With three new strategic agreements, Almirall, S.A. is set to strengthen their early-stage research portfolio and expand their pipeline in medical dermatology.
Alimirall and 23andMe have signed an agreement allowing Almirall to in-license 23andMe's bispecific monoclonal antibody designed to block all three members of the IL-36 cytokine subfamily. This family is associated with multiple inflammatory diseases, including various dermatological conditions.
In addition, Almirall and WuXi Biologics signed a strategic collaboration agreement for multiple bispecific antibodies targeting dermatology diseases including atopic dermatitis. Under the terms of the agreement, Almirall has access to WuXi Biologics' proprietary antibody platforms including WuXiBody to discover multiple novel bispecific antibodies. This strategic collaboration permits Almirall to develop the medication under license and maintain ownership for medical use of the resulting components.
Almirall also entered into an option agreement to acquire Bioniz Therapeutics, Inc. for full global rights to BNZ-1, a multicytokine inhibitor that selectively blocks the activity of three cytokines of the same family: IL-2, IL-9 and IL1-15, currently in phase 1/2 development for refractory Cutaneous T-cell Lymphoma. If Almirall exercises the option, it will also enter into a broader research agreement with Bioniz NewCo, using its multiple cytokine inhibitor platform with the objective to deliver at least 3 IND-approved candidates.
BNZ-1 is also being developed for the treatment of alopecia areata. BNZ-01 has been evaluated in Ph1 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) and is currently being evaluated in a Phase 1/2a study in CTCL patients and ready to start a Phase 2 PoC study in Alopecia Areata.
Under the terms of the agreement, Almirall will make an initial payment of $15 MM to Bioniz in exchange for an option to acquire all Bioniz outstanding shares. Following the availability of phase 1/2 results in CTCL, certain human biomarkers laboratory data and the official FDA End of Phase 2 meeting minutes, Almirall will have 60 days to exercise its option. If Almirall elects to exercise its option, the company will pay an option exercise fee of $47 MM in different installments in the following years. Almirall will make additional payments upon the achievement of certain development, regulatory and commercial milestones.