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Sanofi pays ABL Bio $75M to jump into α-synuclein race, betting on best-in-class potential

입력 2022-01-12 10:56 수정 2022-01-12 10:56

by Sungmin Kim

FDA phase 1 IND submission of ABL301 expected this year... Expected to receive $45 million in near-term milestones

ABL Bio, a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, today announced an exclusive collaboration and worldwide license agreement with SANOFI to develop and commercialize ABL301, a pre-clinical stage bispecific antibody targeting alpha-synuclein and IGF1R to treat Parkinson's disease and other potential indications with enhanced blood-brain barrier (BBB) penetration.

Under the terms of the agreement, ABL will receive $75 million in upfront payments. In addition, ABL is eligible to receive up to $985 million based on the achievement of predefined development, regulatory and commercialization milestones, including $45 million in near-term milestones. ABL is also eligible to receive royalties on net sales if the product from the collaboration is commercialized. The transaction will become effective after customary closing conditions are met, such as the HSR clearance.

SANOFI will receive worldwide exclusive development and commercialization rights to ABL301. Meanwhile, ABL will lead the preclinical development and Phase 1 clinical trial of ABL301. Thereafter, SANOFI will be responsible for further clinical development, regulatory approval and commercialization of ABL301 worldwide.

ABL Bio is expected to submit a phase 1 IND for ABL301 to the FDA this year, and is expected to receive a near-term milestone.

Grabody-B is a BBB shuttling platform that targets the insulin-like growth factor 1 receptor (IGF1R) to maximize BBB penetration of potential therapies for various CNS-related diseases. Utilizing Grabody-B technology, ABL301 effectively carries the anti-alpha-synuclein antibody across the BBB to enhance therapeutic efficacy against Parkinson's disease.

In preclinical studies, ABL301's anti-alpha-synuclein domain showed robust recognition of pathological aggregates with high affinity and with minimal affinity to monomeric alpha-synuclein. By utilizing the Grabody-B platform, ABL301 is proven to enter the brains and cerebrospinal fluid (CSF) of rodents and non-human primates more efficiently than an alpha-synuclein monoclonal antibody. Due to its superior BBB-penetrating capability, ABL301 showed better efficacy to reduce brain aggregated alpha-synuclein in a Parkinson's disease mouse model than the monoclonal alpha- synuclein binding antibody.

"This groundbreaking partnership with SANOFI proves the immense possibilities of ABL's innovative bispecific antibody technology." said Sang Hoon Lee, PhD, CEO of ABL Bio. "We will continue to develop our Grabody-B platform and expand its applicability in other neurodegenerative diseases, such as Alzheimer's, to contribute to improving the lives of patients worldwide."

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