Amgen, Kyowa Kirin Renew Long-Standing Partnership to Promote Atopic Dermatitis Therapy

On June 1st, Amgen and Kyowa Kirin announced they would co-develop and commercialize KHK4083, a potential first-in-class anti-OX40 human monoclonal antibody, a new therapy against atopic dermatitis. This collaboration worth more than $1.2 billion extends a long and successful partnership between the two companies. A previous partnership had yielded both companies their first approved medicine.

OX40 stimulates T cell proliferation and survival, and it is present in the surface of effector T cells. These T cells are present in lesions of atopic dermatitis, which is a chronic disease characterized by an overactive immune system and inflammation that leads to damage of the skin. Current treatments include corticosteroids and a new FDA-approved monoclonal antibody Dupixent against IL-4 and IL-13. New therapies are necessary to address patient’s needs.

Agreement Terms

KHK4083 is a monoclonal antibody with antibody-dependent cellular cytotoxicity. It was developed by Kirin using its proprietary POTELLIGENT defucosylation technology. In a randomized, double-blind, placebo-controlled Phase 2 clinical trial, KHK4083 decreased the area affected and provided significant improvement over placebo after 16 weeks of treatment.

As per the terms of the agreement, Amgen will develop, manufacture, and commercialize KHK4083 for all international markets, except Japan where Kyowa Kirin will retain rights. Both companies will co-promote KHK4083 in the US, and Kirin can opt-in to co-promote in certain other markets. Amgen would pay $400 million up-front to Kirin, and up to $850 million based on milestones. Kirin will also receive significant royalties in future sales. Additionally, Amgen will use its deCODE Genetics subsidiary to determine possible indications beyond atopic dermatitis.

“Kyowa Kirin was one of Amgen’s very first collaborators and we are delighted to be joining forces with them once again to advance this promising late-stage asset to treat atopic dermatitis,” said Robert A. Bradway, chairman, and chief executive officer at Amgen. “We will take advantage of our two decades of experience in inflammatory disease, as well as our industry-leading human genetics capabilities, to help realize the full potential of KHK4083 as quickly as possible.”

OX40 as a Checkpoint Inhibitor

Apart from regulating effector T cells, OX40 can block the generation of regulatory T cells. In mouse studies, inhibiting OX40 has led to an increase in antitumor T cell activity when combined with a checkpoint inhibitor. At least three companies are investigating the efficacy of anti-OX40 antibodies against cancer. These include:

• Pfizer with PF-04518600. Currently in Phase 2 against breast cancer.
• Bristol Myers Squibb with BMS-986178. Currently in Phase 1 against neoplasm, and several types of lymphoma.
• Abbvie with ABBV-368. Currently in Phase 1 against solid tumors.

The safety of KHK4083 has been tested in a Phase 2 clinical trial and is currently preparing to enter Phase 3 for atopic dermatitis. However, Amgen and Kirin have a safe and effective OX40 inhibitor that they could potentially use for cancer treatment.

Related Article: We Have a Winner! Amgen Grabs First FDA Nod in the Race for Undruggable KRAS

Author

Daniel Ojeda