All 31 first-line DLBCL patients achieve 100% ORR and CR across all dose groups; ABL Bio and LigaChem Biosciences-developed ADC candidate moves to dose optimization; 10 Grabody-based clinical programs advance globally
Systimmune Pharmaceuticals, a partner of ABL Bio, has confirmed a 100% complete remission rate in a Phase 1b combination trial of its antibody-drug conjugate candidate CS5001, also known internally at ABL Bio as ABL202.
ABL Bio said Friday that Systimmune disclosed the data through a semiannual business report, covering a Phase 1b trial combining CS5001 with the standard R-CHOP regimen in patients with first-line diffuse large B-cell lymphoma, or DLBCL.
CS5001 is an ADC drug candidate co-developed using ABL Bio's ROR1 monoclonal antibody and LigaChem Biosciences' linker and payload technology, and subsequently licensed to Systimmune.
The trial enrolled 31 first-line DLBCL patients and administered CS5001 at doses ranging from 40 to 90 micrograms per kilogram. Across all dose groups in that range, both the complete remission rate — meaning cancer cells were fully eliminated — and the objective response rate reached 100 percent.
Because complete remission was observed even at the lowest dose of 40 micrograms per kilogram, Systimmune has temporarily paused the ongoing trial to begin a dose-optimization process, aiming to evaluate long-term efficacy and safety and to determine the optimal dose and dosing interval based on accumulated data.
The results demonstrate the anticancer potency of a ROR1-targeting ADC designed by a Korean biotech in the first-line blood cancer treatment market, where unmet medical need remains high. Analysts expect the drug's prospects for subsequent clinical development and global commercialization to strengthen once dose optimization is complete.
"We have confirmed highly encouraging data with 100% CR and ORR across all dose groups, and we expect Systimmune to optimize the dose and schedule and advance subsequent development swiftly," ABL Bio Chief Executive Lee Sang-hoon said. "We hope CS5001 will establish itself as a new treatment option that addresses patients' unmet needs."
ABL Bio is advancing 10 global clinical programs built on its proprietary bispecific antibody platform, Grabody, among others. Programs on track include ABL301, for which Sanofi will lead follow-on trials; ABL001, a biliary tract cancer treatment that has received FDA fast track designation; and ABL111, a gastric cancer treatment currently in a Phase 2 trial. Alongside this, the company continues preclinical research into bispecific ADCs and dual-payload ADCs.
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