Adagene (NASDAQ:ADAG) outlined its clinical and strategic priorities at Leerink Partners’ global healthcare conference, with Chief Strategy Officer Mickael Chane-Du focusing primarily on the company’s lead program, ADG126, and its progress in metastatic microsatellite-stable colorectal cancer (MSS CRC) and other tumor types.
ADG126 positioning and differentiation
Chane-Du described ADG126 as a “next generation masked conditional CTLA-4 antagonist” and said the program is differentiated on three fronts. First, he said Adagene’s CTLA-4 antibody binds a different epitope than ipilimumab, which he said results in “significantly stronger” antibody-dependent cellular cytotoxicity and phagocytosis (ADCC/ADCP), claiming the company believes it is “10x higher compared to Ipi.”
Third, he emphasized tolerability in the clinic. In combination with full-dose pembrolizumab, he said the company has not seen grade 4 or grade 5 treatment-related adverse events and that grade 3 events have been “under control,” adding that discontinuations due to treatment-related adverse events have been “less than 10%.”
MSS CRC data: response rates and upcoming update
Discussing late-line MSS CRC (with or without liver metastasis), Chane-Du noted that PD-1 inhibitors do not have a label in MSS CRC and called the disease an “extremely cold tumor.” He cited a randomized Phase 2 study of nivolumab plus ipilimumab in late-line MSS CRC without liver metastasis with an objective response rate (ORR) of 2.5%.
By contrast, he said ADG126 plus pembrolizumab has shown confirmed response rates “between 15% and 29%,” referencing data presented at ASCO 2025. Unconfirmed response rates were described as 17% to 29%. He attributed the range to a dose-dependent response pattern, stating that higher doses have been associated with higher response rates.
Chane-Du said Adagene plans to provide an update on the doublet data “in the coming weeks.” He also said investors should focus on durability metrics, explaining that follow-up for higher-dose cohorts was earlier at ASCO 2025, limiting conclusions on duration of response, progression-free survival (PFS), and overall survival (OS). The forthcoming update, he said, will allow better assessment of durability at higher doses.
Dose regimens and durability focus
Chane-Du reviewed patient counts across dose cohorts presented at ASCO 2025 and what will change in the next update:
- Lower-dose cohorts: 41 efficacy-evaluable patients across 10 mg/kg dosed every 6 weeks (Q6W) and every 3 weeks (Q3W).
- Higher-dose cohorts: 21 patients across two higher-dose regimens, including a “loading dose” approach (20 mg/kg followed by 10 mg/kg Q3W), with 14 patients in that regimen.
- Expansion cohort: Seven efficacy-evaluable patients at 20 mg/kg Q6W.
He said the upcoming dataset will add five more patients to the 20 mg/kg Q6W regimen, taking the higher-dose total from 21 to 26 patients, alongside more follow-up across regimens.
On durability, he highlighted that in the combined 10 mg/kg dataset (Q3W and Q6W), Adagene had reported a “median of 19–20 months,” with median follow-up close to 18 months, and said the company will provide longer follow-up to evaluate longer-term survival. He also cited a 12-month OS rate comparison, saying fruquintinib’s 12-month OS rate in a similar setting was around 45%–50%, while ADG126 plus pembrolizumab at the lower dose showed 70%. He said the company will share 12-month OS rates for the 20 mg/kg cohorts as well.
Adagene is also running a Phase 2 optimization effort testing 10 mg/kg and 20 mg/kg with what he described as an induction/maintenance approach. For some patients on 20 mg/kg Q6W, he said investigators are encouraged to keep responsive patients at 20 mg/kg Q6W or consider switching to 15 mg/kg Q6W. He said the intent is not concern about safety, but further improvement and balancing efficacy and tolerability over longer treatment durations.
Triplet strategy with fruquintinib and broader combinations
In discussing competitive context, Chane-Du referenced published data for zanzalintinib plus atezolizumab, stating he believed the regimen showed an ORR around 5% in an intent-to-treat population and potentially 8%–9% in patients without liver metastasis, though he cautioned that assumption may not be correct. He contrasted that with Adagene’s higher-dose confirmed ORR near 30% at ASCO 2025 and said tolerability and maintaining patients on therapy are important for durability outcomes.
Adagene is also evaluating a triplet regimen adding fruquintinib to pembrolizumab and ADG126. Chane-Du said fruquintinib was chosen because it is part of the standard of care in late-line MSS CRC and because the company believes combining PD-1, CTLA-4, and VEGF inhibition is relevant. He said data could emerge around mid-year and “as early as AACR 2026,” with an emphasis on demonstrating a safe regimen at full-dose pembrolizumab and a starting full dose of fruquintinib, alongside early efficacy trends. He also said the company expects to share that ADG126 can be combined safely with other regimens, including PD-1 plus bevacizumab.
Other indications and partnerships
Beyond CRC, Chane-Du discussed a Roche collaboration in hepatocellular carcinoma (HCC), describing it as a randomized dataset evaluating ADG126 combined with atezolizumab and bevacizumab versus a control arm of atezolizumab and bevacizumab. He said the dataset has median follow-up of more than 20 months and that Adagene plans to present the results at a medical meeting, including response rate, duration of response, PFS, and OS. He characterized the ADG126 dose as higher than ipilimumab but lower than doses used in Adagene’s MSS CRC program, and argued that continuous CTLA-4 dosing until progression could be important for Treg depletion.
On business development, Chane-Du highlighted an equity investment from Sanofi announced in July of the prior year, including a commitment of up to $25 million and a first tranche of $17 million at $2 per share. He said the relationship began in 2022 as a discovery collaboration around SAFEbody, later expanded with advancement of a third masked antibody and a plan to initiate a Phase 1/2 trial evaluating ADG126 with Sanofi’s bispecific PD-1/IL-15 program. He said the trial is expected to enroll more than 100 solid tumor patients and “should start soon.” He also noted ongoing collaboration with Exelixis using SAFEbody capabilities and a licensing deal with Third Arc Bio focused on T-cell engagers.
Finally, he briefly discussed preclinical masked T-cell engager programs, including an ADG211 CD3 compound and a CD20 CD3 program, stating that preclinical data in non-human primates suggested reduced cytokine release syndrome incidence. He said advancing these programs would preferably be done with a partner given the company’s balance sheet.
About Adagene (NASDAQ:ADAG)
Adagene Inc, headquartered in Suzhou, China, is a clinical-stage biopharmaceutical company specializing in the discovery and development of antibody-based therapeutics for cancer and immune-related diseases. Founded in 2017, the company leverages its proprietary immunome technology platform to mine human antibody repertoires and engineer novel monospecific and bispecific antibodies. Adagene’s pipeline includes multiple candidates in preclinical and early clinical development, with a focus on targeting tumor microenvironments and modulating immune checkpoints to enhance anti-tumor efficacy.
At the core of Adagene’s research and development efforts is its Bihanc™ antibody platform, which combines combinatorial phage display, structure-based design and artificial intelligence to optimize binding affinity, specificity and developability.
