SAR446159 / ABL Bio, Sanofi - LARVOL DELTA

Sanofi advances Parkinson's drug ABL301 to Phase 2, expects royalties from partnership (Chosun Biz) - "'We have completed the Phase 1 clinical trial of the Parkinson's disease treatment agent 'ABL301,' conducted in collaboration with France's Sanofi, and we are currently analyzing the results. Phase 2 will be transferred to Sanofi and is expected to proceed without any setbacks'....The company will receive additional milestones from Sanofi upon entering Phase 2."

Financing • Trial completion • Parkinson's Disease

This is a Study to Evaluate the Safety, Tolerability, PK and PD of IV Administered ABL301 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=91 | Completed | Sponsor: ABL Bio, Inc. | Recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Apr 2025 | Trial primary completion date: Jan 2025 ➔ Apr 2025

Trial completion • Trial completion date • Trial primary completion date

ABL Bio, Parkinson's Disease New Drug 'ABL301' Phase 1 Data Confirmation Imminent [Google translation] (News1 Korea) - "The announcement of the results of the phase 1 clinical trial of 'ABL301' (Sanofi name SAR446159), a new drug candidate for degenerative brain diseases such as Parkinson's disease currently under development by ABL Bio (298380), is imminent...According to industry sources on the 20th, ABL Bio is currently conducting a phase 1 clinical trial of ABL301 with Sanofi and is close to confirming the data."

Trial status • Parkinson's Disease

A BRAIN-SHUTTLED ANTIBODY TARGETING ALPHA SYNUCLEIN AGGREGATES FOR THE TREATMENT OF SYNUCLEINOPATHIES (ADPD 2025) - "In wild type (WT) mice injected in the striatum with aSyn PFFs, treatment with SAR446159 reduced the spread of aSyn pathology as measured by pSer129 aSyn staining and lowered the severity of motor phenotypes. Conclusions The properties of SAR446159 provided the rationale to advance this this next-generation immunotherapeutic for treating neurodegenerative diseases into the clinic."

CNS Disorders • Movement Disorders • Multiple System Atrophy • Parkinson's Disease

ABL Bio Announces BBB Shuttle Platform 'Grabbody-B' at Keystone Symposia [Google translation] (HIT News) - "ABL Bio (CEO Sanghoon Lee) announced on the 13th that it will introduce the research results of its blood-brain barrier (BBB) ​​shuttle platform 'Grabody-B' through posters and oral presentations at the 'Keystone Symposia' to be held from the 17th to the 20th (local time)...The GrabBody-B to be announced by ABL Bio is a BBB shuttle platform based on the insulin-like growth factor 1 receptor (IGF1R), a technology that promotes BBB penetration of antibodies and increases the brain delivery rate of drugs. A representative application case of the platform is 'ABL301', a Parkinson's disease treatment technology transferred to the global pharmaceutical company Sanofi....ABL Bio explained that they will present the results of this study orally upon request by the Keystone Symposia."

Preclinical • Parkinson's Disease

Sanofi, ABL301 introduced by ABL Bio, Phase 1 is going smoothly… Last year's sales 62 trillion 11% [Google translation] (The Bio) - "According to clinical trial information site ClinicalTrials.gov, Phase 1 clinical trial is expected to be completed within this month, and the study is expected to be completed within the first half of the year. The industry expects ABL301 to enter Phase 2 clinical trial in the first half of this year."

New P2 trial • Trial status • Parkinson's Disease

ABL Bio Completes Transfer of ABL301 Manufacturing Technology to Sanofi [Google translation] (Medipana) - "ABL Bio...announced on the 28th that it has completed the manufacturing technology transfer of ABL301, a dual antibody candidate for the treatment of degenerative brain diseases such as Parkinson's disease, to Sanofi and will receive a milestone (stage-by-stage technology fee) of 5 million dollars (approximately 7 billion won)."

Commercial • CNS Disorders • Parkinson's Disease

ABL Bio’s ’ABL001’ to Seek FDA Accelerated Approval Next Year [Google translation] (WikiLeaks Korea) - "The goal for ABL301, a Parkinson's disease treatment, is to announce phase 1 results in the first half of next year and enter phase 2."

New P2 trial • P1 data • CNS Disorders • Parkinson's Disease

This is a Study to Evaluate the Safety, Tolerability, PK and PD of IV Administered ABL301 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=86 | Recruiting | Sponsor: ABL Bio, Inc. | N=40 ➔ 86 | Trial completion date: Sep 2023 ➔ Jan 2025 | Trial primary completion date: Sep 2023 ➔ Jan 2025

Enrollment change • Trial completion date • Trial primary completion date

A BRAIN-SHUTTLED ANTIBODY TARGETING ALPHA SYNUCLEIN AGGREGATES FOR THE TREATMENT OF SYNUCLEINOPATHIES (ADPD 2024) - "The in vitro and in vivo properties of SAR446159 supported the clinical translation of this next-generation immunotherapeutic molecule. Phase I clinical trials were started in late 2022."

CNS Disorders • Movement Disorders • Multiple System Atrophy • Parkinson's Disease

ABL Bio approves application for change to US phase 1 clinical trial for ABL301 [Google translation] (MedigateNews) - "ABL Bio announced on the 18th that the application to change the phase 1 clinical trial plan (IND) submitted for high-dose administration of ABL301 was approved by the U.S. Food and Drug Administration (FDA) on the 17th (local time)....Approximately 56 people will participate in the single dose escalation trial and approximately 30 people will participate in the multiple dose escalation trial. The purpose of this phase 1 trial, led by ABL Bio, is to confirm the safety and tolerability of ABL301 when administered single or repeatedly to healthy adults. ABL Bio plans to evaluate safety and tolerability through indicators such as Adverse Events (AE), Treatment-Emergent Adverse Events (TEAE), and Serious Adverse Events (SAE)."

Clinical protocol • IND • CNS Disorders • Parkinson's Disease

ABL Bio, Parkinson’s disease treatment ’ABL301’ Submission of application for change to U.S. Phase 1 [Google translation] (HIT News) - "ABL Bio...submitted a protocol amendment application (Protocol Amendment) for phase 1 clinical trials for high-dose administration of Parkinson's disease treatment 'ABL301 (development code name)' to the U.S. Food and Drug Administration on the 19th. It was announced that it had been submitted to the FDA. After the change application is approved, ABL Bio plans to conduct single-ascending dose and multiple-ascending dose tests for high doses of ABL301 exceeding 20 mg/kg. Accordingly, ABL Bio will confirm the safety and tolerability of single or repeated administration of ABL301 to healthy adults through phase 1 clinical single dose escalation tests and multiple dose escalation tests."

IND • New P1 trial • CNS Disorders • Parkinson's Disease

A brain-shuttled antibody targeting alpha synuclein aggregates for the treatment of synucleinopathies (Neuroscience 2023) - "Moreover, the IGF1R-binding shuttle enabled greater uptake into the endo-lysosomal trafficking pathway of neurons, potentially allowing this antibody to engage aSyn aggregates both intracellularly and extracellularly. These unique properties make SAR446159 a next-generation immunotherapeutic for treating neurodegenerative diseases."

CNS Disorders • Multiple System Atrophy • Parkinson's Disease

This is a Study to Evaluate the Safety, Tolerability, PK and PD of IV Administered ABL301 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: ABL Bio, Inc.

New P1 trial

ABL Bio, ABL301 US phase 1 IND application for change [Google translation] (Dementia News) - "ABL Bio applied to the US Food and Drug Administration (FDA) to change the phase 1 clinical trial plan for 'ABL301 (test substance name)', a candidate substance for the treatment of Parkinson's disease....The previously applied clinical trial is to confirm the safety and tolerability of ABL301 intravenous injection in single dose escalation (SAD) or multiple dose escalation (MAD) to healthy adult participants. According to the disclosure, ABL Bio decided to first check the safety and tolerability of intravenous ABL301 single dose escalation (SAD) administration to 40 healthy adults through phase 1 clinical trials. Here, the SAD cohort was reduced from 6 to 5. As a secondary goal, the company plans to identify the pharmacokinetic properties of ABL301 in serum and cerebrospinal fluid, and evaluate the immunogenicity of ABL301 in serum."

IND • New P1 trial • CNS Disorders • Parkinson's Disease

ABL Bio Starts Phase 1 of Parkinson's Disease Treatment 'ABL301' [Google translation] (Dementia News) - "ABL Bio announced...that it had submitted a phase 1 clinical trial plan (IND) to the US Food and Drug Administration (FDA) on the 30th (local time) of last month (local time) for the dual antibody candidate ABL301 for the treatment of degenerative brain diseases such as Parkinson's disease....ABL Bio plans to confirm the safety and tolerability of ABL301 intravenous injection as single-dose escalation (SAD) or multiple-dose escalation (MAD) to 68 healthy adults through this clinical trial. Afterwards, the pharmacokinetic properties of ABL301 in serum and cerebrospinal fluid and the immunogenicity of ABL301 in serum will be evaluated."

IND • New P1 trial • CNS Disorders • Parkinson's Disease

A milestone following the completion of non-clinical toxicity testing..“Scheduled to apply for US Phase 1 IND in the fourth quarter of this year” [Google translation] (Biospectator) - "ABL Bio announced on the 15th that it would receive the first short-term milestone of $20 million (about 27.8 billion won) from Sanofi for 'ABL301', a candidate drug for Parkinson's disease. The amount will be paid within 45 days of Sanofi....As ABL Bio completed its non-clinical toxicity study (GLP tox study), it received $20 million out of $45 million in short-term milestones. ABL Bio plans to submit a phase 1 clinical trial plan (IND) to the US FDA in the fourth quarter of this year as planned, and in addition to the $20 million inflow this time, an additional short-term milestone of $25 million will be additionally received according to the progress of clinical development of ABL301. ABL Bio will lead the phase 1 clinical trial of ABL301, and Sanofi will be in charge of the phase 2 clinical trial thereafter."

Commercial • IND • New P1 trial • CNS Disorders • Parkinson's Disease

ABL Bio, 'Article 1.3 technology transfer' Parkinson's treatment material applied for clinical trial in September [Google translation] (News1 Korea) - "ABL Bio plans to apply for an IND for clinical trial approval (IND) for 'ABL301', a dual antibody candidate for the treatment of degenerative brain diseases such as Parkinson's disease in September."

IND • CNS Disorders • Parkinson's Disease

ABL Bio, Sanofi's 'ABL301' technology transfer contract to receive 90 billion won [Google translation] (Pharm News) - "ABL Bio will receive a down payment under the contract for technology transfer and joint development of 'ABL301'. According to the announcement on the 28th, the company said that the ABL301 technology transfer and joint development contract signed with Sanofi came into effect after satisfying administrative procedures such as the US 'Hart-Scott-Rodino Antitrust Improvements Act' (February 26 Korean time) and receive an upfront down payment of $75,000,000 (about 90.2 billion won, about 99.6% of the equity capital of about 99.6 billion won at the end of 2020)."

Commercial • Licensing / partnership • CNS Disorders • Parkinson's Disease

ABL Bio Enters Global Collaboration and License Agreement with SANOFI to Advance ABL301 for the Treatment of Parkinson's Disease (PRNewswire) - "ABL Bio... today announced an exclusive collaboration and worldwide license agreement with SANOFI to develop and commercialize ABL301...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.... 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."

Licensing / partnership • CNS Disorders • Parkinson's Disease

ABL Bio's 'GrabBody-B' technology exports are visualized [Google translation] (EBN) - "ABL Bio's Parkinson's disease treatment 'ABL301' to which GrabBody-B was applied showed 13 times higher BBB permeability than a single antibody as a result of a primate test. As a result of examining the change in the drug concentration in the body compared to the bispecific antibody applied with the existing BBB platform, the half-life of the drug concentration in the blood by half also doubled."

Preclinical • CNS Disorders • Parkinson's Disease

ABL, Parkinson's disease 'BBB αSyn antibody' "Korean patent acquisition" [Google translation] (Biospectator) - "ABL Bio, a company specializing in dual antibodies, announced on the 7th that it has obtained a domestic patent for a dual antibody for the treatment of Parkinson's disease, which is applied with a dual antibody platform 'Grabody-B' with increased brain permeability...'Currently, the patent technology is being reviewed in eight regions including the United States, China and Europe,'...The company plans to apply for an Investigational New Drug (IND) for ABL301 next year."

IND • Patent • CNS Disorders • Parkinson's Disease

"에이비엘, 'ABL301' 영장류서 "BBB 투과 13배 높여" https://t.co/MIzPPTBXd8 via @바이오스펙테이터 #ADPD2021" (@bobnesbitt)

AVL Bio introduces new Grabody-B research results at JPMorgan Healthcare Conference [Google translation] (MedigateNews) - "On the 28th, ABL Bio...announced on the 28th that it was officially invited to participate in the 39th JP Morgan Healthcare Conference, which will be held for four days starting from the 11th of next month. At this event, ABL Bio plans to focus on its dual antibody platform Grabody-B, which increases the penetration rate of the Blood Brain Barrier (BBB), and ABL301, a Parkinson's disease treatment that introduced it. We plan to share the latest data from the recent monkey animal experiments with the pharmaceutical companies that requested the meeting and seek various partnerships."

Preclinical • CNS Disorders • Parkinson's Disease

[VIRTUAL] IMPROVED DELIVERY OF ABL301 INTO BRAIN PARENCHYMA OF PARKINSON’S DISEASE MOUSE BRAINS VIA GRABODY B, ABL BIO’S PROPRIETARY BBB SHUTTLE (ADPD 2021) - "ABL301 is localized into brain parenchyma, possibly to its target, aggregated α-synuclein with higher degree than M30103. Its superior serum PK comparable to mAb might have contributed to its sustained BBB penetration over time. IGF1R expression in capillary and endothelial cells in postmortem brains partially validates Grabody B’s usage as a BBB shuttle in clinical studies."

CNS Disorders • Immunology • Movement Disorders • Parkinson's Disease • IGF1R