique structural and functional properties of naturally occurring heavy-chain-only antibodies. According to Ablynx, the platform is designed to allow for rapid generation and large-scale production of novel biological therapeutics that have potential in a wide range of human diseases.

Obtaining preclinical proof-of-concept was an important milestone in this collaboration, Ablynx CEO Edwin Moses, Ph.D., said in a statement. With no disease-modifying drugs currently approved for osteoarthritis, there is a huge unmet need for new treatments. This Nanobody has the potential to become a first-in-class treatment option for patients suffering from this degenerative joint disease.

Dr. Moses added that ALX-1141 is the second Nanobody expected to enter clinical development from any of four collaborations between Ablynx and Merck KGaA. The other is a bispecific anti-interleukin (IL)-17A/F (M1095) Nanobodydesigned to neutralize the proinflammatory cytokines IL-17A and IL-17Fwhich showed positive results as a psoriasis treatment in a Phase Ib study, the companies said in January.

In February, Ablynx included among its significant clinical and regulatory catalysts anticipated for 2017 the potential advancement to the clinic of another Nanobodya cancer candidate co-developed with Merck & Co. under a 5.78 billion ($6.5 billion) immuno-oncology collaboration launched in 2014 and expanded the following year.

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Ablynx Wins 15M from Merck KGaA as Arthritis Candidate Nears Clinic - Genetic Engineering & Biotechnology News

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