Lee Sang-hoon, CEO of ABL Bio, said, "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," he stated on the 28th.
On the same day, during an online corporate meeting, he noted, "I recently received a notice from Sanofi that the procedure to transfer the ABL301 clinical sponsorship from ABL Bio to Sanofi is currently underway."
ABL Bio previously exported the dual antibody candidate ABL301 for the treatment of Parkinson's disease and other degenerative brain diseases to Sanofi for $1.06 billion (1.46 trillion won) in January 2022. The total milestones the company has received from Sanofi to date amount to $125 million (170 billion won). The company will receive additional milestones from Sanofi upon entering Phase 2.
ABL301 delivers antibodies into the brain to suppress the accumulation of alpha-synuclein protein, the cause of Parkinson's disease. While oxygen and nutrients travel from the blood vessels to the brain, larger substances are blocked by the blood-brain barrier. ABL Bio explained that it uses the blood-brain barrier penetration technology 'GrabBody-B' to deliver antibodies to the brain.
The company tested whether it is possible to deliver drugs to insulin-like growth factor 1 receptor (IGF1R), which aids in the growth of nerve cells, during this Phase 1 clinical trial conducted with Sanofi, marking a world first. The clinical trial is currently in the final stages, and the company stated that it has confirmed both the drug delivery capability and safety. The final report of Phase 1 (CSR) is expected to be released in the third quarter of this year.
The GrabBody-B technology was also exported to British GlaxoSmithKline (GSK) in April this year for 4.1 trillion won following Sanofi. There is potential for additional exports depending on the results of Phase 1 for ABL301.
ABL Bio also disclosed the results of the Phase 1b trial for the dual antibody candidate 'ABL111,' currently under development as a stomach cancer treatment. ABL111 targets the surface protein claudin 18.2 (CLDN18.2) of cancer cells and 4-1BB, which activates immune cells, simultaneously through the dual antibody technology 'GrabBody-T.' In other words, it captures cancer cells with one arm while awakening immune cells to attack the cancer cells with the other arm.
The company reported that the overall response rate (ORR) for patients whose tumor size significantly reduced in the ABL111 Phase 1b trial was 70.6%, and the disease control rate (DCR) for patients whose conditions were well controlled without further progression was 100%. Lee commented, "There is a high likelihood that it will show more efficacy in patients than 'Zolbetuximab,' a stomach cancer treatment by Japan's Astellas."
He said that ABL111 showed good results not only in monotherapy but also in a triple combination therapy when used together with the immune oncology drug (Opdivo) by Bristol-Myers Squibb (BMS) and chemotherapy. He further noted, "In the results of the combination treatment of ABL111 and Opdivo, there were fewer side effects and the efficacy improved," adding that "Some patients treated with ABL111 showed sustained treatment effects for more than 11 months."