ABL Bio Enters Global Collaboration and License Agreement with SANOFI to Advance ABL301 for the Treatment of Parkinson's Disease

• ABL and SANOFI to collaborate on the development of ABL301, a potential first-in-class bispecific antibody targeting alpha-synuclein and containing a proprietary brain shuttle, for alpha-synucleinopathies, including Parkinson's disease
• ABL301 uses ABL's Grabody-B platform technology to effectively cross the blood-brain barrier
• ABL to receive $75M upfront and up to $985M in potential milestone payments for exclusive global license to ABL301

SEONGNAM, South Korea, Jan. 11, 2022 /CNW/ -- ABL Bio, Inc. (KOSDAQ: 298380), 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.

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.

"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."

About ABL301

ABL301 is a bispecific antibody composed of an anti-alpha-synuclein antibody and Grabody-B, a BBB-penetrating shuttle targeting insulin-like growth factor 1 receptor (IGF1R). It is being developed as a potential first-in-class bispecific antibody therapeutics for the treatment of synucleinopathies, including 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.

About Grabody-B

Low brain exposure has been one of the major obstacles to the development of central nervous system (CNS) drugs. Grabody-B is a molecular shuttle to facilitate the CNS-penetration of therapeutics through straightforward generation of a bispecific antibody or antibody-drug conjugate. Grabody-B is a non-neutralizing anti-IGF1R antibody and therefore does not interfere with IGF1R signaling nor seriously affect the body's innate IGF1R axis. Grabody-B has proven to induce significantly higher BBB-penetration of various therapeutic antibodies in rodents and non-human primates with superior efficacy or pharmacodynamic effects compared to monoclonal antibodies. Given IGF1R's relatively specific expression in the CNS and its non-neutralizing property, Grabody-B is believed to be a safe and efficient shuttle to enhance the efficacy of therapeutics for various CNS-related diseases in clinics.

About ABL Bio

ABL Bio, Inc. (KOSDAQ: 298380) is a clinical-stage biotechnology company developing antibody therapeutics for immune-oncology and neurodegenerative diseases. With internal R&D and global partnerships, ABL has developed multiple BsAb platforms, such as 'Grabody-T,' 'Grabody-I' and 'Grabody-B' and built an innovative pipeline of multiple clinical and pre-clinical stage drug candidates. In the oncology area, we have developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, we have developed Grabody-B, which is designed to maximize blood-brain barrier (BBB) penetration. Grabody-B is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration. For more information, please visit www.ablbio.com.

Contact:
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SOURCE ABL Bio, Inc.

Dongeun Lee(Planning), [email protected], [phone]